Atorvastatin Calcium Tablet, Film Coated
FDA Recall NDC 67877-511
FDA Enforcement Report: View Recall Date, Reasons, and Safety Status
Active & Historical Enforcement Reports
The FDA has identified 4 recorded enforcement report(s) associated with Atorvastatin Calcium (NDC 67877-511). A significant event, classified as Class II, was initiated on Sep 19, 2025 by Ascend Laboratories, Llc. The reported reason for this action was: "Failed Dissolution Specifications"
This recall is currently ONGOING. Healthcare providers and patients are advised to check their inventory immediately against the affected codes provided below.
This recall is currently ONGOING. Healthcare providers and patients are advised to check their inventory immediately against the affected codes provided below.
Reported Recall Events
Class II Ongoing
Failed Dissolution Specifications
Sep 19, 2025
Oct 22, 2025
N/A
Recall Profile & Regulatory Data
Event ID
97639
Classification
Class II
Enforcement Status
Ongoing
Recalling Firm
Ascend Laboratories, LLC
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
U.S. Nationwide
Product Description
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
Batch or Lot Expiration Information
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
Affected Packages Involved in this Recall
67877-511-90Product
67877-511-05Product
67877-511-10Product
67877-511-55Product
67877-511-33Product
67877-511-38Product
67877-512-90Product
67877-512-05Product
67877-512-10Product
67877-512-44Product
67877-512-33Product
67877-512-38Product
67877-513-90Product
67877-513-05Product
67877-513-10Product
67877-513-23Product
67877-513-33Product
67877-513-38Product
67877-514-90Product
67877-514-05Product
67877-514-10Product
67877-514-33Product
67877-514-38Product
Class II Ongoing
Failed Dissolution Specifications
Sep 19, 2025
Oct 22, 2025
141,984 bottles
Recall Profile & Regulatory Data
Event ID
97639
Classification
Class II
Enforcement Status
Ongoing
Recalling Firm
Ascend Laboratories, LLC
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
U.S. Nationwide
Product Description
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.
Batch or Lot Expiration Information
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
Affected Packages Involved in this Recall
67877-511-90Product
67877-511-05Product
67877-511-10Product
67877-511-55Product
67877-511-33Product
67877-511-38Product
67877-512-90Product
67877-512-05Product
67877-512-10Product
67877-512-44Product
67877-512-33Product
67877-512-38Product
67877-513-90Product
67877-513-05Product
67877-513-10Product
67877-513-23Product
67877-513-33Product
67877-513-38Product
67877-514-90Product
67877-514-05Product
67877-514-10Product
67877-514-33Product
67877-514-38Product
Class II Ongoing
Failed Dissolution Specifications
Sep 19, 2025
Oct 22, 2025
N/A
Recall Profile & Regulatory Data
Event ID
97639
Classification
Class II
Enforcement Status
Ongoing
Recalling Firm
Ascend Laboratories, LLC
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
U.S. Nationwide
Product Description
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.
Batch or Lot Expiration Information
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
Affected Packages Involved in this Recall
67877-511-90Product
67877-511-05Product
67877-511-10Product
67877-511-55Product
67877-511-33Product
67877-511-38Product
67877-512-90Product
67877-512-05Product
67877-512-10Product
67877-512-44Product
67877-512-33Product
67877-512-38Product
67877-513-90Product
67877-513-05Product
67877-513-10Product
67877-513-23Product
67877-513-33Product
67877-513-38Product
67877-514-90Product
67877-514-05Product
67877-514-10Product
67877-514-33Product
67877-514-38Product
Class II Ongoing
Failed Dissolution Specifications
Sep 19, 2025
Oct 22, 2025
N/A
Recall Profile & Regulatory Data
Event ID
97639
Classification
Class II
Enforcement Status
Ongoing
Recalling Firm
Ascend Laboratories, LLC
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
U.S. Nationwide
Product Description
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.
Batch or Lot Expiration Information
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
Affected Packages Involved in this Recall
67877-511-90Product
67877-511-05Product
67877-511-10Product
67877-511-55Product
67877-511-33Product
67877-511-38Product
67877-512-90Product
67877-512-05Product
67877-512-10Product
67877-512-44Product
67877-512-33Product
67877-512-38Product
67877-513-90Product
67877-513-05Product
67877-513-10Product
67877-513-23Product
67877-513-33Product
67877-513-38Product
67877-514-90Product
67877-514-05Product
67877-514-10Product
67877-514-33Product
67877-514-38Product
About FDA Recall Enforcement Reports
FDA recall data documents classified recall actions associated with a product. Most recalls are limited to specific lots, batches, or package configurations rather than every unit of a drug.
If a recall is listed for an NDC, review the affected lot information and package details carefully. Patients and healthcare professionals should confirm whether a specific product in hand matches the lot or package information before assuming it is affected.
