Multi-event September 2025 FDA Recall Atorvastatin Calcium by Ascend Laboratories, Llc
This Multi-event Class II drug recall was voluntarily initiated by Ascend Laboratories, Llc on September 19, 2025 for the product Atorvastatin Calcium. The FDA reported the reason for recall as failed dissolution specifications. The product was distributed Nationwide and the recall is currently ongoing.
Reported Recall Events
Recall Number: D-0020-2026
Failed Dissolution Specifications
09-19-2025
10-22-2025
Recall Profile & Regulatory Data
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Current regulatory stage of the recall event.
Ongoing
Recalling Firm About Recalling Firm
The firm responsible for the recall.
The firm responsible for the recall.
Ascend Laboratories, LLC
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
General area of initial distribution.
U.S. Nationwide
Product Description About Product Description
Full technical description of the product.
Full technical description of the 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
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
Recall Number: D-0017-2026
Failed Dissolution Specifications
09-19-2025
10-22-2025
141,984 bottles
Recall Profile & Regulatory Data
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Current regulatory stage of the recall event.
Ongoing
Recalling Firm About Recalling Firm
The firm responsible for the recall.
The firm responsible for the recall.
Ascend Laboratories, LLC
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
General area of initial distribution.
U.S. Nationwide
Product Description About Product Description
Full technical description of the product.
Full technical description of 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.
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
Recall Number: D-0018-2026
Failed Dissolution Specifications
09-19-2025
10-22-2025
Recall Profile & Regulatory Data
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Current regulatory stage of the recall event.
Ongoing
Recalling Firm About Recalling Firm
The firm responsible for the recall.
The firm responsible for the recall.
Ascend Laboratories, LLC
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
General area of initial distribution.
U.S. Nationwide
Product Description About Product Description
Full technical description of the product.
Full technical description of the product.
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
Recall Number: D-0019-2026
Failed Dissolution Specifications
09-19-2025
10-22-2025
Recall Profile & Regulatory Data
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Current regulatory stage of the recall event.
Ongoing
Recalling Firm About Recalling Firm
The firm responsible for the recall.
The firm responsible for the recall.
Ascend Laboratories, LLC
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
General area of initial distribution.
U.S. Nationwide
Product Description About Product Description
Full technical description of the product.
Full technical description of the product.
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
