Class IIReported 2025-10-22

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.

Recalled by Ascend Laboratories, LLC

Reason for Recall

Failed Dissolution Specifications

Recall Number

D-0018-2026

Classification

Class II

Status

Ongoing

Category

drug

Initiated

2025-09-19

Reported

2025-10-22

Distribution

U.S. Nationwide

Code 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

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