FDA Class II Recall Issued for Doxepin Hydrochloride Capsules Due to Nitrosamine Impurity

Alembic Pharmaceuticals Limited has voluntarily initiated a nationwide Class II recall of its doxepin hydrochloride capsules, USP, 10 mg. The affected product is distributed in 100-count bottles under NDC 62332-637-31, with lot number 2305015142 and an expiration date of September 30, 2025. The capsules were manufactured in Gujarat, India, for Alembic Pharmaceuticals, Inc., based in Bedminster, New Jersey. A total of 9492 bottles are involved in this recall, which began on July 25, 2025.

The recall was triggered by the detection of a Nitrosamine Drug Substance Related Impurity (NDSRI) above the proposed interim limit, indicating deviations from Current Good Manufacturing Practices (CGMP). Nitrosamines are classified as probable human carcinogens, and their presence above acceptable limits poses potential long-term safety risks. The US Food and Drug Administration (FDA) categorized this as a Class II recall, meaning exposure to the violative product may cause temporary or medically reversible health consequences, but the probability of serious adverse health effects is remote.

Doxepin is a prescription medication commonly used in the treatment of depression and anxiety disorders, as well as insomnia in lower doses. It belongs to the class of tricyclic antidepressants and works by affecting neurotransmitters in the brain to improve mood and sleep. Pharmacists should review their inventory for the affected lot and follow standard procedures for handling drug recalls to ensure patient safety.