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Drug FDA Class II Terminated Sub/super-potent

Cefixime 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

Lupin Pharmaceuticals Inc. Published Sep 4, 2024

Risk level

Class II

May cause a temporary or reversible health problem; slight chance of serious harm.

Severity score 55/100

What should you do?

  • Check whether you have this product, using the lot codes, UPCs, and dates listed below.
  • Do not eat, serve, or sell the affected product.
  • Return it to the place of purchase for a refund, or throw it away in a sealed bag so people and animals can’t get to it.
  • Contact Lupin Pharmaceuticals Inc. or your place of purchase with questions, and see the source record below for full details.
Reason for recall

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

Hazards

Subpotency · primary

Affected products (1)

Cefixime 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

CEFIXIME · 4554 bottles

NDC: 68180-405, 68180-407, 68180-416, 68180-423, 68180-405-01, 68180-407-03, 68180-407-04, 68180-416-08, 68180-416-11, 68180-423-11, 68180-423-08
Code info: Lot #: F201517, Exp 11/30/2024

Affected areas

Nationwide

Timeline

  1. Initiated
    Aug 21, 2024
  2. Published
    Sep 4, 2024
  3. Terminated
    Apr 29, 2025
Recall number
D-0648-2024
Agency
U.S. Food and Drug Administration
Country
US
Source data (openFDA JSON) About FDA enforcement reports

FDA records come from the openFDA drug enforcement-report dataset — the agency's full weekly enforcement list. Most entries are not issued as consumer press releases, so they won't appear on fda.gov/recalls or in a web search. The source record link above resolves this exact recall by its number.