United StatesAtorvastatin Calcium Tablets USP (Rx) in 10 mg (NDC 67877-511-90/05/10), 20 mg (NDC 67877-512-90/05/10), 40 mg (NDC 67877-513-90/05/10) and 80 mg (NDC 67877-514-90/05) bottle sizes (90-, 500-, 1000-count as listed) manufactured by Alkem Laboratories and distributed by Ascend Laboratories are recalled. The recall covers specific lot numbers sold nationwide by Ascend Laboratories because the products failed dissolution specifications.
What's being recalled
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.
Atorvastatin Calcium Tablets USP, 40 mg, Rx Only, a). 90-count (NDC 67877-513-90), b). 500-count (NDC 67877-513-05), c). 1000-count (NDC 67877-513-10), Manufactured by: Alkem Laboratories, Ltd. India, Distributed by: Ascend Laboratories, LLC, Parsippany, NJ 07054.
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.
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
Recalling firm: Ascend Laboratories, LLC, Bedminster, NJ, United States.
How to identify it
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 Lot#: 25140933, Exp. Feb. 2027 Lot#: 25140477, Exp. Dec. 2026 Lot#: 24144254, Exp. Oct. 2026 Lot#: 24144163, Exp. Sep. 2026 Lot#: 24143995, Exp. Sep. 2026 Lot #: 25140150, Exp. Dec. 2026 Lot #: 25140173, Exp. Dec. 2026 Lot #: 25140172, Exp. Dec. 2026 Lot #: 24144720, Exp. Nov. 2026 Lot #: 24144798, Exp. Nov. 2026 Lot #: 24144692, Exp. Oct. 2026 Lot #: 24143755, Exp. Aug. 2026 Lot #: 24143913, Exp. Aug. 2026 Lot #: 24143754, Exp. Aug. 2026 Lot #: 24143047, Exp. June 2026 Lot #: 24142936, Exp. July 2026 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
The hazard
Failed Dissolution Specifications
What to do
Don't stop taking a prescribed medicine without talking to your doctor or pharmacist first. For other products, stop using them and ask the pharmacist, seller or maker what to do.
The notice doesn't give instructions for consumers, so this is general advice for health & beauty recalls. Check the official notice for the details.
Where it was sold
U.S. Nationwide
The official notice
This page is a summary of the notice published by U.S. Food and Drug Administration (enforcement reports), collected from U.S. Food and Drug Administration (enforcement reports). Check the original before you act on it.
Read the official notice (opens in a new tab)