Use cautionDrug recall · FDA · Published December 20, 2018
Allergan OZURDEX 0.7 mg implant recalled due to silicone particulate contamination
Allergan recalls OZURDEX 0.7 mg intravitreal implants (NDC 0023-3348-07) after finding silicone particles during manufacturing. This may cause eye injury. Consumers should contact Allergan for details.
“Allergan OZURDEX 0.7 mg implant recalled due to silicone particulate contamination.” GovInfoNow, updated October 5, 2026. https://govinfonow.com/recall/39303-allergan-ozurdex-0-7-mg-implant-recalled-due-to-silicone. Based on FDA recall #D-0387-2019 (https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0387-2019%22&limit=1).
The FDA announced on Dec. 20, 2018, that Allergan, PLC voluntarily recalled OZURDEX (dexamethasone intravitreal implant) due to Good Manufacturing Practice deviations involving silicone particulate in the product. The agency classified the recall as Class II.
How to tell if you have it
Brand: Allergan
Product: OZURDEX (dexamethasone intravitreal implant) 0.7 mg, 1 single-use plastic applicator contained within carton, Rx only
Distribution: Various accounts throughout the United States including VA and Government Accounts
The hazard
The recall was initiated because a silicone particulate was noted in Ozurdex during manufacturing. GovInfoNow's records show this is a Class II recall due to GMP deviations.
Context
GovInfoNow's records show Allergan, PLC has 7 other recalls on record since May 24, 2018. Other recent recalls of similar products include Imprimis Dexamethasone Moxifloxacin Eye Drops Recall (Dec. 18, 2025), Sun Pharmaceutical DOXOrubin Liposome Injection Recall (May 12, 2026), and Asteria Health ESTRADIOL Pellets Recall (Jan. 26, 2026).
How to tell if you have this one
Check the product label for the NDC code 0023-3348-07 or the expiration date listed in the recall notice (e.g., 06/21/2019). The product is a single-use plastic applicator for eye injections.
Brand
Allergan
Category
Drug
Based on the official FDA remedy
What to do — step by step
Contact Allergan
Reach out to Allergan directly for instructions on how to handle the recalled product.
Where it went and when
Where it was distributed
Distributed nationwide.
Nationwide
Not listed
FDA distribution: “Product was distributed to various accounts throughout the United States including VA and Government Accounts” States read from FDA’s own wording; “not listed” means the notice does not name it.
Distributed nationwide.
Recall timeline
FDA published this recall 27 days after the firm started it.
1Firm started the recall
2Published in FDA’s Enforcement Report
3FDA classified it Class II
Dates from the agency record only; steps without a date are left out.
The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
Official source: FDA Recall #D-0387-2019 (December 20, 2018) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for D-0387-2019 to see it in context.
Plain-language summary written by qwen3:4b on October 5, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.