Cefdinir Oral Suspension recalled nationwide for defective container seals
Lupin Pharmaceuticals is recalling Cefdinir for Oral Suspension due to defective container seals. The recall affects 51,006 bottles distributed nationwide with lot numbers F305184, F305185, and F305186.
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 is an FDA Class II recall for a container seal integrity defect on an antibiotic medication with no reported illnesses or injuries. Per the rubric, this qualifies as a risk-of-harm product where injury has not yet been reported, scoring 3 (High).
Plain-English summary
Lupin Pharmaceuticals Inc. is recalling Cefdinir for Oral Suspension USP, 250 mg/5 mL, packaged in 60 mL bottles. The recall affects 51,006 bottles distributed nationwide in the United States.
The recalled product has lot numbers F305184, F305185, and F305186, with an expiration date of July 31, 2025. The specific defect is lack of seal integrity in the product containers. This is an FDA Class II recall (recall number D-0518-2024).
Patients who have this medication should check their bottle for the recalled lot numbers. Contact your pharmacist or healthcare provider if you have a matching bottle. Do not use the product if the lot number matches the recall, and return it to your pharmacy for proper handling.
For additional information about this recall, visit the FDA's drug recall website or contact your healthcare provider.
The recalled product
- Product
- CEFDINIR (CEFDINIR)
- Brand
- CEFDINIR
- Manufacturer
- Lupin Pharmaceuticals Inc.
- Category
- Drug — Oral Suspension
- Hazard
- seal-integrity-defect
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 #F305184
- F305185
- F305186
- Exp 7/31/ 2025
UPCs (1)
- 0368180723042
Distribution
Distributed nationwide across the United States.
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