Simvastatin Tablets — Class III drug recall D-1842-2019
Terminated recall by Aurobindo Pharma USA Inc., reported 2019-09-04, distributed nationwide. Labeling; Incorrect or Missing Lot and/or Exp Date; some bottles labeled with lot number 05318054B instead of
| Recall number | D-1842-2019 |
|---|---|
| Product type | Drug |
| Classification | Class III |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Aurobindo Pharma USA Inc., East Windsor, NJ, United States |
| Recall initiated | 2019-07-29 |
| Classified | 2019-08-26 |
| Reported by FDA | 2019-09-04 |
| Terminated | 2021-10-28 |
| Distributed | Nationwide (US) |
| Quantity | 2,352 |
| Reason classes | labeling |
| NDC | 65862-0050, 65862-0050-00, 65862-0050-01, 65862-0050-26, 65862-0050-30, 65862-0050-45, 65862-0050-90, 65862-0050-99, 65862-0051, 65862-0051-00, 65862-0051-01, 65862-0051-26, 65862-0051-30, 65862-0051-45, 65862-0051-90, 65862-0051-99, 65862-0052, 65862-0052-00, 65862-0052-01, 65862-0052-26, 65862-0052-30, 65862-0052-45, 65862-0052-90, 65862-0052-99, 65862-0053 and 14 more |
| Expiration dates | 2021-03 |
Product
Simvastatin Tablets, USP 40 mg. Rx Only 1000 Count Bottles Manufactured by: Aurolife Pharma LLC Dayton NJ 08810 Manufactured for: Aurobindo Pharma USA, Inc. Dayton, NJ 08810 NDC 65862-053-99
Reason for recall
Labeling; Incorrect or Missing Lot and/or Exp Date; some bottles labeled with lot number 05318054B instead of 05318034B
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-1842-2019. 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.