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Product safetyFDAUnited StatesImports

Determination That CARAFATE (Sucralfate) Oral Suspension, 1 Gram/10 Milliliters, Was Not Withdrawn From Sale for Reasons of Safety or Effectiveness

2 September 2026

In plain English

FDA has determined CARAFATE (sucralfate) oral suspension, 1 g/10 mL, was not withdrawn for safety or effectiveness reasons, allowing continued approval of ANDAs referencing this product.

Read the official notice
Topic
Product safety
Regulator
FDA
Published
2 September 2026
For
Imports
Where it applies
United States
Source
FDA (Food and Drug Administration)

From the notice

The Food and Drug Administration (FDA, Agency, or we) has determined that CARAFATE (sucralfate) oral suspension, 1 gram (g)/10 milliliters (mL), was not withdrawn from sale for reasons of safety or effectiveness. This determination means that FDA will not begin procedures to withdraw approval of abbreviated new drug applications (ANDAs) that refer to this drug product, and it will allow FDA to continue to approve ANDAs that refer to the product as long as they meet relevant legal and regulato
The full text is at the source

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