Antibiotic Cefdinir Oral Suspension Recalled for Foreign Material Contamination
Lupin Pharmaceuticals is recalling Cefdinir Oral Suspension USP 250 mg/5 mL (Lot F305442, expiration 8/30/2025) due to foreign material found in reconstituted bottles. Approximately 17,070 bottles were distributed nationwide.
What this means for you
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 FDA Class II recall involves contamination from foreign material without reported illnesses or injuries. Per the severity rubric, risk-of-harm products where injury has not yet been reported qualify as High (Score 3).
Plain-English summary
Lupin Pharmaceuticals Inc. is recalling Cefdinir for Oral Suspension USP 250 mg/5 mL due to the presence of foreign material in reconstituted bottles. The affected lot is F305442 with an expiration date of 8/30/2025, and approximately 17,070 bottles were distributed nationwide.
The recall was initiated following product complaints of foreign material found in reconstituted bottles. Cefdinir is a prescription antibiotic used to treat bacterial infections.
Patients who have this medication should not use it and should contact their pharmacy or healthcare provider immediately. Do not discontinue your prescribed antibiotic without consulting your doctor, as you may need an alternative medication to continue treatment.
This is an FDA Class II recall. For more information, contact Lupin Pharmaceuticals Inc. or visit the FDA website.
The recalled product
- Product
- CEFDINIR (CEFDINIR)
- Brand
- CEFDINIR
- Manufacturer
- Lupin Pharmaceuticals Inc.
- Hazard
- foreign-material
- contamination
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 # F305442
- Exp 8/30/2025
UPCs (1)
- 0368180723042
Distribution
Distributed nationwide across the United States.
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