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Use caution Drug recall · FDA · Published June 30, 2016

Tazorac Gel Recall: Failed Content Uniformity

Allergan recalls Tazorac Gel 0.05% due to failed content uniformity specifications. Check lot numbers and expiration dates for affected tubes.

🇺🇸 FDA recall #D-0099-2017DrugTazorac ›
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Recalling firmAllergan Sales, LLC8301 Mars Dr · Waco, TX 76712-6578
✎ GovInfoNow plain-language explainer

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 tube may not be consistent with what is listed on the label. The recall affects both 30 g and 100 g tubes distributed nationwide. Read more at govinfonow.com/recall/42564-tazorac-gel-recall-failed-content-uniformity.

Source Summary by GovInfoNow · govinfonow.com/recall/42564-tazorac-gel-recall-failed-content-uniformity · Updated October 9, 2026 · FDA enforcement record: FDA #D-0099-2017

Cite this page

“Tazorac Gel Recall: Failed Content Uniformity.” GovInfoNow, updated October 9, 2026. https://govinfonow.com/recall/42564-tazorac-gel-recall-failed-content-uniformity. Based on FDA recall #D-0099-2017 (https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0099-2017%22&limit=1).

Why it’s dangerous

Failed content uniformity means the concentration of tazarotene in the gel may vary from tube to tube or within a single tube. This could result in receiving too little medication, rendering it ineffective, or potentially too much, increasing the risk of side effects like skin irritation.

Who’s affected

Patients prescribed Tazorac Gel 0.05% for dermatologic use who purchased the affected lots between manufacture and expiration. Individuals with sensitive skin may be particularly impacted by inconsistent dosing.

How to tell if you have this one

Check your Tazorac Gel 0.05% tubes for the following details: NDC 0023-8335-03 (30 g) with Lot # 82579, Exp. 10/16; or NDC 0023-8335-10 (100 g) with Lot # 85088, Exp. 05/17. The product is packaged in tubes and marked 'Rx only' and 'For Dermatologic Use Only'.

  • Brand
    Tazorac
  • Product
    TAZORAC (tazarotene) Gel 0.05%, Rx only, For Dermatologic Use Only, Not for Ophthalmic Use, packaged in a) 30 g tubes
  • Category
    Drug
FDA recall event · 2 products

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
Recall numberProduct, codes & lotsQuantity
D-0099-2017TAZORAC (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.; a) Lot# 82579; Exp. 10/16 b) Lot:# 85088 Exp. 05/1725,247 tubes (19,499 30 gram/ 5,748 100 gram)
D-0100-2017TAZORAC (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.; Lot # 85037; Exp 05/17 Lot # 82583; Exp 10/1617,112 tubes
Based on the official FDA remedy

What to do — step by step

  1. Check Your Product Details

    Verify if your Tazorac Gel matches the recalled lot numbers (82579 or 85088) and expiration dates (10/16 or 05/17).

  2. Contact Your Pharmacist

    Inform your pharmacist if you have the recalled product so they can assist with replacement or return options.

Where it went and when

Where it was distributed

Distributed nationwide.

Alaska: yesAKMaine: yesMEVermont: yesVTNew Hampshire: yesNHWashington: yesWAIdaho: yesIDMontana: yesMTNorth Dakota: yesNDMinnesota: yesMNIllinois: yesILWisconsin: yesWIMichigan: yesMINew York: yesNYRhode Island: yesRIMassachusetts: yesMAOregon: yesORNevada: yesNVWyoming: yesWYSouth Dakota: yesSDIowa: yesIAIndiana: yesINOhio: yesOHPennsylvania: yesPANew Jersey: yesNJConnecticut: yesCTCalifornia: yesCAUtah: yesUTColorado: yesCONebraska: yesNEMissouri: yesMOKentucky: yesKYWest Virginia: yesWVVirginia: yesVAMaryland: yesMDDelaware: yesDEArizona: yesAZNew Mexico: yesNMKansas: yesKSArkansas: yesARTennessee: yesTNNorth Carolina: yesNCSouth Carolina: yesSCDistrict of Columbia: yesDCOklahoma: yesOKLouisiana: yesLAMississippi: yesMSAlabama: yesALGeorgia: yesGAHawaii: yesHITexas: yesTXFlorida: yesFL

FDA distribution: “Nationwide” States read from FDA’s own wording; “not listed” means the notice does not name it.

Distributed nationwide.

Recall timeline

FDA terminated this recall 17 months after the firm started it.

1. Firm started the recall: Jun 30, 201612. FDA classified it Class II: Oct 13, 201623. Published in FDA’s Enforcement Report: Oct 19, 201634. FDA terminated the recall: Dec 6, 2017420162017
  1. Firm started the recall
  2. FDA classified it Class II
  3. Published in FDA’s Enforcement Report
  4. FDA terminated the recall

Dates from the agency record only; steps without a date are left out.

✎ GovInfoNow

Questions people ask

How can I identify the recalled product?

Look for NDC 0023-8335-03 or NDC 0023-8335-10 on the packaging, along with the specific lot and expiration dates mentioned above.

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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-0099-2017 (June 30, 2016) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for D-0099-2017 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.
GovInfoNow is an independent guide. We are not FDA or any government agency. Always confirm details with the official recall.Data: CPSC · FDA · NHTSA · USDA