Allergan, PLC.

FDA recalling firm · 8 enforcement events · 26 product records · 2018–2020 · CA, NJ

Allergan, PLC. has 8 FDA enforcement events on this register (26 product records) between 2018 and 2020: 4 device and 4 drug; the busiest year was 2019 with 3.

25% of its events are Class I; the most common class is Class II (4). 2 events are listed as ongoing; the recalling firm's address is in CA and 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
30 Dec 2020	Refresh Relieva PF Preservative-Free Lubricant Eye Drops 0.33 fl oz (10 mL) Sterile Distributed by: Allergan, an AbbVie company Madison, NJ 07940 UPC 3 00236 63410 0, NDC 0023-6634-10.	Drug	Class II	1	Terminated
29 Dec 2020	REFRESH CONTACTS¿ Contact Lens Comfort Drops 0.4 fl oz (12 mL) Sterile	Device	Class II	1	Terminated
6 Jul 2020	Skin Medica Acne Treatment Lotion (Benzoyl Peroxide 2.5%), 2 Oz bottle, Distributed in the U.S.A. by Allergan, Irvine, CA 92612, NDC 0023-4965-02	Drug	Class III	2	Terminated
6 Nov 2019	Natrelle Saline-Filled Breast Implant, for the following Styles and sizes, Style LP, Style 68 HP, Style 68 MP, Style LP/UDI: NATRELLE Style 68LP-125 Saline Round Low 10888628000513, NATRELLE Style 68LP-150 Saline Round Low 10888628000520, NATRELLE Style 68LP-175 Saline Round Low 10888628000537, NATRELLE Style…	Device	Class III	4	Terminated
30 Oct 2019	XEN Gel Stent, REF 5513-001(US Model), Sterile, RX Only, (01)10888628032439 ; Other Model Numbers: 5507-001(Global Model) and 5517-001(Australia model) Implant for glaucoma treatment.	Device	Class II	1	Ongoing
24 Jul 2019	Natrelle, Saline-Filled Breast Implant Biocell Full Height with Fill Tube, Sterile, for the following style numbers: Style 163:163-360CC, 163-440CC, 163-530CC, 163-655CC, 163-780CC; Style…	Device	Class I	15	Ongoing
20 Dec 2018	OZURDEX (dexamethasone intravitreal implant) 0.7 mg), 1 single-use plastic applicator contained within carton, Rx only, Allergan Inc Irvine, CA 92612, NDC 0023-3348-07	Drug	Class II	1	Completed
24 May 2018	Allergan Taytulla Softgel Capsules, 1 mg/20 mcg, 6x28 blister card Physicians's Sample - Not for Sale Distributed by: Allergan USA INC Irvine, CA 92612 NDC 0023-5862-28 (Blister Card) NDC 0023-5862-29 (Blister Carton) NDC 0023-5862-31 (Outer carton) UPC 300235862290	Drug	Class I	1	Terminated

By type and class

Device4

Drug4

Class II4

Class I2

Class III2

Class I: 25% of this firm's events; 18% of all events on the register.

Events by year

Enforcement events for Allergan, PLC. by year initiated.

Questions and answers

How many FDA recalls has Allergan, PLC. had?

8 enforcement events (26 product records) on this register, 2018–2020: 4 device, 4 drug.

Are any Allergan, PLC. recalls ongoing?

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

What class are Allergan, PLC. recalls?

4 Class II, 2 Class I, 2 Class III. 25% 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.