Reported Sep 4, 2024 · Terminated

Cefixime for Oral Suspension USP, 100 mg/5 mL, 50 mL bottle, Rx only, Manufactured for: Lupin Pharmaceuticals, Inc.,…

Lupin Pharmaceuticals Inc.

Moderate riskThis product could cause temporary or reversible health problems — stop using it.

What you should do

Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.

Firm contact: Lupin Pharmaceuticals Inc. · Harborplace Tower · Baltimore, MD · 21202-6174

Is this the product you have?

  • Cefixime for Oral Suspension USP, 100 mg/5 mL, 50 mL bottle, Rx only
  • Manufactured forLupin Pharmaceuticals, Inc., Baltimore, Maryland 21202
  • Manufactured by
    • Lupin Limited
    • Mandideep 462 046 INDIA
    • NDC 68180-405-01
Lot codes and dates
    • Lot #: F201517
    • Exp 11/30/2024
Amount recalled
4554 bottles

Where it was sold

  • Nationwide

Why it was recalled

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

This product could cause temporary or reversible health problems — stop using it.

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Where this came from

Source: U.S. Food & Drug Administration (openFDA)

Read the FDA (openFDA drug enforcement) notice

Notice updated Apr 29, 2025 · Data as of Sep 19, 7:23 PM UTC

RecallNow is not a government agency. Every fact on this page is published by the FDA, USDA or CPSC and links back to their notice.