Drug recall D-0020-2026
Product
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
Reason for recall
Failed Dissolution Specifications
Lots and codes
Lot#: 25140249, Exp. Dec. 2026 Lot#: 25140247, Exp. Dec. 2026 Lot#: 24144999, Exp. Nov. 2026 Lot#: 24144942, Exp. Nov. 2026 Lot#: 24144845, Exp. Nov. 2026 Lot#: 24144713, Exp. Nov. 2026 Lot#: 24144652, Exp. Oct. 2026 Lot#: 24143898, Exp. Aug. 2026 Lot#: 24143412, Exp. Aug. 2026 Lot#: 24143582, Exp. Aug. 2026
Recall details
- Recalling firm
- Ascend Laboratories, LLC, Bedminster, NJ
- Distribution
- U.S. Nationwide
- Type
- Voluntary: Firm initiated
- Recall initiated
- September 19, 2025
Related products
- Atorvastatin Calcium – drug information
- NDC 67877-513 Atorvastatin Calcium · Atorvastatin Calcium Trihydrate 40 mg/1 · Ascend Laboratories, LLC
- NDC 67877-512 Atorvastatin Calcium · Atorvastatin Calcium Trihydrate 20 mg/1 · Ascend Laboratories, LLC
- NDC 67877-511 Atorvastatin Calcium · Atorvastatin Calcium Trihydrate 10 mg/1 · Ascend Laboratories, LLC
- NDC 67877-514 Atorvastatin Calcium · Atorvastatin Calcium Trihydrate 80 mg/1 · Ascend Laboratories, LLC