# FDA recall D-1423-2012

> **Bayer Healthcare, LLC** · Class III · drug recall initiated 2012-04-26.

## Product

Midol Complete, Acetaminophen, Caffeine, Pyrilamine Maleate, Gelcaps 24 ct. blister, OTC,  Distributed by Bayer Health Care, Morristown, NJ 07962   NDC 0280-8015-24

## Reason for recall

Labeling: Label Mix-up: This recall was initiated after identifying that the label statement on the blister strip regarding the maximum number of capsules/caplets that should be taken within a 24-hour period, does not match the statement on the carton.

## Distribution

Product was distributed to 93 retail accounts/customers.

## Key facts

- **Recall number:** D-1423-2012
- **Recalling firm:** Bayer Healthcare, LLC
- **Classification:** Class III
- **Product type:** drug
- **Status:** Terminated
- **Initiation date:** 2012-04-26
- **Report date:** 2012-07-25
- **Termination date:** 2014-03-27

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Morristown, NJ, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-1423-2012

## Citation

> AI Analytics. FDA recall D-1423-2012. Retrieved 2026-05-25 from https://api.ai-analytics.org/recall/D-1423-2012. Source: US FDA. Licensed CC0.

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