Lupin Hydrocodone Bitartrate and Homatropine Methylbromide Tablets — Class III drug recall D-0599-2018
Terminated recall by Novel Laboratories, Inc., reported 2018-03-21, distributed nationwide. Failed Impurities/Degradation Specifications
| Recall number | D-0599-2018 |
|---|---|
| Product type | Drug |
| Classification | Class III |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Novel Laboratories, Inc., Somerset, NJ, United States |
| Recall initiated | 2018-03-05 |
| Classified | 2018-03-14 |
| Reported by FDA | 2018-03-21 |
| Terminated | 2020-06-08 |
| Distributed | Nationwide (US) |
| Reason classes | specification failure |
| UPC / GTIN / UDI-DI | 00343386118038 |
| NDC | 43386-0118, 43386-0118-01, 43386-0118-03, 43386-0118-05 |
Product
Lupin Hydrocodone Bitartrate and Homatropine Methylbromide Tablets, USP 5/1.5 mg Rx Only 30 Tablets Manufactured by: Novel Laboratories, Inc. Somerset, NJ 08873 Manufactured for: Lupin Pharmaceuticals, Inc. Baltimore, MD 21202 NDC 43386-118-03 UPC 343386118038
Reason for recall
Failed Impurities/Degradation 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-0599-2018. 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.