Class II U.S. Food and Drug Administration

Mylan Pharmaceuticals Inc Amnesteem Capsules, USP 40 mg recall: Failed Dissolution Specifications

Recall published 8 months ago

Failed Dissolution Specifications

The hazard: Potency, impurity or stability failure

This is a specification failure: testing showed the product does not match what the label promises.

What the notice says: Failed Dissolution Specifications

Why it matters: The product failed a specification test: it may contain more or less active ingredient than the label states, carry an impurity, or degrade before its expiry date. A sub-potent dose can leave a condition untreated; a super-potent one can cause an overdose.

Symptoms and when to call a doctor

The risk depends entirely on the drug. For a medicine where dose matters closely — a blood thinner, an anti-epileptic, a thyroid or heart medicine, insulin — talk to your prescriber before changing anything. Seek urgent care if you have symptoms that suggest too much drug, or if the condition the medicine controls starts breaking through.

This page is general information, not medical advice. If you feel unwell, a clinician who can see you is the only person able to judge your case.

Recall details

Recall number
D-0399-2026
Published
March 11, 2026
Risk level
Class II
Status
Ongoing
Issued by
U.S. Food and Drug Administration
Brand
Mylan Pharmaceuticals Inc
Product type
Prescription & OTC drugs
Units affected
34850 blister packs
Distribution
Nationwide
Made in
United States
Lot / code info
Lot #: 3116110, 3116130, Exp. Date 07/2026

Products covered by this recall

Amnesteem (Isotretinoin) Capsules, USP 40 mg, packaged in 3 x 10-Count Prescription Packs, Rx Only, Manufactured for: Mylan Pharmaceuticals Inc., Morgantown, WV, 26505 USA, Made in France, NDC 0378-6614-93.

Check your product

The notice names 6 codes you can read straight off the package. Type the one printed on yours and the list below narrows to it.

Lot or batch code

Usually ink-stamped near the seam, the cap or the bottom of the pack.

  • 3116110
  • 3116130

Best-by / use-by date

Printed beside the lot code, not on the price sticker.

  • 07

NDC number

On the carton and again on the bottle or blister label.

  • 0378-6614-93

Package size

Match the net weight or the piece count on the front of the pack.

  • 40 mg
  • 10 Count

Codes are lifted verbatim from the FDA — Drug enforcement notice. A code that is missing here may still be covered — the official notice is the complete list.

What to do about Potency

Mylan Pharmaceuticals Inc — This is a specification failure: testing showed the product does not match what the label promises.

  1. Check the lot number on your pack against the codes listed above before you do anything else.
  2. Keep the carton and the leaflet — the lot number is usually printed only on the outer pack.
  3. Report any change in how the medicine is working to FDA MedWatch, which is where most of these signals originate.
  4. Do not stop a prescription on your own. For most conditions an uncertain dose is safer than no dose while you get advice.

Refunds and replacements

With medicines, a replacement supply matters more than cash, and that is what pharmacies are set up to provide.

  • Ask the dispensing pharmacy for a like-for-like replacement from an unaffected lot. This is the fastest route and usually costs nothing.
  • For a mail-order or online pharmacy, use the recall line listed on this page rather than the general support queue.
  • If the recall voided a fill you had already paid for, your insurer will normally authorise a replacement ahead of schedule. Quote the recall number.
  • If you paid out of pocket, ask for a refund of the co-pay or purchase price and keep the receipt the pharmacy issues.

Company contact: MYLAN PHARMACEUTICALS INC — 1311 Pineview Dr, Morgantown, WV, 26505-3276

The official notice

This page summarises a notice published by U.S. Food and Drug Administration. The agency notice is the authoritative version — read it before you act, and treat it as the final word if anything here looks different.

Open the FDA — Drug enforcement record U.S. Food and Drug Administration recalls

Questions people ask about this recall

Why was Mylan Pharmaceuticals Inc prescription & otc drugs recalled?

Failed Dissolution Specifications Failed Dissolution Specifications

How do I know if I have the recalled product?

Match the codes printed on your package against the notice: lot code 3116110, 3116130; best-by date 07. If the code on your package is not on that list, your unit is outside the recall.

What should I do with it right now?

Check the lot number on your pack against the codes listed above before you do anything else.

Can I get my money back?

Ask the dispensing pharmacy for a like-for-like replacement from an unaffected lot. This is the fastest route and usually costs nothing.

Where was the recalled product sold?

It was distributed nationwide.

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