FDA Drug recall D-0599-2018
Lupin Hydrocodone Bitartrate and Homatropine Methylbromide Tablets, USP 5/1.5 mg Rx Only 30 Tablets Manufactured by: Novel Laboratories, Inc
- FDA Drug
- Class III
- terminated
- Published 2018-03-21
On 2018-03-21 the FDA classified a Class III recall of Lupin Hydrocodone Bitartrate and Homatropine Methylbromide Tablets, USP 5/1.5 mg Rx Only 30 Tablets Manufactured by: Novel Laboratories, Inc by Novel Laboratories, citing failed Impurities/Degradation Specifications.
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-0599-2018 |
| Classification | Class III |
| Status | terminated |
| Initiated | 2018-03-05 |
| Published | 2018-03-21 |
| Last updated | 2026-09-13 11:52 UTC |
| Company | Novel Laboratories |
| Distribution | US |
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
Failed Impurities/Degradation Specifications
Identifiers
| upc | 343386118038 |
|---|---|
| ndc | 43386-118-03 |
| ndc | 43386-118-01 |
| ndc | 43386-118-05 |
| ndc | 3433861180 |
| code_info | M16002A (02/2018); M16246A (04/2018); M16246B (04/2018); M16434A (07/2018); M16569A (10/2018); M17015A (01/2019); S700271 (04/2019); |
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-0599-2018%22
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