Tris Pharma Inc. recalls infants* IBUPROFEN, Concentrated Ibuprofen Oral Suspension, USP (NSAID), 50 mg per 1.25 mL, Dye-Free Berry Flavor, 1 FL
Tris Pharma recalls infant ibuprofen oral suspension with possible higher concentration than labeled. Consumers should check product details and contact the company for guidance.
Use caution until it’s fixed
Superpotent Drug: recalled lots may have higher concentration of ibuprofen than amount labeled.
Contact the company & request your remedy
What happened, in plain English
Tris Pharma is recalling infant ibuprofen oral suspension products that may contain higher ibuprofen concentrations than labeled. This could lead to overdose risk if used as directed. Read more at govinfonow.com/recall/39242-tris-pharma-recalls-infant-ibuprofen-suspension-due-to-potential-overdose.
Source Summary by GovInfoNow · govinfonow.com/recall/39242-tris-pharma-recalls-infant-ibuprofen-suspension-due-to-potential-overdose · Updated October 5, 2026 · FDA enforcement record: FDA #D-0494-2019
Cite this page
“Tris Pharma recalls infant ibuprofen suspension due to potential overdose risk.” GovInfoNow, updated October 5, 2026. https://govinfonow.com/recall/39242-tris-pharma-recalls-infant-ibuprofen-suspension-due-to-potential-overdose. Based on FDA recall #D-0494-2019 (https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0494-2019%22&limit=1).
Why it’s dangerous
The recalled product may have a higher concentration of ibuprofen than what's labeled. This could cause overdose if the product is used as directed, especially in infants.
Who’s affected
Parents or caregivers of infants who use this product are most at risk. The recall affects specific lots of the concentrated ibuprofen suspension.
How to tell if you have this one
Check for the product name 'Concentrated Ibuprofen Oral Suspension, USP (NSAID), 50 mg per 1.25 mL, Dye-Free Berry Flavor' on the bottle. The lot number 00717005A with expiration date 02/19 is affected.
- Brand
Tris Pharma- 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 who further distributed Nationwide in the USA.
| Recall number | Product, codes & lots | Quantity |
|---|---|---|
| D-0493-2019 | 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, NDC 59779-925-23.; Lot#: 4718, Exp 12/19 | 46,080 bottles |
| D-0494-2019 | 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.; Lot#: 00717005A, Exp 02/19 | 35,328 bottles |
| D-0495-2019 | Infants' Ibuprofen, Concentrated Ibuprofen Oral Suspension, USP, (NSAID), 50 mg per 1.25 mL, Dye Free, Non-staining Berry Flavor, 1 FL OZ (30 mL) bottle, Distributed by: CVS Pharmacy, Inc., One CVS Drive, Woonsocket, RI 02895, UPC 0 50428 39961 3, NDC 50428-1252-4.; Lot#: 00717006A, Exp 02/19 | 35,280 bottles |
What to do — step by step
Check Product Details
Look for the product name and lot number 00717005A with expiration date 02/19 on the bottle.
Questions people ask
Is this product safe to use?
The recall indicates potential higher concentration than labeled, so it's not safe to use as directed without checking the recall details.
How can I tell if I have the recalled product?
Check for the product name 'Concentrated Ibuprofen Oral Suspension, USP (NSAID), 50 mg per 1.25 mL, Dye-Free Berry Flavor' and lot number 00717005A with expiration date 02/19.
What should I do if I have the recalled product?
The recall does not specify a remedy, so contact Tris Pharma for guidance on safe handling.
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-0494-2019 — Tris Pharma Tris Pharma Hello, I own a Tris Pharma that is covered by recall D-0494-2019 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-0494-2019 (January 15, 2019) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for D-0494-2019 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.