Severity
Moderate
ModerateClass IITerminated
FDA Drug recall · Reported December 26, 2018
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.
Superpotent Drug: recalled lots may have higher concentration of ibuprofen.
Compiled from official public sources by the editorial team.
Verify with FDA Drug →
Tris Pharma Inc. recalled infants* IBUPROFEN, Concentrated Ibuprofen Oral Suspension, USP (NSAID), 50 mg per 1.25 m… - a moderate-severity action.
infants* IBUPROFEN, Concentrated Ibuprofen Oral Suspension, USP (NSAID), 50 mg per 1.25 m… was recalled by Tris Pharma Inc. in December 26, 2018. Reason: Superpotent Drug: recalled lots may have higher concentration of ibuprofen.. Check the official notice for the remedy. Verify recall #D-0335-2019 with the FDA Drug before acting.
The recall
Tris Pharma Inc. issued this moderate-severity FDA Drug recall-Superpotent Drug: recalled lots may have higher concentration of ibuprofen..
- Moderate
- severity level
- Class II
- classification
- December 26, 2018
- reported
Sourced from official FDA Drug enforcement records. Verify recall #D-0335-2019 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.
Recall Insight
This FDA Drug action (record #D-0335-2019) was formally reported on December 26, 2018, with the manufacturer initiating the action on November 26, 2018. It is classified under Moderate severity (Class II), with a current status of Terminated. Tris Pharma Inc. is listed as the recalling firm, operating out of Monmouth Junction, NJ. Federal records list the affected scope as 164,304 bottles.
The documented reason for this recall is: Superpotent Drug: recalled lots may have higher concentration of ibuprofen. Distribution data in the federal record shows the product reached: One distributor in PA who further distributed Nationwide in the USA.. Distribution scope directly affects the consumer exposure window and determines whether a recall remains regional or escalates into a nationwide advisory.
Within the same product category the archive holds 6 closely related recalls, 5 from FDA Drug - clustering in a narrow category often points to a systemic quality-control or supplier issue rather than a one-off defect. Always verify the recall number against the official agency record before acting.
Drugs & Medications recalls over time
Where this recall sits in its category - 14,287 drugs & medications recalls on record
Of 101,704 recalls in the database, 24,878 are high severity, 72,426 moderate, and 4,400 low. This recall is classified moderate severity.
Counts reflect market size and reporting activity, not inherent danger, we do not rank products by risk from raw recall volume.
Affected scope
164,304 bottles
Related Recalls
6
5 from same agency
Product description
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.
Reason for recall
Superpotent Drug: recalled lots may have higher concentration of ibuprofen.
Recall Profile
| Attribute | Value |
|---|---|
| Agency | U.S. Food and Drug Administration |
| Severity class | Moderate (Class II) |
| Status | Terminated |
| Recall number | D-0335-2019 |
| Date reported | December 26, 2018 |
| Date initiated | November 26, 2018 |
| Recalling firm | Tris Pharma Inc. |
| Firm location | Monmouth Junction, NJ |
| Affected scope | 164,304 bottles |
| Distribution | One distributor in PA who further distributed Nationwide in the USA. |
Profile values are sourced directly from the official FDA Drug enforcement record. Source: U.S. Food and Drug Administration.
What to do with this recall
Match your product against the recall record, then act on the agency remedy.
- Check the recall number (D-0335-2019) and product description against the item you own. Search the archive
- Confirm the current status with FDA Drug before acting, recall details can be updated.
- Follow the documented remedy (refund, replacement, repair, or disposal) rather than general advice. What to do next
This page summarizes the official FDA Drug record for research and awareness; it is not legal, medical, or safety advice. Verify with the issuing agency before acting.
Frequently Asked Questions
What product was recalled? ▼
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.. Recalled by Tris Pharma Inc.. Units affected: 164,304 bottles.
Why was this product recalled? ▼
Superpotent Drug: recalled lots may have higher concentration of ibuprofen.
Which agency issued this recall? ▼
This recall was issued by the FDA Drug on December 26, 2018. Severity: Moderate. Recall number: D-0335-2019.
Where was the recalled product distributed? ▼
Distribution: One distributor in PA who further distributed Nationwide in the USA..
How do I check if my product is affected by a recall? ▼
Check the product description and recall number (D-0335-2019) against your product. Visit the official FDA Drug website for the most current information. You can also use our Recall Checker tool to search by product name or brand.
Should I stop using a recalled medication or medical device? ▼
Do not stop using a recalled medication or device without consulting your healthcare provider first, as abruptly discontinuing treatment could pose its own health risks. Your doctor can advise on alternatives or whether the recall applies to your specific product lot. Check the recall number and lot information against your product packaging.
Nearby Recalls in This Category
Other recalls in the same product category, useful for spotting patterns across the same defect class or manufacturer.
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Compare this recall with PRED MILD, prednisolone acetate ophthalmic suspension, USP,… →
Every figure on PlainRecalls is rendered directly from official FDA, CPSC and NHTSA recall records, no number is typed in by an editor. This recall: FDA Drug, reported December 26, 2018. Severity classes follow each agency's own taxonomy (FDA Class I/II/III; CPSC and NHTSA by hazard type), and related-recall context is computed across the full archive. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error. Data current as of July 2026.