Warning
Teva Pharmaceuticals USA Recalls Isotretinoin Capsules
This is a Class II recall. This product may cause temporary health problems or pose a slight threat of a serious nature.
Source: FDA
WarningRecall #D-0446-2026Drug / Pharmaceutical
Teva Pharmaceuticals USA Recalls Isotretinoin Capsules
Teva Pharmaceuticals USA, Inc · Class II — Moderate Risk
Product Description
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).
Reason for Recall
Superpotent and Subpotent
FDA Classification
Class II — Moderate Risk
A situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
Distribution
FL, OH, PR & MS
Remedy
Consumers should stop using this product. Contact the recalling firm for further instructions regarding this product.
411 Press Analysis
Teva Pharmaceuticals USA, Inc has recalled a pharmaceutical product that the FDA classified as Class II affecting 8376 packages. The recall was initiated on January 12, 2026. Superpotent and Subpotent. It was distributed in FL, OH, PR & MS. Class II recalls involve products that might cause a temporary health problem or pose only a slight threat of a serious nature. Consumers should discontinue use and contact the firm.
Sources: FDA openFDA Enforcement Database
This recall appears in: Other Injury Hazards and Teva Pharmaceuticals USA recalls.