Low risk — use of or exposure to this product is not likely to cause adverse health consequences.
Isotretinoin Capsules Recalled by Amneal Pharmaceuticals, Inc. Due to Failed Impurities/Degradation Specifications: Tretinoin levels slightly above specification...
What You Should Do
Stop using this product immediately. Do not consume, use, or distribute it.
Return the product to the place of purchase for a full refund. If you have questions, contact Amneal Pharmaceuticals, Inc. directly.
Affected Products
Isotretinoin Capsules, USP 10 mg. Rx Only, 3 Prescription Blister Packs of 10- Capsules Each (30 Capsules)-. Distributed by: Amneal Pharmaceuticals LLC, Bridgewater, NJ 08807. NDC 69238-1174-3
Quantity: 2460 cartons/3 blister cards/10 capsules each
Why Was This Recalled?
Failed Impurities/Degradation Specifications: Tretinoin levels slightly above specification limits.
Where Was This Sold?
Recalled product was distributed to retailers and wholesalers who may have further distribute the product.
About Amneal Pharmaceuticals, Inc.
Amneal Pharmaceuticals, Inc. has 10 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Drug). Last updated March 26, 2026. View original report