CLASS II Drug recall · Reported 20 Feb 2019 · FDA Enforcement Report

Infants' Ibuprofen, Concentrated Ibuprofen Oral Suspension recalled

Tris Pharma is recalling Infants' Ibuprofen, Concentrated Ibuprofen Oral Suspension, USP, (Nsaid), 50 mg per, Dye, distributed nationwide in the US. The recall was initiated on 15 Jan 2019 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesLot#: 00717006A, Exp 02/19

Quantity recalled35,280 bottles

Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.

Recall details

Recall number: D-0495-2019
FDA event ID: 81960
Recalling firm: Tris Pharma, Monmouth Junction, NJ
Classification: Class II
Status: Terminated
Recall initiated: 15 Jan 2019
FDA classified: 14 Feb 2019
Reported: 20 Feb 2019
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Potency & Assay
Drug class: Pain Medication

Timeline

15 Jan 2019	Recall initiated by company
14 Feb 2019	Classified by FDA	+30 days
20 Feb 2019	Published in enforcement report	+6 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

Reason for recall

Superpotent Drug: recalled lots may have higher concentration of ibuprofen than amount labeled.

Potency and specification recalls happen when a batch tests outside its approved limits for strength, purity or dissolution, which can mean the dose delivered is higher or lower than labelled.

Product as listed by the FDA

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.

Where it was distributed

One distributor who further distributed Nationwide in the USA.

Nationwide

Stores named: CVS

Questions about this recall

Why was it recalled?

Superpotent Drug: recalled lots may have higher concentration of ibuprofen than amount labeled.

Which lots are affected?

Lot#: 00717006A, Exp 02/19

Where was it sold?

One distributor who further distributed Nationwide in the USA.

What should I do if I have it?

Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.

What does Class II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

Other products in this recall event

2 other products · FDA event 81960

This product is part of a recall event; the main page for the event is infants* Ibuprofen, Concentrated Ibuprofen Oral Suspension recalled.

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

More recalls from Tris Pharma

All 8

Reported	Class	Recall	Company	Reason	Where
31 Jul 2019Drug	CLASS II	Hydrocodone Polistirex and Chlorpheniramine Polistirex recalledHydrocodone Polistirex And Chlorpheniramine Polistirex	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

Other Infants' Ibuprofen recalls

All 6

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
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