Sucralfate Oral Suspension, 1g per 10mL, 16 oz (414 mL) PET bottle (12 bottles per case), Rx Only...
FDA Drug Recall #D-0047-2024 — Class I — October 18, 2023
Recall Summary
| Recall Number | D-0047-2024 |
| Classification | Class I — Serious risk |
| Date Initiated | October 18, 2023 |
| Status | Terminated |
| Voluntary | Voluntary: Firm initiated |
Recalling Firm
| Firm | VistaPharm LLC |
| Location | Largo, FL |
| Product Type | Drugs |
| Quantity | 180 bottles |
Product Description
Sucralfate Oral Suspension, 1g per 10mL, 16 oz (414 mL) PET bottle (12 bottles per case), Rx Only, Manufactured and Distributed by: VistaPharm, Inc. Largo, FL 33771 USA, NDC 66689-305-16
Reason for Recall
Microbial Contamination of Non-Sterile Products: identified as Bacillus cereus.
Distribution Pattern
USA Nationwide
Lot / Code Information
Lot#: 810300, Exp 10/2023
Other Recalls from VistaPharm LLC
| Recall # | Classification | Product | Date |
|---|---|---|---|
| D-0093-2024 | Class III | Mycophenolate Mofetil for Oral Suspension, USP,... | Oct 26, 2023 |
| D-0126-2024 | Class III | Aminocaproic Acid Oral Solution, 0.25 grams/mL,... | Oct 17, 2023 |
| D-1149-2023 | Class II | Sucralfate Oral Suspension 1g per 10mL, FOR ORA... | Aug 30, 2023 |
Frequently Asked Questions
Injectable drugs and eye drops must be completely free of microbial contamination because they bypass the body's natural defenses. A contaminated injectable can introduce bacteria or fungi directly into the bloodstream, potentially causing sepsis, meningitis, or localized infections — all of which can be life-threatening. Contamination of sterile products almost always results in a Class I recall. If you received an injectable drug from a recalled lot, contact your healthcare provider immediately, even if you feel well, as some infections can have delayed onset.
Not necessarily. Many drug recalls are initiated because of quality system failures or test results that suggest a product might not meet specifications — even if no patients have reported harm. The FDA uses a precautionary approach: if there is reason to believe quality standards were not met, a recall is required regardless of whether adverse effects have been reported. Class I recalls typically involve a reasonable probability of harm; Class II recalls may cause temporary health issues; Class III recalls are for products unlikely to cause adverse health consequences but that still violate regulations.
Pharmacies typically receive recall notices directly from drug wholesalers and manufacturers within days of the recall being announced. Your pharmacist can look up whether any product in your prescription history matches a recalled lot number. For current recalls, the FDA publishes updates at FDA.gov/safety/recalls-market-withdrawals-safety-alerts and sends MedWatch email alerts for significant drug safety issues. You can sign up for MedWatch alerts at FDA.gov. Most major pharmacy chains also have their own recall notification systems that automatically alert pharmacists when a recalled product is in their inventory.
What Should You Do?
Stop using this medication if affected by this recall. Contact your pharmacist or prescribing doctor immediately for guidance. Do not flush medications — use a drug take-back program.