Trazodone Hydrochloride, Usp, 50 Mg, 100-count Bottle, Rx Only, Manufactured By: Granules India Limited, Hyderabad, 500 081, India, Manufactured For: Granules Pharmaceuticals Inc., Chantilly, Va 20151
Trazodone Recall Summary Granules Pharmaceuticals is recalling Trazodone Hydrochloride 50 mg tablets (100-count bottles, NDC 70010-231-01) distributed nationwide because some bottles contain foreign tablets or capsules mixed in with the medication. This is a serious safety issue classified as Class I. The recall affects patients who received this medication across all 50 states and Washington D.C.
- Recalling firm
- Granules Pharmaceuticals Inc.
- Product
- Trazodone Hydrochloride, USP, 50 mg, 100-Count Bottle, Rx only, Manufactured by: Granules India Limited, Hyderabad, 500 081, India, Manufactured for: Granules Pharmaceuticals Inc., Chantilly, VA 20151, NDC 70010-231-01.
- Reason
- Presence of Foreign Tablets/Capsules
- Classification
- Class I
- Category
- drug recall
- Country
- United States
- Agency
- U.S. Food and Drug Administration
- Recall date
- 2026-01-26
- Status
- Ongoing
- Areas affected
- AL, AK, AZ, AR, CA, CO, CT, DE, FL, GA, HI, ID, ...
- Distribution
- US Nationwide.
Official recall notice from U.S. Food and Drug Administration
Recall details on Nibble Recalls: https://trynibble.app/recalls/e4ee1eeb-7a64-4e58-8ea7-5d341cf5a60a