Trazodone Hydrochloride Tablets Recalled Due to the Presence of Foreign Tablets

Key Takeaways:

• The US Food and Drug Administration (FDA) has issued a voluntary Class II recall for trazodone hydrochloride tablets, USP, 50 mg. The affected batch has been identified as Lot 1394026 (expires February 2028), containing 175 392 bottles.
• The recall was initiated by Teva Pharmaceuticals USA, Inc due to the presence of foreign tablets, a quality issue that is likely to cause temporary or medically reversible adverse health consequences or has a low probability of serious adverse health consequences.
• Trazodone is used to treat depression.

The FDA has issued a Class II recall for trazodone hydrochloride tablets, USP, 50 mg, affecting 175 392 bottles. This product is manufactured by Pliva Hrvatska in Croatia and is being recalled by Teva Pharmaceuticals USA, Inc based in Parsippany, New Jersey. The recall was initiated on August 24, 2026, and received a Class II classification on September 8, 2026. A Class II classification means the use of this product is likely to cause temporary or medically reversible adverse health consequences or has a low probability of serious adverse health consequences.

The recall was initiated after foreign tablets were discovered in the product. This deficiency affects Lot 1394026, which will expire in February 2028. Teva Pharmaceuticals USA sent out a public notice via letter; no press release has been issued for this recall.

Trazodone is a prescription medication that treats depression by increasing serotonin levels. Pharmacists should identify and quarantine Lot 1394026, remove it from inventory, and coordinate with prescribers to provide an alternative supply.

Reference

FDA. Enforcement Report. September 9, 2026. Accessed September 9, 2026. https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=222375