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Class II · ModerateRecall completed

Cefixime

Could cause temporary or reversible harm; serious harm is unlikely.

Does this affect you?
Check your lot numberLot #: F201517, Exp 11/30/2024
Where it was soldUSA nationwide.
Find the lot number printed on your box or bottle. If it matches — and you take this medicine — call your pharmacist. Don't stop a prescribed medicine on your own.

What happened

Subpotent Drug- An out of specification ( OOS ) result observed in assay test during 18-month long term stability study.

What to do

  1. Check the lot number and expiry on your medicine against the recall above.
  2. Talk to your pharmacist or doctor before changing anything — don't stop on your own.
  3. Report any problems to FDA MedWatch (1-800-FDA-1088 or fda.gov/medwatch).

Who makes it

Made byLupin Limited, Mandideep 462 046 INDIA foreign manufacturer
Brand nameCEFIXIME
Generic nameCEFIXIME
Active ingredient(s)CEFIXIME
Distributed by / forLupin Pharmaceuticals, Inc., Baltimore, Maryland 21202
NDC68180-405-01
Show the full FDA record
Full product labelCefixime for Oral Suspension USP, 100 mg/5 mL, 50 mL bottle, Rx only, Manufactured for: Lupin Pharmaceuticals, Inc., Baltimore, Maryland 21202, Manufactured by: Lupin Limited, Mandideep 462 046 INDIA, NDC 68180-405-01
Recalling firmLupin Pharmaceuticals Inc.
DistributionUSA nationwide.
Quantity4554 bottles
Recall initiated2024-08-21
Report date2024-09-04
Recall completed2025-04-29
Recall numberD-0648-2024
ClassificationClass II
FDA statusTerminated
Origin on fileBaltimore MD United States

Related

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Source: U.S. FDA enforcement database (openFDA). Look this up on the official FDA recalls site ↗

This is public FDA recall information, not medical advice. A recall does not always mean your specific bottle is affected. Never stop a prescribed medicine without asking your pharmacist or doctor.