Class II
Ongoing
Atorvastatin Calcium Tablets USP, 10 mg, Rx Only a) 90-count bottle (NDC 67877-511-90), b). 500-count bottle (NDC 67877-511-05), c). 1000-count bottle (NDC 67877-511-10) Manufactured by: Alkem Laboratories, Ltd. India, Distributed by: Ascend Laboratories, LLC, Parsippany, NJ 07054.
This recall is currently active, issued October 22, 2025. It was issued by Ascend Laboratories, Llc.
- Company
- Ascend Laboratories, Llc
- Recall Initiated
- September 19, 2025
- Posted
- October 22, 2025
- Recall Number
- D-0017-2026
- Voluntary / Mandated
- Voluntary: Firm initiated
- Quantity
- 141,984 bottles
- Firm Location
- Bedminster, NJ, United States
- Official Source
- View on FDA website ↗
Reason for Recall
Failed Dissolution Specifications
Distribution
U.S. Nationwide
Lot / Code Info
Lot#: 25141249, Exp. Feb. 2027 Lot#: 24144938, Exp. Nov. 2026 Lot#: 24144868, Exp. Nov. 2026 Lot#: 24144867, Exp. Nov. 2026 Lot#: 24144458, Exp. Sep. 2026 Lot#: 24143994, Exp. Sep. 2026 Lot#: 24142987, Exp. July 2026 Lot#: 24143316, Exp. July 2026
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