Hydrocortisone & Acetic Acid Otic Solution Recalled for Potency and Impurity Failures
Taro Pharmaceuticals recalled Hydrocortisone 1% & Acetic Acid 2% Otic Solution (lot AD12890) due to failed impurity specifications and lower-than-established active ingredient levels during stability testing.
What this means for you
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: This is an FDA Class III recall with no reported illnesses or injuries. The hazard involves quality control failure (degradation products and subpotent active ingredient), which represents a theoretical rather than immediate safety risk.
Plain-English summary
Taro Pharmaceuticals U.S.A., Inc. is recalling lot AD12890 (expiration 09/30/2024) of Hydrocortisone 1% & Acetic Acid 2% Otic Solution (NDC 51672-3007-01), a prescription ear drop medication. The product was manufactured in Brampton, Ontario, Canada and distributed in the United States.
The recall was initiated due to out-of-specification results identified during stability testing: related impurities were found at elevated levels, and the active ingredient (hydrocortisone) was present at levels slightly lower than the established specification. These quality control failures indicate potential concerns regarding product efficacy and safety standards.
The recalled product consists of 96 vials distributed to a single pharmaceutical distributor. Healthcare providers and patients who may have received this lot should contact their pharmacist or healthcare provider for guidance. The FDA has not received reports of illnesses or injuries associated with this product.
The recalled product
- Product
- Hydrocortisone 1% & Acetic Acid 2% Otic Solution, 10 mL bottle, Rx only, Mfg by: Taro Pharmaceuticals, Inc., Brampton, Ontario, Canada L6T 1C1, Distributed by: Taro Pharmaceuticals U.S.A., Inc., Hawthorne, NY 10532, NDC 51672-3007-01
- Manufacturer
- Taro Pharmaceuticals U.S.A., Inc.
- Category
- Drug — Otic Medication
- Affected units
- 96
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (2)
- Lot # AD12890
- Exp 09/30/2024
Distribution
Distribution scope not specified by the agency.
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