Lupin Pharmaceuticals recalls Cefixime oral suspension (100mg/5mL) due to potential subpotency from stability testing. This may affect medication effectiveness. Contact for return instructions.
Subpotent Drug- An out of specification ( OOS ) result observed in assay test during 18-month long term stability study.
Lupin Pharmaceuticals is recalling a specific cefixime oral suspension product because testing showed it may not contain the full amount of active ingredient it should. This could mean the medication is less effective than it should be, potentially leading to treatment failure.
The medication was found to have lower-than-stated active ingredient levels during long-term stability testing. This means it might not work as effectively as intended, potentially leading to treatment failure for infections.
Prescription patients who received this specific cefixime oral suspension product. Those with medical conditions requiring precise antibiotic dosing may be at slightly higher risk.
Check for the product name 'Cefixime for Oral Suspension USP', 100 mg/5 mL, 50 mL bottle, prescription-only. Look for NDC 68180-405-01 and lot number F201517.
Verify the product name, NDC number, and lot number to confirm if it matches the recalled items.
The recall is due to potential reduced effectiveness, not immediate safety risks. The product may still be safe but less effective than labeled.
Check for NDC 68180-405-01 and lot number F201517 on the product label.
The recall does not specify a return or disposal action. Check with your healthcare provider for guidance.
We’ve drafted a message you can send Lupin Pharmaceuticals to request your refund or repair — edit it as you like.
Subject: Recall D-0648-2024 — Lupin Pharmaceuticals Lupin Pharmaceuticals Hello, I own a Lupin Pharmaceuticals that is covered by recall D-0648-2024 from Lupin Pharmaceuticals. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.