Quality issue
Medications
FDA
Is the infants IBUPROFEN, Concentrated Ibuprofen Oral… safe?
Tris Pharma Inc. · Recalled Nov 26, 2018
No — the infants IBUPROFEN, Concentrated Ibuprofen Oral… was recalled on Nov 26, 2018 due to a potency/quality issue. May be stronger than labeled, which could lead to accidental overdose. If you have this product: This product may not work as intended (it may be weaker or stronger than labeled). Stop using it and replace it with an unaffected product. Ask your pharmacist or pediatrician if you have dosing concerns.
Why it was recalled
May be stronger than labeled, which could lead to accidental overdose.
What to do
This product may not work as intended (it may be weaker or stronger than labeled). Stop using it and replace it with an unaffected product. Ask your pharmacist or pediatrician if you have dosing concerns.
View the official FDA recall →
This is an official recall published by FDA. Recall details are current as of 2026-06-25; verify the latest status at the source.
infants IBUPROFEN, Concentrated Ibuprofen Oral…: common questions
Is the infants IBUPROFEN, Concentrated Ibuprofen Oral… safe?
No. The infants IBUPROFEN, Concentrated Ibuprofen Oral… was recalled on Nov 26, 2018 due to a potency/quality issue. May be stronger than labeled, which could lead to accidental overdose.
Has the infants IBUPROFEN, Concentrated Ibuprofen Oral… been recalled?
Yes. The infants IBUPROFEN, Concentrated Ibuprofen Oral… was recalled on Nov 26, 2018. The recall was issued by FDA (recall ID D-0335-2019).
Why was the infants IBUPROFEN, Concentrated Ibuprofen Oral… recalled?
May be stronger than labeled, which could lead to accidental overdose.
What should I do if I have the infants IBUPROFEN, Concentrated Ibuprofen Oral…?
This product may not work as intended (it may be weaker or stronger than labeled). Stop using it and replace it with an unaffected product. Ask your pharmacist or pediatrician if you have dosing concerns.
Where can I find the official recall notice for the infants IBUPROFEN, Concentrated Ibuprofen Oral…?
The official FDA recall record is available
here. Always verify recall details with the official source.
TinySafe is an independent app and is not affiliated with, endorsed by, or sponsored by the FDA or CPSC. Always confirm recall details with the official source. The absence of a recall does not guarantee a product is safe.
