Atorvastatin Calcium Tablet USP 80 mg — Class II drug recall D-1515-2019
Terminated recall by Ascend Laboratories LLC, reported 2019-07-31, distributed nationwide. Failed Dissolution Specifications
| Recall number | D-1515-2019 |
|---|---|
| Product type | Drug |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Ascend Laboratories LLC, Parsippany, NJ, United States |
| Recall initiated | 2019-07-19 |
| Classified | 2019-07-24 |
| Reported by FDA | 2019-07-31 |
| Terminated | 2021-06-07 |
| Distributed | Nationwide (US) |
| Reason classes | specification failure |
| NDC | 67877-0514-05, 67877-0514-90 |
| Lot numbers | 19140443, 19140525, 19140535, 19140756, 19140757, 19140758, 19141696, 19141793 |
| Expiration dates | 2020-12, 2021-01, 2021-03 |
Product
Atorvastatin Calcium Tablet USP 80 mg, a) 90 count (NDC 67877-0514-90) and b) 500 count (NDC 67877-0514-05) bottles, Rx only, Manufactured by: Alkem Laboratories, Ltd, Mumbai INDIA, Distributed by: Ascend Laboratories, LLC, Parsippany, NJ
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-1515-2019. 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.