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Telmisartan and hydrochlorothiazide

Drug class: Angiotensin 2 Receptor Blocker, Thiazide Diuretic

The FDA’s “Established Pharmacologic Class”: the group of medicines that work in a similar way.

Official FDA data, not advice

Everything here comes from the U.S. Food and Drug Administration (FDA): the drug label, the NDC Directory, Drugs@FDA, recall reports and the drug shortage list. Each fact shows its source and date.

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

In an emergency, call 911. If someone may have taken too much of a medicine, call Poison Help: 1‑800‑222‑1222.

Telmisartan and hydrochlorothiazide key facts

Drug class
Angiotensin 2 Receptor Blocker
Used for
MICARDIS HCT (telmisartan and hydrochlorothiazide) is indicated for the treatment of hypertension, to lower blood pressure. (source)
Prescription or over the counter
Prescription (Rx)
Generic available
Yes
Typical pharmacy cost
$0.3483 per tablet (hydrochlorothiazide 12.5 mg · telmisartan 40 mg; NADAC)
Latest FDA recall
June 29, 2022 (Class II)

Sources: FDA label (December 31, 2024); FDA NDC Directory (October 30, 2026); CMS NADAC (November 4, 2026); FDA enforcement reports (October 27, 2026). Not medical advice.

Quick answers

What is Telmisartan and hydrochlorothiazide used for?
The FDA-approved label (Micardis HCT, Boehringer Ingelheim Pharmaceuticals, Inc., December 31, 2024) says: “MICARDIS HCT (telmisartan and hydrochlorothiazide) 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. …” This page is not medical advice. Talk to your doctor or pharmacist before you start, stop or change any medicine.
What are the side effects of Telmisartan and hydrochlorothiazide?
The “Adverse Reactions” section of the FDA label (Micardis HCT, Boehringer Ingelheim Pharmaceuticals, Inc., December 31, 2024) begins: “The following adverse reactions are discussed elsewhere in labeling: Hypotension [see Warnings and Precautions (5.2)] Renal Impairment [see Warnings and Precautions (5.3)] Electrolytes and Metabolic Disorders [see Warnings and Precautions (5.4)] The most common adverse reactions (≥2% of patients) were upper respiratory tract infection, dizziness, sinusitis, diarrhea, fatigue, influenza-like symptoms, and nausea (6.1) To report SUSPECTED ADVERSE REACTIONS, contact Boehringer Ingelheim Pharmaceuticals, Inc. at (800) 542-6257 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 reaction 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.” … This page is not medical advice. Talk to your doctor or pharmacist before you start, stop or change any medicine.
What are the drug interactions of Telmisartan and hydrochlorothiazide?
The “Drug Interactions” section of the FDA label (Micardis HCT, Boehringer Ingelheim Pharmaceuticals, Inc., December 31, 2024) begins: “Lithium: Risk of lithium toxicity (7.2) Non-steroidal anti-inflammatory drugs (NSAIDs): Reduced diuretic, natriuretic, and antihypertensive effects; increased risk of renal impairment (7.3) Dual blockade of renin-angiotensin system: Increased risk of renal impairment, hypotension, and hyperkalemia (7.4) Antidiabetic drugs: Dosage adjustment may be required (7.6) Cholestyramine and colestipol: Reduced absorption of thiazides (7.7) 7.1 Agents Increasing Serum Potassium Co-administration of telmisartan with other drugs that raise serum potassium levels may result in hyperkalemia.” … This page is not medical advice. Talk to your doctor or pharmacist before you start, stop or change any medicine.
Does Telmisartan and hydrochlorothiazide have a boxed warning?
Yes. The FDA label for Micardis HCT has a boxed warning (“WARNING: FETAL TOXICITY”), the FDA’s strongest warning. Read it on the full label and ask your pharmacist.
Is there a shortage of Telmisartan and hydrochlorothiazide?
No current shortage is listed by the FDA for the products of this medicine (FDA data from October 30, 2026).
Has Telmisartan and hydrochlorothiazide been recalled?
FDA enforcement reports list 2 recalls of products of this medicine; the newest started June 29, 2022 (Class II). A recall usually concerns specific lots, not every product.
Who makes Telmisartan and hydrochlorothiazide?
9 companies list prescription products of Telmisartan and hydrochlorothiazide in the FDA NDC Directory, including AvKARE, Aurobindo Pharma Limited and Glenmark Pharmaceuticals Inc., USA.

