Simvastatin Tablets — Class III drug recall D-0223-2018
Terminated recall by Hetero Labs, Ltd. - Unit III, reported 2018-01-24, distributed nationwide. Presence of foreign substance: metallic razor blade was found in one bottle.
| Recall number | D-0223-2018 |
|---|---|
| Product type | Drug |
| Classification | Class III |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Hetero Labs, Ltd. - Unit III, Hyderabad, N/A, India |
| Recall initiated | 2017-12-22 |
| Classified | 2018-01-16 |
| Reported by FDA | 2018-01-24 |
| Terminated | 2018-03-23 |
| Distributed | Nationwide (US) |
| NDC | 31722-0510, 31722-0510-01, 31722-0510-10, 31722-0510-30, 31722-0510-90, 31722-0511, 31722-0511-01, 31722-0511-10, 31722-0511-30, 31722-0511-90, 31722-0512, 31722-0512-01, 31722-0512-10, 31722-0512-30, 31722-0512-90, 31722-0513, 31722-0513-01, 31722-0513-10, 31722-0513-30, 31722-0513-90, 31722-0514, 31722-0514-01, 31722-0514-05, 31722-0514-30, 31722-0514-90 |
| Lot numbers | 06/19, E171280 |
Product
Simvastatin Tablets, USP, 40 mg, 1000-count bottle, Rx only, Manufactured for: Camber Pharmaceuticals, Inc., Piscataway, NJ 08854, Manufactured by: Hetero (trademark), Hetero Labs Limited, Jeedimetla, Hyderabad - 500 055, India, NDC 31722-513-10
Reason for recall
Presence of foreign substance: metallic razor blade was found in one bottle.
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-0223-2018. 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.