Tazorac Gel Recall: Failed Content Uniformity
Allergan recalls Tazorac Gel 0.05% due to failed content uniformity specifications. Check your lot numbers and expiration date for affected units.
Recall notice
Failed Content Uniformity Specifications.
Contact the company
What happened, in plain English
Allergan Sales, LLC is recalling specific lots of Tazorac (tazarotene) Gel 0.05% because the product failed content uniformity specifications. This means the amount of active ingredient in each unit may not be consistent with what is listed on the label. The recall affects 17,802 units distributed nationwide and in Puerto Rico. Read more at govinfonow.com/recall/42768-tazorac-gel-recall-failed-content-uniformity.
Source Summary by GovInfoNow · govinfonow.com/recall/42768-tazorac-gel-recall-failed-content-uniformity · Updated October 9, 2026 · FDA enforcement record: FDA #D-1064-2016
Cite this page
“Tazorac Gel Recall: Failed Content Uniformity.” GovInfoNow, updated October 9, 2026. https://govinfonow.com/recall/42768-tazorac-gel-recall-failed-content-uniformity. Based on FDA recall #D-1064-2016 (https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-1064-2016%22&limit=1).
Why it’s dangerous
The recall is due to failed content uniformity specifications, which implies the dosage of tazarotene may vary from the labeled amount. The record does not specify if this results in under-dosing (reduced efficacy) or over-dosing (increased side effects), so the specific health risk mechanism is not clearly defined.
Who’s affected
Consumers who purchased Tazorac Gel 0.05% from pharmacies or healthcare providers between distribution dates leading up to May 10, 2016, specifically those with lot numbers 84172 or 84173.
How to tell if you have this one
Check your Tazorac Gel tube for the National Drug Code (NDC) numbers 0023-8335-03 (30g tube) or 0023-8335-10 (100g tube). Verify the lot number is either 84172 or 84173 and the expiration date is FEB/2017.
- Brand
Tazorac- Category
Drug
All 2 products in this recall
FDA lists each product line separately under one recall event. Check your product description, lot or code numbers against each row. Every row shares the hazard and remedy on this page.
- Classification
Class II- Status
Terminated- Distribution
Nationwide and Puerto Rico
| Recall number | Product, codes & lots | Quantity |
|---|---|---|
| D-1064-2016 | 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; Lot #: a) 84172, b) 84173, Exp FEB/2017 | 17802 units |
| D-1065-2016 | Tazorac (tazarotene) Gel 0.05%, 15 x 3.5g, sample packs, Allergan Inc, Irvine, CA 92612. UPC 300238335159; Lot #: 84126, Exp FEB/2017 | N/A |
What to do — step by step
Check your product details
Verify if your Tazorac Gel matches the NDC numbers, lot numbers (84172 or 84173), and expiration date (FEB/2017) listed in the recall.
Contact your pharmacist
Since the remedy is not stated in the record, contact your pharmacy or healthcare provider to ask about next steps for replacement or refund.
Where it went and when
Where it was distributed
Distributed nationwide.
FDA distribution: “Nationwide and Puerto Rico” States read from FDA’s own wording; “not listed” means the notice does not name it.
Distributed nationwide.
Recall timeline
FDA terminated this recall 19 months after the firm started it.
- Firm started the recall
- FDA classified it Class II
- Published in FDA’s Enforcement Report
- FDA terminated the recall
Dates from the agency record only; steps without a date are left out.
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Where this comes from
The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
- Official source: FDA Recall #D-1064-2016 (May 10, 2016) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for D-1064-2016 to see it in context.
- Plain-language summary written by qwen3.6:35b-a3b on October 9, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
- GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.