Valsartan and hydrochlorothiazide

What Valsartan and hydrochlorothiazide is used for

Quoted from the “Indications and Usage” section of the FDA-approved label.

Diovan HCT (valsartan and hydrochlorothiazide, USP) is indicated for the treatment of hypertension, to lower blood pressure. Lowering blood pressure reduces the risk of fatal and nonfatal cardiovascular events, primarily strokes and myocardial infarctions. …

— FDA label: Diovan HCT, Novartis Pharmaceuticals Corporation, effective February 13, 2026. Read the full label on DailyMed →

Label quoted: the one for the most common form (tablet, film coated, oral), Diovan HCT, Novartis Pharmaceuticals Corporation; it covers 5 products in the FDA NDC Directory. The side effects, interactions, dosage and pregnancy quotes below come from this same label.

The FDA has 47 labels for products of this medicine (different makers and forms); uses can differ between them. Check the label that comes with your own medicine.

This page is not medical advice. Talk to your doctor or pharmacist before you start, stop or change any medicine.

Conditions named on the label

These condition names appear word for word in the label’s “Indications and Usage” text (matched with a reviewed table). Each page lists hospitals whose own websites name the condition.

Related medical specialties

Boxed warning

A boxed warning (“black box”) is the FDA’s strongest warning on a drug label, for serious or life-threatening risks.

This label has a boxed warning. Its heading: WARNING: FETAL TOXICITY. Read it on the full label →

46 of 47 FDA labels for this medicine have a boxed warning.

Valsartan and hydrochlorothiazide boxed warning: what the label says

Quoted from the boxed warning of the FDA-approved label.

WARNING: FETAL TOXICITY When pregnancy is detected, discontinue Diovan HCT as soon as possible. (5.1) Drugs that act directly on the renin-angiotensin system can cause injury and death to the developing fetus. (5.1) WARNING: FETAL TOXICITY See full prescribing information for complete boxed warning. When pregnancy is detected, discontinue Diovan HCT as soon as possible.

Read more of this section

(5.1) Drugs that act directly on the renin-angiotensin system can cause injury and death to the developing fetus. (5.1)

— FDA label: Diovan HCT, Novartis Pharmaceuticals Corporation, effective February 13, 2026. Read the full label on DailyMed →

Valsartan and hydrochlorothiazide side effects

Quoted from the “Adverse Reactions” section of the FDA-approved label. Tell your doctor about any side effect that worries you.

The most common reasons for discontinuation of therapy with Diovan HCT were headache and dizziness. The only adverse experience that occurred in ≥ 2% of patients treated with Diovan HCT and at a higher incidence than placebo was nasopharyngitis (2.4% vs. 1.9%).

Read more of this section

(6.1) To report SUSPECTED ADVERSE REACTIONS, contact Novartis Pharmaceuticals Corporation at 1-888-669-6682 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. 6.1 Clinical Trials Experience Because clinical studies are conducted under widely varying conditions, adverse reactions rates observed in the clinical studies of a drug cannot be directly compared to rates in the clinical studies of another drug and may not reflect the rates observed in practice. The adverse reaction information from clinical trials does, however, provide a basis for identifying the adverse events that appear to be related to drug use and for approximating rates. Hypertension Diovan HCT (valsartan and hydrochlorothiazide, USP) has been evaluated for safety in more than 5700 patients, including over 990 treated for over 6 months, and over 370 for over 1 year. Adverse experiences have generally been mild and transient in nature and have only infrequently required discontinuation of therapy. The overall incidence of adverse reactions with Diovan HCT was comparable to placebo. The overall frequency of adverse reactions was neither dose-related nor related to gender, age, or race. In controlled clinical trials, discontinuation of therapy due to side effects was required in 2.3% of valsartan-hydrochlorothiazide patients and 3.1% of placebo patients. The most common reasons for discontinuation of therapy with Diovan HCT were headache and dizziness. The only adverse reaction that occurred in controlled clinical trials in at least 2% of patients treated with Diovan HCT and at a higher incidence in valsartan-hydrochlorothiazide (n = 4372) than placebo (n = 262) patients was nasopharyngitis (2.4% vs. 1.9%). Dose-related orthostatic effects were seen in fewer than 1% of patients. In individual trials, a dose-related increase in the incidence of dizziness was observed in patients treated with Diovan HCT. Initial Therapy-Hypertension In a clinical study in patients with severe hypertension (diastolic blood pressure ≥ 110 mmHg and systolic blood pressure ≥ 140 mmHg), the overall pattern of adverse reactions reported through 6 weeks of follow-up was similar in patients treated with Diovan HCT as initial therapy and in patients treated with valsartan as initial therapy. Comparing the groups treated with Diovan HCT (force-titrated to 320/25 mg) and valsartan (force-titrated to 320 mg), dizziness was observed in 6% and 2% of patients, respectively. Hypotension was observed in 1% of those patients receiving Diovan HCT and 0% of patients receiving valsartan. There were no reported cases of syncope in either treatment group.

