Lupin Cefixime Oral Suspension Recall: Subpotent Drug Risk
Lupin Pharmaceuticals recalls Cefixime oral suspension (100mg/5mL) due to potential subpotency from stability testing. This may affect medication effectiveness. Contact for return instructions.
Lower-risk recall
Subpotent Drug- An out of specification ( OOS ) result observed in assay test during 18-month long term stability study.
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What happened, in plain English
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. Read more at govinfonow.com/recall/32560-lupin-cefixime-oral-suspension-recall-subpotent-drug-risk.
Source Summary by GovInfoNow · govinfonow.com/recall/32560-lupin-cefixime-oral-suspension-recall-subpotent-drug-risk · Updated August 17, 2026 · FDA enforcement record: FDA #D-0648-2024
Cite this page
“Lupin Cefixime Oral Suspension Recall: Subpotent Drug Risk.” GovInfoNow, updated August 17, 2026. https://govinfonow.com/recall/32560-lupin-cefixime-oral-suspension-recall-subpotent-drug-risk. Based on FDA recall #D-0648-2024 (https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0648-2024%22&limit=1).
Why it’s dangerous
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.
Who’s affected
Prescription patients who received this specific cefixime oral suspension product. Those with medical conditions requiring precise antibiotic dosing may be at slightly higher risk.
How to tell if you have this one
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.
- Brand
Lupin Pharmaceuticals- Category
Drug
What to do — step by step
Check Product Details
Verify the product name, NDC number, and lot number to confirm if it matches the recalled items.
Where it went and when
Where it was distributed
Distributed nationwide.
FDA distribution: “USA nationwide.” States read from FDA’s own wording; “not listed” means the notice does not name it.
Distributed nationwide.
Recall timeline
FDA terminated this recall 8 months after the firm started it.
- Firm started the recall
- FDA classified it Class II
- Published in FDA’s Enforcement Report
- FDA terminated the recall
Dates from the agency record only; steps without a date are left out.
Questions people ask
Is this product safe to use?
The recall is due to potential reduced effectiveness, not immediate safety risks. The product may still be safe but less effective than labeled.
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Where this comes from
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.
- Official source: FDA Recall #D-0648-2024 (August 21, 2024) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for D-0648-2024 to see it in context.
- Plain-language summary written by qwen3:4b on August 17, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
- GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.