CLASS II Drug recall · Reported 26 Dec 2018 · 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 26 Nov 2018 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-0335-2019
- FDA event ID
- 81354
- Recalling firm
- Tris Pharma, Monmouth Junction, NJ
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 26 Nov 2018
- FDA classified
- 17 Dec 2018
- Reported
- 26 Dec 2018
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Potency & Assay
- Drug class
- Pain Medication
Timeline
| 26 Nov 2018 | Recall initiated by company | |
| 17 Dec 2018 | Classified by FDA | +21 days |
| 26 Dec 2018 | Published in enforcement report | +9 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.
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, 0.5 FL OZ (15 mL) bottle, Distributed by Wal-Mart Stores, Inc., Bentonville, AR 72716, NDC 49035-125-23, UPC 0 78742 02016 7.
Where it was distributed
One distributor in PA 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.
Which lots are affected?
Lot #: 00717009A, Exp 02/19; 00717015A, Exp 04/19; 00717024A, Exp 08/19
Where was it sold?
One distributor in PA 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 81354| 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 |