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, 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
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-0494-2019
- 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 Berry Flavor, 1 FL OZ (30 mL) bottle, Distributed by Wal-Mart Stores, Inc., Bentonville, AR 72716, NDC 49035-125-24.
Where it was distributed
One distributor who further distributed Nationwide in the USA.
Stores named: Walmart
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#: 00717005A, 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| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| CLASS II | Infants' Ibuprofen, Concentrated Ibuprofen Oral Suspension recalled | Tris Pharma | Potency & Assay | Nationwide | |
| 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 |
|---|---|---|---|---|---|
| Drug | CLASS II | Hydrocodone Polistirex and Chlorpheniramine Polistirex recalledHydrocodone Polistirex And Chlorpheniramine Polistirex | Tris Pharma | Potency & Assay | Nationwide |
| Drug | CLASS II | Infants' Ibuprofen, Concentrated Ibuprofen Oral Suspension recalled | Tris Pharma | Potency & Assay | Nationwide |
| Drug | CLASS II | Infants' Ibuprofen, Concentrated Ibuprofen Oral Suspension recalled | Tris Pharma | Potency & Assay | Nationwide |
| Drug | CLASS II | Infants' Ibuprofen, Concentrated Ibuprofen Oral Suspension recalled | Tris Pharma | Potency & Assay | Nationwide |
| Drug | 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 |
|---|---|---|---|---|---|
| Drug | CLASS II | Infants' Ibuprofen, Concentrated Ibuprofen Oral Suspension recalled | Tris Pharma | Potency & Assay | Nationwide |
| Drug | CLASS II | Infants' Ibuprofen, Concentrated Ibuprofen Oral Suspension recalled | Tris Pharma | Potency & Assay | Nationwide |
| Drug | CLASS II | Infants' Ibuprofen, Concentrated Ibuprofen Oral Suspension recalled | Tris Pharma | Potency & Assay | Nationwide |
| Drug | CLASS II | Infants' Ibuprofen, Concentrated Ibuprofen Oral Suspension recalled | Tris Pharma | Potency & Assay | Nationwide |
| Drug | CLASS II | infants* Ibuprofen, Concentrated Ibuprofen Oral Suspension recalled | Tris Pharma | Potency & Assay | Nationwide |