FDA Drug recall D-0305-2026
Trazodone Hydrochloride, USP, 50 mg, 100-Count Bottle, Rx only, Manufactured by: Granules India Limited, Hyderabad, 500 081, India, Manufac…
- FDA Drug
- Class II
- ongoing
- Published 2026-02-11
On 2026-02-11 the FDA classified a Class II recall of Trazodone Hydrochloride, USP, 50 mg, 100-Count Bottle, Rx only, Manufactured by: Granules India Limited, Hyderabad, 500 081, India, Manufac… by Granules Pharmaceuticals, citing presence of Foreign Tablets/Capsules.
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-0305-2026 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2026-01-26 |
| Published | 2026-02-11 |
| Last updated | 2026-09-13 11:52 UTC |
| Company | Granules Pharmaceuticals |
| Distribution | US |
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
Identifiers
| ndc | 70010-231-03 |
|---|---|
| ndc | 70010-231-01 |
| ndc | 70010-231-05 |
| ndc | 70010-231-10 |
| ndc | 70010-232-03 |
| ndc | 70010-232-01 |
| ndc | 70010-232-05 |
| ndc | 70010-232-10 |
| ndc | 70010-233-03 |
| ndc | 70010-233-01 |
| ndc | 70010-233-05 |
| ndc | 70010-234-03 |
| ndc | 70010-234-01 |
| ndc | 70010-234-05 |
| code_info | Batch # 6160008A, Exp Date: 12/31/2026 |
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:52 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0305-2026%22
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