Atorvastatin Calcium Tablets USP, 80 mg, Rx Only, a). 90-count(NDC 67877-514-90), b). 500-count(N...
FDA Recall #D-0020-2026 — Class II — September 19, 2025
Product Description
Atorvastatin Calcium Tablets USP, 80 mg, Rx Only, a). 90-count(NDC 67877-514-90), b). 500-count(NDC 67877-514-05), Manufactured by: Alkem Laboratories, Ltd. India, Distributed by: Ascend Laboratories, LLC, Parsippany, NJ 07054
Reason for Recall
Failed Dissolution Specifications
Recalling Firm
Ascend Laboratories, LLC — Bedminster, NJ
Classification
Class II — May cause temporary or medically reversible adverse health consequences.
Product Type
Drugs
Distribution
U.S. Nationwide
Code Information
Lot#: 25140249, Exp. Dec. 2026 Lot#: 25140247, Exp. Dec. 2026 Lot#: 24144999, Exp. Nov. 2026 Lot#: 24144942, Exp. Nov. 2026 Lot#: 24144845, Exp. Nov. 2026 Lot#: 24144713, Exp. Nov. 2026 Lot#: 24144652, Exp. Oct. 2026 Lot#: 24143898, Exp. Aug. 2026 Lot#: 24143412, Exp. Aug. 2026 Lot#: 24143582, Exp. Aug. 2026
Status
Ongoing
Voluntary / Mandated
Voluntary: Firm initiated