Medications & Supplements/Prescription Drugs

Sucralfate Tablets Recalled for Quality Control Failures

Agency Publication Date: August 22, 2025

Summary

American Health Packaging is recalling 26,992 blister packs of Sucralfate Tablets (1 gram) because the company filed for Chapter 11 bankruptcy and can no longer monitor its quality control program. Without this oversight, the manufacturer cannot guarantee that the tablets meet safety standards for identity, strength, and purity. This recall includes the 100-tablet unit-dose cartons distributed nationwide.

Risk

The lack of quality oversight means the medication is considered adulterated and may not contain the correct amount of active ingredients or could have unknown quality defects. This could result in the medication being ineffective for its intended use or causing unexpected side effects.

What You Should Do

This recall affects 1 gram Sucralfate Tablets distributed by American Health Packaging in 100-count cartons containing 10x10 unit-dose blister packs.
Identify your product by looking for NDC 60687-695-01 on the carton or NDC 60687-695-11 on the individual unit doses. Specifically check for lot numbers 1015038 (Exp 07/31/2025), 1015898 (Exp 09/30/2025), 1016873 (Exp 10/31/2025), or 1023398 (Exp 07/31/2026).
If you have health concerns, contact your healthcare provider or pharmacist. Return any unused product to the place of purchase for a refund, throw it away, or contact Amerisource Health Services LLC for further instructions.
Call the FDA Consumer Complaint hotline at 1-888-723-3332 (1-888-SAFEFDA) for additional questions.

Your Remedy Options

You have 2 options:

Option 1: Full Refund

How to: Contact your healthcare provider or pharmacist for guidance, or return any unused product to the place of purchase for a refund

Option 2: Dispose of Product

How to: Throw the product away. For prescription medications, a DEA take-back location or pharmacy mail-back program is preferred when available.

Affected Products

Product: Sucralfate Tablets, USP (1 gram)by American Health Packaging

Variants: 1 gram, 100 Tablets (10x10), Rx Only

Lot Numbers:

1015038 (Exp 07/31/2025)

1015898 (Exp 09/30/2025)

1016873 (Exp 10/31/2025)

1023398 (Exp 07/31/2026)

NDC:

60687-695-01

60687-695-11

Distributed by American Health Packaging.

Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 97361

Status: Active

Manufacturer: Amerisource Health Services LLC

Sold By: Pharmacies

Manufactured In: United States

Units Affected: 26,992 blister packs

Distributed To: Nationwide

Were You Affected by This Recall?

If you or a family member were harmed by this recalled product, you may have legal rights. Consider consulting a consumer protection attorney to understand your options for compensation.

Find an Attorney

This is general information, not legal advice. Go Backs is not a law firm and does not provide legal services.

AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.

Sources: FDA iRES · Raw API Response

openFDA Disclaimer: This recall information is sourced from the openFDA API. Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Refer to the openFDA terms of service for more information.

Summary

What You Should Do

This recall affects 1 gram Sucralfate Tablets distributed by American Health Packaging in 100-count cartons containing 10x10 unit-dose blister packs.

Identify your product by looking for NDC 60687-695-01 on the carton or NDC 60687-695-11 on the individual unit doses. Specifically check for lot numbers 1015038 (Exp 07/31/2025), 1015898 (Exp 09/30/2025), 1016873 (Exp 10/31/2025), or 1023398 (Exp 07/31/2026).

If you have health concerns, contact your healthcare provider or pharmacist. Return any unused product to the place of purchase for a refund, throw it away, or contact Amerisource Health Services LLC for further instructions.

Call the FDA Consumer Complaint hotline at 1-888-723-3332 (1-888-SAFEFDA) for additional questions.