Drug recall: Tazorac (tazarotene) Gel 0.05%, Rx only, packaged in a) 30g (NDC 0023-8335-03) and b) 100g (NDC 0023-8335-10) tubes…

Class II FDA enforcement event 74126. Recall start date: 10 May 2016. Status in the FDA record: Terminated. Termination date: 6 Dec 2017.

Reason for recall, in the words of FDA

Failed Content Uniformity Specifications.

Class II, in the words of FDA

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

Allergan Sales, LLC started this drug recall on 10 May 2016. The firm address in the FDA record is in Waco, TX. FDA put the recall in Class II. FDA event 74126 has 2 product records. The first FDA enforcement report date is 13 Jul 2016. The record gives the status Terminated, with the termination date 6 Dec 2017.

FDA enforcement report The 2 product records

It is important to note that most of the time recall classifications are determined after the recalling firm provides all of the information needed to determine the risk posed to public health. The classification and posting in the FDA Enforcement Report should not be seen as an expansion or change to a firm’s voluntary public warning.
FDA publishes these words. Source: FDA, Enforcement Reports, Important Note, read on 1 Oct 2026. openFDA export of 28 Sep 2026.

Distribution

In the words of FDA.

Nationwide and Puerto Rico

Recalling firm

Allergan Sales, LLC, Waco, TX.

Recalling firm: The firm that the FDA record names for a recall.

FDA records how the recall started: Voluntary: Firm initiated.

Products

2 product records in the event.

FDA event 74126: product records
Recall number	Product	Quantity	Class	Status	Report date
D-1064-2016	Tazorac (tazarotene) Gel 0.05%, Rx only, packaged in a) 30g (NDC 0023-8335-03) and b) 100g (NDC 0023-8335-10) tubes, Allergan Inc, Irvine, CA 92612	17802 units	Class II	Terminated	13 Jul 2016
D-1065-2016	Tazorac (tazarotene) Gel 0.05%, 15 x 3.5g, sample packs, Allergan Inc, Irvine, CA 92612. UPC 300238335159	N/A	Class II	Terminated	13 Jul 2016

openFDA, about the status: FDA does not update the status of a recall after the recall has been classified according to its level of hazard. As such, the status of a recall (open, completed, or terminated) will remain unchanged after published in the Enforcement Reports. Source: openFDA, Drug Recall Enforcement Reports, Disclaimer.

Enforcement report: The FDA publication that lists recalls. It has one record for each product of a recall.

Enforcement event: All the product records that have one FDA event number. This site shows one event on one page.

Class II: The middle of the three FDA recall classes.

The event in context

Drug events that started in 2016: 288
Share of these events in Class II: 46%
Product records in this event: 2Median of the firm: 2
Events of the firm on the register: 8

Other events of the firm

Other FDA enforcement events of Allergan Sales, LLC
Initiated	Product (first record)	Type	Class	Records
14 Mar 2024	Keller Funnel 2, REF: HA-001, STERILEEO, Rx Only,	Device	Class II	1
19 Mar 2019	Combigan (brimonidine tartrate/timolol maleate ophthalmic solution) 0.2%/0.5% 5 mL bottles, Rx only, Allergan, Inc. Irvi	Drug	Class II	1
19 Oct 2017	Combigan (brimonidine tartrate/timolol maleate ophthalmic solution) 0.2%/0.5%, Rx only, packaged in a) 2.5 mL NDC# 0023-	Drug	Class III	2
1 May 2017	Blephamide (sulfacetamide sodium and prednisolone acetate ophthalmic ointment, USP) 10%/0.2% sterile, 3.5 g tube, RX onl	Drug	Class II	1
16 Mar 2017	Lumigan (bimatoprost ophthalmic solution) 0.01%, 7.5 mL bottle, Rx only, Allergan Irvine, CA 92612, NDC 0023-3205-08.	Drug	Class III	1
30 Jun 2016	TAZORAC (tazarotene) Gel 0.05%, Rx only, For Dermatologic Use Only, Not for Ophthalmic Use, packaged in a) 30 g tubes (N	Drug	Class II	2
24 Aug 2015	Refresh Lacri-Lube (Mineral Oil 42.5% and White Petrolatum 56.8%) Lubricant Eye Ointment, packaged in a) Net wt. 0.12 oz	Drug	Class II	4

Allergan Sales, LLC: all 8 events

Official channels

FDA enforcement report D-1064-2016The FDA record of the first product of this event.
FDA: recalls, market withdrawals and safety alertsThe recall notices on the FDA site.
FDA MedWatchThe FDA safety reporting program for drugs and medical devices.

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Cite this page

Recall Register. FDA enforcement event 74126. https://recallregister.com/fda/ii/74126/. Source: openFDA enforcement reports. Data through 28 Sep 2026.

Sources

Source: openFDA drug enforcement reports
Licence: CC0 1.0
Export date: 28 Sep 2026
Newest FDA report date on the register: 23 Sep 2026

FDA has one record for each product. This site puts the records with the same event number on one page. The class of the event is the highest class of its records. How the register is made. Report an error.

Questions

Where was the product distributed?: The FDA record gives this distribution: Nationwide and Puerto Rico
What quantity of product is in FDA event 74126?: The event has 2 product records. The first record gives this quantity: 17802 units
How did the recall start?: The FDA record says: Voluntary: Firm initiated
How many drug recalls of 2016 have the same class?: 46% of the 288 drug events that started in 2016 are in Class II.