FDA DrugsClass II
Trazodone Hydrochloride, USP, 50 mg, 100-Count Bottle, Rx only, Manufactured by:...
Published: February 11, 2026Recall ID: D-0305-2026Category: drugsCountry: US
Reason for Recall / Hazard
Presence of Foreign Tablets/Capsules
Product Description & Identification
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.
Additional Source Details
| Field | Value |
|---|---|
| City | Chantilly |
| State | VA |
| Openfda › Upc › 1 | 0370010232013 |
| Openfda › Upc › 2 | 0370010233010 |
| Openfda › Upc › 3 | 0370010231016 |
| Openfda › Upc › 4 | 0370010234017 |
| Openfda › Unii | 6E8ZO8LRNM |
| Openfda › Route | ORAL |
| Openfda › Rxcui › 1 | 856364 |
| Openfda › Rxcui › 2 | 856369 |
| Openfda › Rxcui › 3 | 856373 |
| Openfda › Rxcui › 4 | 856377 |
| Openfda › Spl id | 5096700d-3b93-70a3-e063-6294a90ad1d0 |
| Openfda › Brand name | TRAZODONE HYDROCHLORIDE |
| Openfda › Spl set id | 5bc5f266-6c0e-4b9a-b6e0-ea694928b948 |
| Openfda › Package ndc › 1 | 70010-231-03 |
| Openfda › Package ndc › 2 | 70010-231-01 |
| Openfda › Package ndc › 3 | 70010-231-05 |
| Openfda › Package ndc › 4 | 70010-231-10 |
| Openfda › Package ndc › 5 | 70010-232-03 |
| Openfda › Package ndc › 6 | 70010-232-01 |
| Openfda › Package ndc › 7 | 70010-232-05 |
| Openfda › Package ndc › 8 | 70010-232-10 |
| Openfda › Package ndc › 9 | 70010-233-03 |
| Openfda › Package ndc › 10 | 70010-233-01 |
| Openfda › Package ndc › 11 | 70010-233-05 |
| Openfda › Package ndc › 12 | 70010-234-03 |
| Openfda › Package ndc › 13 | 70010-234-01 |
| Openfda › Package ndc › 14 | 70010-234-05 |
| Openfda › Product ndc › 1 | 70010-231 |
| Openfda › Product ndc › 2 | 70010-232 |
| Openfda › Product ndc › 3 | 70010-233 |
| Openfda › Product ndc › 4 | 70010-234 |
| Openfda › Generic name | TRAZODONE HYDROCHLORIDE |
| Openfda › Product type | HUMAN PRESCRIPTION DRUG |
| Openfda › Substance name | TRAZODONE HYDROCHLORIDE |
| Openfda › Manufacturer name | Granules Pharmaceuticals Inc. |
| Openfda › Application number | ANDA218988 |
| Openfda › Is original packager | true |
| Event id | 98345 |
| Address 1 | 3701 Concorde Pkwy |
| Address 2 | N/A |
| Code info | Batch # 6160008A, Exp Date: 12/31/2026 |
| Postal code | 20151-1126 |
| Report date | 20260211 |
| Product type | Drugs |
| Product quantity | 71424 bottles. |
| Reason for recall | Presence of Foreign Tablets/Capsules |
| Voluntary mandated | Voluntary: Firm initiated |
| Recall initiation date | 20260126 |
| Initial firm notification | N/A |
| Center classification date | 20260211 |
Overview
- Recalling FirmGranules Pharmaceuticals Inc.
- StatusOngoing
- Risk LevelClass II
- DistributionUS Nationwide.