Updated August 11, 2026

Adderall ER Recall: Your "Extended-Release" Capsules May Be Instant-Release (Lannett)

Evan Brown
Written by Evan Brown
Prescription Savings Researcher
Dr Megan Harris Medically Reviewed by Dr. Megan Harris, MD
Editorial Review: This guide is built directly from the FDA's enforcement report on this recall and Lannett Company's consignee notice. We give you the exact lot number, NDC, and expiration date so you can check your own bottle in under a minute, rather than a general recall summary.
Quick Answer

Lannett Company recalled one lot of its generic Adderall XR, 5 mg, 100-count bottles, because the capsules contain only immediate-release pellets despite being labeled extended-release. The affected lot is 25285401A, expiring April 2027, under NDC 0527-0790-37. The FDA classified this as a Class II recall — it can cause temporary or reversible health effects, but it is not the more serious Class I category.

Only 1,392 bottles are affected. This is not a recall of all Adderall XR, all generic Adderall XR, or even all Lannett Adderall XR — just this single lot. If your bottle's lot number matches, call your pharmacy today to arrange a replacement. If it doesn't match, your medication is not part of this recall.

Class II

FDA recall classification —
not Class I

1,392

Bottles affected,
one lot only

5 mg

Only strength affected,
100-count bottles

Key Takeaways

  • Only one lot is affected: 25285401A, Lannett's generic Adderall XR 5 mg, 100-count bottles, NDC 0527-0790-37, expiring April 2027.
  • The FDA classified this as a Class II recall, meaning temporary or reversible harm is possible, not the more severe Class I category reserved for a reasonable chance of serious injury or death.
  • The defect means capsules meant to release medication over 10–12 hours instead act like immediate-release amphetamine, wearing off in roughly 4–6 hours.
  • Brand-name Adderall XR, Mydayis, and generic Adderall XR from other manufacturers are not affected by this recall.
  • The ongoing national stimulant shortage means a replacement fill may take a little longer than usual — plan ahead rather than assuming instant availability at your pharmacy.

If you or your child takes generic Adderall XR and just heard the word "recall," here's what you actually need to know before you do anything else: this is not a recall of the drug Adderall XR in general. It's a recall of one specific lot, from one manufacturer, in one strength and bottle size. The problem is serious for the people affected — capsules labeled to last half a day that actually wear off in a few hours — but the scope is small and specific, and checking whether it applies to you takes about 30 seconds.

Most coverage of FDA recalls reads like a copy-pasted government notice: drug name, lot number, "consult your doctor," done. We're doing this differently. Below, you'll find the exact lot number to check against your own bottle, a plain-English explanation of what actually happens in your body when an extended-release capsule turns out to be immediate-release, and a clear plan for what to do whether or not your bottle matches — including how this recall fits into the stimulant shortage that's made switching medications harder than it used to be.

Check Your Bottle in 30 Seconds

Grab your prescription bottle and compare it against these four details. If all four match, you have an affected bottle.

Recalled Product Details

All four must match for your bottle to be part of this recall

Lot Number
25285401A
NDC Number
0527-0790-37
Strength
5 mg
Expiration
04/2027

The lot number is printed on the bottle label, usually near the expiration date, and often abbreviated "LOT" or "L." The NDC number is the 10 or 11-digit code also on the label, sometimes broken up with dashes. The medication itself is labeled as dextroamphetamine saccharate, amphetamine aspartate monohydrate, dextroamphetamine sulfate, and amphetamine sulfate extended-release capsules, distributed by Lannett Company, Inc., in 100-count bottles.

If your bottle doesn't match this lot number, it is not part of this recall — even if it's the same drug, strength, and manufacturer. Other lots of Lannett's 5 mg Adderall XR, and all other strengths, are not affected. Don't stop a working medication over a recall that doesn't apply to your specific bottle.

