FDA Drug recall D-0836-2018
Hydrocodone Bitartrate and Acetaminophen Tablets, USP, 5 mg/325 mg, 1000-count bottle Rx Only, Manufactured by: Novel Laboratories, Inc
- FDA Drug
- Class III
- terminated
- Published 2018-06-06
On 2018-06-06 the FDA classified a Class III recall of Hydrocodone Bitartrate and Acetaminophen Tablets, USP, 5 mg/325 mg, 1000-count bottle Rx Only, Manufactured by: Novel Laboratories, Inc by Lupin Somerset, citing labeling: Missing Label.
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-0836-2018 |
| Classification | Class III |
| Status | terminated |
| Initiated | 2018-05-24 |
| Published | 2018-06-06 |
| Last updated | 2026-09-13 11:52 UTC |
| Company | Lupin Somerset |
| Distribution | OH |
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
Labeling: Missing Label
Identifiers
| upc | 343386356102 |
|---|---|
| ndc | 43386-358-05 |
| ndc | 43386-358-01 |
| ndc | 43386-358-10 |
| ndc | 43386-358-03 |
| ndc | 43386-357-01 |
| ndc | 43386-357-05 |
| ndc | 43386-357-10 |
| ndc | 43386-357-03 |
| ndc | 43386-356-01 |
| ndc | 43386-356-05 |
| ndc | 43386-356-10 |
| ndc | 43386-356-03 |
| ndc | 3433863561 |
| code_info | Lot # S800257; Exp. 01/20 |
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-0836-2018%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.