Ascend Laboratories, LLC recalls Atorvastatin Calcium Tablets USP, 80 mg, Rx Only, a). 90-count(NDC 67877-514-90), b). 500-count(NDC 67877-514-05), Manu…

Recall date

September 19, 2025

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

D-0020-2026

FDA classification

Class II

Brand / firm

Ascend Laboratories, LLC

Sold / distributed

U.S. Nationwide

Why it was recalled

Failed Dissolution Specifications

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

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