FDA DrugsClass III
traZODONE Hydrochloride Tablets, USP, 100mg, 1,000 Tablets, Rx only, Manufacture...
Published: January 7, 2026Recall ID: D-0247-2026Category: drugsCountry: US
Reason for Recall / Hazard
Failed Tablet/Capsule Specifications: Product complaint received that some tablets had a dent on the plain side of the tablet surface.
Product Description & Identification
traZODONE Hydrochloride Tablets, USP, 100mg, 1,000 Tablets, Rx only, Manufactured by: Zydus Lifesciences Ltd., India, Distributed by: Zydus Pharmaceuticals (USA) Inc., Pennington, NJ 08534, NDC 68382-806-10
Additional Source Details
| Field | Value |
|---|---|
| City | Pennington |
| State | NJ |
| Openfda › Upc | 0368382808011 |
| 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 | 24cb2e4c-a9ba-4283-8396-343f6aa03121 |
| Openfda › Brand name | TRAZODONE HYDROCHLORIDE |
| Openfda › Spl set id | 704aebf9-2fff-4ef3-8323-9ff0d7f0ffd9 |
| Openfda › Package ndc › 1 | 68382-805-01 |
| Openfda › Package ndc › 2 | 68382-805-30 |
| Openfda › Package ndc › 3 | 68382-805-77 |
| Openfda › Package ndc › 4 | 68382-805-05 |
| Openfda › Package ndc › 5 | 68382-805-10 |
| Openfda › Package ndc › 6 | 68382-805-06 |
| Openfda › Package ndc › 7 | 68382-805-16 |
| Openfda › Package ndc › 8 | 68382-806-06 |
| Openfda › Package ndc › 9 | 68382-806-16 |
| Openfda › Package ndc › 10 | 68382-806-01 |
| Openfda › Package ndc › 11 | 68382-806-05 |
| Openfda › Package ndc › 12 | 68382-806-10 |
| Openfda › Package ndc › 13 | 68382-806-30 |
| Openfda › Package ndc › 14 | 68382-806-77 |
| Openfda › Package ndc › 15 | 68382-807-06 |
| Openfda › Package ndc › 16 | 68382-807-16 |
| Openfda › Package ndc › 17 | 68382-807-01 |
| Openfda › Package ndc › 18 | 68382-807-05 |
| Openfda › Package ndc › 19 | 68382-807-10 |
| Openfda › Package ndc › 20 | 68382-807-30 |
| Openfda › Package ndc › 21 | 68382-807-77 |
| Openfda › Package ndc › 22 | 68382-808-06 |
| Openfda › Package ndc › 23 | 68382-808-16 |
| Openfda › Package ndc › 24 | 68382-808-01 |
| Openfda › Package ndc › 25 | 68382-808-05 |
| Openfda › Package ndc › 26 | 68382-808-10 |
| Openfda › Package ndc › 27 | 68382-808-30 |
| Openfda › Package ndc › 28 | 68382-808-77 |
| Openfda › Package ndc › 29 | 68382-609-01 |
| Openfda › Package ndc › 30 | 68382-609-05 |
| Openfda › Package ndc › 31 | 68382-609-10 |
| Openfda › Package ndc › 32 | 68382-610-01 |
| Openfda › Package ndc › 33 | 68382-610-05 |
| Openfda › Package ndc › 34 | 68382-610-10 |
| Openfda › Product ndc › 1 | 68382-609 |
| Openfda › Product ndc › 2 | 68382-805 |
| Openfda › Product ndc › 3 | 68382-806 |
| Openfda › Product ndc › 4 | 68382-807 |
| Openfda › Product ndc › 5 | 68382-808 |
| Openfda › Product ndc › 6 | 68382-610 |
| Openfda › Generic name | TRAZODONE HYDROCHLORIDE |
| Openfda › Product type | HUMAN PRESCRIPTION DRUG |
| Openfda › Substance name | TRAZODONE HYDROCHLORIDE |
| Openfda › Manufacturer name | Zydus Pharmaceuticals USA Inc. |
| Openfda › Application number | ANDA205253 |
| Openfda › Is original packager | true |
| Event id | 98184 |
| Address 1 | 73 Route 31 N |
| Address 2 | N/A |
| Code info | Lot # EA00237A, Exp Date: 04/30/2027 |
| Postal code | 08534-3601 |
| Report date | 20260107 |
| Product type | Drugs |
| Product quantity | 2,136 1000-count bottles |
| Reason for recall | Failed Tablet/Capsule Specifications: Product complaint received that some tablets had a dent on the plain side of the tablet surface. |
| Voluntary mandated | Voluntary: Firm initiated |
| Recall initiation date | 20251219 |
| Initial firm notification | Letter |
| Center classification date | 20251231 |
Overview
- Recalling FirmZydus Pharmaceuticals (USA) Inc
- StatusOngoing
- Risk LevelClass III
- DistributionNationwide in the USA