Tris Pharma Inc.: FDA recalls

FDA enforcement events from 2017 to 2019; export dated 3 Nov 2026. The recall start date and FDA report date are separate fields. Read the recall classes.

FDA enforcement reports name Tris Pharma Inc. as the recalling firm in 4 events. The events have 8 product records. The recalls started from 2017 to 2019. All the events are drug recalls. By FDA enforcement events, Tris Pharma Inc. is number 831 of 1,628 firms that have a page. Events that Tris Pharma Inc. started: none in 2024 and none in 2025. For all FDA enforcement events, the count rose by 3.6%, from 1,773 in 2024 to 1,836 in 2025.

See the 4 events

It is important to note that most of the time recall classifications are determined after the recalling firm provides all of the information needed to determine the risk posed to public health. The classification and posting in the FDA Enforcement Report should not be seen as an expansion or change to a firm’s voluntary public warning.
FDA publishes these words. Source: FDA, Enforcement Reports, Important Note, read on 1 Oct 2026. openFDA export of 3 Nov 2026.

Enforcement events

4 events, newest first.

FDA enforcement events of Tris Pharma Inc.
Initiated	Product (first record)	Type	Class	Records	Status
11 Jul 2019	Hydrocodone Polistirex and Chlorpheniramine Polistirex Extended-Release Suspension, (equivalent to 10 mg hydrocodone bitartrate and 8 mg chlorpheniramine maleate per 5 mL), 16 fl. oz. (473 mL) bottle, Rx only, Manufactured by: Tris Pharma, Inc., Monmouth Junction, NJ 08852, NDC 27808-086-02.	Drug	Class II	1	Terminated
15 Jan 2019	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, NDC 59779-925-23.	Drug	Class II	3	Terminated
26 Nov 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.	Drug	Class II	3	Terminated
15 Jun 2017	Morphine Sulfate Oral Solution, 100 mg/ 5 mL (20 mg/mL), packaged in a 1 oz. bottle containing 30 mL with an oral syringe, Rx Only, Manufactured by: Tris Pharma, Inc. Monmouth Junction, NJ 08852, NDC 27808-082-01	Drug	Class II	1	Terminated

An event with 1 product record and a class that is not Class I has no page. It has a row in this table.

Enforcement event: All the product records that have one FDA event number. This site shows one event on one page.

Recalling firm: The firm that the FDA record names for a recall.

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Type and class

Tris Pharma Inc.: events for each product type
Type		Events
Drug		4

Tris Pharma Inc.: events in each class
Class		Events
Class II		4

Share of the events of the firm in Class I: 0%
Share of all events on the register in Class I: 18%
Events with the status Ongoing: 0

openFDA, about the status: FDA does not update the status of a recall after the recall has been classified according to its level of hazard. As such, the status of a recall (open, completed, or terminated) will remain unchanged after published in the Enforcement Reports. Source: openFDA, Drug Recall Enforcement Reports, Disclaimer.

Events by year

FDA enforcement events of Tris Pharma Inc., by the year that the recall started. The largest year is 2019, with 2 events.

Official channels

FDA enforcement reportsThe FDA search of the weekly enforcement reports.
FDA: recalls, market withdrawals and safety alertsThe recall notices on the FDA site.
FDA: report a problemThe FDA page that shows where a report about a product goes.
FDA MedWatchThe FDA safety reporting program for drugs and medical devices.

Cite this page

Recall Register. Tris Pharma Inc.: FDA recalls. https://recallregister.com/firm/tris-pharma-inc/. Source: openFDA enforcement reports. Data through 3 Nov 2026.

Sources

Source: openFDA enforcement reports
Licence: CC0 1.0
Export date: 3 Nov 2026
State of the firm address: NJ

The firm name is the spelling in the FDA records. A company with 2 spellings has 2 pages.

A firm with more products can have more recalls. This site does not rate one firm against another. How the register is made. Report an error.

Questions

Which classes do the FDA recalls of Tris Pharma Inc. have?: Class II: 4 events. The class is for the product of a recall. It is not a class of the firm.
What is the newest FDA recall of Tris Pharma Inc.?: FDA event 83346, which the firm started on 11 Jul 2019. The first product in the record is: Hydrocodone Polistirex and Chlorpheniramine Polistirex Extended-Release Suspension, (equivalent to 10 mg hydrocodone bitartrate and 8 mg chlorpheniramine maleate per 5 mL), 16 fl. oz. (473 mL) bottle, Rx only, Manufactured by: Tris Pharma, Inc., Monmouth Junction, NJ 08852, NDC 27808-086-02.
How many FDA recalls of Tris Pharma Inc. have the status Ongoing?: No event has the status Ongoing in the openFDA file. openFDA says about the status: FDA does not update the status of a recall after the recall has been classified according to its level of hazard. As such, the status of a recall (open, completed, or terminated) will remain unchanged after published in the Enforcement Reports.