HYDROCODONE BITARTRATE and ACETAMINOPHEN TABLETS — Class I drug recall D-057-2013
Ongoing recall by Vintage Pharmaceuticals LLC DBA Qualitest Pharmaceuticals, reported 2012-11-28, distributed nationwide. Superpotent (Multiple Ingredient) Drug: Confirmed customer complaints of oversized tablets resulting in superp
| Recall number | D-057-2013 |
|---|---|
| Product type | Drug |
| Classification | Class I |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Vintage Pharmaceuticals LLC DBA Qualitest Pharmaceuticals, Huntsville, AL, United States |
| Recall initiated | 2012-09-10 |
| Classified | 2012-11-16 |
| Reported by FDA | 2012-11-28 |
| Distributed | Nationwide (US) |
| Quantity | 14,445 bottles |
| Reason classes | potency |
| NDC | 00603-3888-21 |
| Lot numbers | 12/13, C1440512A |
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 for recall
Superpotent (Multiple Ingredient) Drug: Confirmed customer complaints of oversized tablets resulting in superpotent assays of both the hydrocodone and acetaminophen components.
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-057-2013. 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.