CLASS II Drug recall · Reported 16 Jan 2019 · FDA Enforcement Report

Ozurdex (dexamethasone intravitreal implant) 0.7 mg)-use recalled

Allergan is recalling Ozurdex (dexamethasone intravitreal implant) 0.7 mg)-use, distributed nationwide in the US. The recall was initiated on 20 Dec 2018 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesE78689, exp. date 06/21/2019 E78726, exp. date 06/29/2019 E78729, exp. date 07/01/2019 E78894, exp. date 08/09/2019 E79157, exp. date 09/05/2019 E79233, exp. date 09/15/2019 E79366, exp. date 10/06/2019 E79891, exp. date 12/07/2019 E80122, exp. date 01/18/2020 E80216, exp. date 02/06/2020 E81080, exp. date 05/09/2020 E81083, exp. date 05/22/2020 E81273, exp. date 05/31/2020 E81344, exp. date 06/21/2020 E82526, exp. date 12/11/2020 E82638, exp. date 12/20/2020 E82738, exp. date 01/18/2021 E82741, exp. date 01/23/2021 E82847, exp. date 01/29/2021 E82852, exp. date 02/01/2021 E83029, exp. date 02/26/2021 E83364, exp. date 04/18/2021

NDC0023-3348

Quantity recalled133,716 Cartons

Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.

Recall details

Recall number: D-0387-2019
FDA event ID: 81855
Recalling firm: Allergan, Madison, NJ
Brand: Ozurdex
Manufacturer: Allergan, Inc.
Classification: Class II
Status: Completed
Recall initiated: 20 Dec 2018
FDA classified: 18 Jan 2019
Reported: 16 Jan 2019
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Particulate Matter

Timeline

20 Dec 2018	Recall initiated by company
16 Jan 2019	Published in enforcement report	+27 days
18 Jan 2019	Classified by FDA	+2 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

Reason for recall

GMP Deviations: A silicone particulate was noted in Ozurdex.

Product as listed by the FDA

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

Where it was distributed

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

Nationwide Virginia

Questions about this recall

Why was it recalled?

GMP Deviations: A silicone particulate was noted in Ozurdex.

Which lots are affected?

E78689, exp. date 06/21/2019 E78726, exp. date 06/29/2019 E78729, exp. date 07/01/2019 E78894, exp. date 08/09/2019 E79157, exp. date 09/05/2019 E79233, exp. date 09/15/2019 E79366, exp. date 10/06/2019 E79891, exp. date 12/07/2019 E80122, exp. date 01/18/2020 E80216, exp. date 02/06/2020 E81080, exp. date 05/09/2020 E81083, exp. date 05/22/2020 E81273, exp. date 05/31/2020 E81344, exp. date 06/21/2020 E82526, exp. date 12/11/2020 E82638, exp. date 12/20/2020 E82738, exp. date 01/18/2021 E82741, exp. date 01/23/2021 E82847, exp. date 01/29/2021 E82852, exp. date 02/01/2021 E83029, exp. date 02/26/2021 E83364, exp. date 04/18/2021

Where was it sold?

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

What should I do if I have it?

Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.

What does Class II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

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