FDA Drug recall D-166-2013
Hydrocodone Bitartrate and Acetaminophen Tablets, USP, 10 mg/500 mg
- FDA Drug
- Class I
- terminated
- Published 2013-02-27
On 2013-02-27 the FDA classified a Class I recall of Hydrocodone Bitartrate and Acetaminophen Tablets, USP, 10 mg/500 mg by Mylan Institutional D B A Udl Laboratories, citing superpotent (Multiple Ingredient) Drug: 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-166-2013 |
| Classification | Class I |
| Status | terminated |
| Initiated | 2012-12-14 |
| Published | 2013-02-27 |
| Last updated | 2026-09-13 11:51 UTC |
| Company | Mylan Institutional D B A Udl Laboratories |
| Distribution | US |
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
Superpotent (Multiple Ingredient) Drug: Oversized tablets resulting in superpotent assays of both the hydrocodone and acetaminophen components.
Identifiers
| code_info | Lot #: 3037841, 3040859, 3042573, Exp 12/13 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:51 UTC. Current status: terminated.
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FDA Drug · Class II · 2022-05-18 · Mylan Institutional D B A Udl Laboratories - Alprazolam Tablets, USP, 0.25 mg, 10x10 per carton, Rx Only, Manufactured for: Mylan Pharmaceuticals Inc., Morgantown, WV 26505 USA. NDC: 5…
FDA Drug · Class II · 2019-03-27 · Mylan Institutional D B A Udl Laboratories - Diltiazem HCl Extended-release Capsules, USP 120 mg, 80 capsules, 8 blister cards of 10 capsules each per carton, Rx Only, Manufactured by:…
FDA Drug · Class III · 2018-08-29 · Mylan Institutional D B A Udl Laboratories - Loxapine Capsules, USP 50 mg, packaged in 100 Unit Dose capsules, Rx only, Manufactured by Mylan Pharmaceuticals Inc
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All Mylan Institutional D B A Udl Laboratories recalls
Source
Official record: https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-166-2013%22
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