Antibiotic Cefdinir Oral Suspension Recalled Over Foreign Material
Lupin Pharmaceuticals is recalling Cefdinir for Oral Suspension due to foreign material found in reconstituted bottles. This FDA Class II recall affects 17,040 bottles 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 foreign material contamination in an antibiotic medication with potential to cause harm if ingested. No illnesses or injuries have been reported, making this a risk-of-harm scenario without documented injury, consistent with a High severity classification per the rubric.
Plain-English summary
Lupin Pharmaceuticals Inc. is recalling one lot of Cefdinir for Oral Suspension USP 125 mg/5 mL due to the discovery of foreign material in a reconstituted bottle. Cefdinir is an antibiotic used to treat bacterial infections.
The affected product is Lot # F305292 with an expiration date of 8/30/2025. The recall affects 17,040 bottles that were distributed nationwide throughout the United States.
Consumers who have this medication should stop using it immediately and contact their pharmacy or healthcare provider. The FDA has classified this as a Class II recall. Those with questions can contact Lupin Pharmaceuticals or the FDA.
The recalled product
- Product
- CEFDINIR (CEFDINIR)
- Brand
- CEFDINIR
- Manufacturer
- Lupin Pharmaceuticals Inc.
- Category
- Drug — Oral Suspension
- Hazard
- foreign-material
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 # F305292
- Exp 8/30/2025
UPCs (1)
- 0368180723042
Distribution
Distributed nationwide across the United States.
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