— FDA label: Diovan HCT, Novartis Pharmaceuticals Corporation, effective February 13, 2026. This is part of the section. Read the full label on DailyMed →

Valsartan and hydrochlorothiazide drug interactions

Quoted from the “Drug Interactions” section of the FDA-approved label. Tell your pharmacist about every medicine, vitamin and herbal product you take.

Valsartan-Hydrochlorothiazide: Lithium: Increases in serum lithium concentrations and lithium toxicity have been reported during concomitant administration of lithium with angiotensin II receptor antagonists or thiazides. Monitor lithium levels in patients taking Diovan HCT.

Read more of this section

Valsartan: Agents Increasing Serum Potassium: Concomitant use of valsartan with other agents that block the renin-angiotensin system, potassium-sparing diuretics (e.g., spironolactone, triamterene, amiloride), potassium supplements, salt substitutes containing potassium or other drugs that may increase potassium levels (e.g., heparin) may lead to increases in serum potassium and in heart failure patients to increases in serum creatinine. If co-medication is considered necessary, monitoring of serum potassium is advisable. Non-Steroidal Anti-Inflammatory Agents (NSAIDs), Including Selective Cyclooxygenase-2 Inhibitors (COX-2 Inhibitors): In patients who are elderly, volume-depleted (including those on diuretic therapy), or with compromised renal function, coadministration of NSAIDs, including selective COX-2 inhibitors, with angiotensin II receptor antagonists, including valsartan, may result in deterioration of renal function, including possible acute renal failure. These effects are usually reversible. Monitor renal function periodically in patients receiving valsartan and NSAID therapy. The antihypertensive effect of angiotensin II receptor antagonists, including valsartan, may be attenuated by NSAIDs including selective COX-2 inhibitors. Dual Blockade of the Renin-Angiotensin System (RAS): Dual blockade of the RAS with angiotensin receptor blockers, ACE inhibitors, or aliskiren is associated with increased risks of hypotension, hyperkalemia, and changes in renal function (including acute renal failure) compared to monotherapy. Most patients receiving the combination of two RAS inhibitors do not obtain any additional benefit compared to monotherapy. In general, avoid combined use of RAS inhibitors. Closely monitor blood pressure, renal function and electrolytes in patients on valsartan and other agents that affect the RAS. Do not coadminister aliskiren with valsartan in patients with diabetes. Avoid use of aliskiren with valsartan in patients with renal impairment (GFR < 60 mL/min). Hydrochlorothiazide: When administered concurrently, the following drugs may interact with thiazide diuretics: Antidiabetic Drugs (oral agents and insulin) - Dosage adjustment of the antidiabetic drug may be required. Nonsteroidal Anti-inflammatory Drugs (NSAIDs and COX-2 selective inhibitors) - When Diovan HCT and nonsteroidal anti-inflammatory agents are used concomitantly, the patient should be observed closely to determine if the desired effect of the diuretic is obtained. Carbamazepine – May lead to symptomatic hyponatremia.

— FDA label: Diovan HCT, Novartis Pharmaceuticals Corporation, effective February 13, 2026. This is part of the section. Read the full label on DailyMed →

Valsartan and hydrochlorothiazide dosage

Quoted from the “Dosage and Administration” section of the FDA-approved label. Your own dose is the one your doctor prescribes: do not change it on your own.

