Recall Register

Allergan, PLC.: FDA recalls

FDA enforcement events from 2018 to 2020; export dated . The recall start date and FDA report date are separate fields. Read the recall classes.

FDA enforcement reports name Allergan, PLC. as the recalling firm in 8 events. The events have 26 product records. The recalls started from 2018 to 2020. By FDA enforcement events, Allergan, PLC. is number 442 of 1,628 firms that have a page. Events that Allergan, PLC. 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. Class II is 50.0% of its events and 73.7% of all FDA 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 . openFDA export of .

Enforcement events

8 events, newest first.

FDA enforcement events of Allergan, PLC.
InitiatedProduct (first record)TypeClassRecordsStatus
30 Dec 2020Refresh 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.DrugClass II1Terminated
29 Dec 2020REFRESH CONTACTS Contact Lens Comfort Drops 0.4 fl oz (12 mL) SterileDeviceClass II1Terminated
6 Jul 2020Skin Medica Acne Treatment Lotion (Benzoyl Peroxide 2.5%), 2 Oz bottle, Distributed in the U.S.A. by Allergan, Irvine, CA 92612, NDC 0023-4965-02DrugClass III2Terminated
6 Nov 2019Natrelle 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…DeviceClass III4Terminated
30 Oct 2019XEN 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.DeviceClass II1Ongoing
24 Jul 2019Natrelle, 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…DeviceClass I15Ongoing
20 Dec 2018OZURDEX (dexamethasone intravitreal implant) 0.7 mg), 1 single-use plastic applicator contained within carton, Rx only, Allergan Inc Irvine, CA 92612, NDC 0023-3348-07DrugClass II1Completed
24 May 2018Allergan 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 300235862290DrugClass I1Terminated

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.

Type and class

Allergan, PLC.: events for each product type
TypeEvents
Device4
Drug4
Allergan, PLC.: events in each class
ClassEvents
Class II4
Class I2
Class III2
Share of the events of the firm in Class I
25%
Share of all events on the register in Class I
18%
Events with the status Ongoing
2

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 Allergan, PLC., by the year that the recall started. The largest year is 2019, with 3 events.

Official channels

Cite this page

Recall Register. Allergan, PLC.: FDA recalls. https://recallregister.com/firm/allergan-plc/. Source: openFDA enforcement reports. Data through .

Sources

Source
openFDA enforcement reports
Licence
CC0 1.0
Export date
3 Nov 2026
State of the firm address
CA, 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 Allergan, PLC. have?
Class II: 4 events. Class I: 2 events. Class III: 2 events. The class is for the product of a recall. It is not a class of the firm.
Which product types do the FDA recalls of Allergan, PLC. have?
Device: 4 events. Drug: 4 events.
What is the newest FDA recall of Allergan, PLC.?
FDA event 87016, which the firm started on 30 Dec 2020. The first product in the record is: 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.
How many FDA recalls of Allergan, PLC. have the status Ongoing?
2 events have 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.