Skip to content
Back to recalls
Drug FDA Class II Terminated Failed specifications

clomiPRAMINE Hydrochloride Capsules USP 25 mg, 100 count bottles, 5801 Pelican Bay Boulevard, Suite 500, Naples, Florida 34108, NDC# 68180-492-01

Lupin Pharmaceuticals Inc. Published Jul 30, 2025

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

Failed Impurities/Degradation Specifications: an out of specification result observed in degradation product test (any unspecified degradation product) during retention sample testing at expiry.

Hazards

Failed Degradation Product Specification · primary

Affected products (1)

clomiPRAMINE Hydrochloride Capsules USP 25 mg, 100 count bottles, 5801 Pelican Bay Boulevard, Suite 500, Naples, Florida 34108, NDC# 68180-492-01

CLOMIPRAMINE HYDROCHLORIDE · 2,724 bottles

NDC: 68180-492, 68180-493, 68180-494, 68180-492-01, 68180-492-07, 68180-492-09, 68180-492-06, 68180-493-01, 68180-493-07, 68180-493-09, 68180-493-06, 68180-494-01, 68180-494-07, 68180-494-09, 68180-494-06
Lot codes: M300464
Code info: Lot # M300464, exp. date June, 2025

Affected areas

Nationwide

Timeline

  1. Initiated
    Jun 27, 2025
  2. Published
    Jul 30, 2025
  3. Terminated
    Jan 5, 2026
Recall number
D-0537-2025
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.