Hydrocortisone 1% & Acetic Acid 2% Otic Solution — Class III drug recall D-0633-2024
Completed recall by Taro Pharmaceuticals U.S.A., Inc., reported 2024-08-21. Failed Impurities/Degradation Specifications: Out-of-specification results obtained for related impurities and
| Recall number | D-0633-2024 |
|---|---|
| Product type | Drug |
| Classification | Class III |
| Status | Completed |
| Voluntary or mandated | Voluntary |
| Recalling firm | Taro Pharmaceuticals U.S.A., Inc., Hawthorne, NY, United States |
| Recall initiated | 2024-08-07 |
| Classified | 2024-08-13 |
| Reported by FDA | 2024-08-21 |
| Quantity | 96 vials |
| Reason classes | potency, specification failure |
| NDC | 51672-3007-01 |
| Lot numbers | AD12890 |
| Expiration dates | 2024-09-30 |
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 for recall
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/D-0633-2024. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.