Fluocinolone Acetonide Ear Drops Recalled Due to Failed Specification
Glenmark Pharmaceuticals is recalling Fluocinolone Acetonide Oil 0.01% ear drops due to failed excipient specifications. The affected lots nationwide do not meet required quality standards for isopropyl alcohol content.
What this means for you
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: This is an FDA Class II recall due to failed pharmaceutical excipient quality specifications. With no reported adverse events or illnesses, this represents a precautionary quality control issue rather than an identified serious health hazard.
Plain-English summary
Glenmark Pharmaceuticals Inc., USA, is recalling Fluocinolone Acetonide Oil 0.01% (Ear Drops) because the product failed excipient specifications. Specifically, the isopropyl alcohol content in the affected lots did not meet required quality standards.
The recall affects 38,496 bottles distributed nationwide. The affected lot numbers are 05220346 and 05220369 (expiring 1/31/2024), 05220582 (expiring 2/29/2024), and 05220861 (expiring 3/31/2024). The product is manufactured by Glenmark Pharmaceuticals Ltd. in India and distributed by Glenmark Pharmaceuticals Inc., USA, under NDC 68462-185-56.
Patients using affected medication should contact their healthcare provider. Healthcare providers and distributors should check their inventories against the lot numbers and contact their supplier for instructions regarding return or replacement of affected products.
The recalled product
- Product
- FLUOCINOLONE ACETONIDE (FLUOCINOLONE ACETONIDE)
- Brand
- FLUOCINOLONE ACETONIDE
- Manufacturer
- Glenmark Pharmaceuticals Inc., USA
- Category
- Drug — Prescription Drug
- Hazard
- specification-failure
- manufacturing-defect
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (5)
- Lot #: 05220346
- 05220369 Exp 1/31/ 2024
- 05220582
- Exp 2/29/2024
- 05220861 Exp 3/31/2024
Distribution
Distributed nationwide across the United States.
Related recalls
Same brand · FLUOCINOLONE ACETONIDE
- ModerateTopical Corticosteroid Drug Recalled for Out-of-Specification Impurity
FDA (Drugs) · 2026-01-21
Same category
- CriticalWarfarin Tablets Recalled After Mix-Up Between 2.5 mg and 5 mg Strengths
FDA (Drugs) · 2026-07-21
- ModerateFDA Recalls Pred Mild Ophthalmic Suspension Due to Failed Stability Specifications
FDA (Drugs) · 2026-06-03
- ModerateNicotine Transdermal System Patches Recalled for Oxidative Impurity Specification Failure
FDA (Drugs) · 2026-06-03
- HighLiraglutide Injection Recalled Due to Particulate Matter in Cartridges
FDA (Drugs) · 2026-05-27
- LowPrimidone Tablets Recalled for Cross-Contamination with Acemetacin
FDA (Drugs) · 2026-05-27