FDA recall D-0019-2026

Ascend Laboratories, LLC · Class II · drug

Product

Atorvastatin Calcium Tablets USP, 20 mg, Rx Only, a). 90-count(NDC 67877-512-90), b). 500-count (NDC 67877-512-05), c). 1000-count(NDC 67877-512-10),Manufactured by: Alkem Laboratories, Ltd. India, Distributed by: Ascend Laboratories, LLC, Parsippany, NJ 07054.

Reason for recall

Failed Dissolution Specifications

Distribution

U.S. Nationwide

Key facts

Status: Ongoing
Initiation date: 2025-09-19
Report date: 2025-10-22
Voluntary/Mandated: Voluntary: Firm initiated
Location: Bedminster, NJ, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0019-2026