Quick Facts at a Glance
- Recall Date
- October 9, 2025
- Hazard Level
- HIGH
- Brands
- Sucralfate, American Health Packaging
- Category
- Health & Personal Care
- Sold At
- Multiple Retailers
- Geographic Scope
- 1 states
- At-Risk Groups
- GENERAL
What to Do Now
Use this page like a recall checklist: verify the product first, then act on the official remedy.
Immediate steps
- 1Stop using the product until you confirm whether it is included in the recall.
- 2Compare the product label, model number, UPC, color, size, and purchase location against the identifiers below.
- 3Follow the official remedy from FDA - Drug Safety; save photos, receipts, labels, and correspondence before contacting the company.
- 4If the product could harm a child, older adult, pet, or patient, move it out of reach immediately.
Check these identifiers
- Brand
- Sucralfate, American Health Packaging
- Product type
- Sucralfate Tablet, 1 g
- Model numbers
- Lot #: 1017392 Exp 01/31/2026, 1017415 Exp 12/31/2025
- UPC codes
- 60687-695, 60687-695-11, 60687-695-01
- Sold at
- Multiple Retailers
- Where affected
- ALL
Recall Timeline
Key dates and source checks for this recall record.
Recall announced
October 9, 2025
Reported by FDA DRUG
October 22, 2025
RecallRadar source check
April 18, 2026
Consumer action
Use the official remedy and keep documentation.
Hazard Information
CGMP Deviations: The recalling firm filed for Chapter 11 on September 30, 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.
What You Should Do
Consumers and healthcare providers should stop using this product immediately. Contact Amerisource Health Services LLC or your healthcare provider for guidance. Notification method: Letter
About This Product
Sucralfate is used to treat active duodenal and gastric ulcers. The recalled product is an oral tablet issued Rx only and distributed nationwide. This recall centers on CGMP deviations, not on reported patient harm.
Why This Is Dangerous
CGMP deviations prevent the sponsor from ensuring the product’s identity, strength, quality and purity. The product is deemed adulterated under current manufacturing standards.
Industry Context
This recall is not presented as part of a broader industry pattern.
Real-World Impact
Patients relying on this therapy could be affected if the product does not meet quality standards. No injuries reported yet, but adulteration risk warrants stopping use and seeking guidance.
Practical Guidance
How to identify if yours is affected
- Check NDC on bottle: 60687-695-01
- Check carton NDC: 60687-695-11
- Identify Lot numbers: 1017392 or 1017415
- Check Expiration Dates: 01/31/2026 and 12/31/2025
Where to find product info
Recall letter and FDA enforcement page list affected lots and disposal/return instructions
What timeline to expect
Refunds or replacements, if offered, will be communicated via recall notification letter; no specific timeline published
If the manufacturer is unresponsive
- File a formal complaint with the FDA if the company is unresponsive
- Consult your pharmacist or physician for alternatives
- Keep records of all correspondence
How to prevent similar issues
- Always verify NDC numbers when dispensing or purchasing sucralfate
- Ask for current lot numbers and expiration dates from pharmacies
- Avoid purchasing recalled lots in the future; verify packaging before use
Documentation advice
Keep the recall notice, take photos of packaging, save purchase receipts, document lot numbers and expiration dates, log any adverse events
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Product Details
Product: Sucralfate Tablets, USP 1 g, 100 tablets, (10x10) Rx Only NDC: 60687-695-01 Carton NDC: 60687-695-11 Distributor: American Health Packaging, Columbus, OH 43217 Quantity recalled: 27,868 blister packs Distribution: Nationwide in the United States Recall date: 2025-10-09 Status: Active Brand: Sucralfate Lot numbers/Exp dates: Lot 1017392 — Exp 01/31/2026; Lot 1017415 — Exp 12/31/2025
Reported Incidents
No injuries or incidents have been reported.
Key Facts
- 27,868 blister packs affected
- NDC 60687-695-01 on primary packaging
- Lot numbers 1017392 and 1017415 with Expirations 01/31/2026 and 12/31/2025
- Distributed nationwide in the United States
- Recall status: Active
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Safety Guide
Not sure what to do next? Our guide walks you through the process step by step.
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