Quick Facts at a Glance
- Recall Date
- July 29, 2025
- Hazard Level
- HIGH
- Brands
- SUCRALFATE, American Health Packaging
- Category
- Health & Personal Care
- Sold At
- Unknown
- Geographic Scope
- 1 states
- At-Risk Groups
- GENERAL, PREGNANT, PREGNANT
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 Tablets
- Model numbers
- Lot 1015038, Lot 1015898, Lot 1016873, Lot 1023398
- UPC codes
- 60687-695, 60687-695-11, 60687-695-01
- Sizes
- 1 gram tablets
- Sold at
- Unknown
- Where affected
- ALL
Recall Timeline
Key dates and source checks for this recall record.
Recall announced
July 29, 2025
Reported by FDA DRUG
September 3, 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 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.
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 tablets are used to treat ulcers and gastritis by creating a protective barrier in the stomach.
Why This Is Dangerous
CGMP deviations mean the product identity, strength, quality and purity cannot be assured, potentially exposing patients to adulterated medication.
Industry Context
This recall is not described as part of a broader industry pattern in the summary.
Real-World Impact
Consumers may face ineffective treatment due to adulterated product and potential safety concerns; affected patients should contact providers for guidance.
Practical Guidance
How to identify if yours is affected
- Check NDC 60687-695-01 on carton and 60687-695-11 on unit dose
- Confirm packaging shows distributor American Health Packaging, Columbus, OH
Where to find product info
FDA recall page and enforcement report D-0598-2025 at accessdata.fda.gov
What timeline to expect
Refunds or replacements coordinated by Amerisource Health Services LLC; timelines not specified
If the manufacturer is unresponsive
- Escalate to FDA MedWatch if manufacturer is unresponsive
- Consult healthcare provider for interim treatment guidance
How to prevent similar issues
- Verify CGMP compliance before purchasing drugs
- Check for recalls on FDA recalls database
- Buy from reputable pharmacies with clear lot tracking
Documentation advice
Keep recall notification letters, product packaging, lot numbers, and correspondence with healthcare providers
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Product Details
Product: Sucralfate Tablets, USP 1 gram, 100 tablets per package (10x10). Distributor: American Health Packaging, Columbus, OH 43217. NDC 60687-695-01 carton; Unit Dose NDC 60687-695-11. Quantity recalled: 26,992 blister packs. Distribution: Nationwide. Classification: Class II. Recall date: 2025-07-29. Status: Active.
Reported Incidents
No specific injuries or incidents are described in the notice. The recall notice uses regulatory language rather than incident counts.
Key Facts
- 26,992 blister packs recalled
- CGMP Deviations cited due to Chapter 11 filing
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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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