FDA Recall D-0445-2026

Teva Pharmaceuticals USA, Inc · Parsippany, NJ

Class II Ongoing 122 days on record

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

Product

Isotretinoin Capsules, USP, 30 mg, Rx Only, 10 count Prescription Pack, Manufactured for: Teva Pharmaceuticals USA, Inc., Parsippany, NJ 07054, NDC 0591-2435-15 (carton), NDC 0591-2435-45 (blister pack).

Lot / code: Lots 100055426, Exp. date 02/2026, 100071518, Exp. date 04/2027 & 100072450, Exp. Date 07/2027

Quantity: 21984 packages

Reason for recall

Superpotent and Subpotent

Recall record

Recall number: D-0445-2026
Classification: Class II
Status: Ongoing
Voluntary or mandated: Voluntary: Firm initiated
Firm notification: Letter
Distribution: FL, OH, PR & MS
Recall initiated: 2026-01-12
Classified by FDA Center: 2026-04-08
FDA published: 2026-04-15
Recalling firm: Teva Pharmaceuticals USA, Inc
Firm location: Parsippany, NJ

Drug identification

Brand name(s): ISOTRETINOIN
Generic name(s): ISOTRETINOIN
Manufacturer(s): Actavis Pharma, Inc.
NDC(s): 0591-2433, 0591-2434, 0591-2451, 0591-2435, 0591-2501, 0591-2436
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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