Class II · Moderate risk Ongoing
Claravis
Reason Failed Impurities/Degradation Specifications: Out of specification for specific impurity Tretinoin
Isotretinoin Capsules
Class II — Moderate risk. May cause temporary or reversible harm; serious harm unlikely.
Why it was recalled
Superpotent and Subpotent
What was recalled
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
- NDC code
- 0591-2436-15
- Origin
- NJ, United States
- Initiated by
- Voluntary: Firm initiated
- FDA recall number
- D-0446-2026
What should you do? A recall doesn't always mean your specific bottle is affected - it often applies to certain lots only. Check the lot number on your package against the FDA notice, and talk to your pharmacist before stopping any medication.
Other Isotretinoin recalls
See all
Class II · Moderate risk Ongoing
Amnesteem
Reason Failed Dissolution Specifications
Class II · Moderate risk Ongoing
Isotretinoin Capsules
Reason Superpotent and Subpotent
Class II · Moderate risk Ongoing
Isotretinoin Capsules
Reason Superpotent Drug: The 3-month stability result for assay was found to be above specification limit
Class II · Moderate risk Terminated
Myorisan
Reason Unit Dose Mispackaging: Customer complaint that a carton labeled as Myorisan 20 mg Capsules, USP erroneously contained one 10-count blister card of the 40 mg product in addition to two 10-count blister cards of the 20 mg product.
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