Dose once daily. Titrate as needed to a maximum dose of 320/25mg. (2) May be used as add-on/switch therapy for patients not adequately controlled on any of the components (valsartan or HCTZ). (2) May be substituted for titrated components. (2.3) 2.1 General Considerations The usual starting dose is Diovan HCT 160/12.5 mg once daily.

Read more of this section

The dosage can be increased after 1 to 2 weeks of therapy to a maximum of one 320/25 tablet once daily as needed to control blood pressure [see Clinical Studies (14.2)]. Maximum antihypertensive effects are attained within 2 to 4 weeks after a change in dose. 2.2 Add-On Therapy A patient whose blood pressure is not adequately controlled with valsartan (or another ARB) alone or hydrochlorothiazide alone may be switched to combination therapy with Diovan HCT. A patient who experiences dose-limiting adverse reactions on either component alone may be switched to Diovan HCT containing a lower dose of that component in combination with the other to achieve similar blood pressure reductions. The clinical response to Diovan HCT should be subsequently evaluated and if blood pressure remains uncontrolled after 3 to 4 weeks of therapy, the dose may be titrated up to a maximum of 320/25 mg. 2.3 Replacement Therapy Diovan HCT may be substituted for the titrated components. 2.4 Initial Therapy Diovan HCT is not recommended as initial therapy in patients with intravascular volume depletion [see Warnings and Precautions (5.2)]. 2.5 Use with Other Antihypertensive Drugs Diovan HCT may be administered with other antihypertensive agents.

— FDA label: Diovan HCT, Novartis Pharmaceuticals Corporation, effective February 13, 2026. Read the full label on DailyMed →

Valsartan and hydrochlorothiazide in pregnancy

Quoted from the pregnancy part of the FDA-approved label. Ask your doctor before you take any medicine while pregnant or planning a pregnancy.

Risk Summary Diovan HCT can cause fetal harm when administered to a pregnant woman. Use of drugs that act on the renin-angiotensin system during the second and third trimesters of pregnancy reduces fetal renal function and increases fetal and neonatal morbidity and death.

Read more of this section

Most epidemiologic studies examining fetal abnormalities after exposure to antihypertensive use in the first trimester have not distinguished drugs affecting the renin-angiotensin system from other antihypertensive agents. Published reports include cases of anhydramnios and oligohydramnios in pregnant women treated with valsartan (see Clinical Considerations). When pregnancy is detected discontinue Diovan HCT as soon as possible. The estimated background risk of major birth defects and miscarriage for the indicated population is unknown. All pregnancies have a background risk of birth defect, loss, or other adverse outcomes. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2-4% and 15-20%, respectively. Clinical Considerations Disease-associated maternal and/or embryo/fetal risk Hypertension in pregnancy increases the maternal risk for pre-eclampsia, gestational diabetes, premature delivery, and delivery complications (e.g., need for cesarean section and post-partum hemorrhage). Hypertension increases the fetal risk for intrauterine growth restriction and intrauterine death. Pregnant women with hypertension should be carefully monitored and managed accordingly. Fetal/Neonatal Adverse Reactions Valsartan Oligohydramnios in pregnant women who use drugs affecting the renin-angiotensin system in the second and third trimesters of pregnancy can result in the following: reduced fetal renal function leading to anuria and renal failure, fetal lung hypoplasia, skeletal deformations, including skull hypoplasia, hypotension and death. Perform serial ultrasound examinations to assess the intra-amniotic environment. Fetal testing may be appropriate, based on the week of gestation. Patients and physicians should be aware, however, that oligohydramnios may not appear until after the fetus has sustained irreversible injury. If oligohydramnios is observed, consider alternative drug treatment. Closely observe neonates with histories of in utero exposure to Diovan HCT for hypotension, oliguria, and hyperkalemia. In neonates with a history of in utero exposure to Diovan HCT, if oliguria or hypotension occurs, support blood pressure and renal perfusion. Exchange transfusions or dialysis may be required as a means of reversing hypotension and replacing renal function. Hydrochlorothiazide Thiazides can cross the placenta, and concentrations reached in the umbilical vein approach those in the maternal plasma. Hydrochlorothiazide, like other diuretics, can cause placental hypoperfusion. It accumulates in the amniotic fluid, with reported concentrations up to 19 times higher than in umbilical vein plasma.