What Actually Happened

Lannett Company initiated this recall after discovering that bottles labeled as extended-release amphetamine mixed salts capsules, 5 mg, actually contained capsules filled only with immediate-release pellets. In extended-release stimulant capsules, the inside of the capsule normally contains a mix of pellets: some coated to dissolve right away, others coated to dissolve gradually over several hours, which is what gives ER products their long, steady coverage. When a batch ends up filled entirely with the immediate-release type of pellet, the capsule looks identical from the outside but behaves completely differently once swallowed.

Lannett notified pharmacies and distributors directly by letter rather than issuing a public press release, which is standard for a recall of this size and classification. That's also why you may not have heard about it through typical news channels — the notification process for a narrow, single-lot recall like this one runs through the supply chain rather than the evening news.

What an ER-Labeled, IR-Filled Capsule Actually Does to Your Day

This is the part that actually matters for how you feel, not just the regulatory description. Extended-release amphetamine capsules are designed to release medication gradually so that a single morning dose covers roughly 10 to 12 hours. Immediate-release capsules release everything at once and typically last 4 to 6 hours before wearing off.

If your capsule was mislabeled, taking it at 8 a.m. expecting all-day coverage would actually give you a dose that behaves like an immediate-release tablet — a quicker onset, followed by symptoms returning by early afternoon instead of staying controlled into the evening. For some patients that shows up as a return of inattention or restlessness at work or school. For others, it can show up as an unexpectedly sharp comedown, sometimes described as feeling irritable, foggy, or fatigued once the medication's effect drops off faster than expected.

Why this matters for you: If you've had an unusually rough afternoon lately — energy crashing hours earlier than normal, or ADHD symptoms coming back well before your next dose was due — and you take generic Adderall XR, it's worth checking your lot number today rather than assuming it's just a bad day.

Class I vs. Class II vs. Class III: What This Recall Actually Is

FDA recall classifications get thrown around loosely in a lot of recall coverage, so here's what each one actually means and where this recall lands.

FDA drug recall classifications
Class What It Means This Recall?
Class I Reasonable probability of serious adverse health consequences or death No
Class II May cause temporary or medically reversible health consequences, or remote probability of serious harm Yes — this is the classification issued
Class III Unlikely to cause any adverse health consequence No

In plain terms: the FDA is treating this as a real problem worth pulling the product for, but not one expected to cause lasting harm for most patients. That distinction matters if you're trying to gauge how urgently to act — urgently enough to check today, but not a reason to panic if you took an affected dose a few days ago.

Lannett's Recent ADHD Medication Recall History

This isn't Lannett's first labeling-related recall in this drug category. Seeing the pattern helps put this specific recall in context.

Recent Lannett ADHD medication recalls
Date Initiated Product Issue FDA Class
October 2024 Lisdexamfetamine dimesylate 10 mg Failed content uniformity specifications Class II
August 2025 Lisdexamfetamine dimesylate 40 mg Bottles labeled 40 mg actually contained 30 mg capsules Class II
August 2025 Amphetamine mixed salts tablets, 10 mg Bottle strength mislabeling; distributed in Ohio only Class II
June 2026 Amphetamine mixed salts extended-release capsules, 5 mg (this recall) ER-labeled capsules contained only IR pellets Class II

None of these have been Class I recalls, and each affected a specific lot or strength rather than Lannett's entire ADHD product line. If you take a Lannett-manufactured stimulant regularly, it's a reasonable habit to glance at the lot number each time you pick up a refill, simply because this manufacturer has had more than one labeling-related recall in this category over the past two years.

What to Do If You Already Took a Mislabeled Dose

1

Don't panic, but don't drive if you feel off

If you notice your focus or alertness dropping earlier than usual, treat it the way you would any day your medication didn't work as expected — avoid driving or operating machinery if you feel impaired, foggy, or unusually fatigued.

