Hydrocodone Bitartrate and Acetaminophen Tablets — Class I drug recall D-166-2013
Terminated recall by Mylan Institutional, Inc. (d.b.a. UDL Laboratories), reported 2013-02-27, distributed nationwide. Superpotent (Multiple Ingredient) Drug: Oversized tablets resulting in superpotent assays of both the hydrocod
| Recall number | D-166-2013 |
|---|---|
| Product type | Drug |
| Classification | Class I |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Mylan Institutional, Inc. (d.b.a. UDL Laboratories), Rockford, IL, United States |
| Recall initiated | 2012-12-14 |
| Classified | 2013-02-15 |
| Reported by FDA | 2013-02-27 |
| Terminated | 2016-08-09 |
| Distributed | Nationwide (US) |
| Quantity | 3,407 cartons |
| Reason classes | potency |
| NDC | 51079-0254-21 |
| Lot numbers | 12/13, 3037841, 3040859, 3042573 |
Product
Hydrocodone Bitartrate and Acetaminophen Tablets, USP, 10 mg/500 mg; 100 Tablets (5 x 20), 5 cards each containing 20 blistered tablets per carton, Rx only; Manufactured for: Qualitest Pharmaceuticals, Huntsville, AL 35811, Pkg by & Distributed by UDL Laboratories, Inc., Rockford, IL 61103; NDC 51079-254-21.
Reason for recall
Superpotent (Multiple Ingredient) Drug: 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-166-2013. 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.