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Medium RiskFDA Drug
Medications & Supplements/Prescription Drugs

Allergan, PLC.: Ozurdex Intravitreal Implant Recalled for Silicone Particle Contamination

Agency Publication Date: January 9, 2019
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Summary

Allergan, PLC. has recalled approximately 133,716 cartons of Ozurdex (dexamethasone intravitreal implant) 0.7 mg, a prescription medication used for eye conditions. The recall was initiated because a silicone particle was discovered within the implant during manufacturing, which is a violation of Good Manufacturing Practices. Consumers should be aware that these affected units were distributed nationwide to various accounts, including government and VA facilities.

Risk

The presence of a foreign silicone particle inside the eye implant could lead to unintended inflammation or other complications within the eye where the medication is administered. While the risk is categorized as medium, any foreign material introduced during an intravitreal injection poses a potential safety concern for patients.

What You Should Do

  1. Check your Ozurdex (dexamethasone intravitreal implant) 0.7 mg carton for the following affected lot numbers and expiration dates: E78689 (06/21/2019), E78726 (06/29/2019), E78729 (07/01/2019), E78894 (08/09/2019), E79157 (09/05/2019), E79233 (09/15/2019), E79366 (10/06/2019), E79891 (12/07/2019), E80122 (01/18/2020), E80216 (02/06/2020), E81080 (05/09/2020), E81083 (05/22/2020), E81273 (05/31/2020), E81344 (06/21/2020), E82526 (12/11/2020), E82638 (12/20/2020), E82738 (01/18/2021), E82741 (01/23/2021), E82847 (01/29/2021), E82852 (02/01/2021), E83029 (02/26/2021), and E83364 (04/18/2021).
  2. Verify the NDC (National Drug Code) on the carton is 0023-3348-07.
  3. If you have an affected product, contact your healthcare provider or pharmacist immediately for guidance on treatment and to discuss any concerns regarding previous injections.
  4. Return any unused, affected Ozurdex implants to the pharmacy or place of purchase for a refund and contact Allergan, PLC. for further instructions.
  5. For additional questions, contact the FDA Consumer Complaint line at 1-888-723-3332 (1-888-SAFEFDA) or visit www.fda.gov/safety/recalls.

Your Remedy Options

๐Ÿ’ฐFull Refund

Healthcare provider consultation and product return

How to: Contact your healthcare provider or pharmacist for guidance. Return any unused product to the pharmacy for a refund

Affected Products

Product: OZURDEX (dexamethasone intravitreal implant) 0.7 mg
Model:
NDC 0023-3348-07
Lot Numbers:
E78689 (Exp 06/21/2019)
E78726 (Exp 06/29/2019)
E78729 (Exp 07/01/2019)
E78894 (Exp 08/09/2019)
E79157 (Exp 09/05/2019)
E79233 (Exp 09/15/2019)
E79366 (Exp 10/06/2019)
E79891 (Exp 12/07/2019)
E80122 (Exp 01/18/2020)
E80216 (Exp 02/06/2020)
E81080 (Exp 05/09/2020)
E81083 (Exp 05/22/2020)
E81273 (Exp 05/31/2020)
E81344 (Exp 06/21/2020)
E82526 (Exp 12/11/2020)
E82638 (Exp 12/20/2020)
E82738 (Exp 01/18/2021)
E82741 (Exp 01/23/2021)
E82847 (Exp 01/29/2021)
E82852 (Exp 02/01/2021)
E83029 (Exp 02/26/2021)
E83364 (Exp 04/18/2021)
Date Ranges: 06/21/2019 - 04/18/2021

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 81855
Status: Resolved
Manufacturer: Allergan, PLC.
Sold By: VA accounts; Government Accounts; Hospitals; Pharmacies
Manufactured In: United States
Units Affected: 133,716 Cartons
Distributed To: Nationwide

Were You Affected by This Recall?

If you or a family member were harmed by this recalled product, you may have legal rights. Consider consulting a consumer protection attorney to understand your options for compensation.

Find an Attorney

This is general information, not legal advice. Go Backs is not a law firm and does not provide legal services.

AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.

Sources: FDA iRES ยท Raw API Response

openFDA Disclaimer: This recall information is sourced from the openFDA API. Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Refer to the openFDA terms of service for more information.