CLASS II Drug recall · Reported 17 Jan 2018 · FDA Enforcement Report
Valsartan Tablets, USP, 160 mg recalled by Prinston Pharmaceutical
Prinston Pharmaceutical is recalling Valsartan Tablets, USP, 160 mg, distributed nationwide in the US. The recall was initiated on 29 Nov 2017 and the FDA has classified it as Class II.
Check your package
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
Recall details
- Recall number
- D-0209-2018
- FDA event ID
- 78651
- Recalling firm
- Prinston Pharmaceutical, Cranbury, NJ
- Brand
- Valsartan
- Manufacturer
- Solco Healthcare US, LLC
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 29 Nov 2017
- FDA classified
- 8 Jan 2018
- Reported
- 17 Jan 2018
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Other Reasons
- Drug class
- Blood Pressure Medication
Timeline
| 29 Nov 2017 | Recall initiated by company | |
| 8 Jan 2018 | Classified by FDA | +40 days |
| 17 Jan 2018 | Published in enforcement report | +9 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Failed Tablet/Capsule Specifications: confirmed customer complaint of thicker and heavier tablets in bottle.
Product as listed by the FDA
Valsartan Tablets, USP, 160 mg, 90-count bottles, Rx Only, Manufactured by: Zhejiang Huahai Pharmaceutical Co., Ltd, Xunqiao, Linhai, Zhejiang 317024, China; Distributed by: Solco Healthcare US, LLC, Cranbury, NJ 08512, USA; NDC 43547-369-09.
Where it was distributed
Nationwide in the USA and Puerto Rico
Questions about this recall
Why was it recalled?
Failed Tablet/Capsule Specifications: confirmed customer complaint of thicker and heavier tablets in bottle.
Which lots are affected?
Lot #: 343B17025, Exp 03/31/19
Where was it sold?
Nationwide in the USA and Puerto Rico
What should I do if I have it?
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
More recalls from Prinston Pharmaceutical
All 16| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Irbesartan and HydrochlorothiazideTablets, USP 150/12.5 mg recalledIrbesartan And Hydrochlorothiazide | Prinston Pharmaceutical | Nitrosamine Impurity | Nationwide |
| Drug | CLASS II | Irbesartan and Hydrochlorothiazide Tablets, USP 150/12.5 mg Rx Only recalledIrbesartan And Hydrochlorothiazide | Prinston Pharmaceutical | Nitrosamine Impurity | Nationwide |
| Drug | CLASS II | Irbesartan and Hydrochlorothiazide Tablets, USP 300/12.5 mg recalledIrbesartan And Hydrochlorothiazide | Prinston Pharmaceutical | Nitrosamine Impurity | Nationwide |
| Drug | CLASS II | Irbesartan Tablets 300 mg recalled by Prinston PharmaceuticalIrbesartan | Prinston Pharmaceutical | Nitrosamine Impurity | Nationwide |
| Drug | CLASS II | Irbesartan and Hydrochlorothiazide Tablets, USP 300/12.5 mg recalledIrbesartan And Hydrochlorothiazide | Prinston Pharmaceutical | Nitrosamine Impurity | Nationwide |
Other Valsartan recalls
All 88| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Diovan (valsartan) 160 mg recalled by Novartis PharmaceuticalsDiovan | Novartis Pharmaceuticals | Potency & Assay | Nationwide |
| Drug | CLASS II | Valsartan Tablets recalled by Cardinal HealthValsartan | Cardinal Health | Manufacturing (CGMP) Deviations | FL, GA, SC |
| Drug | CLASS II | Valsartan Tablets 160 mg recalled by Rising Pharmaceuticals | Rising Pharmaceuticals | Nitrosamine Impurity | Nationwide |
| Drug | CLASS II | Valsartan Tablets USP 80 mg recalled by Aurobindo Pharma USAValsartan | Aurobindo Pharma USA | Nitrosamine Impurity | Nationwide |
| Drug | CLASS II | Valsartan Tablets USP 320 mg recalled by Aurobindo Pharma USAValsartan | Aurobindo Pharma USA | Nitrosamine Impurity | Nationwide |