Hydrocodone bitartrate and acetaminophen Tablets — Class I drug recall D-138-2013
Terminated recall by Vintage Pharmaceuticals LLC DBA Qualitest Pharmaceuticals, reported 2013-02-06, distributed nationwide. Superpotent (Multiple Ingredient) Drug: Complaint received of oversized tablets.
| Recall number | D-138-2013 |
|---|---|
| Product type | Drug |
| Classification | Class I |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Vintage Pharmaceuticals LLC DBA Qualitest Pharmaceuticals, Huntsville, AL, United States |
| Recall initiated | 2012-12-06 |
| Classified | 2013-01-30 |
| Reported by FDA | 2013-02-06 |
| Terminated | 2021-07-20 |
| Distributed | Nationwide (US) |
| Quantity | 897,379 bottles |
| Reason classes | potency |
| NDC | 00603-3888-02, 00603-3888-04, 00603-3888-16, 00603-3888-20, 00603-3888-21, 00603-3888-22, 00603-3888-26, 00603-3888-28, 00603-3888-32 |
Product
Hydrocodone bitartrate and acetaminophen Tablets, USP, 10 mg/500 mg, packaged in a) 30-count bottles, NDC 0603-3888-16; b) 60-count bottles, NDC 0603-3888-20; c) 90-count bottles, NDC 0603-3888-02; d) 100-count bottles, NDC 0603-3888-21; e) 120-count bottles, NDC 0603-3888-22; f) 150-count bottles, NDC 0603-3888-26; g) 180-count bottles, NDC 0603-3888-04; h) 500-count bottles, NDC 0603-3888-28; and i) 1000-count bottles, NDC 0603-3888-32, Rx only, Mfg. for: Qualitest Pharmaceuticals, Huntsville, AL 35811.
Reason for recall
Superpotent (Multiple Ingredient) Drug: Complaint received of oversized 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-138-2013. 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.