Tris Pharma Inc.

FDA recalling firm · 4 enforcement events · 8 product records · 2017–2019 · NJ

Tris Pharma Inc. has 4 FDA enforcement events on this register (8 product records) between 2017 and 2019: 4 drug; the busiest year was 2019 with 2.

0% of its events are Class I; the most common class is Class II (4). 0 events are listed as ongoing; the recalling firm's address is in NJ.

Recall classification reflects the relative degree of health hazard. Event counts depend on a firm's size and product range; they are not a comparison of one firm with another.

Enforcement events

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

By type and class

Drug4

Class II4

Class I: 0% of this firm's events; 18% of all events on the register.

Events by year

Enforcement events for Tris Pharma Inc. by year initiated.

Questions and answers

How many FDA recalls has Tris Pharma Inc. had?

4 enforcement events (8 product records) on this register, 2017–2019: 4 drug.

Are any Tris Pharma Inc. recalls ongoing?

0 events are listed as ongoing in the current openFDA export.

What class are Tris Pharma Inc. recalls?

4 Class II. 0% are Class I against 18% of all events on the register. Class reflects the relative degree of health hazard of the product, not the firm.

Where does this data come from?

openFDA food, drug and device enforcement reports (CC0), export dated 28 Sep 2026.

Provenance

Source: openFDA enforcement reports (CC0), export dated 28 Sep 2026. Firm names are grouped exactly as FDA spells them; the same company can appear under several spellings. Only organisations are shown. See the methodology.