FDA Drug recall D-1842-2019
Simvastatin Tablets, USP 40 mg
- FDA Drug
- Class III
- terminated
- Published 2019-09-04
On 2019-09-04 the FDA classified a Class III recall of Simvastatin Tablets, USP 40 mg by Aurobindo Pharma Usa, citing labeling; Incorrect or Missing Lot and/or Exp Date; some bottles labeled with lot number 05318054B instead of 05318034B.
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-1842-2019 |
| Classification | Class III |
| Status | terminated |
| Initiated | 2019-07-29 |
| Published | 2019-09-04 |
| Last updated | 2026-09-13 11:52 UTC |
| Company | Aurobindo Pharma Usa |
| Distribution | US |
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
Labeling; Incorrect or Missing Lot and/or Exp Date; some bottles labeled with lot number 05318054B instead of 05318034B
Identifiers
| ndc | 65862-050-30 |
|---|---|
| ndc | 65862-050-45 |
| ndc | 65862-050-90 |
| ndc | 65862-050-01 |
| ndc | 65862-050-00 |
| ndc | 65862-050-99 |
| ndc | 65862-050-26 |
| ndc | 65862-051-30 |
| ndc | 65862-051-45 |
| ndc | 65862-051-90 |
| ndc | 65862-051-01 |
| ndc | 65862-051-00 |
| ndc | 65862-051-99 |
| ndc | 65862-051-26 |
| ndc | 65862-052-30 |
| ndc | 65862-052-45 |
| ndc | 65862-052-90 |
| ndc | 65862-052-01 |
| ndc | 65862-052-00 |
| ndc | 65862-052-99 |
| ndc | 65862-052-26 |
| ndc | 65862-053-30 |
| ndc | 65862-053-45 |
| ndc | 65862-053-90 |
| ndc | 65862-053-01 |
| ndc | 65862-053-00 |
| ndc | 65862-053-99 |
| ndc | 65862-053-22 |
| ndc | 65862-054-30 |
| ndc | 65862-054-45 |
| ndc | 65862-054-90 |
| ndc | 65862-054-00 |
| ndc | 65862-054-99 |
| ndc | 65862-054-39 |
| code_info | 05318054B, exp 3/2021 |
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:52 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-1842-2019%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.