infants* IBUPROFEN, Concentrated Ibuprofen Oral Suspension, USP (NSAID), 50 mg per 1.25 mL, Dye-Free Berry Flavor, 1 FL OZ (30 mL) bottle, Distributed by Wal-Mart Stores, Inc., Bentonville, AR 72716, NDC 49035-125-24.
Class I - DangerousWhat Should You Do?
- Check if you have this product: Lot#: 00717005A, Exp 02/19
- Do not eat it: Even if it looks and smells fine, do not consume this product.
- Throw it away or return it: You can return the product to the store for a full refund.
- Seek medical attention if needed: If you've consumed this product and feel unwell, contact your doctor immediately.
- Report problems: Report any issues to the FDA's Safety Reporting Portal.
⚠️ Emergency: If you experience severe symptoms after consuming this product, call 911 or Poison Control at 1-800-222-1222.
Recall Details
- Company:
- Tris Pharma Inc.
- Reason for Recall:
- Superpotent Drug: recalled lots may have higher concentration of ibuprofen than amount labeled.
- Classification:
- Class I - Dangerous
Dangerous or defective products that predictably could cause serious health problems or death.
- Status:
- terminated
Product Information
Full Description:
infants* IBUPROFEN, Concentrated Ibuprofen Oral Suspension, USP (NSAID), 50 mg per 1.25 mL, Dye-Free Berry Flavor, 1 FL OZ (30 mL) bottle, Distributed by Wal-Mart Stores, Inc., Bentonville, AR 72716, NDC 49035-125-24.
Product Codes/Lot Numbers:
Lot#: 00717005A, Exp 02/19
Official Source
Always verify recall information with the official FDA source:
View on FDA.govFDA Recall Number: D-0494-2019
Related Recalls
Superpotent Drug and Failed Stability Specifications: High out-of-specification results for the active ingredients, hydrocodone and chlorpheniramine, as well as high out-of-specification results for the preservatives.
Superpotent Drug: recalled lots may have higher concentration of ibuprofen than amount labeled.
Superpotent Drug: recalled lots may have higher concentration of ibuprofen than amount labeled.