Amnesteem Isotretinoin Capsules 40 mg
Mylan is recalling Amnesteem Isotretinoin 40 mg capsules (NDC 0378-6614-93) due to failed dissolution specifications.
Do not use this medication without consulting your healthcare provider or pharmacist. Contact your pharmacy or doctor immediately if you have this product to determine whether you should continue taking it or switch to an alternative medication. Return the product to your pharmacy.
Recall at a glance
- Quantity recalled
- 34850 blister packs
Why it was recalled
Mylan Pharmaceuticals is recalling Amnesteem (Isotretinoin) Capsules, USP 40 mg, packaged in 3 x 10-Count Prescription Packs (NDC 0378-6614-93) due to failed dissolution specifications. The affected product was manufactured in France and distributed nationwide. Patients should contact their healthcare provider or pharmacist before discontinuing use.
Is mine affected?
Check the NDC or UPC and strength printed on the package. Yours is affected if it matches one below.
Amnesteem (Isotretinoin) Capsules, USP
- Strength
- 40 mg
- NDC / UPC
- NDC 0378-6614-93
Where it was sold
Distributed nationwide.
Timeline
- Firm initiated recall
- Publicly announced
- Listed on Recall Canary
- Summary updated
Official source
Other recent recalls from MYLAN PHARMACEUTICALS INC
Editorial summary by Recall Canary · summary updated 2026-04-27 · primary source: U.S. Food and Drug Administration · severity reflects the agency's published classification