FDA Drug recall D-057-2013
HYDROCODONE BITARTRATE and ACETAMINOPHEN TABLETS, USP, 10 mg/500 mg, 100-count bottle, Rx only, Mfg. for: QUALITEST PHARMACEUTICALS, HUNTSV…
- FDA Drug
- Class I
- ongoing
- 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, 100-count bottle, Rx only, Mfg. for: QUALITEST PHARMACEUTICALS, HUNTSV… by Vintage Pharmaceuticals, citing superpotent (Multiple Ingredient) Drug: Confirmed customer complaints of oversized tablets resulting in superpotent assays of both the hydrocodone and acetaminophen components.
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-057-2013 |
| Classification | Class I |
| Status | ongoing |
| Initiated | 2012-09-10 |
| Published | 2012-11-28 |
| Last updated | 2026-09-13 11:51 UTC |
| Company | Vintage Pharmaceuticals |
| Distribution | US |
Product
HYDROCODONE BITARTRATE and ACETAMINOPHEN TABLETS, USP, 10 mg/500 mg, 100-count bottle, Rx only, Mfg. for: QUALITEST PHARMACEUTICALS, HUNTSVILLE, AL 35811, NDC 0603-3888-21
Reason
Superpotent (Multiple Ingredient) Drug: Confirmed customer complaints of oversized tablets resulting in superpotent assays of both the hydrocodone and acetaminophen components.
Identifiers
| code_info | Lot number: C1440512A, Exp 12/13 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:51 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-057-2013%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.