# FDA recall D-0662-2016

> **Medline Industries Inc** · Class I · drug recall initiated 2015-09-25.

## Product

ACETAMINOPHEN EXTRA-STRENGTH PAIN RELIEVER tablets, 500 mg, 100-count bottle, Distributed by Medline Industries, Inc., Mundelein, ILL 60060, NDC 53329-641-30.

## Reason for recall

Labeling: Label Error on Declared Strength- Bottles containing 500 mg acetaminophen tablets mislabeled to contain 325 mg tablets.

## Distribution

Nationwide

## Key facts

- **Recall number:** D-0662-2016
- **Recalling firm:** Medline Industries Inc
- **Classification:** Class I
- **Product type:** drug
- **Status:** Terminated
- **Initiation date:** 2015-09-25
- **Report date:** 2016-02-24
- **Termination date:** 2016-06-29

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

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0662-2016

## Citation

> AI Analytics. FDA recall D-0662-2016. Retrieved 2026-05-25 from https://api.ai-analytics.org/recall/D-0662-2016. Source: US FDA. Licensed CC0.

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