What Telmisartan and hydrochlorothiazide is used for

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

MICARDIS HCT (telmisartan and hydrochlorothiazide) 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: Micardis HCT, Boehringer Ingelheim Pharmaceuticals, Inc., effective December 31, 2024. Read the full label on DailyMed →

Label quoted: the one for the most common form (tablet, oral), Micardis HCT, Boehringer Ingelheim Pharmaceuticals, Inc.; it covers 3 products in the FDA NDC Directory. The side effects, interactions, dosage and pregnancy quotes below come from this same label.

The FDA has 7 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 →

7 of 7 FDA labels for this medicine have a boxed warning.

Telmisartan 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 MICARDIS HCT as soon as possible [see Warnings and Precautions (5.1) and Use in Specific Populations (8.1)]. Drugs that act directly on the renin-angiotensin system can cause injury and death to the developing fetus [see Warnings and Precautions (5.1) and Use in Specific Populations (8.1)]. WARNING: FETAL TOXICITY See full prescribing information for complete boxed warning.

Read more of this section

When pregnancy is detected, discontinue MICARDIS HCT as soon as possible. (5.1, 8.1) Drugs that act directly on the renin-angiotensin system can cause injury and death to the developing fetus. (5.1, 8.1)

— FDA label: Micardis HCT, Boehringer Ingelheim Pharmaceuticals, Inc., effective December 31, 2024. Read the full label on DailyMed →

Telmisartan 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 following adverse reactions are discussed elsewhere in labeling: Hypotension [see Warnings and Precautions (5.2)] Renal Impairment [see Warnings and Precautions (5.3)] Electrolytes and Metabolic Disorders [see Warnings and Precautions (5.4)] The most common adverse reactions (≥2% of patients) were upper respiratory tract infection, dizziness, sinusitis, diarrhea, fatigue, influenza-like symptoms, and nausea (6.1) To report SUSPECTED ADVERSE REACTIONS, contact Boehringer Ingelheim Pharmaceuticals, Inc. at (800) 542-6257 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 reaction 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.

Read more of this section

MICARDIS HCT has been evaluated for safety in more than 1700 patients, including 716 treated for hypertension for longer than 6 months and 420 for more than 1 year. Adverse reactions have been limited to those that have been previously reported with telmisartan and/or hydrochlorothiazide. Adverse reactions occurring at an incidence of ≥2% in patients treated with telmisartan/hydrochlorothiazide and at a greater rate than in patients treated with placebo, are presented in Table 1 [see Clinical Studies (14)]. Table 1 Adverse Reactions Occurring at an Incidence of ≥2% in Patients Treated with Telmisartan/Hydrochlorothiazide and at a Greater Rate Than in Patients Treated with Placebo* * includes all doses of telmisartan (20 to 160 mg), hydrochlorothiazide (6.25 to 25 mg), and combinations thereof Telmisartan/Hydrochlorothiazide (n = 414) Placebo (n = 74) Telmisartan (n = 209) Hydrochlorothiazide (n = 121) Body as a whole Fatigue 3% 1% 3% 3% Influenza-like symptoms 2% 1% 2% 3% Central/Peripheral nervous system Dizziness 5% 1% 4% 6% Gastrointestinal system Diarrhea 3% 0% 5% 2% Nausea 2% 0% 1% 2% Respiratory system disorder Sinusitis 4% 3% 3% 6% Upper respiratory tract infection 8% 7% 7% 10% Other adverse reactions observed for telmisartan/hydrochlorothiazide were: pain (including back and abdominal), dyspepsia, erythema, vomiting, bronchitis, and pharyngitis. Adverse reactions occurred at approximately the same rates in men and women, older and younger patients, and black and non-black patients.

— FDA label: Micardis HCT, Boehringer Ingelheim Pharmaceuticals, Inc., effective December 31, 2024. This is part of the section. Read the full label on DailyMed →

Telmisartan 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.

Lithium: Risk of lithium toxicity (7.2) Non-steroidal anti-inflammatory drugs (NSAIDs): Reduced diuretic, natriuretic, and antihypertensive effects; increased risk of renal impairment (7.3) Dual blockade of renin-angiotensin system: Increased risk of renal impairment, hypotension, and hyperkalemia (7.4) Antidiabetic drugs: Dosage adjustment may be required (7.6) Cholestyramine and colestipol: Reduced absorption of thiazides (7.7) 7.1 Agents Increasing Serum Potassium Co-administration of telmisartan with other drugs that raise serum potassium levels may result in hyperkalemia.

