# FDA recall D-166-2013

> **Mylan Institutional, Inc. (d.b.a. UDL Laboratories)** · Class I · drug recall initiated 2012-12-14.

## 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.

## Distribution

Nationwide

## Key facts

- **Recall number:** D-166-2013
- **Recalling firm:** Mylan Institutional, Inc. (d.b.a. UDL Laboratories)
- **Classification:** Class I
- **Product type:** drug
- **Status:** Terminated
- **Initiation date:** 2012-12-14
- **Report date:** 2013-02-27
- **Termination date:** 2016-08-09

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Rockford, IL, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-166-2013

## Citation

> AI Analytics. FDA recall D-166-2013. Retrieved 2026-05-26 from https://api.ai-analytics.org/recall/D-166-2013. Source: US FDA. Licensed CC0.

---

*[Dataset catalog](/datasets/) · [FDA recalls dataset](/datasets/fda-recalls) · CC0 1.0*