Lupin Pharmaceuticals Inc. recalls Cephalexin for Oral Suspension USP 250mg/5 mL, Rx Only Manufactured for: Lupin Pharmaceuticals, Inc., Baltimore,
Lupin Pharmaceuticals recalls Cephalexin 250mg/5mL oral suspension (Rx only) due to possible sucrose contamination in packaging. Affected lots manufactured in Baltimore, Maryland, with NDC 68180-441-01.
Lower-risk recall
CGMP Deviations; presence of extraneous material in the was observed in area that is between the primary package that is heat sealed and secondary packaging (poly-woven bag) of sucrose (an excipient) used in the finished product.
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What happened, in plain English
Lupin Pharmaceuticals is recalling Cephalexin oral suspension (250mg/5mL, prescription only) because extraneous material was found in the packaging. This could pose a risk of contamination if the product is ingested. Consumers should check their prescription bottles for the specific lot number and NDC code. Read more at govinfonow.com/recall/39251-lupin-recalls-cephalexin-oral-suspension-with-extraneous-material-risk.
Source Summary by GovInfoNow · govinfonow.com/recall/39251-lupin-recalls-cephalexin-oral-suspension-with-extraneous-material-risk · Updated October 5, 2026 · FDA enforcement record: FDA #D-0423-2019
Cite this page
“Lupin recalls Cephalexin oral suspension with extraneous material risk.” GovInfoNow, updated October 5, 2026. https://govinfonow.com/recall/39251-lupin-recalls-cephalexin-oral-suspension-with-extraneous-material-risk. Based on FDA recall #D-0423-2019 (https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0423-2019%22&limit=1).
Why it’s dangerous
The recall involves extraneous material (sucrose) found between the primary heat-sealed package and secondary poly-woven bag packaging. This contamination could potentially be ingested if the product is not properly handled or stored.
Who’s affected
Prescription patients who received Cephalexin 250mg/5mL oral suspension with NDC 68180-441-01, lot F801282, manufactured in Baltimore, Maryland. Patients who have taken the product are most at risk.
How to tell if you have this one
Check your prescription bottle for the NDC code 68180-441-01 and lot number F801282. The product was manufactured by Lupin Pharmaceuticals in Baltimore, Maryland, with an expiration date of June 2020.
- Brand
Lupin- Category
Drug
What to do — step by step
Check Product Details
Look for the NDC code 68180-441-01 and lot number F801282 on the prescription bottle.
Questions people ask
Is this product safe to use?
The recall indicates possible sucrose contamination in the packaging, but the product is not considered immediately dangerous. Patients should check their specific lot number and NDC code.
What should I do if I have this product?
Check your prescription bottle for the NDC code 68180-441-01 and lot number F801282. If you have the affected product, contact your pharmacy for guidance.
How can I confirm if my product is recalled?
The product was manufactured by Lupin Pharmaceuticals in Baltimore, Maryland, with NDC 68180-441-01 and lot F801282. Check your bottle for these details.
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-0423-2019 — Lupin Lupin Hello, I own a Lupin that is covered by recall D-0423-2019 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-0423-2019 (January 9, 2019) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for D-0423-2019 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.