Mylan Recalls Amnesteem Isotretinoin Capsules Due to Dissolution Failure
Mylan Pharmaceuticals is recalling specific lots of Amnesteem (Isotretinoin) 40 mg capsules because they failed dissolution specifications.
Use caution until it’s fixed
Failed Dissolution Specifications
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What happened, in plain English
Mylan Pharmaceuticals Inc. has recalled Amnesteem (Isotretinoin) Capsules, USP 40 mg due to failed dissolution specifications. The affected product is packaged in 3 x 10-count prescription packs and was manufactured in France for distribution nationwide within the United States. The recall covers 34,850 blister packs distributed before the recall date of February 24, 2026. Read more at govinfonow.com/recall/31473-mylan-recalls-amnesteem-isotretinoin-capsules-due-to-dissolution-failure.
Source Summary by GovInfoNow · govinfonow.com/recall/31473-mylan-recalls-amnesteem-isotretinoin-capsules-due-to-dissolution-failure · Updated October 9, 2026 · FDA enforcement record: FDA #D-0399-2026
Cite this page
“Mylan Recalls Amnesteem Isotretinoin Capsules Due to Dissolution Failure.” GovInfoNow, updated October 9, 2026. https://govinfonow.com/recall/31473-mylan-recalls-amnesteem-isotretinoin-capsules-due-to-dissolution-failure. Based on FDA recall #D-0399-2026 (https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0399-2026%22&limit=1).
Why it’s dangerous
The capsules failed dissolution specifications, meaning the drug may not release properly from the pill. This could result in the body absorbing less of the active ingredient than expected, potentially reducing the treatment's effectiveness for acne or other conditions requiring isotretinoin.
Who’s affected
Patients who have been prescribed Amnesteem (Isotretinoin) Capsules, USP 40 mg by a healthcare provider. Individuals possessing the specific lots listed in the record are at risk of receiving medication that may not dissolve as intended.
How to tell if you have this one
Check your medication bottle for the brand name Amnesteem and the strength of 40 mg. Verify if it is packaged in 3 x 10-count prescription packs with NDC 0378-6614-93. Look for Lot numbers 3116110 or 3116130 with an expiration date of 07/2026.
- Brand
Mylan Pharmaceuticals- Category
Drug
What to do — step by step
Check Your Medication
Verify if your Amnesteem capsules match the recalled lot numbers (3116110, 3116130) and expiration date (07/2026).
Contact Your Pharmacist
Inform your pharmacist or healthcare provider if you have the recalled product to discuss replacement options.
Where it went and when
Where it was distributed
Distributed nationwide.
FDA distribution: “Nationwide within the United States” States read from FDA’s own wording; “not listed” means the notice does not name it.
Distributed nationwide.
Recall timeline
FDA published this recall 15 days after the firm started it.
- Firm started the recall
- Published in FDA’s Enforcement Report
- FDA classified it Class II
Dates from the agency record only; steps without a date are left out.
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Where this comes from
The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
- Official source: FDA Recall #D-0399-2026 (February 24, 2026) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for D-0399-2026 to see it in context.
- Plain-language summary written by qwen3.6:35b-a3b on October 9, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
- GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.