2

Do not take an extra dose to compensate

If symptoms return in the afternoon, resist the urge to take another capsule on top of what you already took. Taking additional stimulant medication outside your prescribed schedule can cause its own problems, including sleep disruption and appetite suppression.

3

Note which bottle and approximately how many doses you took from it

Your pharmacist or prescriber may ask how many capsules from the affected lot you actually took, which helps them assess whether any follow-up is needed.

4

Report it if your reaction was significant

If you experienced a notable adverse reaction, report it to the FDA's MedWatch program and to Lannett Company directly. This helps the FDA track the real-world impact of the mislabeling beyond the lab-confirmed defect.

Decision Tree: What Should You Do Right Now?

Does your bottle's lot number match 25285401A?

Check the label next to the expiration date first

Lot Matches

Stop using this bottle

Call your pharmacy today to arrange a replacement

Don't have a replacement lined up yet?

Ask your prescriber about a short-term bridge plan while you wait for stock

Lot Doesn't Match

Your medication is not part of this recall

Continue your regimen as prescribed

Still noticing coverage issues?

That may be a separate dosing or shortage-related issue — talk to your prescriber

Either way

Keep the bottle and label until the issue is fully resolved, in case your pharmacy or prescriber needs to reference it

Step-by-Step: How to Respond to This Recall

1

Check your lot number against 25285401A

Do this before anything else. It takes less time than reading the rest of this article.

2

Call your dispensing pharmacy if it matches

Ask specifically for a replacement from an unaffected lot. Pharmacies that filled this lot should already have been notified, so you may not be the first patient to call about it.

3

Keep taking your medication as prescribed while you sort out the replacement

Don't stop a stimulant regimen abruptly on your own. If you're waiting on a replacement fill, talk to your prescriber about how to bridge the gap safely.

4

Ask whether your insurance requires anything extra for a recall-driven replacement

Most insurers and pharmacies process recall replacements without a new copay or prior authorization, but it's worth confirming, especially if your plan requires prior authorization for stimulants in general — see our Express Scripts prior authorization guide and Aetna prior authorization guide for what that process typically looks like.

5

If your pharmacy is out of replacement stock, check nearby options before waiting

Given the ongoing national stimulant shortage, some pharmacies may not have immediate replacement inventory. Our Adderall shortage guide covers current availability patterns and what to do when your usual pharmacy comes up empty.

Eligibility Comparison: Cost Help If You Need to Switch

If this recall pushes you toward a different manufacturer, strength, or pharmacy, it's worth knowing your cost options upfront. Because Adderall XR and its generics are decades-old and heavily genericized, there's no manufacturer income-based patient assistance program the way there is for many newer, expensive brand-name drugs — cost help here comes from discount cards, 340B clinics, and insurance coverage rules instead.

Eligibility rules across cost-saving options
Option Insurance Required? Income-Based? Best For
GoodRx / SingleCare / Inside Rx discount cards No — cannot combine with insurance No Uninsured or cash-paying patients switching pharmacies
State Medicaid Medicaid enrollment required Yes Medicaid enrollees needing a formulary-covered alternative
340B community health centers No insurance required Yes Patients receiving care at a qualifying clinic
Commercial insurance formulary switch Commercial insurance required No Insured patients whose plan covers an alternative manufacturer
Manufacturer patient assistance (Adderall XR generics) N/A Not applicable — no program exists No one — stimulant generics generally aren't PAP-eligible

Our GoodRx vs. Inside Rx comparison can help you find the lowest verified cash price at a nearby pharmacy if you end up needing to fill at a new location.

Income Limit Comparison for Assistance Options

Because there's no manufacturer PAP for this drug category, income-based help comes primarily through Medicaid and safety-net clinics rather than a drugmaker's program. Here's how those compare using the 2026 Federal Poverty Level of $33,000 for a family of four in the 48 contiguous states.

