Skip to content
Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 81354

3 recalled-product records grouped only because every row carries this exact official event ID.

Open FDA event record

Event summary

Timeline bucket
November 26, 2018
Product types
Drug
Classifications
Class II
Statuses
Terminated
Recalling firm wording
Tris Pharma Inc.

Dossier provenance

Source snapshots represented here

  • openFDA Drug Enforcement Report-date coverage June 20, 2012–July 08, 2026 Known gap: openFDA describes 2004-present coverage, but the current export has no report-date records in this interval.

Enforcement coverage uses report dates; product initiation dates can precede those bounds. Device-enrichment coverage uses FDA event_date_initiated.

How coverage and grouping work

Complete imported group

Every recalled product in this event

3 official enforcement rows

Product dates, classifications, firms, and source wording remain attached to their individual rows. Opening this dossier never hides products that did not match a prior timeline filter.

drug · product 1 of 3

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.

D-0335-2019
Recall number
D-0335-2019
Initiated
November 26, 2018
Classification
Class II
Status
Terminated
Recalling firm
Tris Pharma Inc.
Quantity
164,304 bottles

App-derived interpretation

Potency or specification failure reason.potency_specification_failure · v1.0.0
Superpotent

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

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

Code information

Lot #: 00717009A, Exp 02/19; 00717015A, Exp 04/19; 00717024A, Exp 08/19

Distribution pattern

One distributor in PA who further distributed Nationwide in the USA.

drug · product 2 of 3

Infants' Ibuprofen, Concentrated Ibuprofen Oral Suspension, USP, (NSAID), 50 mg per 1.25 mL, Dye-Free Non-Staining Berry Flavor, 0.5 FL OZ (15 mL) bottle, Distributed by Family Dollar Services, Inc., 10301 Monroe Road, Matthews, NC 28105, NDC 55319-250-23, UPC 0 32251 03374 2.

D-0336-2019
Recall number
D-0336-2019
Initiated
November 26, 2018
Classification
Class II
Status
Terminated
Recalling firm
Tris Pharma Inc.
Quantity
19,488 bottles

App-derived interpretation

Potency or specification failure reason.potency_specification_failure · v1.0.0
Superpotent

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

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

Code information

Lot #: 00717024A, Exp 08/19

Distribution pattern

One distributor in PA who further distributed Nationwide in the USA.

drug · product 3 of 3

Infants' Ibuprofen, Concentrated Ibuprofen Oral Suspension, USP, (NSAID), 50 mg per 1.25 mL, Dye Free, Non-staining Berry Flavor, 0.5 FL OZ (15 mL) bottle, Distributed by: CVS Pharmacy, Inc., One CVS Drive, Woonsocket, RI 02895, UPC 0 50428 39338 3.

D-0337-2019
Recall number
D-0337-2019
Initiated
November 26, 2018
Classification
Class II
Status
Terminated
Recalling firm
Tris Pharma Inc.
Quantity
20,736 bottles

App-derived interpretation

Potency or specification failure reason.potency_specification_failure · v1.0.0
Superpotent

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

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

Code information

Lot #: 00717024A, Exp 08/19

Distribution pattern

One distributor in PA who further distributed Nationwide in the USA.

Field note

Send feedback

We'll only use this to respond to your feedback.