FDA-Drug2026-02-11Class IIPROCESSING DEFECT
Granules Pharmaceuticals trazodone recalled for foreign tablets in bottles
What this means
Granules Pharmaceuticals is recalling certain bottles of trazodone 50 mg because some bottles may contain foreign tablets or capsules mixed in. This affects 71,424 bottles with batch number 6160008A and an expiration date of 12/31/2026. No injuries have been reported.
- Check if you have trazodone from Granules Pharmaceuticals with batch #6160008A
- If you do, stop taking it and contact your pharmacist or doctor
- Do not flush medications; ask your pharmacist how to safely dispose of them
- Call your pharmacy or doctor if you have questions about your prescription
The agency's original wording
Hazard
Presence of Foreign Tablets/Capsules
Intended for
Adults
Illnesses reported
None reported
Sold states
US Nationwide.
Affected count
71424 bottles.
Manufactured in
3701 Concorde Pkwy, N/A, Chantilly, VA, United States
Products
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.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0305-2026Want us to check the next one for you?
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