FDA recall D-0377-2025

Product

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

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.

Distribution

USA nationwide

Key facts

Status

Terminated

Initiation date

2025-04-10

Report date

2025-04-30

Termination date

2026-01-05

Voluntary/Mandated

Voluntary: Firm initiated

Location

Naples, FL, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0377-2025