It’s the generic for one of the most recognizable drugs that's commonly prescribed to treat certain mental health conditions.
More Than 3,600 Bottles of a Popular Anxiety and Depression Medication Were Just Recalled Nationwide
Published on Jun. 07, 2025
Depression rates have risen rapidly in recent years, with 29% of American adults reporting they’ve been diagnosed with depression “at some point in their lifetime,” according to 2023 Gallup data. But it’s not just adults who are affected—a 2024 study found antidepressant usage jumped nearly 130% for teen girls ages 12 to 17 between 2020 and 2022 (and 56.5% for young women between the ages of 18 and 25).
If you’re one of the millions of Americans taking an antidepressant to treat your symptoms, just know you’re not alone—but also know there’s a new recall that might affect your prescription.
On Monday, the U.S. Food and Drug Administration (FDA) informed the public about a nationwide recall affecting 3,672 bottles and 972 cartons of the drug fluoxetine.
Fluoxetine, often referred to by the brand name Prozac, is used to treat depression, as well as anxiety, eating disorders, and obsessive-compulsive disorder (OCD), according to the Cleveland Clinic. Fluoxetine is a selective serotonin reuptake inhibitor (SSRI), a commonly prescribed group of medications.
Fluoxetine has an important history in treating mental health conditions. In fact, it was “the first SSRI approved and marketed in the United States,” according to research published by the American Psychological Association’s Experimental and Clinical Psychopharmacology journal.
The FDA report lists the following product details:
Fluoxetine Tablets, USP, 20 mg, 30-count bottle
- Rx only
- Lot #: BDX6K001
- Expiration Date: 06/30/2025
- National Drug Code (NDC): 13668-473-30
- 3,672 total bottles
Fluoxetine Tablets, USP, 20 mg, 28-count Carton (4×7 Unit-dose)
- Lot #: BDX6K001
- Expiration Date: 06/30/2025
- NDC: 13668-473-91 (Carton); 13668-473-70 (Blister)
- 972 total cartons
Both the bottles and cartons of recalled fluoxetine were manufactured by Torrent Pharmaceuticals Ltd. in India and manufactured for Torrent Pharma Inc. in Basking Ridge, New Jersey, according to the report.
Though the recall was first initiated last week on May 27, the FDA has now given it a Class II designation. As a Class II recall, the products involved “may cause temporary or medically reversible adverse health effects.”
If you have the recalled drugs on hand, contact your pharmacy or prescribing medical provider for further assistance.
For daily wellness updates, subscribe to The Healthy by Reader’s Digest newsletter and follow The Healthy on Facebook and Instagram. Keep reading:
