Cefixime oral suspension antibiotic recalled nationwide for subpotency
Lupin Pharmaceuticals is recalling Cefixime 100 mg/5 mL oral suspension due to subpotency discovered during stability testing. The affected lot (F201517) was distributed nationwide.
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: FDA Class II recall with no reported illnesses or injuries. The hazard is subpotency (reduced drug efficacy) discovered through stability testing, representing a precautionary recall rather than an acute safety threat.
Plain-English summary
Lupin Pharmaceuticals, Inc. is recalling one lot of Cefixime for Oral Suspension USP (100 mg/5 mL, 50 mL bottle, NDC 68180-405-01). The recall affects 4,554 bottles distributed nationwide.
The recall was initiated due to an out-of-specification (OOS) result observed during assay testing in an 18-month stability study. The affected product was determined to be subpotent, meaning it contains less than the labeled amount of active ingredient.
Patients currently taking this medication should contact their healthcare provider or pharmacist to determine whether they have been dispensed the recalled product. The lot number is F201517 with an expiration date of 11/30/2024.
Consumers or healthcare providers who have this product should stop use and contact Lupin Pharmaceuticals or the FDA for guidance on appropriate next steps.
The recalled product
- Product
- CEFIXIME (CEFIXIME)
- Brand
- CEFIXIME
- Manufacturer
- Lupin Pharmaceuticals Inc.
- Hazard
- subpotency
- reduced-efficacy
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 #: F201517
- Exp 11/30/2024
UPCs (4)
- 0368180423089
- 0368180407034
- 0368180416081
- 0368180416111
Distribution
Distributed nationwide across the United States.
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