Prescription Drug Sucralfate Suspension Recalled for Out-of-Specification Potency
VistaPharm LLC is recalling Sucralfate Oral Suspension 1g/10mL due to out-of-specification assay results. The active ingredient concentration does not meet FDA specifications in approximately 14,400 affected bottles distributed nationwide.
The agency’s classification
FDA (Drugs): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: FDA Class II recall for a prescription drug with out-of-specification potency is a risk-of-harm situation. No illnesses or injuries have been reported, but deviation from specification poses potential safety risks including treatment failure if subpotent or adverse effects if superpotent.
Plain-English summary
VistaPharm LLC is recalling Sucralfate Oral Suspension 1g per 10mL due to out-of-specification assay results. The affected product, lot number 921100 (expiration February 2025), was distributed nationwide to 68 consignees, with approximately 14,400 bottles involved.
Out-of-specification assay results indicate the actual concentration of the active ingredient does not meet FDA specifications. The product may be either superpotent (higher concentration) or subpotent (lower concentration) than labeled.
Consumers who have purchased this product should stop use and consult their pharmacist or healthcare provider. Do not discontinue prescribed medication without medical guidance.
The recalled product
- Product
- SUCRALFATE (SUCRALFATE)
- Brand
- SUCRALFATE
- Manufacturer
- VistaPharm LLC
- Category
- Drug — Oral suspension
- Hazard
- Affected units
- 14,400
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (2)
- Lot #: 921100
- Exp. 02/2025
UPCs (1)
- 0366689305165
Distribution
Distributed nationwide across the United States.
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