# FDA recall D-250-2013

> **Precision Dose Inc.** · Class II · drug recall initiated 2013-03-21.

## Product

Children's Acetaminophen Oral Suspension, 650 mg/20.3 mL unit dose cup (NDC 68094-650-59), packaged in 30-count cups per shipper case (NDC 68094-650-62), Pkg. By: Precision Dose, Inc., S. Beloit, IL  61080.

## Reason for recall

Labeling: Not Elsewhere Classified: This unit dose product is being recalled because the product's name includes the word "Children's" which is misleading since the 650 mg dose of acetaminophen contained within it, is an adult dose.

## Distribution

Nationwide and Puerto Rico

## Key facts

- **Recall number:** D-250-2013
- **Recalling firm:** Precision Dose Inc.
- **Classification:** Class II
- **Product type:** drug
- **Status:** Terminated
- **Initiation date:** 2013-03-21
- **Report date:** 2013-04-24
- **Termination date:** 2015-05-07

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

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-250-2013

## Citation

> AI Analytics. FDA recall D-250-2013. Retrieved 2026-05-26 from https://api.ai-analytics.org/recall/D-250-2013. Source: US FDA. Licensed CC0.

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