# FDA recall D-0182-2026

> **Fresenius Kabi USA, LLC** · Class I · drug recall initiated 2025-11-06.

## Product

Famotidine Injection, USP, 20 mg per 2 mL (10 mg per mL), 2 mL vials, Rx only, Fresenius Kabi USA, LLC, NDC 63323-739-11 (unit of use), 63323-739-12 (unit of sale).

## Reason for recall

Microbial Contamination of Sterile Products; out of limit results obtained for endotoxin testing.

## Distribution

Nationwide within the United States as well as AK, HI, and PR.

## Key facts

- **Recall number:** D-0182-2026
- **Recalling firm:** Fresenius Kabi USA, LLC
- **Classification:** Class I
- **Product type:** drug
- **Status:** Ongoing
- **Initiation date:** 2025-11-06
- **Report date:** 2025-12-03

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

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0182-2026

## Citation

> AI Analytics. FDA recall D-0182-2026. Retrieved 2026-06-05 from https://api.ai-analytics.org/recall/D-0182-2026. Source: US FDA. Licensed CC0.

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