2026 income thresholds by program (family of four, 48 contiguous states)
Program Income Threshold Approx. Annual Income (Family of 4)
Medicaid (varies by state) Often 138%–200% FPL for adults ~$45,540–$66,000
340B sliding-scale clinics Clinic-specific, often up to 200% FPL for the deepest discount Up to ~$66,000
Discount cards (GoodRx, SingleCare, Inside Rx) Not income-based Available to anyone regardless of income

If you're on Medicare, check our Medicare Part D guide and Extra Help (LIS) guide to see how a pharmacy or manufacturer switch could affect your plan's formulary tier for stimulant medications.

Covered Medications: Brand, Generic, and Alternatives

Where each option stands if you need to switch after this recall
Medication Affected by This Recall? Typical Coverage
Lannett generic Adderall XR, 5 mg, Lot 25285401A Yes — this recall Should not be dispensed until replaced
Lannett generic Adderall XR, other lots and strengths No Unaffected; normal insurance and cash pricing rules apply
Generic Adderall XR from other manufacturers No Unaffected; may require a new prescription if switching manufacturers
Brand Adderall XR No Unaffected; typically higher cash price than generic
Mydayis (amphetamine extended-release) No Unaffected; separate formulation, may need new prior authorization

Application Process for Each Assistance Option

How to access each cost-saving or replacement option
Option How to Apply
Recall replacement from your pharmacy Call your pharmacy directly; no application needed, just your existing prescription
GoodRx / SingleCare / Inside Rx Free sign-up online or via app; present the coupon or card at the pharmacy counter
Medicaid Apply through your state Medicaid agency or Healthcare.gov if not yet enrolled
340B community health center Schedule an appointment at a qualifying clinic and ask about their sliding-fee scale

Never pay extra out of pocket for a recall-related replacement. A straightforward exchange of an affected bottle for an unaffected one should not cost you anything beyond what you'd normally pay for that fill. If a pharmacy tries to charge a new, higher copay for a pure lot swap, ask them to check with their claims department before you pay.

Approval and Replacement Timelines

Process Typical Timeline
Pharmacy lot replacement (in stock) Same day in most cases
Pharmacy replacement requiring reorder (shortage-affected) A few days to a couple of weeks, depending on local supply
New prescription for a different manufacturer or formulation Same day to 2 business days once your prescriber sends it
Prior authorization for an alternative stimulant 3–14 business days depending on your plan

Renewal and Ongoing Monitoring

  • Once your bottle is replaced, there's no special renewal process — your normal refill schedule continues as before.
  • If you switch manufacturers to avoid a shortage-affected product, ask your prescriber to note the preferred manufacturer on future prescriptions if your pharmacy can accommodate it.
  • Check the lot number on every refill from a manufacturer with a recent recall history, at least until you've filled a few cycles without issue.
  • Sign up for FDA MedWatch alerts if you want to be notified directly about future recalls affecting medications you take.

Pros and Cons of Your Replacement Options

Pros

  • A straightforward lot replacement from your existing pharmacy is usually free, fast, and requires no new paperwork
  • Discount cards can meaningfully lower your cost if you end up needing to fill at a different pharmacy or with a different manufacturer
  • 340B clinics and Medicaid coverage exist independent of any single manufacturer's recall history
  • Catching this early, before you've taken many doses from the affected lot, limits how much it affects your day-to-day functioning

Cons

  • The ongoing stimulant shortage can slow down a replacement fill if your pharmacy doesn't have alternate stock on hand
  • Switching manufacturers sometimes means a new prior authorization, even for the same drug and strength
  • Insurance formularies don't always let you request a specific generic manufacturer by name
  • Some patients notice subtle differences in how different generic manufacturers' extended-release formulations feel, even when the active ingredient is identical

Common Mistakes That Make This Worse

  • Assuming this recall applies to all Adderall XR, and stopping a working, unaffected medication out of caution.
  • Taking an extra dose to compensate for a "weak" capsule instead of checking the lot number first.
  • Waiting until you're completely out of medication before calling your pharmacy about a replacement.
  • Throwing away the affected bottle before your pharmacy or prescriber asks you to bring it in, if they need it for their own recall documentation.
  • Assuming a mislabeled ER-to-IR mix-up is the same issue as a shortage-driven stockout — they're different problems that sometimes require different fixes.
  • Not reporting a significant adverse reaction because it seems like a minor inconvenience rather than something worth documenting.

