# FDA recall D-0598-2025

> **Amerisource Health Services LLC** · Class II · drug recall initiated 2025-07-29.

## Product

Sucralfate Tablets, USP 1 gram, 100 Tablets, (10x10), Rx Only, Distributed by: American Health Packaging, Columbus, Ohio 43217 NDC 60687-695-01 - Carton NDC [60687-695-11- Unit Dose]

## 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

## Key facts

- **Recall number:** D-0598-2025
- **Recalling firm:** Amerisource Health Services LLC
- **Classification:** Class II
- **Product type:** drug
- **Status:** Ongoing
- **Initiation date:** 2025-07-29
- **Report date:** 2025-09-03

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

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0598-2025

## Citation

> AI Analytics. FDA recall D-0598-2025. Retrieved 2026-07-08 from https://api.ai-analytics.org/recall/D-0598-2025. Source: US FDA. Licensed CC0.

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