FDA Drug recall D-058-2013
Hydrocodone Bitartrate and Acetaminophen Tablets USP, 10 mg/500 mg, 500-count Tablets per bottle, Rx only, Manufactured By: Watson Laborato…
- FDA Drug
- Class I
- terminated
- Published 2012-11-28
On 2012-11-28 the FDA classified a Class I recall of Hydrocodone Bitartrate and Acetaminophen Tablets USP, 10 mg/500 mg, 500-count Tablets per bottle, Rx only, Manufactured By: Watson Laborato… by Watson Laboratories, citing superpotent (Multiple Ingredient) Drug: There is the potential for oversized and superpotent tablets.
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-058-2013 |
| Classification | Class I |
| Status | terminated |
| Initiated | 2012-09-21 |
| Published | 2012-11-28 |
| Last updated | 2026-09-13 11:51 UTC |
| Company | Watson Laboratories |
| Distribution | US |
Product
Hydrocodone Bitartrate and Acetaminophen Tablets USP, 10 mg/500 mg, 500-count Tablets per bottle, Rx only, Manufactured By: Watson Laboratories, Inc., Corona, CA 92880 USA, NDC 00591-0540-05.
Reason
Superpotent (Multiple Ingredient) Drug: There is the potential for oversized and superpotent tablets.
Identifiers
| code_info | Lot #: 519406A, 521759A, Exp 04/14 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:51 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-058-2013%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.