Hydrocortisone 1% & Acetic Acid 2% Otic Solution recall
FDA recall D-0633-2024 · initiated Aug 7, 2024
Taro Pharmaceuticals U.S.A., Inc. recalled Hydrocortisone 1% & Acetic Acid 2% Otic Solution in Aug 2024 — an FDA Class III recall (D-0633-2024) because 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.
Unlikely to cause harm but violates FDA labeling or manufacturing regulations.
Why it was recalled
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.
Wrong strength, or it did not keep
The product did not contain what the label promised, or stopped meeting specification before its expiry date. Under-strength medicine can mean an untreated condition.
This is a manufacturing or quality failure, not a finding that the medicine is unsafe to take — across every recall we hold, none was issued for that reason. It does not mean the batch was harmless.
Is your product affected? Check the lot number
A recall covers only specific lots. Find the lot number and expiration date on your package and compare them to the affected codes below — if yours is not listed, it was not part of this recall.
Quantity recalled: 96 vials
Details
- 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
- Recalling company
- Taro Pharmaceuticals U.S.A., Inc.
- Classification
- Class III
- Status
- Completed
- Type
- Voluntary: Firm initiated
- Distribution
- Product was distributed to one distributor
- Initiated
- Aug 7, 2024
- FDA report date
- Aug 21, 2024
Frequently asked
- Was Hydrocortisone 1% & Acetic Acid 2% Otic Solution recalled?
- Taro Pharmaceuticals U.S.A., Inc. recalled Hydrocortisone 1% & Acetic Acid 2% Otic Solution in Aug 2024 — an FDA Class III recall (D-0633-2024) because 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. Unlikely to cause harm but violates FDA labeling or manufacturing regulations.
- Why was Hydrocortisone 1% & Acetic Acid 2% Otic Solution recalled?
- Per the FDA enforcement record, the reason for recall D-0633-2024 was: 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.
- Is a recalled Hydrocortisone 1% & Acetic Acid 2% Otic Solution dangerous to take?
- An FDA recall removes specific lots from the market for a defined reason and does not by itself mean the medicine is unsafe for everyone — your specific lot may never have been affected. Unlikely to cause harm but violates FDA labeling or manufacturing regulations. Check the FDA notice for the affected lot numbers and expiration dates, and ask your pharmacist or doctor before stopping a prescribed medicine. This reproduces public FDA data and is not medical advice.
- Which lots of Hydrocortisone 1% & Acetic Acid 2% Otic Solution are affected?
- Distributed: Product was distributed to one distributor. The recall covers these lots — Lot # AD12890, Exp 09/30/2024. Check the lot number and expiration date on your package against this list; if yours is not listed, it was not part of recall D-0633-2024.