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Recall Enforment Report D-0017-2026

Recall Details

Multi event Drug Recall Enforcement Report Class II voluntary initiated by Ascend Laboratories, LLC, originally initiated on 09-19-2025 for the product 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. The product was recalled due to failed dissolution specifications. The product was distributed nationwide and the recall is currently ongoing.

Recall Enforcement Reports

Recall Number Recall Initiation Date Report Date Recall Classification Quantity Product Description Recall Reason Status
D-0017-202609-19-202510-22-2025Class II141,984 bottlesAtorvastatin 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.Failed Dissolution SpecificationsOngoing
D-0018-202609-19-202510-22-2025Class IIAtorvastatin 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.Failed Dissolution SpecificationsOngoing
D-0020-202609-19-202510-22-2025Class IIAtorvastatin 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 07054Failed Dissolution SpecificationsOngoing
D-0019-202609-19-202510-22-2025Class IIAtorvastatin 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.Failed Dissolution SpecificationsOngoing

Recalled Products

NDC Proprietary Name Non-Proprietary Name Dosage Form Route Name Company Name Product Type
67877-511Atorvastatin Calcium Atorvastatin CalciumTablet, Film CoatedOralAscend Laboratories, LlcHuman Prescription Drug
67877-512Atorvastatin Calcium Atorvastatin CalciumTablet, Film CoatedOralAscend Laboratories, LlcHuman Prescription Drug
67877-513Atorvastatin Calcium Atorvastatin CalciumTablet, Film CoatedOralAscend Laboratories, LlcHuman Prescription Drug
67877-514Atorvastatin Calcium Atorvastatin CalciumTablet, Film CoatedOralAscend Laboratories, LlcHuman Prescription Drug