CLASS II Drug recall · Reported 30 Sep 2015 · FDA Enforcement Report

FML (fluorometholone ophthalmic ointment) 0.1% tube recalled

Allergan Sales is recalling FML (fluorometholone ophthalmic ointment) 0.1% tube, distributed nationwide in the US. The recall was initiated on 24 Aug 2015 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesLot #: 86258, Exp 09/16; 87189, Exp 12/16; 87514, Exp 02/17

Quantity recalled28,292 tubes

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-1819-2015
FDA event ID: 72016
Recalling firm: Allergan Sales, Waco, TX
Classification: Class II
Status: Terminated
Recall initiated: 24 Aug 2015
FDA classified: 22 Sep 2015
Reported: 30 Sep 2015
Type: Voluntary: Firm initiated
Customers notified by: N/A
Reason category: Particulate Matter
Drug class: Eye Drops

Timeline

24 Aug 2015	Recall initiated by company
22 Sep 2015	Classified by FDA	+29 days
30 Sep 2015	Published in enforcement report	+8 days

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

Reason for recall

Presence of Particulate Matter: Due to customer complaints of small black particles, identified as part of the ointment tube cap, generated by the action of unscrewing the cap from the aluminum tube and potentially introducing the particle into the product.

Product as listed by the FDA

FML (fluorometholone ophthalmic ointment) 0.1%, 3.5 g tube, Rx only, Allergan, Inc., Irvine, CA 92612, NDC 0023-0316-04, UPC 3 0023-0316-04 0.

Where it was distributed

Nationwide, Puerto Rico, and Barbados

Nationwide Puerto Rico

Questions about this recall

Why was it recalled?

Which lots are affected?

Lot #: 86258, Exp 09/16; 87189, Exp 12/16; 87514, Exp 02/17

Where was it sold?

Nationwide, Puerto Rico, and Barbados

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.

Other products in this recall event

3 other products · FDA event 72016

This product is part of a recall event; the main page for the event is Refresh Lacri-Lube (Mineral Oil recalled by Allergan Sales.

Reported	Class	Recall	Company	Reason	Where
30 Sep 2015	CLASS II	Refresh Lacri-Lube (Mineral Oil recalled by Allergan SalesRefresh Lacri-lube	Allergan Sales	Particulate Matter	Nationwide
30 Sep 2015	CLASS II	Blephamide (sulfacetamide sodium recalled by Allergan Sales	Allergan Sales	Particulate Matter	Nationwide
30 Sep 2015	CLASS II	Refresh P.M. (Mineral Oil recalled by Allergan SalesRefresh P.m	Allergan Sales	Particulate Matter	Nationwide

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