Reported Mar 11, 2026 · Ongoing
Amnesteem (Isotretinoin) Capsules, USP 40 mg, packaged in 3 x 10-Count Prescription Packs, Rx Only, Manufactured for:…
Mylan Pharmaceuticals Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: MYLAN PHARMACEUTICALS INC · 1311 Pineview Dr · Morgantown, WV · 26505-3276
Is this the product you have?
- Amnesteem (Isotretinoin) Capsules, USP 40 mg, packaged in 3 x 10-Count Prescription Packs, Rx Only
- Manufactured forMylan Pharmaceuticals Inc., Morgantown, WV, 26505 USA, Made in France, NDC 0378-6614-93
- Lot codes and dates
Lot #: 31161103116130Exp. Date 07/2026
- Amount recalled
- 34850 blister packs
Where it was sold
- Nationwide
Why it was recalled
Failed Dissolution Specifications
This product could cause temporary or reversible health problems — stop using it.
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