# FDA recall D-0362-2025

> **Chattem Inc** · Class II · drug recall initiated 2025-03-26.

## Product

Unisom, SleepMinis, Diphenhydramine HCl, Mini-Capsules, 25 mg, 60 Mini-Capsules bottles, Dist. by Chattem, Inc., P.O. Box 2219, Chattanooga, TN 37409-0219, USA, UPC 0 41167 00670 2

## Reason for recall

CGMP Deviations; detection of Nitrosamine Drug Substance-Related Impurities (NDSRI), N-nitroso-desmethyl-diphenhydramine (n-dph), above the FDA Recommended Intake Limit

## Distribution

Nationwide.

## Key facts

- **Recall number:** D-0362-2025
- **Recalling firm:** Chattem Inc
- **Classification:** Class II
- **Product type:** drug
- **Status:** Ongoing
- **Initiation date:** 2025-03-26
- **Report date:** 2025-04-23

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Chattanooga, TN, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0362-2025

## Citation

> AI Analytics. FDA recall D-0362-2025. Retrieved 2026-06-09 from https://api.ai-analytics.org/recall/D-0362-2025. Source: US FDA. Licensed CC0.

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