Recall archive / FDA drug enforcement
Hydrocortisone 1% & Acetic Acid 2% Otic Solution, 10 mL bottle, Rx only, Mfg by: Taro Pharmaceuticals, Inc., Brampton... — FDA record D-0633-2024
Reported completed
Status as reported in the agency record. FDA warns that enforcement status may not track the current recall lifecycle; check the current official notice.
Source date Aug 7, 2024. Retrieved Oct 1, 2026. Last updated Oct 1, 2026.
Archive changed Oct 1, 2026. USDA FSIS records are unavailable; check FSIS directly. Source coverage and dates.
What the record says
- 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
- Reason
- 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.
- Classification
- Class III
- Recalling firm
- Taro Pharmaceuticals U.S.A., Inc.
- Quantity
- 96 vials
- Agency-reported status
- Completed
- Source record identifier
- D-0633-2024
What the recall classes mean. Classification is an agency assessment, not individual medical advice.
Lot and product identifiers
| Label field | Details supplied by the agency |
|---|---|
| Lot, code or applicability | Lot # AD12890, Exp 09/30/2024 |
Match all identifying details in the current notice. A brand name alone is not enough.
Distribution
Product was distributed to one distributor
No US distribution state could be established from this record. Check the official notice.
Dates in the source
- Report date
- Aug 21, 2024
- Recall initiation date
- Aug 7, 2024
- Center classification date
- Aug 13, 2024
FDA company pages use the listing date; enforcement records use initiation dates; CPSC uses recall date; NHTSA uses report-received date. These dates are not interchangeable.