Lupin Pharmaceuticals Recalls Cefixime Suspension Over Failed Specifications
Lupin Pharmaceuticals is recalling Cefixime for Oral Suspension 100mg/5mL (4,608 bottles) due to failed impurity and degradation specifications. The product was distributed nationwide.
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 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: This is an FDA Class II recall for a pharmaceutical product that failed impurity and degradation quality specifications. While no illnesses or injuries have been reported, pharmaceutical products with specification failures represent a potential risk of harm to patients, meeting the criterion for High severity.
Plain-English summary
Lupin Pharmaceuticals Inc. is recalling Cefixime for Oral Suspension 100mg/5mL due to failed impurities and degradation specifications. The recall affects 4,608 bottles with lot number F304833 and expiration date 06/2025, distributed nationwide in the United States.
No illnesses or injuries have been reported in connection with this product. Patients taking this medication should contact their healthcare provider to determine appropriate next steps, including whether to obtain a replacement supply. Do not discontinue antibiotic therapy without medical guidance, as interruption of treatment could result in ineffective therapy for the infection being treated.
The recalled product
- Product
- CEFIXIME (CEFIXIME)
- Brand
- CEFIXIME
- Manufacturer
- Lupin Pharmaceuticals Inc.
- Hazard
- Affected units
- 4,608
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 #: F304833
- Exp 06/2025
UPCs (4)
- 0368180423089
- 0368180407034
- 0368180416081
- 0368180416111
Distribution
Distributed nationwide across the United States.
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