US Drug Recall Register
Class II · Moderate risk Ongoing Initiated Sep 19, 2025 (12 months ago)

Atorvastatin Calcium Tablets USP, 80 mg, Rx Only, a). 90-count(NDC 67877-514-90), b)…

Class II — Moderate risk. May cause temporary or reversible harm; serious harm unlikely.

Why it was recalled

Failed Dissolution Specifications

What was recalled

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

Recalling firm
Ascend Laboratories, LLC
NDC code
67877-514-90
Origin
NJ, United States
Initiated by
Voluntary: Firm initiated
FDA recall number
D-0020-2026

What should you do? A recall doesn't always mean your specific bottle is affected - it often applies to certain lots only. Check the lot number on your package against the FDA notice, and talk to your pharmacist before stopping any medication.

Other Atorvastatin recalls

See all