— FDA label: Diovan HCT, Novartis Pharmaceuticals Corporation, effective February 13, 2026. This is part of the section. Read the full label on DailyMed →

When Valsartan and hydrochlorothiazide should not be used

Quoted from the “Contraindications” section of the FDA-approved label.

Diovan HCT (valsartan and hydrochlorothiazide, USP) is contraindicated in patients who are hypersensitive to any component of this product. Because of the hydrochlorothiazide component, this product is contraindicated in patients with anuria or hypersensitivity to other sulfonamide-derived drugs. Do not coadminister aliskiren with Diovan HCT in patients with diabetes [see Drug Interactions (7)].

Read more of this section

Anuria; Hypersensitivity to any sulfonamide-derived drugs or any component; Do not coadminister aliskiren with Diovan HCT in patients with diabetes. (4)

— FDA label: Diovan HCT, Novartis Pharmaceuticals Corporation, effective February 13, 2026. Read the full label on DailyMed →

Valsartan and hydrochlorothiazide overdose

Quoted from the “Overdosage” section of the FDA-approved label. If someone may have taken too much, call Poison Help at 1-800-222-1222 (or 911 in an emergency).

Limited data are available related to overdosage in humans. The most likely manifestations of overdosage would be hypotension and tachycardia; bradycardia could occur from parasympathetic (vagal) stimulation. Depressed level of consciousness, circulatory collapse and shock have been reported. If symptomatic hypotension should occur institute supportive treatment. Valsartan is not removed from the plasma by dialysis.

Read more of this section

The degree to which hydrochlorothiazide is removed by hemodialysis has not been established. The most common signs and symptoms observed in patients are those caused by electrolyte depletion (hypokalemia, hypochloremia, hyponatremia) and dehydration resulting from excessive diuresis. If digitalis has also been administered, hypokalemia may accentuate cardiac arrhythmias. In rats and marmosets, single oral doses of valsartan up to 1524 and 762 mg/kg in combination with hydrochlorothiazide at doses up to 476 and 238 mg/kg, respectively, did not show any adverse treatment-related effects. These no adverse effect doses in rats and marmosets, respectively, represent 46.5 and 23 times the MRHD of valsartan and 188 and 113 times the MRHD of hydrochlorothiazide on a mg/m 2 basis (Calculations assume an oral dose of 320 mg/day valsartan in combination with 25 mg/day hydrochlorothiazide and a 60-kg patient.) Valsartan was without grossly observable adverse effects at single oral doses up to 2,000 mg/kg in rats and up to 1,000 mg/kg in marmosets, except for salivation and diarrhea in the rat and vomiting in the marmoset at the highest dose (60 and 31 times, respectively, the MRHD on a mg/m 2 basis) (Calculations assume an oral dose of 320 mg/day and a 60-kg patient). The oral LD 50 of hydrochlorothiazide is greater than 10 g/kg in both mice and rats, which represents 2027 and 4054 times, respectively, the MRHD on a mg/m 2 basis (Calculations assume an oral dose of 25 mg/day and a 60-kg patient.)

— FDA label: Diovan HCT, Novartis Pharmaceuticals Corporation, effective February 13, 2026. Read the full label on DailyMed →

Forms and how it is given

Same medicine, other forms and combinations

Prescription medicine pages on this site that share an active ingredient with this one, from the FDA NDC Directory. A combination is a different medicine: ask your pharmacist before you switch.

