Lupin Pharmaceuticals Inc. recalls Cefixime for Oral Suspension USP, 100mg/5mL, Rx Only, Manufactured for: Lupin Pharmaceutical, Inc. Baltimore, Maryland
Lupin Pharmaceuticals recalls Cefixime oral suspension (100mg/5mL) due to low potency from stability testing. Affected lots may not contain full active ingredient.
Lower-risk recall
Subpotent Drug: low out of specification (OOS) test result observed in long term stability study.
Contact the company & request your remedy
What happened, in plain English
Lupin Pharmaceuticals is recalling a specific Cefixime oral suspension product because lab tests showed it contains less active drug than expected. This could mean the medication isn't as effective as it should be for treating infections. Read more at govinfonow.com/recall/37145-lupin-cefixime-oral-suspension-recall-subpotent-drug-risk.
Source Summary by GovInfoNow · govinfonow.com/recall/37145-lupin-cefixime-oral-suspension-recall-subpotent-drug-risk · Updated October 5, 2026 · FDA enforcement record: FDA #D-1252-2020
Cite this page
“Lupin Cefixime Oral Suspension Recall: Subpotent Drug Risk.” GovInfoNow, updated October 5, 2026. https://govinfonow.com/recall/37145-lupin-cefixime-oral-suspension-recall-subpotent-drug-risk. Based on FDA recall #D-1252-2020 (https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-1252-2020%22&limit=1).
Why it’s dangerous
The drug was found to have lower-than-expected potency during long-term stability testing. This means it may not provide the intended therapeutic effect for infections when taken as prescribed.
Who’s affected
Prescription patients using the recalled Cefixime oral suspension (100mg/5mL) from Lupin Pharmaceuticals. Those with ongoing infections may need alternative treatment.
How to tell if you have this one
Check for the product name 'Cefixime for Oral Suspension USP, 100mg/5mL', prescription-only status, and lot number F800779 with expiry 4/2020. The NDC code 68180-405-01 identifies this specific batch.
- Brand
Lupin- Category
Drug
What to do — step by step
Check Product Details
Verify the product name, prescription status, and lot number F800779 with expiry 4/2020 to confirm if it's affected.
Questions people ask
Is this product safe to use?
The recall indicates potential reduced effectiveness, but no immediate safety risk. Consult your doctor for alternative treatment options.
How can I tell if I have the recalled product?
Look for the product name 'Cefixime for Oral Suspension USP, 100mg/5mL', prescription-only status, and lot number F800779 with expiry 4/2020.
What should I do if I have the recalled product?
The recall does not specify a remedy, so contact your doctor to discuss alternative treatment options.
Contact Lupin
We’ve drafted a message you can send Lupin to request your refund or repair — edit it as you like.
Subject: Recall D-1252-2020 — Lupin Lupin Hello, I own a Lupin that is covered by recall D-1252-2020 from Lupin. 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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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-1252-2020 (April 15, 2020) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for D-1252-2020 to see it in context.
- Plain-language summary written by qwen3:4b on October 5, 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.