Class IIReported 2025-10-22

Atorvastatin Calcium Tablets USP, 10 mg, Rx Only a) 90-count bottle (NDC 67877-511-90), b). 500-count bottle (NDC 67877-511-05), c). 1000-count bottle (NDC 67877-511-10) Manufactured by: Alkem Laboratories, Ltd. India, Distributed by: Ascend Laboratories, LLC, Parsippany, NJ 07054.

Recalled by Ascend Laboratories, LLC

Reason for Recall

Failed Dissolution Specifications

Recall Number

D-0017-2026

Classification

Class II

Status

Ongoing

Category

drug

Initiated

2025-09-19

Reported

2025-10-22

Distribution

U.S. Nationwide

Code Info

Lot#: 25141249, Exp. Feb. 2027 Lot#: 24144938, Exp. Nov. 2026 Lot#: 24144868, Exp. Nov. 2026 Lot#: 24144867, Exp. Nov. 2026 Lot#: 24144458, Exp. Sep. 2026 Lot#: 24143994, Exp. Sep. 2026 Lot#: 24142987, Exp. July 2026 Lot#: 24143316, Exp. July 2026

Source: openFDA enforcement report. WhichRecall is not affiliated with the FDA. See our disclaimer.