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Drug FDA Class II Terminated Failed specifications

clomiPRAMINE hydrochloride Capsules USP, 25 mg, 100-count bottle, Rx only, Manufactured For: Lupin Pharmaceuticals, Inc., Baltimore, MD 21202, United States, Manufactured By: Lupin Limited, Nagpur, 441 108 INDIA, NDC 68180-492-01

Lupin Pharmaceuticals Inc. Published Apr 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 18-month long term stability study.

Hazards

Failed Degradation Product Specifications · primary

Affected products (1)

clomiPRAMINE hydrochloride Capsules USP, 25 mg, 100-count bottle, Rx only, Manufactured For: Lupin Pharmaceuticals, Inc., Baltimore, MD 21202, United States, Manufactured By: Lupin Limited, Nagpur, 441 108 INDIA, NDC 68180-492-01

CLOMIPRAMINE HYDROCHLORIDE · 2724 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
Code info: Lot #: M300442, Exp Date: 6/30/2025

Affected areas

Nationwide

Timeline

  1. Initiated
    Apr 10, 2025
  2. Published
    Apr 30, 2025
  3. Terminated
    Jan 5, 2026
Recall number
D-0377-2025
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.