# FDA recall D-058-2013

> **Watson Laboratories Inc** · Class I · drug recall initiated 2012-09-21.

## Product

Hydrocodone Bitartrate and Acetaminophen Tablets USP, 10 mg/500 mg, 500-count Tablets per bottle, Rx only, Manufactured By: Watson Laboratories, Inc., Corona, CA  92880 USA, NDC 00591-0540-05.

## Reason for recall

Superpotent (Multiple Ingredient) Drug: There is the potential for oversized and superpotent tablets.

## Distribution

Nationwide

## Key facts

- **Recall number:** D-058-2013
- **Recalling firm:** Watson Laboratories Inc
- **Classification:** Class I
- **Product type:** drug
- **Status:** Terminated
- **Initiation date:** 2012-09-21
- **Report date:** 2012-11-28
- **Termination date:** 2014-03-24

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Corona, CA, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-058-2013

## Citation

> AI Analytics. FDA recall D-058-2013. Retrieved 2026-06-04 from https://api.ai-analytics.org/recall/D-058-2013. Source: US FDA. Licensed CC0.

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