CLASS II Drug recall · Reported 19 Oct 2016 · FDA Enforcement Report

Tazorac (tazarotene) Gel recalled by Allergan Sales

Allergan Sales is recalling Tazorac (tazarotene) Gel 0.05%, distributed nationwide in the US. The recall was initiated on 30 Jun 2016 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesLot # 85037; Exp 05/17 Lot # 82583; Exp 10/16

Quantity recalled17,112 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-0100-2017
FDA event ID: 74623
Recalling firm: Allergan Sales, Waco, TX
Classification: Class II
Status: Terminated
Recall initiated: 30 Jun 2016
FDA classified: 13 Oct 2016
Reported: 19 Oct 2016
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Packaging Defects
Drug class: Creams, Ointments & Gels

Timeline

30 Jun 2016	Recall initiated by company
13 Oct 2016	Classified by FDA	+105 days
19 Oct 2016	Published in enforcement report	+6 days

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

Reason for recall

Failed Content Uniformity Specifications

Packaging recalls include wrong labels, wrong products in the wrong bottle, missing leaflets, short-filled or empty capsules and seals that fail.

Product as listed by the FDA

TAZORAC (tazarotene) Gel 0.05%, Rx only, packaged in 15 x 3.5 g professional sample containers, Manufactured by: Allergan Inc., Irvine, CA 92512. UPC: 300238335159.

Where it was distributed

Nationwide

Questions about this recall

Why was it recalled?

Failed Content Uniformity Specifications

Which lots are affected?

Lot # 85037; Exp 05/17 Lot # 82583; Exp 10/16

Where was it sold?

Nationwide

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

1 other product · FDA event 74623

This product is part of a recall event; the main page for the event is Tazorac (tazarotene) Gel recalled by Allergan Sales.

Reported	Class	Recall	Company	Reason	Where
19 Oct 2016	CLASS II	Tazorac (tazarotene) Gel recalled by Allergan Sales	Allergan Sales	Packaging Defects	Nationwide

More recalls from Allergan Sales

All 14

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8 May 2024Device	CLASS II	Keller Funnel recalled by Allergan Sales	Allergan Sales	Other	Nationwide
3 Apr 2019Drug	CLASS II	Combigan (brimonidine tartrate/timolol maleate ophthalmic recalledCombigan	Allergan Sales	Manufacturing (CGMP) Deviations	TN
22 Nov 2017Drug	CLASS III	Lumigan (bimatoprost ophthalmic solution) recalled by Allergan SalesLumigan	Allergan Sales	Potency & Assay	Nationwide
22 Nov 2017Drug	CLASS III	Combigan (brimonidine tartrate/timolol maleate ophthalmic recalledCombigan	Allergan Sales	Potency & Assay	Nationwide
5 Jul 2017Drug	CLASS II	Blephamide (sulfacetamide sodium recalled by Allergan Sales	Allergan Sales	Potency & Assay	Nationwide

Other Tazorac (tazarotene recalls

All 4

Reported	Class	Recall	Company	Reason	Where
19 Oct 2016Drug	CLASS II	Tazorac (tazarotene) Gel recalled by Allergan Sales	Allergan Sales	Packaging Defects	Nationwide
13 Jul 2016Drug	CLASS II	Tazorac (tazarotene) Gel 0.05%, ., sample packs recalled	Allergan Sales	Other	Nationwide
13 Jul 2016Drug	CLASS II	Tazorac (tazarotene) Gel recalled by Allergan Sales	Allergan Sales	Packaging Defects	Nationwide