Real Examples: How Patients Are Handling This

Example 1 — Parent of a school-age child: A parent notices their child's teacher reporting afternoon focus problems that hadn't been an issue in months. Checking the pharmacy bottle turns up a lot number matching the recall. The pharmacy swaps the bottle same-day, and the afternoon symptoms resolve within a few days of switching back to properly functioning ER capsules.

Example 2 — Adult with a driving-heavy job: An adult patient who drives for work notices unusually early fatigue on a specific week. After checking the lot number and confirming a match, they hold off on driving until they've picked up a replacement fill, and mention the incident to their prescriber at their next visit.

Example 3 — Patient whose bottle doesn't match: A patient who saw the recall headline checks their bottle, finds a different lot number entirely, and continues their regimen as normal — a useful reminder that hearing about a recall and being affected by it are two different things.

How This Fits Into the Ongoing Adderall Shortage

This recall lands in the middle of a national stimulant shortage that has run, on and off, since October 2022. As of mid-2026, Adderall and its generics remain on the FDA's drug shortage list, with availability varying significantly by strength, manufacturer, and region. That context matters here for one practical reason: if your pharmacy needs to replace a recalled bottle and doesn't have another lot of the same strength on hand, the shortage can make that replacement take longer than it would in a normal supply environment.

If you're dealing with both this recall and a hard time finding your usual strength in stock, our Adderall shortage guide covers which strengths are hit hardest right now, how to check real-time pharmacy availability, and what to discuss with your prescriber if you need a temporary bridge plan.


Bottom Line

This is a real, FDA-confirmed recall, but a narrow one: one lot, one strength, one manufacturer, Class II severity. If your bottle's lot number is 25285401A, call your pharmacy today and get it swapped. If it isn't, your medication isn't part of this recall, and the smartest thing you can do is bookmark the lot number so you can double-check it on your next refill too.

The bigger lesson here applies beyond this single recall: extended-release stimulants depend entirely on a manufacturing process working correctly, and a labeling slip can turn a 12-hour medication into a 4-hour one without any visible difference in the pill itself. Checking your lot number against active recalls each time you refill is a small habit that costs nothing and catches exactly this kind of problem early.


How We Researched This Guide

This guide was prepared by the Refill Relay Editorial Team using the FDA's drug recall enforcement report for this lot, state board of pharmacy recall notices, and Lannett Company's history of prior ADHD medication recalls, checked directly rather than through secondhand summaries.

Every article undergoes editorial review for accuracy, readability, and consistency before publication. We specifically verified the FDA recall classification for this incident to avoid overstating its severity, since inflated recall language spreads quickly in patient communities.


References

  1. U.S. Food and Drug Administration (FDA). Drug recall enforcement report, Lannett Company, Inc., dextroamphetamine saccharate, amphetamine aspartate monohydrate, dextroamphetamine sulfate, and amphetamine sulfate extended-release capsules, 5 mg, Lot 25285401A.
  2. Lannett Company, Inc. Consignee recall notification letter.
  3. State board of pharmacy recall alert bulletins, 2026.
  4. U.S. Food and Drug Administration (FDA). MedWatch Safety Information and Adverse Event Reporting Program.
  5. U.S. Food and Drug Administration (FDA). Drug Shortages Database, amphetamine mixed salts.

About Refill Relay

Refill Relay publishes evidence-based educational resources that help patients understand prescription insurance, patient assistance programs, pharmacy benefits and medication access. Our editorial team combines payer and manufacturer policy research with practical guidance to make complex healthcare topics easier to navigate.

