Fluocinolone Acetonide Oil — Class II drug recall D-0259-2024
Terminated recall by Glenmark Pharmaceuticals Inc., USA, reported 2024-01-31, distributed nationwide. Failed Excipient Specifications: OOS for assay of Isopropyl Alcohol
| Recall number | D-0259-2024 |
|---|---|
| Product type | Drug |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Glenmark Pharmaceuticals Inc., USA, Mahwah, NJ, United States |
| Recall initiated | 2024-01-04 |
| Classified | 2024-01-22 |
| Reported by FDA | 2024-01-31 |
| Terminated | 2024-08-16 |
| Distributed | Nationwide (US) |
| Quantity | 38,496 bottles |
| Reason classes | potency, specification failure |
| NDC | 68462-0185, 68462-0185-56 |
| Lot numbers | 05220346, 05220369, 05220582, 05220861, 1/31, 2024 |
| Expiration dates | 2024-02-29, 2024-03-31 |
Product
Fluocinolone Acetonide Oil, 0.01% (Ear Drops), package in 1 Oz. (20 mL fill volume) bottle, Rx only, Manufactured by: Glenmark Pharmaceuticals Ltd., Village: Kishanpura, Baddi Nalagarh Road, District: Solan, Himachal Pradesh - 173205, India, Manufactured for: Glenmark Pharmaceuticals Inc., USA, Mahwah, NJ 07430, NDC 68462-185-56
Reason for recall
Failed Excipient Specifications: OOS for assay of Isopropyl Alcohol
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-0259-2024. 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.