Drug recall: OZURDEX (dexamethasone intravitreal implant) 0.7 mg), 1 single-use plastic applicator contained within carton, Rx only,

FDA enforcement event 81855 · Class II · initiated 20 Dec 2018 · status Completed

DrugVoluntary: Firm initiated1 product recordMadison, NJ

Allergan, PLC. (Madison, NJ) initiated this drug recall on 20 Dec 2018; FDA lists 1 product record under event 81855, classified Class II.

FDA defines Class II as a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote. 60% of the 367 drug enforcement events initiated in 2018 carry the same class.

Status: Completed. Initiation: voluntary: firm initiated. Allergan, PLC. has 8 enforcement events on this register, with a median of 1 product record per event.

Recall classification reflects the relative degree of health hazard. Text in quotation marks is FDA's. openFDA export dated 28 Sep 2026.

Recalling firm

Allergan, PLC., Madison, NJ.

Reason for recall

"GMP Deviations: A silicone particulate was noted in Ozurdex."

Distribution

"Product was distributed to various accounts throughout the United States including VA and Government Accounts"

Product records

Recall number	Product	Quantity	Class	Status	Report date
D-0387-2019	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	133,716 Cartons	Class II	Completed	16 Jan 2019

Context

60%of 2018 drug events are Class II367 events that year

1product record in this eventfirm median: 1

8events on this register for the firm

Other enforcement events for Allergan, PLC.

Initiated	Product (first record)	Type	Class	Records
30 Dec 2020	Refresh Relieva PF Preservative-Free Lubricant Eye Drops 0.33 fl oz (10 mL) Sterile Distributed by: Allergan, an AbbVie	Drug	Class II	1
29 Dec 2020	REFRESH CONTACTS¿ Contact Lens Comfort Drops 0.4 fl oz (12 mL) Sterile	Device	Class II	1
6 Jul 2020	Skin Medica Acne Treatment Lotion (Benzoyl Peroxide 2.5%), 2 Oz bottle, Distributed in the U.S.A. by Allergan, Irvine, C	Drug	Class III	2
6 Nov 2019	Natrelle Saline-Filled Breast Implant, for the following Styles and sizes, Style LP, Style 68 HP, Style 68 MP, Style LP/	Device	Class III	4
30 Oct 2019	XEN Gel Stent, REF 5513-001(US Model), Sterile, RX Only, (01)10888628032439 ; Other Model Numbers: 5507-001(Global Model	Device	Class II	1
24 Jul 2019	Natrelle, Saline-Filled Breast Implant Biocell Full Height with Fill Tube, Sterile, for the following style numbers: Sty	Device	Class I	15
24 May 2018	Allergan Taytulla Softgel Capsules, 1 mg/20 mcg, 6x28 blister card Physicians's Sample - Not for Sale Distributed by: Al	Drug	Class I	1

All 8 events for Allergan, PLC.

Questions and answers

Why was this drug recalled?

FDA's record gives the reason for recall as: "GMP Deviations: A silicone particulate was noted in Ozurdex."

What does Class II mean?

FDA classifies recalls by relative degree of health hazard. Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote.

Where was the product distributed?

FDA's distribution pattern field reads: "Product was distributed to various accounts throughout the United States including VA and Government Accounts"

Is the recall still ongoing?

FDA lists the status as Completed. "Terminated" means FDA has determined that all reasonable efforts to remove or correct the product have been made.

Where does this data come from?

openFDA enforcement reports (food, drug and device), CC0, export dated 28 Sep 2026. Text in quotation marks is FDA's. The FDA enforcement report linked above is authoritative.

Provenance

Source: openFDA drug enforcement reports (CC0), export dated 28 Sep 2026; records grouped by FDA event number. The class shown for the event is the most severe class among its records. Errors in processing are corrected at the next build; see corrections.