Diovan (valsartan) 160 mg, 90 tablets, Rx only, Manufactured by: Patheon Manufacturing Services LLC, Greenville, NC 27834, Distributed by: Novartis Pharmaceutical Corp, East Hanover, NJ 07936, NDC 0078-0359-34
USDiovan (valsartan) 160 mg, 90 tablets, Rx only, Manufactured by: Patheon Manufacturing Services LLC, Greenville, NC 27834, Distributed by: Novartis Pharmaceutical Corp, East Hanover, NJ 07936, NDC 0078-0359-34
Recalling Firm: Novartis Pharmaceuticals Corporation
Reason for Recall / Hazard
Failed Dissolution Specifications
Product Description & Identification
Diovan (valsartan) 160 mg, 90 tablets, Rx only, Manufactured by: Patheon Manufacturing Services LLC, Greenville, NC 27834, Distributed by: Novartis Pharmaceutical Corp, East Hanover, NJ 07936, NDC 0078-0359-34
Additional Source Details
| Field | Value |
|---|---|
| City | East Hanover |
| State | NJ |
| Openfda › Nui › 1 | N0000000070 |
| Openfda › Nui › 2 | N0000175561 |
| Openfda › Unii | 80M03YXJ7I |
| Openfda › Route | ORAL |
| Openfda › Rxcui › 1 | 349199 |
| Openfda › Rxcui › 2 | 349200 |
| Openfda › Rxcui › 3 | 349201 |
| Openfda › Rxcui › 4 | 349483 |
| Openfda › Rxcui › 5 | 351761 |
| Openfda › Rxcui › 6 | 351762 |
| Openfda › Rxcui › 7 | 352001 |
| Openfda › Rxcui › 8 | 352274 |
| Openfda › Spl id | 8b57e357-5cfb-49a6-a600-59ce118fd1e9 |
| Openfda › Brand name | DIOVAN |
| Openfda › Spl set id | 5ddba454-f3e6-43c2-a7a6-58365d297213 |
| Openfda › Package ndc › 1 | 0078-0423-15 |
| Openfda › Package ndc › 2 | 0078-0358-34 |
| Openfda › Package ndc › 3 | 0078-1245-34 |
| Openfda › Package ndc › 4 | 0078-0359-34 |
| Openfda › Package ndc › 5 | 0078-1252-34 |
| Openfda › Package ndc › 6 | 0078-0360-34 |
| Openfda › Package ndc › 7 | 0078-1259-34 |
| Openfda › Product ndc › 1 | 0078-0358 |
| Openfda › Product ndc › 2 | 0078-0423 |
| Openfda › Product ndc › 3 | 0078-1245 |
| Openfda › Product ndc › 4 | 0078-0359 |
| Openfda › Product ndc › 5 | 0078-1252 |
| Openfda › Product ndc › 6 | 0078-0360 |
| Openfda › Product ndc › 7 | 0078-1259 |
| Openfda › Generic name | VALSARTAN |
| Openfda › Product type | HUMAN PRESCRIPTION DRUG |
| Openfda › Substance name | VALSARTAN |
| Openfda › Pharm class epc | Angiotensin 2 Receptor Blocker [EPC] |
| Openfda › Pharm class moa | Angiotensin 2 Receptor Antagonists [MoA] |
| Openfda › Manufacturer name | Novartis Pharmaceuticals Corporation |
| Openfda › Application number | NDA021283 |
| Openfda › Is original packager | true |
| Event id | 99552 |
| Address 1 | 1 Health Plz |
| Code info | Lot AV5913C, Expiry: 6/2027 |
| Postal code | 07936-1016 |
| Report date | 20260819 |
| Product type | Drugs |
| Reason for recall | Failed Dissolution Specifications |
| Voluntary mandated | Voluntary: Firm initiated |
| Recall initiation date | 20260804 |
| Initial firm notification | Letter |
| Center classification date | 20260807 |
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Overview
- Recalling FirmNovartis Pharmaceuticals Corporation
- StatusOngoing
- Risk LevelClass II
- DistributionUS Nationwide
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🚨 SAFETY ALERT: Novartis Pharmaceuticals Corporation - Diovan (valsartan) 160 mg, 90 tablets, Rx only, Manufactured by: Patheon Manufacturing Services LLC, Greenville, NC 27834, Distributed by: Novartis Pharmaceutical Corp, East Hanover, NJ 07936, NDC 0078-0359-34 Check if your household is affected: https://therecallfile.com/recalls/diovan-valsartan-160-mg-90-tablets-rx-only-manufactured-by-patheon-man/FDA-D-0746-2026
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