The Recall Desk
HighFDA (Drugs)·D-0537-2025·Announced 2025-07-30

[pending] CLOMIPRAMINE HYDROCHLORIDE (CLOMIPRAMINE HYDROCHLORIDE CAPSULES)

Pending LLM rewrite. Source: FDA_DRUG D-0537-2025.

What this means for you

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: Pending LLM scoring against the rubric.

Plain-English summary

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

The recalled product

Product
CLOMIPRAMINE HYDROCHLORIDE (CLOMIPRAMINE HYDROCHLORIDE CAPSULES)
Brand
CLOMIPRAMINE HYDROCHLORIDE
Manufacturer
Lupin Pharmaceuticals Inc.

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (3)

  • Lot # M300464
  • exp. date June
  • 2025

UPCs (2)

  • 0368180494065
  • 0368180493068

Distribution

Distributed nationwide across the United States.

Same brand · CLOMIPRAMINE HYDROCHLORIDE