Other medicines with one of these active ingredients

• Amlodipine besylate valsartan hydrochlorothiazideExforge Hct · 30 products
• HydrochlorothiazideInzirqo · 171 products
• ValsartanDiovan · 145 products
• Losartan potassium and hydrochlorothiazideHyzaar · 111 products
• Sacubitril and valsartanEntresto · 103 products
• Lisinopril and hydrochlorothiazideZestoretic · 95 products
• Olmesartan medoxomil and hydrochlorothiazideBenicar Hct · 81 products
• Triamterene and hydrochlorothiazide69 products
• Amlodipine and valsartanExforge · 44 products
• Olmesartan medoxomil / amlodipine besylate / hydrochlorothiazideTribenzor · 43 products
• Bisoprolol fumarate and hydrochlorothiazide42 products
• Irbesartan and hydrochlorothiazideAvalide · 31 products
• Telmisartan and hydrochlorothiazideMicardis Hct · 27 products
• Benazepril hydrochloride and hydrochlorothiazideLotensin Hct · 21 products
• Candesartan cilexetil and hydrochlorothiazideAtacand Hct · 16 products
• Metoprolol tartrate and hydrochlorothiazide14 products
• Quinapril HCL and hydrochlorothiazide12 products
• Spironolactone and hydrochlorothiazide12 products
• Enalapril maleate and hydrochlorothiazideVaseretic · 5 products
• Captopril and hydrochlorothiazide4 products
• Fosinopril sodium and hydrochlorothiazide4 products
• Amiloride hydrochloride and hydrochlorothiazide1 product

Companies that list this medicine

Labelers in the FDA NDC Directory: the company named on the package (maker or distributor), with the number of prescription products.

• A-S Medication Solutions11 products
• Proficient Rx LP10 products
• Bryant Ranch Prepack8 products
• Northwind Health Company, LLC5 products
• Macleods Pharmaceuticals Limited5 products
• AvKARE5 products
• Solco Healthcare US, LLC5 products
• ScieGen Pharmaceuticals, Inc.5 products
• Amneal Pharmaceuticals of New York LLC5 products
• Lupin Pharmaceuticals, Inc.5 products
• Mylan Pharmaceuticals Inc.5 products
• Zydus Lifesciences Limited5 products
• Novartis Pharmaceuticals Corporation5 products
• Alembic Pharmaceuticals Limited5 products
• Aurobindo Pharma Limited5 products
• Golden State Medical Supply, Inc.5 products
• Amneal Pharmaceuticals LLC5 products
• Alembic Pharmaceuticals Inc.5 products

FDA approval history

• NDA: New Drug Application: how a new (usually brand-name) medicine is approved.
• ANDA: Abbreviated New Drug Application: how a generic version is approved.

Generic approvals (9)

• ANDA078020Mylan Pharms Inc · September 21, 2012
• ANDA078946Lupin Ltd · March 21, 2013
• ANDA201662Alembic · March 21, 2013
• ANDA202519Aurobindo Pharma Ltd · March 21, 2013
• ANDA203145Macleods Pharms Ltd · April 19, 2013
• ANDA206083Prinston Inc · February 8, 2016
• ANDA203000Zydus Lifesciences · March 15, 2019
• ANDA204382Amneal Pharms · August 11, 2023
• ANDA204687Sciegen Pharms · April 23, 2026

Shortage status

The FDA drug shortage list does not show these products.

FDA Drug Shortages database →

Recalls

From FDA enforcement reports, matched by the product’s NDC code. A recall usually covers specific lots only: check the lot number on your package and ask your pharmacist. Do not stop a medicine on your own.

1. December 31, 2018 · Class II · Ongoing · D-0366-2019

   CGMP Deviations: FDA lab confirmed presence an impurity, N-nitrosodimethylamine (NDEA) contained in the API used to manufacture the product above the interim acceptable daily intake level of 0.083 parts per million.

   Valsartan and Hydrochlorothiazide tablets USP 160mg/12.5 mg, 90-count bottle, Rx Only, Manufactured for: Aurobindo Pharma USA, Inc., Dayton, NJ 08810. NDC 65862-548-90. — Aurobindo Pharma USA Inc.

2. December 31, 2018 · Class II · Ongoing · D-0368-2019

   CGMP Deviations: FDA lab confirmed presence an impurity, N-nitrosodimethylamine (NDEA) contained in the API used to manufacture the product above the interim acceptable daily intake level of 0.083 parts per million.

   Valsartan and Hydrochlorothiazide tablets USP 80 mg/12.5 mg, 90-count bottle, Rx Only, Manufactured for: Aurobindo Pharma USA, Inc., Dayton, NJ 08810. NDC 65862-547-90. — Aurobindo Pharma USA Inc.

3. December 31, 2018 · Class II · Ongoing · D-0365-2019

   CGMP Deviations: FDA lab confirmed presence an impurity, N-nitrosodimethylamine (NDEA) contained in the API used to manufacture the product above the interim acceptable daily intake level of 0.083 parts per million.

