Determination That CARAFATE (Sucralfate) Oral Suspension, 1 Gram/10 Milliliters, Was Not Withdrawn From Sale for Reasons of Safety or Effectiveness
FDA confirms CARAFATE (sucralfate) oral suspension remains on the market, not withdrawn for safety or effectiveness reasons.
Aforeworn detected this change in the Pharmaceutical Manufacturing (FDA/DEA) space on September 2, 2026 and published this briefing so affected operators are forewarned rather than caught off guard. It is rated Medium urgency. Branded drug makers, generic/ANDA manufacturers, API & contract manufacturers, compounding outsourcing (503B). should confirm how it applies to their specific situation before acting. There is a time constraint attached: N/A. Acting after that point can mean penalties, a lapsed licence, or lost eligibility — exactly the kind of surprise Aforeworn exists to prevent. Aforeworn monitors Pharmaceutical Manufacturing (FDA/DEA) continuously and turns every detected change into a plain-English briefing like this one, so you always know first. Forewarned is forearmed.
What changed
The FDA's determination that CARAFATE is still available for sale, ensuring continued market access.
Who it affects
Branded drug makers, generic/ANDA manufacturers, API & contract manufacturers, compounding outsourcing (503B).
What you must do
Review product lines and ensure compliance with current manufacturing and distribution practices for CARAFATE.
Deadline
N/A
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