Editorial Standards

  • Primary-source verification directly against FDA enforcement reports
  • Editorial review before publication
  • Regular updates when recall status or manufacturer guidance changes
  • Clear distinction between educational content and medical advice

Related Resources

Frequently Asked Questions

No. The FDA classified this as a Class II recall, meaning the mislabeling could cause temporary or medically reversible health consequences, or carries only a remote probability of serious harm. Class I recalls, reserved for situations with a reasonable chance of serious injury or death, were not issued here.

Lot 25285401A, expiring April 2027. The recalled product is Lannett Company's dextroamphetamine saccharate, amphetamine aspartate monohydrate, dextroamphetamine sulfate, and amphetamine sulfate extended-release capsules, 5 mg, in 100-count bottles under NDC 0527-0790-37. Only this specific lot is affected.

Stop using the bottle and call your dispensing pharmacy right away. Do not stop taking your ADHD medication altogether without talking to your prescriber, since abruptly discontinuing a stimulant regimen has its own downsides. Your pharmacy can typically replace the affected bottle with unaffected stock or a different lot at no extra cost.

If you took a capsule from the affected lot expecting 10 to 12 hours of coverage, you likely only got 4 to 6 hours of effect instead, similar to an immediate-release dose. Watch for a return of ADHD symptoms in the afternoon, avoid driving if you feel your focus or alertness drop off earlier than expected, and contact your prescriber if you have concerns about your dosing that day.

Just this one lot. The recall covers 1,392 bottles of a single strength, 5 mg, in 100-count bottles, from a single manufacturer, Lannett Company. It does not affect other lots, other strengths, other manufacturers' generic Adderall XR, or brand-name Adderall XR.

No. This recall is limited to Lannett Company's generic extended-release amphetamine mixed salts capsules. Brand-name Adderall XR and Mydayis, along with generic versions made by other manufacturers, are not part of this recall.

The recalled quantity is small, 1,392 bottles, so it's unlikely to meaningfully worsen the broader national stimulant shortage on its own. That said, it arrives during a shortage that has already made pharmacy switches and refill timing more difficult, so give yourself extra lead time if you need a replacement fill.

Report adverse events or quality problems directly to the FDA through its MedWatch Safety Information and Adverse Event Reporting Program. You can also report the issue directly to Lannett Company. Your pharmacist or prescriber can help you file either report if you're not sure how.

In most cases, yes. Pharmacies can typically substitute an unaffected lot or an equivalent generic under your existing valid prescription, the same way they would for any other recall-driven exchange. If your pharmacy insists on a new prescription, ask your prescriber's office to send a fresh one promptly rather than going without medication.

Given the ongoing national stimulant shortage, some pharmacies may not have immediate replacement stock. Call two or three nearby pharmacies before assuming it's unavailable everywhere, and ask your prescriber about a short-term alternative strength or formulation while you wait.

No. This recall is specific to one lot from Lannett Company. Generic extended-release amphetamine mixed salts from other manufacturers, such as Teva, Sandoz, or Aurobindo, are not part of this recall unless a separate notice says otherwise.

The FDA maintains a searchable drug recall enforcement database that updates weekly, and you can sign up for FDA MedWatch email alerts to get notified directly. Many state boards of pharmacy also publish recall notices, and your pharmacy should notify you directly if a medication you've filled is recalled.

Evan Brown
Evan Brown
Prescription Savings Researcher

Evan researches prescription assistance programs, manufacturer savings cards, and drug pricing trends to help patients find accurate, current information on lowering their medication costs.

Dr. Megan Harris, MD
Dr. Megan Harris, MD
Medical Reviewer, Board-Certified Internal Medicine

Dr. Harris reviews Refill Relay's clinical and coverage content for medical accuracy, ensuring guidance around medications and insurance processes reflects current standards of care.

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