The Recall Desk
ModerateFDA (Drugs)·D-1064-2016·Announced 2016-07-13

Allergan Recalls Tazorac Gel 0.05% Due to Content Uniformity Failures

Allergan is recalling Tazorac (tazarotene) Gel 0.05% because the product failed content uniformity specifications. The recall covers 17,802 units distributed nationwide and in Puerto Rico.

What this means for you

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, which typically indicates a risk of temporary or medically reversible adverse health consequences. The specific defect is a failure in content uniformity, which is a quality control issue rather than a direct contamination or structural defect leading to severe injury.

Plain-English summary

Allergan Sales, LLC is recalling Tazorac (tazarotene) Gel 0.05%, a prescription-only medication packaged in 30g and 100g tubes. The recall was initiated because the product failed content uniformity specifications. This means the amount of active ingredient in the product may not be consistent throughout the tube, potentially affecting its efficacy or safety.

The affected products are identified by Lot # 84172 (30g tubes, NDC 0023-8335-03) and Lot # 84173 (100g tubes, NDC 0023-8335-10), with an expiration date of February 2017. A total of 17,802 units were distributed nationwide and in Puerto Rico.

Consumers and healthcare providers should check their inventory for these specific lot numbers and expiration dates. If you have this product, you should stop using it and contact your healthcare provider or pharmacist for guidance on replacement or disposal. The FDA has classified this recall as Class II, indicating that use of, or exposure to, the violative product may cause temporary or medically reversible adverse health consequences.

The recalled product

Product
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
Manufacturer
Allergan Sales, LLC
Category
Drug — Topical Prescription Medication
Hazard
Affected units
17,802

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 (3)

  • Lot #: a) 84172
  • b) 84173
  • 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 →

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