FDA Recall D-0521-2026

Teva Pharmaceuticals USA, Inc · Parsippany, NJ

Class II Ongoing 38 days on record

Moderate impact — Class II recall — temporary or medically reversible adverse health consequence possible; remote probability of serious adverse health consequence.

Product

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.

Lot / code: Lots#: 100067507, 100067508, Exp 07/31/2026

Quantity: 5,101 cartons

Reason for recall

Failed Impurities/Degradation Specifications: Out of specification for specific impurity Tretinoin

Recall record

Recall number: D-0521-2026
Classification: Class II
Status: Ongoing
Voluntary or mandated: Voluntary: Firm initiated
Firm notification: Letter
Distribution: Nationwide in the USA, Puerto Rico and Virgin Islands
Recall initiated: 2026-04-06
Classified by FDA Center: 2026-05-06
FDA published: 2026-04-29
Recalling firm: Teva Pharmaceuticals USA, Inc
Firm location: Parsippany, NJ

Drug identification

Brand name(s): CLARAVIS
Generic name(s): ISOTRETINOIN
Manufacturer(s): Teva Pharmaceuticals USA, Inc.
NDC(s): 0555-1054, 0555-1055, 0555-1056, 0555-1057
Route(s): ORAL

Operational response

Class II recalls indicate possible temporary or reversible health consequences. Remove affected lots from active dispensing. Segregate inventory. Check the firm’s recall notification for guidance on patient outreach.

For the official FDA enforcement record, see FDA's Recall Search.

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