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.
Failed Content Uniformity Specifications: Out-of-specification result for the Betamethasone Dipropionate assay of a stability sample
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.
The cream failed stability testing, meaning the medication content may not be consistent across the product. This could result in the cream not delivering the intended dose of medication to the skin. The issue was detected during a stability test, which checks how the product maintains quality over time.
Prescription users of the 15g Clotrimazole and Betamethasone Dipropionate Cream USP (1%/0.05%) who received this specific lot number (AC33883) from the manufacturer. Patients using this medication for skin conditions may be at risk if the cream doesn't deliver the correct dose.
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.
Look for the lot number AC33883 and expiration date June 2023 on the tube label.
The recall is due to failed content uniformity testing, which means the medication content may not be consistent. The product is still safe to use but may not deliver the correct dose.
The recall record does not specify a remedy, so no action is required beyond checking the product details.
Check for the lot number AC33883 and expiration date June 2023 on the tube label. This specific product was distributed by Taro Pharmaceuticals U.S.A., Inc. in the United States.
We’ve drafted a message you can send Taro to request your refund or repair — edit it as you like.
Subject: Recall D-0727-2022 — Taro Taro Hello, I own a Taro that is covered by recall D-0727-2022 from Taro. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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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.
