Allergan Recalls Tazorac Gel 0.05% Due to Content Uniformity Failures
Allergan Sales, LLC is recalling Tazorac (tazarotene) Gel 0.05% because it failed content uniformity specifications. The recall covers 25,247 tubes distributed nationwide.
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 involves a temporary or medically reversible adverse health consequence. The specific defect is a failure of content uniformity specifications, which is a quality control issue rather than a high-risk pathogen or structural defect, placing it in the Moderate category.
Plain-English summary
Allergan Sales, LLC is recalling Tazorac (tazarotene) Gel 0.05%, a prescription-only dermatologic product, because it failed content uniformity specifications. The affected product is packaged in 30 g and 100 g tubes and is manufactured by Allergan Inc. in Irvine, California.
The recall includes 25,247 tubes, consisting of 19,499 30-gram tubes and 5,748 100-gram tubes. The specific lots affected are Lot #82579 (expiration 10/16) and Lot #85088 (expiration 05/17). The product was distributed nationwide.
Consumers and healthcare providers should check their inventory for the specific NDC, lot, and expiration numbers listed above. If the product matches the recalled description, it should be returned to the pharmacy or point of purchase for a refund or replacement. Patients should consult their healthcare provider for alternative treatment options if they are currently using the recalled product.
The recalled product
- Product
- TAZORAC (tazarotene) Gel 0.05%, Rx only, For Dermatologic Use Only, Not for Ophthalmic Use, packaged in a) 30 g tubes (NDC: 0023-8335-03, UPC: 300238335036) and b)100 g tubes,(NDC: 0023-8335-10, UPC: 300238335104), Manufactured by: Allergan Inc., Irvine, CA 92512.
- Manufacturer
- Allergan Sales, LLC
- Category
- Drug — Dermatologic
- Hazard
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)
- a) Lot# 82579
- Exp. 10/16 b) Lot:# 85088 Exp. 05/17
Distribution
Distributed nationwide across the United States.
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.
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