# FDA recall D-0197-2025

> **Akron Pharma, Inc.** · Class III · drug recall initiated 2024-12-12.

## Product

Diphenhydramine HCl 25 mg, 100 capsules per bottle, Akron Pharma, Manufactured for: Akron Pharma, Inc., 373 RT US 46 W Building E, Suite 117, Fairfield, NJ 07004, NDC 71399-8028-1.

## Reason for recall

Labeling: Not Elsewhere Classified: Tablets/Capsules imprinted with wrong ID.

## Distribution

Nationwide in the US

## Key facts

- **Recall number:** D-0197-2025
- **Recalling firm:** Akron Pharma, Inc.
- **Classification:** Class III
- **Product type:** drug
- **Status:** Ongoing
- **Initiation date:** 2024-12-12
- **Report date:** 2025-01-22

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

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0197-2025

## Citation

> AI Analytics. FDA recall D-0197-2025. Retrieved 2026-07-13 from https://api.ai-analytics.org/recall/D-0197-2025. Source: US FDA. Licensed CC0.

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*[Dataset catalog](/datasets/) · [FDA recalls dataset](/datasets/fda-recalls) · CC0 1.0*