Atorvastatin Calcium Tablets USP — Class II drug recall D-0020-2026
Ongoing recall by Ascend Laboratories, LLC, reported 2025-10-22, distributed nationwide. Failed Dissolution Specifications
| Recall number | D-0020-2026 |
|---|---|
| Product type | Drug |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Ascend Laboratories, LLC, Bedminster, NJ, United States |
| Recall initiated | 2025-09-19 |
| Classified | 2025-10-10 |
| Reported by FDA | 2025-10-22 |
| Distributed | Nationwide (US) |
| Reason classes | specification failure |
| NDC | 67877-0511, 67877-0511-05, 67877-0511-10, 67877-0511-33, 67877-0511-38, 67877-0511-55, 67877-0511-90, 67877-0512, 67877-0512-05, 67877-0512-10, 67877-0512-33, 67877-0512-38, 67877-0512-44, 67877-0512-90, 67877-0513, 67877-0513-05, 67877-0513-10, 67877-0513-23, 67877-0513-33, 67877-0513-38, 67877-0513-90, 67877-0514, 67877-0514-05, 67877-0514-10, 67877-0514-33 and 2 more |
| Lot numbers | 24143412, 24143582, 24143898, 24144652, 24144713, 24144845, 24144942, 24144999, 25140247, 25140249 |
| Expiration dates | 2026-08-20, 2026-10-20, 2026-11-20, 2026-12-20 |
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
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/D-0020-2026. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.