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Lower risk Drug recall · FDA · Published February 25, 2022

Taro recalls Clotrimazole-Betamethas: Failed content uniformity in stability test

Taro Pharmaceuticals recalls 15g Clotrimazole-Betamethasone cream tubes due to failed content uniformity in stability testing. Rx-only product with specific lot number and expiration date.

🇺🇸 FDA recall #D-0727-2022DrugTaro ›
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Contact the company

Recalling firmTaro Pharmaceuticals U.S.A., Inc.3 Skyline Dr · Hawthorne, NY 10532-2174
✎ GovInfoNow plain-language explainer

Taro Pharmaceuticals is recalling certain prescription cream tubes that failed stability testing for consistent medication content. This could mean the cream may not deliver the correct dose of medication as intended. Read more at govinfonow.com/recall/35206-taro-recalls-clotrimazole-betamethas-failed-content-uniformity-in-stability-test.

Source Summary by GovInfoNow · govinfonow.com/recall/35206-taro-recalls-clotrimazole-betamethas-failed-content-uniformity-in-stability-test · Updated August 18, 2026 · FDA enforcement record: FDA #D-0727-2022

Cite this page

“Taro recalls Clotrimazole-Betamethas: Failed content uniformity in stability test.” GovInfoNow, updated August 18, 2026. https://govinfonow.com/recall/35206-taro-recalls-clotrimazole-betamethas-failed-content-uniformity-in-stability-test. Based on FDA recall #D-0727-2022 (https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0727-2022%22&limit=1).

The FDA announced on Feb. 25, 2022, that Taro Pharmaceuticals U.S.A., Inc. recalled Clotrimazole and Betamethasone Dipropionate Cream USP due to failed content uniformity specifications. The agency said the recall was voluntary and has since been terminated.

How to tell if you have it

  • Brand: Taro
  • Product: Clotrimazole and Betamethasone Dipropionate Cream USP, 1%/0.05%, 15 g tubes, Rx only
  • NDC: 51672-4048-1
  • Lot #: AC33883
  • Exp. Date: June 2023

The hazard

According to the FDA, the product failed content uniformity specifications because of an out-of-specification result for the Betamethasone Dipropionate assay of a stability sample.

Context

GovInfoNow's records show Taro Pharmaceuticals U.S.A., Inc. has 20 other recalls on record since Nov. 21, 2012. Other recent recalls include the Aug. 7, 2024, Taro Pharmaceuticals Hydrocortisone Otic Solution Recall for impurities risk and the Dec. 15, 2021, Taro Clobetasol Ointment Recall for R. Pickettii bacteria risk. Similar recent recalls of other products include the Aug. 3, 2026, Lupin Clobetasol Cream Recall for failed content uniformity and the March 25, 2026, Sun Pharmaceutical Fluocinonide Cream Recall for failed viscosity testing.

How to tell if you have this one

Check for the product name 'Clotrimazole and Betamethasone Dipropionate Cream USP, 1%/0.05%, 15g tubes' with lot number AC33883 and expiration date June 2023. This prescription-only cream was manufactured by Taro Pharmaceuticals Industries Ltd. in Haifa, Israel.

  • Brand
    Taro
  • Category
    Drug
Based on the official FDA remedy

What to do — step by step

  1. Check Product Details

    Look for the lot number AC33883 and expiration date June 2023 on the tube label.

Where it went and when

Where it was distributed

Distributed in New York.

Alaska: not listedAKMaine: not listedMEVermont: not listedVTNew Hampshire: not listedNHWashington: not listedWAIdaho: not listedIDMontana: not listedMTNorth Dakota: not listedNDMinnesota: not listedMNIllinois: not listedILWisconsin: not listedWIMichigan: not listedMINew York: yesNYRhode Island: not listedRIMassachusetts: not listedMAOregon: not listedORNevada: not listedNVWyoming: not listedWYSouth Dakota: not listedSDIowa: not listedIAIndiana: not listedINOhio: not listedOHPennsylvania: not listedPANew Jersey: not listedNJConnecticut: not listedCTCalifornia: not listedCAUtah: not listedUTColorado: not listedCONebraska: not listedNEMissouri: not listedMOKentucky: not listedKYWest Virginia: not listedWVVirginia: not listedVAMaryland: not listedMDDelaware: not listedDEArizona: not listedAZNew Mexico: not listedNMKansas: not listedKSArkansas: not listedARTennessee: not listedTNNorth Carolina: not listedNCSouth Carolina: not listedSCDistrict of Columbia: not listedDCOklahoma: not listedOKLouisiana: not listedLAMississippi: not listedMSAlabama: not listedALGeorgia: not listedGAHawaii: not listedHITexas: not listedTXFlorida: not listedFL

FDA distribution: “Product was distributed to one retail consignee in NY.” States read from FDA’s own wording; “not listed” means the notice does not name it.

States: New York.

Recall timeline

FDA terminated this recall 2.5 years after the firm started it.

1. Firm started the recall: Feb 25, 202212. FDA classified it Class III: Mar 29, 202223. Published in FDA’s Enforcement Report: Apr 6, 202234. FDA terminated the recall: Sep 9, 2024420222024
  1. Firm started the recall
  2. FDA classified it Class III
  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.

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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-0727-2022 (February 25, 2022) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for D-0727-2022 to see it in context.
  • Plain-language summary written by qwen3:4b on August 18, 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