Hydrocodone Bitartrate and Acetaminophen Tablets USP — Class I drug recall D-058-2013
Terminated recall by Watson Laboratories Inc, reported 2012-11-28, distributed nationwide. Superpotent (Multiple Ingredient) Drug: There is the potential for oversized and superpotent tablets.
| Recall number | D-058-2013 |
|---|---|
| Product type | Drug |
| Classification | Class I |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Watson Laboratories Inc, Corona, CA, United States |
| Recall initiated | 2012-09-21 |
| Classified | 2012-11-16 |
| Reported by FDA | 2012-11-28 |
| Terminated | 2014-03-24 |
| Distributed | Nationwide (US) |
| Quantity | 4,874 bottles |
| Reason classes | potency |
| NDC | 00591-0540-05 |
| Lot numbers | 04/14, 519406A, 521759A |
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 for recall
Superpotent (Multiple Ingredient) Drug: There is the potential for oversized and superpotent tablets.
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-058-2013. 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.