Claravis (isotretinoin capsule, USP), 10 mg, Packaged as a) 100-count carton, NDC 0555-1054-56, with 10x10 blister packs NDC 0555-1054-60; b) 30-count carton, NDC 0555-1054-86, with 3X10 blister pack NDC 0555-1054-60; Rx only, Teva Pharmaceuticals USA, Inc., North Wales, PA 19454.
Class II · Ongoing
Failed Impurities/Degradation Specifications: Out of specification for specific impurity Tretinoin
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Affected lots / codes — check yours against thisLots#: 100067507, 100067508, Exp 07/31/2026
- Recalling firm
- Teva Pharmaceuticals USA, Inc, Parsippany, NJ
- Classification
- Class II (temporary or reversible harm possible)
- Status
- Ongoing
- Quantity
- 5,101 cartons
- Distribution
- Nationwide in the USA, Puerto Rico and Virgin Islands
- Recall initiated
- April 6, 2026
- Classified
- May 6, 2026
- Initiation
- Voluntary: Firm initiated
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Official source. This record is published by the U.S. FDA through the openFDA
enforcement database. View the unmodified government record:
https://api.fda.gov/drug/enforcement.json?search=recall_number%3A%22D-0521-2026%22
https://api.fda.gov/drug/enforcement.json?search=recall_number%3A%22D-0521-2026%22
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Important. Recalls target specific lots and codes — compare the affected lots
above against your own product. This page reproduces public FDA data for readability;
EveryRecall is independent and not affiliated with the FDA.
Check this brand across all 8 databases →