FDA Recalls Oseltamivir Phosphate Oral Suspension for Out-of-Specification Impurities
Amneal Pharmaceuticals is recalling 46,037 bottles of Oseltamivir Phosphate Oral Suspension due to failed quality test results showing impurities and degradation. The FDA classified this as a Class II recall affecting nationwide distribution.
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: FDA Class II recall with no reported illnesses, injuries, or deaths. The hazard is theoretical—impurities and degradation detected through testing without documented patient harm. Per the rubric, Class II recalls without hospitalization reports and with no reported adverse events are classified as Moderate.
Plain-English summary
Amneal Pharmaceuticals of New York, LLC is recalling Oseltamivir Phosphate for Oral Suspension 6mg/ml in 60 mL bottles. The recall affects 46,037 bottles distributed nationwide. Affected lot numbers are BF22722A (expiration 08/31/2024) and BJ15122A (expiration 09/30/2024), with NDC 69238-1273-6.
The FDA initiated this Class II recall due to failed impurities and degradation specifications. Out-of-specification test results indicated the product did not meet required quality and stability standards.
Individuals with this medication should contact their healthcare provider or pharmacist regarding appropriate next steps.
The recalled product
- Product
- OSELTAMIVIR PHOSPHATE (OSELTAMIVIR PHOSPHATE)
- Brand
- OSELTAMIVIR PHOSPHATE
- Manufacturer
- Amneal Pharmaceuticals of New York, LLC
- Hazard
- Affected units
- 46,037
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 (4)
- Lot # BF22722A
- Exp. 08/31/2024
- BJ15122A
- Exp. 09/30/2024
UPCs (1)
- 0369238127362
Distribution
Distributed nationwide across the United States.
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