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Class II · ModerateRecall completed

Cefdinir

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

Does this affect you?
Check your lot numberLot #F305184, F305185, F305186, Exp 7/31/ 2025
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

Defective container: lack of seal integrity.

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 nameCEFDINIR
Generic nameCEFDINIR
Active ingredient(s)CEFDINIR
Distributed by / forLupin Pharmaceuticals, Inc., Baltimore, MD 21202
NDC68180-723-04
Show the full FDA record
Full product labelCefdinir for Oral Suspension USP, 250 mg/5 mL, packaged in a 60 mL bottle, Rx only, Manufactured for: Lupin Pharmaceuticals, Inc., Baltimore, MD 21202, Manufactured by: Lupin Limited, Mandideep, 462 046 India, NDC 68180-723-04
Recalling firmLupin Pharmaceuticals Inc.
DistributionUSA Nationwide
Quantity51,006 bottles
Recall initiated2024-05-08
Report date2024-06-05
Recall completed2025-04-29
Recall numberD-0518-2024
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.