Inopak Ltd

FDA recalling firm · 3 enforcement events · 14 product records · 2017–2019 · NJ

Inopak Ltd has 3 FDA enforcement events on this register (14 product records) between 2017 and 2019: 3 drug; the busiest year was 2017 with 1.

0% of its events are Class I; the most common class is Class II (3). 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
22 Apr 2019	ANTIBACTERIAL Foaming Hand Wash With Moisturizers labeled as Antibacterial Foaming Soap, ACTIVE:P.C.M.X, packaged in a) 18 oz bottles, 12/18 oz bottles per case, 5063-432-02; b) 1 gallon bottles, 4/1 gallon bottles per case, 5063-420-03; c) Options Systems Antibacterial Foaming Hand Wash with .3% PCMX, packaged in…	Drug	Class II	10	Terminated
16 May 2018	Option Systems Antibacterial Foaming Hand Wash with .3% PCMX, 1000 mL pouches, Inopak, LTD, Ringwood, NJ	Drug	Class II	1	Terminated
23 Aug 2017	Option Systems Antibacterial Foaming Hand Wash, 0.3% P.C.M.X., 8 fl oz and 18 fl oz. bottles and 500, mL 800 mL, and 1000 mL pouches, ALSO labeled as STYLE Antibacterial Hand Soap, Inopak Ltd Ringwood, NJ --- NDC 5031-431-02	Drug	Class II	3	Terminated

By type and class

Drug3

Class II3

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

Events by year

Enforcement events for Inopak Ltd by year initiated.

Questions and answers

How many FDA recalls has Inopak Ltd had?

3 enforcement events (14 product records) on this register, 2017–2019: 3 drug.

Are any Inopak Ltd recalls ongoing?

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

What class are Inopak Ltd recalls?

3 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.