# FDA recall D-823-2013

> **Watson Laboratories Inc** · Class III · drug recall initiated 2013-07-19.

## Product

Oxycodone and Acetaminophen Capsules, USP 5mg/500 mg, packaged in a)100-count bottle (NDC 0591-0737-01), b) 500-count bottle (NDC 0591-0737-05), Rx only, Manufactured by Watson Laboratories, Inc., Corona, CA92880.

## Reason for recall

Subpotent drug: Two lots of Oxycodone and Acetaminophen Capsules, USP 5/500 mg are being recalled due to low out of specification (OOS) assay result obtained at expiry (24 months) for the oxycodone portion of the product.

## Distribution

Nationwide

## Key facts

- **Recall number:** D-823-2013
- **Recalling firm:** Watson Laboratories Inc
- **Classification:** Class III
- **Product type:** drug
- **Status:** Terminated
- **Initiation date:** 2013-07-19
- **Report date:** 2013-07-31
- **Termination date:** 2014-07-29

- **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-823-2013

## Citation

> AI Analytics. FDA recall D-823-2013. Retrieved 2026-06-16 from https://api.ai-analytics.org/recall/D-823-2013. Source: US FDA. Licensed CC0.

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