Allergan Recalls Tazorac Gel 0.05% Due to Content Uniformity Failures
Allergan Sales, LLC is recalling 17,112 tubes of Tazorac (tazarotene) Gel 0.05% because the product failed content uniformity specifications.
What this means for you
Illness, injury, or structural failure has been reported. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The FDA classified this recall as Class II. Per the rubric, an FDA Class II recall is assigned a severity score of 4 (Severe), as it indicates a potential for temporary or medically reversible adverse health consequences.
Plain-English summary
Allergan Sales, LLC is recalling 17,112 tubes of Tazorac (tazarotene) Gel 0.05%, a prescription-only medication packaged in 15 x 3.5 g professional sample containers. The recall was initiated because the product failed to meet content uniformity specifications. The affected product is manufactured by Allergan Inc. in Irvine, CA, and carries UPC 300238335159.
The recall covers two specific lots: Lot # 85037 with an expiration date of 05/17, and Lot # 82583 with an expiration date of 10/16. The affected units were distributed nationwide. 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.
Consumers and healthcare providers should stop using the affected Tazorac gel and return it to the pharmacy or point of purchase for a refund or replacement. Patients should consult their healthcare provider for alternative treatment options if necessary.
The recalled product
- Product
- 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.
- Manufacturer
- Allergan Sales, LLC
- Category
- Drug — Topical Prescription
- Hazard
- Affected units
- 17,112
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 # 85037
- Exp 05/17 Lot # 82583
- Exp 10/16
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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