Infants* Ibuprofen recalls

The FDA has published 6 recalls involving Infants* Ibuprofen since 2018. The latest was reported on 20 Feb 2019. Most were for potency & assay. Recalls usually affect specific lots, not every bottle on the market. Check the lot number on each recall page before acting.

Total recalls6since 2018

Last 12 months0reported

Class I00% of total

Ongoing0latest 20 Feb 2019

Recalls per month, last 24 months

click a bar for that month

0Dec '24 0 0 0Mar 0 0 0Jun 0 0 0Sep 0 0 0Dec 0 0 0Mar 0 0 0Jun 0 0 0Sep 0 0

Severity split

Class I 0 0%Class II 6 100%Class III 0 0%

Why infants* ibuprofen is recalled

Potency & Assay6100%

Companies

Tris Pharma6100%

By year

2019350%
2018350%

All infants* ibuprofen recalls, newest first

6 total

Reported	Class	Recall	Company	Reason	Where
20 Feb 2019Drug	CLASS II	Infants' Ibuprofen, Concentrated Ibuprofen Oral Suspension recalled	Tris Pharma	Potency & Assay	Nationwide
20 Feb 2019Drug	CLASS II	Infants' Ibuprofen, Concentrated Ibuprofen Oral Suspension recalled	Tris Pharma	Potency & Assay	Nationwide
20 Feb 2019Drug	CLASS II	infants* Ibuprofen, Concentrated Ibuprofen Oral Suspension recalled	Tris Pharma	Potency & Assay	Nationwide
26 Dec 2018Drug	CLASS II	Infants' Ibuprofen, Concentrated Ibuprofen Oral Suspension recalled	Tris Pharma	Potency & Assay	Nationwide
26 Dec 2018Drug	CLASS II	Infants' Ibuprofen, Concentrated Ibuprofen Oral Suspension recalled	Tris Pharma	Potency & Assay	Nationwide
26 Dec 2018Drug	CLASS II	infants* Ibuprofen, Concentrated Ibuprofen Oral Suspension recalled	Tris Pharma	Potency & Assay	Nationwide

Should you stop taking Infants* Ibuprofen?

Not on your own. Most recalls affect specific lots from one manufacturer, and stopping a prescription suddenly can be riskier than the defect. Check your lot number and NDC against the recall, then call the pharmacy that dispensed it for a replacement.