Lupin Pharmaceuticals recalled one lot of Clomipramine Hydrochloride capsules. The Florida-based drug manufacturer announced the recall back in June 2025. They did it after the medication failed in-house stability testing for drug degradation.

What You Should Know About the Recall

The recall affects 2,724 bottles of 100-count Clomipramine Hydrochloride capsules. The recall targets the 25 mg doses. It comes from Lot No. M300464 with a June 2025 expiration date.

Lupin Pharmaceuticals didn’t provide any press release with the recall. But the company filed the information with the Food and Drug Administration.

What You Should Know About Clomipramine

Doctors prescribe Clomipramine for patients with Obsessive-Compulsive Disorder (OCD).

It’s also classified as an antidepressant and carries an FDA “Black Box Warning.” This is the strictest label for prescription medications. The warning highlights an increased risk of suicidal thoughts and behavior. It focuses on the effect of its short-term use on children, adolescents, and young adult users.

Physicians and caregivers must weigh these risks against the clinical benefits before prescribing.

What Consumers Can Do

Patients taking Clomipramine from the affected lot should consult their healthcare provider immediately. Before they change their prescription schedule, they should talk about it. It’s very important to get medical advice before making any sudden changes. These could have major adverse effects.

Patients experiencing adverse effects should notify a medical professional. They should also report the issue to the FDA. They can call 1-800-332-1088 or go to www.fda.gov/medwatch.

This recall shows how important it is to keep testing drugs for safety. It also stresses the possible dangers of drugs that don’t meet quality standards.