FDA Drug recall D-0259-2024
Fluocinolone Acetonide Oil, 0.01% (Ear Drops), package in 1 Oz. (20 mL fill volume) bottle, Rx only, Manufactured by: Glenmark Pharmaceutic…
- FDA Drug
- Class II
- terminated
- Published 2024-01-31
On 2024-01-31 the FDA classified a Class II recall of Fluocinolone Acetonide Oil, 0.01% (Ear Drops), package in 1 Oz. (20 mL fill volume) bottle, Rx only, Manufactured by: Glenmark Pharmaceutic… by Glenmark Pharmaceuticals Usa, citing failed Excipient Specifications: OOS for assay of Isopropyl Alcohol.
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-0259-2024 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2024-01-04 |
| Published | 2024-01-31 |
| Last updated | 2026-09-13 11:52 UTC |
| Company | Glenmark Pharmaceuticals Usa |
| Distribution | US |
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
Failed Excipient Specifications: OOS for assay of Isopropyl Alcohol
Identifiers
| ndc | 68462-185-56 |
|---|---|
| code_info | Lot #: 05220346, 05220369 Exp 1/31/ 2024; 05220582, Exp 2/29/2024; 05220861 Exp 3/31/2024 |
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:52 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0259-2024%22
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