The Recall Desk
Agency classClass IIOur severity:ModerateFDA (Drugs)·D-1065-2016·Announced 2016-07-13

Allergan Recalls Tazorac Gel 0.05% Sample Packs for Content Uniformity Failure

Allergan Sales, LLC is recalling Tazorac (tazarotene) Gel 0.05% sample packs due to failed content uniformity specifications.

The agency’s classification

FDA (Drugs): Class II

Class II is 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.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 2/5 (Moderate).

Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.

Our severity reasoning: The recall is classified as FDA Class II, and the source text does not report any illnesses or injuries, fitting the criteria for a moderate severity score.

Plain-English summary

Allergan Sales, LLC is recalling Tazorac (tazarotene) Gel 0.05%, 15 x 3.5g sample packs. The recall is being conducted because the product failed content uniformity specifications.

The affected product is identified by Lot # 84126 with an expiration date of FEB/2017. The product was distributed nationwide and in Puerto Rico.

Consumers should stop using the recalled product and contact their healthcare provider or the recalling firm for further instructions.

The recalled product

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

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (2)

  • Lot #: 84126
  • Exp FEB/2017

Distribution

Distributed nationwide across the United States.

The notice also names 1 state specifically:

Part of a larger recall action

This product is one of 2 recalled by Allergan Sales, LLC under a single FDA (Drugs) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 2 products in this recall →

Similar recalls