ALLERGAN

FDA recalling firm · 4 enforcement events · 4 product records · 2017–2018 · NJ

ALLERGAN has 4 FDA enforcement events on this register (4 product records) between 2017 and 2018: 4 drug; the busiest year was 2017 with 2.

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
8 Nov 2018	INFed (Iron Dextran Injection USP) 100 mg elemental iron/2 mL (50 mg/mL), Rx only, packaged in 2 mL Sterile Single Dose Vial, Mfd by Patheon Italia S.p.A. Ferentino, Italy NDC 52544-931-07	Drug	Class II	1	Terminated
2 Feb 2018	NORCO (Hydrocodone Bitartrate and Acetaminophen) Tablets, USP, 10 mg/325 mg, 100-count bottles, Rx Only, Distributed by: Allergan USA, Inc., Irvine, CA 92612, NDC 0023-6022-01.	Drug	Class III	1	Terminated
13 Dec 2017	INFeD (Iron Dextran Injection USP) 100 mg elemental iron/2 ml (50 mg/mL), Rx Only, packaged in a) single dose vials, (NDC 52544-931-07), b) carton of 10 x 2 ml Single Dose Vials (NDC 52544-931-02) Distributed by: Actavis Pharma, Inc. Parsippany, NJ 07054, Manufactured by: Patheon Italia S.p.A. Ferentino, Italy 03013.	Drug	Class II	1	Terminated
4 Dec 2017	Viokace (pancrelipase) tablets, 20,880 USP units, 100-count bottle, Rx only, Distributed by; Allergan USA Inc., Irvine, CA 92612, Manufactured in Canada, NDC 58914-117-10	Drug	Class II	1	Terminated

By type and class

Drug4

Class II3

Class III1

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

Events by year

Enforcement events for ALLERGAN by year initiated.

Questions and answers

How many FDA recalls has ALLERGAN had?

4 enforcement events (4 product records) on this register, 2017–2018: 4 drug.

Are any ALLERGAN recalls ongoing?

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

What class are ALLERGAN recalls?

3 Class II, 1 Class III. 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.