United StatesIsotretinoin Capsules, USP 30 mg and 40 mg, 10-count prescription packs manufactured for Teva Pharmaceuticals USA (NDC 0591-2435-15/45 for 30 mg and NDC 0591-2436-15/45 for 40 mg) are affected; listed lots and expiration dates are 100055426 (Exp. 02/2026), 100071518 (04/2027), 100072450 (07/2027), 100075305 (06/2027), 100075512 (07/2027) and 100076103 (07/2027). They were recalled due to being potentially superpotent or subpotent and were distributed in FL, OH, PR and MS.
What's being recalled
Isotretinoin Capsules, USP, 30 mg, Rx Only, 10 count Prescription Pack, Manufactured for: Teva Pharmaceuticals USA, Inc., Parsippany, NJ 07054, NDC 0591-2435-15 (carton), NDC 0591-2435-45 (blister pack).
Isotretinoin Capsules, USP, 40 mg, 10 count Prescription Pacs, Rx only, Manufactured for: Teva Pharmaceuticals USA, Inc., Parsippany, NJ 07054, NDC 0591-2436-15 (carton), NDC 0591-2436-45 (blister pack).
Recalling firm: Teva Pharmaceuticals USA, Inc, Parsippany, NJ, United States.
How to identify it
Lots 100055426, Exp. date 02/2026, 100071518, Exp. date 04/2027 & 100072450, Exp. Date 07/2027 Lots 100075305 Exp date 06/2027, 100075512, Exp date 07/2027 & 100076103, Exp date 07/2027 .
The hazard
Superpotent and Subpotent
What to do
Don't stop taking a prescribed medicine without talking to your doctor or pharmacist first. For other products, stop using them and ask the pharmacist, seller or maker what to do.
The notice doesn't give instructions for consumers, so this is general advice for health & beauty recalls. Check the official notice for the details.
Where it was sold
FL, OH, PR & MS
The official notice
This page is a summary of the notice published by U.S. Food and Drug Administration (enforcement reports), collected from U.S. Food and Drug Administration (enforcement reports). Check the original before you act on it.
Read the official notice (opens in a new tab)