Atorvastatin Calcium Tablets USP 40 mg, 1000-count bottle, Rx Only, Manufactured for…

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

Recalling firm

Biocon Pharma INC

NDC code

70377-079-13

Origin

NJ, United States

Initiated by

Voluntary: Firm initiated

FDA recall number

D-0306-2025

Other Atorvastatin recalls

See all

Class II · Moderate risk Ongoing Sep 19, 2025

Atorvastatin Calcium Tablets USP, 80 mg, Rx Only, a). 90-count(NDC 67877-514-90), b). 500-count(NDC 67877-514-05), Manufactured…

Reason Failed Dissolution Specifications

Ascend Laboratories, LLC NDC 67877-514-90 D-0020-2026

Class II · Moderate risk Ongoing Sep 19, 2025

Atorvastatin Calcium Tablets USP, 20 mg, Rx Only, a). 90-count(NDC 67877-512-90), b). 500-count (NDC 67877-512-05), c)…

Reason Failed Dissolution Specifications

Ascend Laboratories, LLC NDC 67877-512-90 D-0019-2026

Class II · Moderate risk Ongoing Sep 19, 2025

Atorvastatin Calcium Tablets USP, 40 mg, Rx Only, a). 90-count (NDC 67877-513-90), b). 500-count (NDC 67877-513-05), c)…

Reason Failed Dissolution Specifications

Ascend Laboratories, LLC NDC 67877-513-90 D-0018-2026

Class II · Moderate risk Ongoing Sep 19, 2025

Atorvastatin Calcium Tablets USP, 10 mg, Rx Only a) 90-count bottle (NDC 67877-511-90), b). 500-count bottle (NDC 67877-511-05)…

Reason Failed Dissolution Specifications

Ascend Laboratories, LLC NDC 67877-511-90 D-0017-2026

Class II · Moderate risk Terminated Sep 24, 2024

Atorvastatin Calcium Tablets, USP, 40mg, Rx only, 1000 Tablets per bottle, Manufactured for: Nivagen Pharmaceuticals, Inc…

Reason Presence of Foreign Tablets/Capsules: A Carbamazepine Extended-Release 400 mg tablet was found in a 1000-count bottle of Atorvastatin Calcium…

Nivagen Pharmaceuticals Inc D-0001-2025