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Drug FDA Class II Completed Sub/super-potent

Mupirocin Ointment, USP, 2%, 22 g, Rx only, Manufactured by: Glenmark Pharmaceuticals, Ltd., Colvale-Bardez, Goa 403513, India. Manufactured for: Glenmark Pharmaceuticals Inc., USA, Mahwah, NJ, 07430, NDC 68462-180-22.

Glenmark Pharmaceuticals Inc., USA Published Oct 2, 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 Glenmark Pharmaceuticals Inc., USA or your place of purchase with questions, and see the source record below for full details.
Reason for recall

Subpotent Drug

Hazards

Subpotency · primary

Affected products (1)

Mupirocin Ointment, USP, 2%, 22 g, Rx only, Manufactured by: Glenmark Pharmaceuticals, Ltd., Colvale-Bardez, Goa 403513, India. Manufactured for: Glenmark Pharmaceuticals Inc., USA, Mahwah, NJ, 07430, NDC 68462-180-22.

MUPIROCIN · 2,031,480 ointments

NDC: 68462-180, 68462-180-22
Code info: Lot #: 19223615, 19223537, 19223544,19223568, 19223593,19223641, Exp. Date 08/2024; 19224055,19224281, 19224307, 19224321, 19224341, 19224467, Exp. Date 09/2024; 19224525, 19224542, 19224560,19224580, Exp. Date 10/2024; 19224990, 19224998, 19225014, 19225033, 19225293, 19225304, 19225320, 19225349, 19225367, 19225379, 19225401, Exp. Date 11/2024; 19230115, 19230123, 19230132, 19230137, 19230167, 19230170, Exp. Date 12/2024; 19230572, 19230607, 19230614, 19230628, 19230631, Exp. Date 1/2025; 19230874, 19230925,19230941, 19230957, 19230976,19231232, 19231238, 19231282,19231285, Exp. Date 02/2025.

Affected areas

Nationwide

Timeline

  1. Initiated
    Aug 30, 2024
  2. Published
    Oct 2, 2024
Recall number
D-0660-2024
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.