   Valsartan and Hydrochlorothiazide tablets USP 320mg/12.5 mg, 90-count bottle, Rx Only, Manufactured for: Aurobindo Pharma USA, Inc., Dayton, NJ 08810. NDC 65862-550-90. — Aurobindo Pharma USA Inc.

4. December 31, 2018 · Class II · Ongoing · D-0369-2019

   CGMP Deviations: FDA lab confirmed presence an impurity, N-nitrosodimethylamine (NDEA) contained in the API used to manufacture the product above the interim acceptable daily intake level of 0.083 parts per million.

   Valsartan and Hydrochlorothiazide tablets USP 160 mg/25 mg, 90-count bottle, Rx Only, Manufactured for: Aurobindo Pharma USA, Inc., Dayton, NJ 08810. NDC 65862-549-90. — Aurobindo Pharma USA Inc.

5. December 31, 2018 · Class II · Ongoing · D-0367-2019

   CGMP Deviations: FDA lab confirmed presence an impurity, N-nitrosodimethylamine (NDEA) contained in the API used to manufacture the product above the interim acceptable daily intake level of 0.083 parts per million.

   Valsartan and Hydrochlorothiazide tablets USP 320 mg/25 mg, 90-count bottles, Rx Only, Manufactured for: Aurobindo Pharma USA, Inc., Dayton, NJ 08810. NDC 65862-551-90. — Aurobindo Pharma USA Inc.

6. December 4, 2018 · Class II · Ongoing · D-0328-2019

   GCMP Deviations: FDA analysis confirmed presence of trace amounts of an impurity, N-nitrosodiethylamine (NDEA) found in the API used to manufacture the product.

   Valsartan and Hydrochlorothiazide Tablets, USP 80/12.5 mg, (a) 90-count bottle (NDC 0378-6321-77), (b) 500-count bottles (NDC 0378-6321-05), Rx Only, Made in India, Manufactured for: Mylan Pharmaceuticals, Inc., Morganto — Mylan Laboratories Limited, (Nashik FDF)

7. December 4, 2018 · Class II · Ongoing · D-0332-2019

   GCMP Deviations: FDA analysis confirmed presence of trace amounts of an impurity, N-nitrosodiethylamine (NDEA) found in the API used to manufacture the product.

   Valsartan and Hydrochlorothiazide Tablets, USP 320/25 mg, (a) 90-count bottle (NDC 0378-6325-77), (b) 500-count bottles (NDC 0378-6325-05), Rx Only, Made in India, Manufactured for: Mylan Pharmaceuticals, Inc., Morgantow — Mylan Laboratories Limited, (Nashik FDF)

8. December 4, 2018 · Class II · Ongoing · D-0330-2019

   GCMP Deviations: FDA analysis confirmed presence of trace amounts of an impurity, N-nitrosodiethylamine (NDEA) found in the API used to manufacture the product.

   Valsartan and Hydrochlorothiazide Tablets, USP 160/25 mg, (a) 90-count bottle (NDC 0378-6323-77), (b) 500-count bottles (NDC 0378-6323-05), Rx Only, Made in India, Manufactured for: Mylan Pharmaceuticals, Inc., Morgantow — Mylan Laboratories Limited, (Nashik FDF)

9. December 4, 2018 · Class II · Ongoing · D-0329-2019

   GCMP Deviations: FDA analysis confirmed presence of trace amounts of an impurity, N-nitrosodiethylamine (NDEA) found in the API used to manufacture the product.

   Valsartan and Hydrochlorothiazide Tablets, USP 160/12.5 mg, (a) 90-count bottle (NDC 0378-6322-77), (b) 500-count bottles (NDC 0378-6322-05), Rx Only, Made in India, Manufactured for: Mylan Pharmaceuticals, Inc., Morgant — Mylan Laboratories Limited, (Nashik FDF)

10. December 4, 2018 · Class II · Ongoing · D-0331-2019

    GCMP Deviations: FDA analysis confirmed presence of trace amounts of an impurity, N-nitrosodiethylamine (NDEA) found in the API used to manufacture the product.

