Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
Isotretinoin Capsules Recalled by Teva Pharmaceuticals USA, Inc Due to Superpotent Drug: The 3-month stability result for assay...
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 Teva Pharmaceuticals USA, Inc directly.
Affected Products
Isotretinoin Capsules, USP 40mg, 30-count 3x10 blister packs per carton, Rx Only, Manufactured For: Teva Pharmaceuticals USA, Inc., Parsippany, NJ 07054. Blister Pack NDC 0591-2436-45, Carton NDC 0591-2436-15
Quantity: 5,304 3x10-cartons
Why Was This Recalled?
Superpotent Drug: The 3-month stability result for assay was found to be above specification limit
Where Was This Sold?
This product was distributed nationwide across all 50 states.
About Teva Pharmaceuticals USA, Inc
Teva Pharmaceuticals USA, Inc has 20 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Drug). Last updated March 26, 2026. View original report