# FDA recall D-1430-2012

> **Mallinckrodt Inc.** · Class III · drug recall initiated 2012-05-25.

## Product

Hydrocodone Bitartrate and Acetaminophen Oral Solution, 7.5 mg/500 mg per 15 mL, 16 fl oz (473 mL) bottle, Rx only, Mallinckrodt Inc., Hazelwood, MO 63042 USA, NDC 0406-0375-16, UPC 3 0406-0375-16 1.

## Reason for recall

Subpotent (Multiple Ingredient) Drug: Low out of specification assay results for the hydrocodone bitartrate ingredient was found.

## Distribution

Nationwide

## Key facts

- **Recall number:** D-1430-2012
- **Recalling firm:** Mallinckrodt Inc.
- **Classification:** Class III
- **Product type:** drug
- **Status:** Terminated
- **Initiation date:** 2012-05-25
- **Report date:** 2012-08-08
- **Termination date:** 2015-04-17

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Hobart, NY, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-1430-2012

## Citation

> AI Analytics. FDA recall D-1430-2012. Retrieved 2026-05-25 from https://api.ai-analytics.org/recall/D-1430-2012. Source: US FDA. Licensed CC0.

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