Depression medication recalled after possible ‘metal shaving’ in a tablet
One lot of an antidepressant that carries an FDA boxed warning has been recalled after a customer complaint about “the presence of foreign material embedded resembling a metal shaving in one tablet.”
That’s in the FDA’s Enforcement Report on the March 21 recall of 75 mg strength Venlafaxine by Zydus Pharmaceuticals, a recall that covers 13,128 bottles. No announcement was made in a news release or consumer advisory.
The enforcement report was issued because the FDA placed this as a Class II recall, which the agency defines as “use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote.”
This covers lot No. M314265 with expiration Oct. 31, 2025, of NDC No. 68382-021-01. Return recalled bottles to the pharmacy and notify the prescribing medical professional.
Report any medical problems, first, to a medical professional. Then tell the FDA’s MedWatch program, either online or by calling 888-463-6332 (INFO-FDA) and pressing “2” when prompted. Next, inform Zydus by calling 877-993-8779, Prompt 2, Monday through Friday, 9 a.m. to 5 p.m. Eastern time, or by emailing Medicalaffairs@zydususa.com.
For questions about this recall, reach out to Zydus at the phone number above, but Prompt 1, Monday through Friday, 8:30 a.m. to 5 p.m. Eastern time, or by email at customerservice@zydususa.com.
Venlafaxine carries a boxed warning, the strongest the FDA requires, about the “increased risk of suicidal thinking and behavior in children, adolescents, and young adults in short-term studies of Major Depressive Disorder (MDD) and other psychiatric disorders. Anyone considering the use of venlafaxine tablets or any other antidepressant in a child, adolescent, or young adult must balance this risk with the clinical need.”
This story was originally published April 7, 2025 at 10:45 AM with the headline "Depression medication recalled after possible ‘metal shaving’ in a tablet."
