Recall: D-0020-2026

Class II - Potentially Harmful

Class IIClassification

2025-09-19Initiated

OngoingStatus

Ascend Laboratories, LLCFirm

Product

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

Failed Dissolution Specifications

Distribution

U.S. Nationwide

Source: FDA drug enforcement report via openFDA (Voluntary: Firm initiated). If you take this product, talk to your pharmacist or doctor before stopping it.