D-0018-2026Class II

Ascend Laboratories, LLC

Recalling firm

Product type

Drug

Status

Ongoing

Report date

2025-10-22

Distribution

U.S. Nationwide

Firm state

Initiated by

Voluntary: Firm initiated

SPEQ quality domain

Validation & Qualification

Reason for recall

Failed Dissolution Specifications

Product description

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.

Code / lot info

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

Other recalls SPEQ maps to Validation & Qualification

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See all Validation & Qualification recalls →

Data: U.S. FDA openFDA enforcement API. Recall details are as reported by the FDA. The quality-domain mapping and severity are a SPEQ editorial interpretation of the recall reason, not an official FDA classification.