    Valsartan and Hydrochlorothiazide Tablets, USP 320/12.5 mg, (a) 90-count bottle (NDC 0378-6324-77), (b) 500-count bottles (NDC 0378-6324-05), Rx Only, Made in India, Manufactured for: Mylan Pharmaceuticals, Inc., Morgant — Mylan Laboratories Limited, (Nashik FDF)

11. November 20, 2018 · Class II · Ongoing · D-0317-2019

    CGMP Deviations: FDA lab confirmed presence an impurity, N-nitrosodiethylamine (NDEA) contained in the API used to manufacture the product.

    Valsartan and Hydrochlorothiazide Tablets, USP, 320 mg/25 mg, (a) 500-count bottle, Rx Only, Made in India, Manufactured for: Mylan Pharmaceuticals, Inc., Morgantown, WV 26505, U.S.A. NDC 0378-6325-05. — Mylan Pharmaceuticals Inc.

12. July 13, 2018 · Class II · Ongoing · D-0975-2018

    CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product.

    Solco Healthcare US Valsartan and Hydrochlorothiazide, USP, 320 MG/12.5 MG Tablets, 90-count bottle, Rx Only, Manufactured by: Zhejiang Huahai Pharmaceutical Co., Ltd. Xynqiao, Linhai, Zhejiang 317024, China Distributed — Prinston Pharmaceutical Inc

13. July 13, 2018 · Class II · Ongoing · D-0976-2018

    CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product.

    Solco Healthcare US Valsartan and Hydrochlorothiazide, USP, 320 MG/25 MG Tablets, 90-count bottles, Rx Only, Manufactured by: Zhejiang Huahai Pharmaceutical Co., Ltd. Xynqiao, Linhai, Zhejiang 317024, China Distributed b — Prinston Pharmaceutical Inc

14. July 13, 2018 · Class II · Ongoing · D-0973-2018

    CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product.

    Solco Healthcare US Valsartan and Hydrochlorothiazide, USP, 160 MG/12.5 MG Tablets, 90-count bottles, Rx Only, Manufactured by: Zhejiang Huahai Pharmaceutical Co., Ltd. Xynqiao, Linhai, Zhejiang 317024, China Distributed — Prinston Pharmaceutical Inc

15. July 13, 2018 · Class II · Ongoing · D-0974-2018

    CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product.

    Solco Healthcare US Valsartan and Hydrochlorothiazide, USP, 160 MG/25 MG Tablets, 90-count bottle, Rx Only, Manufactured by: Zhejiang Huahai Pharmaceutical Co., Ltd. Xynqiao, Linhai, Zhejiang 317024, China Distributed by — Prinston Pharmaceutical Inc

16. July 13, 2018 · Class II · Ongoing · D-0972-2018

    CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product.

    Solco Healthcare US Valsartan and Hydrochlorothiazide, USP, 80 MG/12.5 MG Tablets, 90-count bottles, Rx Only, Manufactured by: Zhejiang Huahai Pharmaceutical Co., Ltd. Xynqiao, Linhai, Zhejiang 317024, China Distributed — Prinston Pharmaceutical Inc

Official identifiers

Next steps

• Find a pharmacy near youAsk which price applies to you and whether your product is affected by a recall
• Latest FDA drug recallsAll medicines, newest first
• Diovan HCTBrand page: products, maker and price
• Heart failureCondition named on the label: hospitals that treat it
• High blood pressureCondition named on the label: hospitals that treat it
• StrokeCondition named on the label: hospitals that treat it
• A-S Medication SolutionsMaker or distributor
• Proficient Rx LPMaker or distributor
• Bryant Ranch PrepackMaker or distributor
• All prescription drugs A to ZSearch by generic, brand or Spanish name

Sources

1. FDA-approved label on DailyMed (National Library of Medicine) — Diovan HCT, Novartis Pharmaceuticals Corporation, effective February 13, 2026; via openFDA, FDA data exported October 30, 2026, retrieved October 31, 2026
2. NDC Directory (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
3. Drugs@FDA (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
4. Drug recall enforcement reports (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 27, 2026, retrieved October 31, 2026
5. Drug shortages (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026

openFDA data is provided by the FDA as is; it may be incomplete. Always rely on the label that comes with your medicine. FDA Enforcement Report search →

Report an error → · Information for medicine makers