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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 # F305292, Exp 8/30/2025
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

Presence of foreign substance: Product complaint of foreign material in reconstituted bottle.

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, Maryland 21202, United States
NDC68180-722-04
Show the full FDA record
Full product labelCefdinir for Oral Suspension USP 125 mg/5 mL (60 mL when reconstituted), 60 mL bottle, Rx only, Manufactured for: Lupin Pharmaceuticals, Inc., Baltimore, Maryland 21202, United States, Manufactured by: Lupin Limited, Mandideep 462 046, India, NDC 68180-722-04
Recalling firmLupin Pharmaceuticals Inc.
DistributionUSA nationwide
Quantity17,040 bottles
Recall initiated2024-04-24
Report date2024-05-22
Recall completed2025-04-29
Recall numberD-0497-2024
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.