Tris Pharma Inc. recalls infants* IBUPROFEN, Concentrated Ibuprofen Oral Suspension, USP (NSAID), 50 mg per 1.25 mL, Dye-Free Berry Flavor, 0.5
Tris Pharma recalls infants' concentrated ibuprofen oral suspension with potential higher ibuprofen concentration. Consumers should check product labels for specific lot numbers and expiration dates to avoid risks.
Lower-risk recall
Superpotent Drug: recalled lots may have higher concentration of ibuprofen.
Contact the company & request your remedy
What happened, in plain English
Tris Pharma is recalling concentrated ibuprofen oral suspension for infants because some batches may contain higher-than-intended ibuprofen levels. This could lead to overdose risks if used incorrectly. Read more at govinfonow.com/recall/39411-tris-pharma-recalls-concentrated-ibuprofen-for-infants-due-to-high.
Source Summary by GovInfoNow · govinfonow.com/recall/39411-tris-pharma-recalls-concentrated-ibuprofen-for-infants-due-to-high · Updated October 5, 2026 · FDA enforcement record: FDA #D-0335-2019
Cite this page
“Tris Pharma recalls concentrated ibuprofen for infants due to high drug concentration.” GovInfoNow, updated October 5, 2026. https://govinfonow.com/recall/39411-tris-pharma-recalls-concentrated-ibuprofen-for-infants-due-to-high. Based on FDA recall #D-0335-2019 (https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0335-2019%22&limit=1).
Why it’s dangerous
The product may have a higher concentration of ibuprofen than labeled, which could cause overdose if given to infants. This is especially concerning because infants metabolize medications differently and are more vulnerable to side effects.
Who’s affected
Parents or caregivers of infants using this specific ibuprofen suspension. Infants are most at risk due to their small body size and sensitivity to medication.
How to tell if you have this one
Check the product label for the following: 0.5 FL OZ (15 mL) bottle, Dye-Free Berry Flavor, and lot numbers 00717009A (exp 02/19), 00717015A (exp 04/19), or 00717024A (exp 08/19).
- Brand
Tris Pharma- Product
infants* IBUPROFEN, Concentrated Ibuprofen Oral Suspension, USP (NSAID), 50 mg per 1.25 mL, Dye-Free Berry Flavor, 0.5- Category
Drug
All 3 products in this recall
FDA lists each product line separately under one recall event. Check your product description, lot or code numbers against each row. Every row shares the hazard and remedy on this page.
- Classification
Class II- Status
Terminated- Distribution
One distributor in PA who further distributed Nationwide in the USA.
| Recall number | Product, codes & lots | Quantity |
|---|---|---|
| D-0335-2019 | infants* IBUPROFEN, Concentrated Ibuprofen Oral Suspension, USP (NSAID), 50 mg per 1.25 mL, Dye-Free Berry Flavor, 0.5 FL OZ (15 mL) bottle, Distributed by Wal-Mart Stores, Inc., Bentonville, AR 72716, NDC 49035-125-23, UPC 0 78742 02016 7.; Lot #: 00717009A, Exp 02/19; 00717015A, Exp 04/19; 00717024A, Exp 08/19 | 164,304 bottles |
| D-0336-2019 | Infants' Ibuprofen, Concentrated Ibuprofen Oral Suspension, USP, (NSAID), 50 mg per 1.25 mL, Dye-Free Non-Staining Berry Flavor, 0.5 FL OZ (15 mL) bottle, Distributed by Family Dollar Services, Inc., 10301 Monroe Road, Matthews, NC 28105, NDC 55319-250-23, UPC 0 32251 03374 2.; Lot #: 00717024A, Exp 08/19 | 19,488 bottles |
| D-0337-2019 | Infants' Ibuprofen, Concentrated Ibuprofen Oral Suspension, USP, (NSAID), 50 mg per 1.25 mL, Dye Free, Non-staining Berry Flavor, 0.5 FL OZ (15 mL) bottle, Distributed by: CVS Pharmacy, Inc., One CVS Drive, Woonsocket, RI 02895, UPC 0 50428 39338 3.; Lot #: 00717024A, Exp 08/19 | 20,736 bottles |
What to do — step by step
Check Product Label
Look for the lot numbers 00717009A, 00717015A, or 00717024A with specific expiration dates.
Questions people ask
Why is this product being recalled?
The recall is due to potential higher concentrations of ibuprofen in some batches, which could lead to overdose risks in infants.
How can I tell if my product is affected?
Check the label for the lot numbers 00717009A (exp 02/19), 00717015A (exp 04/19), or 00717024A (exp 08/19).
What should I do if I have the recalled product?
The recall record does not specify a remedy, so contact Tris Pharma directly for guidance.
Contact Tris Pharma
We’ve drafted a message you can send Tris Pharma to request your refund or repair — edit it as you like.
Subject: Recall D-0335-2019 — Tris Pharma infants* IBUPROFEN, Concentrated Ibuprofen Oral Suspension, USP (NSAID), 50 mg per 1.25 Hello, I own a infants* IBUPROFEN, Concentrated Ibuprofen Oral Suspension, USP (NSAID), 50 mg per 1.25 mL, Dye-Free Berry Flavor, 0.5 that is covered by recall D-0335-2019 from Tris Pharma. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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Where this comes from
The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
- Official source: FDA Recall #D-0335-2019 (November 26, 2018) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for D-0335-2019 to see it in context.
- Plain-language summary written by qwen3:4b on October 5, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
- GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.