Trazodone Hydrochloride recall (Granules Pharmaceuticals Inc.)
DrugClass IIOngoing
Summary: Granules Pharmaceuticals Inc. is recalling 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.
What is being recalled
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.
Why
Presence of Foreign Tablets/Capsules
How serious is it
Class II is the middle level: using or being exposed to this product may cause temporary or medically reversible health problems, and the chance of serious harm is remote.
Where it was sold
US Nationwide.
How to tell if yours is affected
Batch # 6160008A, Exp Date: 12/31/2026
What to do
Check the product name, lot number and expiration date on your package against the codes above. If they match, do not stop taking a prescription medicine without talking to your doctor or pharmacist first; ask them about a replacement. Return or dispose of the product as your pharmacy advises.
Recall facts
| Recall number | D-0305-2026 |
| Category | Drug |
| Agency | U.S. Food and Drug Administration (FDA) |
| Severity | Class II |
| Status | Ongoing |
| Recall started | January 26, 2026 |
| Reported | February 11, 2026 |
| Company | Granules Pharmaceuticals Inc. |
| Company location | Chantilly, VA, United States |
| Initiated by | Voluntary: Firm initiated |
| Quantity | 71424 bottles. |
More recalls from Granules Pharmaceuticals Inc. · all drug recalls · recalls from January 2026