Hydrocodone Bitartrate and Acetaminophen Tablets — Class III drug recall D-0836-2018
Terminated recall by LUPIN SOMERSET, reported 2018-06-06, distributed in OH. Labeling: Missing Label
| Recall number | D-0836-2018 |
|---|---|
| Product type | Drug |
| Classification | Class III |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | LUPIN SOMERSET, Somerset, NJ, United States |
| Recall initiated | 2018-05-24 |
| Classified | 2018-05-31 |
| Reported by FDA | 2018-06-06 |
| Terminated | 2021-01-26 |
| Distributed | OH |
| Reason classes | labeling |
| UPC / GTIN / UDI-DI | 00343386356102 |
| NDC | 43386-0356, 43386-0356-01, 43386-0356-03, 43386-0356-05, 43386-0356-10, 43386-0357, 43386-0357-01, 43386-0357-03, 43386-0357-05, 43386-0357-10, 43386-0358, 43386-0358-01, 43386-0358-03, 43386-0358-05, 43386-0358-10 |
| Lot numbers | 01/20, S800257 |
Product
Hydrocodone Bitartrate and Acetaminophen Tablets, USP, 5 mg/325 mg, 1000-count bottle Rx Only, Manufactured by: Novel Laboratories, Inc. Somerset NJ 08873 Manufactured for: Lupin Pharmaceuticals, Inc. Baltimore, MD 212020 NDC 43386-356-10 UPC 343386356102
Reason for recall
Labeling: Missing Label
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-0836-2018. 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.