CLASS II Drug recall · Reported 13 Jul 2016 · FDA Enforcement Report

Tazorac (tazarotene) Gel 0.05%, ., sample packs recalled

Allergan Sales is recalling Tazorac (tazarotene) Gel 0.05%, ., sample packs, Allergan Inc, Irvine, CA 92612, distributed nationwide in the US. The recall was initiated on 10 May 2016 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesLot #: 84126, Exp FEB/2017

Quantity recalledN/A

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-1065-2016
FDA event ID: 74126
Recalling firm: Allergan Sales, Waco, TX
Classification: Class II
Status: Terminated
Recall initiated: 10 May 2016
FDA classified: 6 Jul 2016
Reported: 13 Jul 2016
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Other Reasons
Drug class: Creams, Ointments & Gels

Timeline

10 May 2016	Recall initiated by company
6 Jul 2016	Classified by FDA	+57 days
13 Jul 2016	Published in enforcement report	+7 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.

Product as listed by the FDA

Tazorac (tazarotene) Gel 0.05%, 15 x 3.5g, sample packs, Allergan Inc, Irvine, CA 92612. UPC 300238335159

Where it was distributed

Nationwide and Puerto Rico

Nationwide Puerto Rico

Questions about this recall

Why was it recalled?

Failed Content Uniformity Specifications.

Which lots are affected?

Lot #: 84126, Exp FEB/2017

Where was it sold?

Nationwide and Puerto Rico

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 74126

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
13 Jul 2016	CLASS II	Tazorac (tazarotene) Gel recalled by Allergan Sales	Allergan Sales	Packaging Defects	Nationwide

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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
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 recalled by Allergan Sales	Allergan Sales	Packaging Defects	Nationwide