FDA Recall D-0018-2026

Ascend Laboratories, LLC · Bedminster, NJ

Class II Ongoing 237 days on record

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

Product

Atorvastatin Calcium Tablets USP, 40 mg, Rx Only, a). 90-count (NDC 67877-513-90), b). 500-count (NDC 67877-513-05), c). 1000-count (NDC 67877-513-10), Manufactured by: Alkem Laboratories, Ltd. India, Distributed by: Ascend Laboratories, LLC, Parsippany, NJ 07054.

Lot / code: Lot#: 25140933, Exp. Feb. 2027 Lot#: 25140477, Exp. Dec. 2026 Lot#: 24144254, Exp. Oct. 2026 Lot#: 24144163, Exp. Sep. 2026 Lot#: 24143995, Exp. Sep. 2026

Reason for recall

Failed Dissolution Specifications

Recall record

Recall number: D-0018-2026
Classification: Class II
Status: Ongoing
Voluntary or mandated: Voluntary: Firm initiated
Firm notification: Letter
Distribution: U.S. Nationwide
Recall initiated: 2025-09-19
Classified by FDA Center: 2025-10-10
FDA published: 2025-10-22
Recalling firm: Ascend Laboratories, LLC
Firm location: Bedminster, NJ

Drug identification

Brand name(s): ATORVASTATIN CALCIUM
Generic name(s): ATORVASTATIN CALCIUM
Manufacturer(s): Ascend Laboratories, LLC
NDC(s): 67877-511, 67877-512, 67877-513, 67877-514
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.

‹ All recalls