# FDA recall D-0547-2025

> **Nostrum Laboratories, Inc.** · Class II · drug recall initiated 2025-07-11.

## Product

Sucralfate Tablets, USP 1 gram, packaged in a) 100-count bottles NDC 29033-0003-01, and b) 500-count bottles, NDC 29033-0003-05), Rx Only, Manufactured by: Nostrum Laboratories, Inc., Kansas City, MO 64120.

## Reason for recall

CGMP Deviations: The recalling firm filed for Chapter 11 in September 2024. As a result, it cannot monitor the quality program and hence cannot assure that products meet the identity, strength, quality, and purity characteristics that they are purported or represented to possess, rendering the products adulterated.

## Distribution

nationwide within the United States

## Key facts

- **Recall number:** D-0547-2025
- **Recalling firm:** Nostrum Laboratories, Inc.
- **Classification:** Class II
- **Product type:** drug
- **Status:** Ongoing
- **Initiation date:** 2025-07-11
- **Report date:** 2025-08-06

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Bryan, OH, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0547-2025

## Citation

> AI Analytics. FDA recall D-0547-2025. Retrieved 2026-07-07 from https://api.ai-analytics.org/recall/D-0547-2025. Source: US FDA. Licensed CC0.

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