FDA Recalls Flunisolide Nasal Solution Due to Out-of-Specification Impurities
Ingenus Pharmaceuticals is recalling Flunisolide Nasal Solution nationwide because the product contains impurities that exceed acceptable limits. The recall affects two lots distributed across the United States.
The agency’s classification
FDA (Drugs): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 2/5 (Moderate).
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 for a quality-control issue (out-of-specification impurities) with no reported hospitalizations, illnesses, or injuries. The hazard is precautionary in nature, consistent with a moderate-severity contamination recall.
Plain-English summary
Ingenus Pharmaceuticals LLC is recalling Flunisolide Nasal Solution, USP 0.025% (25 mL bottles) nationwide. The recall is due to the product being out of specification for related substances, meaning it contains impurities that exceed acceptable limits.
The affected lots are #22E040 (Exp. 07/2023) and #22F038 (Exp. 08/2023). A total of 6,176 bottles were distributed nationwide within the United States. The product is identified by NDC 50742-317-25.
This is a Class II recall issued by the FDA.
The recalled product
- Product
- FLUNISOLIDE (FLUNISOLIDE)
- Brand
- FLUNISOLIDE
- Manufacturer
- Ingenus Pharmaceuticals Llc
- Category
- Drug — Nasal Solution
- Hazard
- Affected units
- 6,176
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 (2)
- Lot #: 22E040 Exp. 07/2023
- 22F038 Exp. 08/2023
UPCs (1)
- 350742317257
Distribution
Distributed nationwide across the United States.
Related recalls
Same manufacturer · Ingenus Pharmaceuticals Llc
See all →- ModerateClobetasol Propionate Foam Recalled for CGMP Deviations
FDA (Drugs) · 2022-01-26
- ModerateIngenus Recalls Leucovorin Calcium Injection Due to Crystallization
FDA (Drugs) · 2019-10-23
- LowIngenus Recalls Diclofenac Sodium Topical Solution Due to Leaking Bottles
FDA (Drugs) · 2019-04-03
- SevereIngenus Recalls Irinotecan Hydrochloride Injection Due to Potency Issues
FDA (Drugs) · 2018-07-11
- SevereIngenus Recalls Irinotecan Hydrochloride Injection Due to Potency Issues
FDA (Drugs) · 2018-07-11
Same hazard · impurities
See all →- SevereZydus Recalls Hydrocortisone Sodium Succinate Injection for Impurity Failures
FDA (Drugs) · 2026-10-21
- LowSun Pharmaceutical Recalls Tretinoin Cream Due to Impurity Specifications
FDA (Drugs) · 2026-10-14
- LowSun Pharmaceutical Recalls Tretinoin Cream Due to Impurity Failures
FDA (Drugs) · 2026-10-14
- LowSun Pharmaceutical Recalls Tretinoin Cream Due to Impurity Failures
FDA (Drugs) · 2026-10-14
- ModerateCipla Recalls Fosfomycin Tromethamine Due to Impurity Specification Failures
FDA (Drugs) · 2026-10-14
Similar recalls
- ModerateLupin Recalls Fluocinolone Acetonide Topical Solution Due to Impurity Failures
FDA (Drugs) · 2018-10-31
- ModerateFluocinolone topical solution recalled after failing an impurity specification
FDA (Drugs) · 2026-01-21
- SevereIngenus Recalls Irinotecan Hydrochloride Injection Due to Potency Issues
FDA (Drugs) · 2018-07-11
- LowFresenius Kabi Recalls Ondansetron Injection Due to Failed Impurity Specifications
FDA (Drugs) · 2019-06-19
- ModerateFurosemide tablets recalled for presence of N-nitroso impurity
FDA (Drugs) · 2026-04-29
- LowIngenus Recalls Diclofenac Sodium Topical Solution Due to Leaking Bottles
FDA (Drugs) · 2019-04-03