Taro Pharmaceuticals recalls Hydrocortisone 1% & Acetic Acid 2% Otic Solution due to impurities and assay issues. This prescription ear drop may pose risks if used improperly.
Failed Impurities/Degradation Specifications: Out-of-specification results obtained for related impurities and slightly lower than the established level of the Hydrocortisone Assay obtained during stability testing.
Taro Pharmaceuticals is recalling prescription ear drops containing hydrocortisone and acetic acid because stability testing found impurities and lower-than-expected hydrocortisone levels. This could lead to unsafe concentrations if the product degrades over time.
The product failed stability testing, showing impurities and reduced hydrocortisone levels. This could mean the ear drop may not work as intended or could cause irritation if used improperly.
Prescription users of this ear drop product, particularly those with chronic ear conditions requiring regular use. Individuals using the product beyond its expiration date may be at higher risk.
Check for the 10 mL bottle labeled Hydrocortisone 1% & Acetic Acid 2% Otic Solution. The product was manufactured by Taro Pharmaceuticals, Inc. in Brampton, Ontario, Canada, with lot number AD12890 and expiration date 09/30/2024.
Look for the 10 mL bottle with the product name and lot number AD12890 on the label.
The recall indicates potential impurities and lower hydrocortisone levels, but the product is still safe for use until the expiration date. Consult your doctor for guidance.
The recall does not specify a remedy, so contact your doctor or pharmacist for advice on whether to continue using the product.
Check for the 10 mL bottle labeled Hydrocortisone 1% & Acetic Acid 2% Otic Solution with lot number AD12890 and expiration date 09/30/2024.
We’ve drafted a message you can send Taro Pharmaceuticals to request your refund or repair — edit it as you like.
Subject: Recall D-0633-2024 — Taro Pharmaceuticals Taro Pharmaceuticals Hello, I own a Taro Pharmaceuticals that is covered by recall D-0633-2024 from Taro Pharmaceuticals. 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.
