FDA Issues Class II Recall for Fluoxetine Tablets Due to Nitrosamine Impurity

The US Food and Drug Administration (FDA) has issued a Class II recall for Fluoxetine Tablets, USP, 20 mg, in both 30-count bottles and 28-count unit-dose cartons, due to the presence of N-Nitroso Fluoxetine, a potentially carcinogenic impurity, exceeding the interim acceptable intake limit. The affected products, all from Lot BDX6K001, carry an expiration date of June 30, 2025, and were manufactured by Torrent Pharmaceuticals Ltd. in India and distributed by Torrent Pharma Inc., based in Basking Ridge, New Jersey. The recall was voluntarily initiated on May 27, 2025, and applies to distribution across the United States.

The FDA officially classified the recall as Class II on June 2, 2025, indicating that use of the product may cause temporary or medically reversible health issues, though serious adverse events are unlikely. Torrent Pharma notified consignees by email, and although no public press release was issued, pharmacists are urged to verify inventory for both the NDC 13668-473-30 (bottle) and NDCs 13668-473-91 (carton) / 13668-473-70 (blister). Prompt removal of affected stock is recommended to ensure compliance and protect patient health.

Fluoxetine is a selective serotonin reuptake inhibitor (SSRI) used to treat major depressive disorder, obsessive-compulsive disorder, bulimia nervosa, and panic disorder. Given its widespread use for long-term mental health treatment, any impurity-related quality issue is critical.