Read more of this section

Monitor serum potassium in such patients. 7.2 Lithium Increases in serum lithium concentrations and lithium toxicity have been reported with concomitant use of thiazide diuretics or angiotensin II receptor antagonists, including telmisartan. Monitor lithium levels in patients receiving MICARDIS HCT and lithium. 7.3 Non-Steroidal Anti-Inflammatory Agents including Selective Cyclooxygenase-2 Inhibitors Telmisartan Non-Steroidal Anti-Inflammatory Agents 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, co-administration of NSAIDs, including selective COX-2 inhibitors, with ARBs, including telmisartan, may result in deterioration of renal function, including possible acute renal failure. These effects are usually reversible. The antihypertensive effect of ARBs may be attenuated by NSAIDs. Therefore, monitor renal function and blood pressure periodically in patients receiving MICARDIS HCT and NSAIDs. Hydrochlorothiazide Administration of a non-steroidal anti-inflammatory agent, including a selective COX-2 inhibitor, can reduce the diuretic, natriuretic, and antihypertensive effects of diuretics. Therefore, when MICARDIS HCT and non-steroidal anti-inflammatory agents including selective COX-2 inhibitors are used concomitantly, observe closely to determine if the desired effect of the diuretic is obtained. 7.4 Dual Blockade of the Renin-Angiotensin-Aldosterone System and Changes in Renal Function Dual blockade of the renin-angiotensin-aldosterone system (RAS) with angiotensin blockers, ACE inhibitors, or aliskiren is associated with increased risks of hypotension, hyperkalemia, and renal impairment. The ONTARGET trial enrolled 25,620 patients ≥55 years old with atherosclerotic disease or diabetes with end-organ damage, randomizing them to telmisartan (ARB) only, ramipril (ACE inhibitor) only, or the combination, and followed them for a median of 56 months. Patients who received the combination of ARB and ACE inhibitor did not obtain any additional benefit (no additional reduction of risk of cardiovascular death, myocardial infarction, stroke, or hospitalization from heart failure) compared to ARB monotherapy or ACE inhibitor monotherapy, but experienced an increased incidence of renal dysfunction (e.g., acute renal failure) compared with monotherapy groups. In general, avoid combined use of RAS inhibitors. Closely monitor blood pressure, renal function and electrolytes in patients on MICARDIS HCT and other agents that affect the RAS. Do not co-administer aliskiren with MICARDIS HCT in patients with diabetes.

— FDA label: Micardis HCT, Boehringer Ingelheim Pharmaceuticals, Inc., effective December 31, 2024. This is part of the section. Read the full label on DailyMed →

Telmisartan 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.

Usual starting dose is 80 mg/12.5 mg once daily (2.1) Titrate up to 160 mg/25 mg as needed (2.1) Initiate patients with biliary obstructive disorders or hepatic insufficiency at 40 mg/12.5 mg (2.2) 2.1 Dosing Information Initiate a patient whose blood pressure is not adequately controlled with telmisartan monotherapy 80 mg on MICARDIS HCT, 80 mg/12.5 mg orally once daily. Dose can be titrated up to 160 mg/25 mg after 2 to 4 weeks, if necessary.

Read more of this section

Initiate a patient whose blood pressure is not adequately controlled by 25 mg once daily of hydrochlorothiazide, or is controlled but who experiences hypokalemia with this regimen on MICARDIS HCT 80 mg/12.5 mg once daily. Dose can be titrated up to 160 mg/25 mg after 2 to 4 weeks, if necessary. Patients titrated to the individual components (telmisartan and hydrochlorothiazide) may instead receive the corresponding dose of MICARDIS HCT. MICARDIS HCT may be administered with other antihypertensive drugs. 2.2 Dose Adjustment for Hepatic Impairment Initiate patients with biliary obstructive disorders or hepatic insufficiency under close medical supervision using the 40 mg/12.5 mg combination. MICARDIS HCT tablets are not recommended for patients with severe hepatic impairment [see Use in Specific Populations (8.6) and Clinical Pharmacology (12.3)]. 2.3 Important Administration Instructions MICARDIS HCT tablets should not be removed from blisters until immediately before administration.

— FDA label: Micardis HCT, Boehringer Ingelheim Pharmaceuticals, Inc., effective December 31, 2024. Read the full label on DailyMed →

Telmisartan 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 MICARDIS 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 (see Clinical Considerations).

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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. Studies in rats and rabbits with telmisartan showed fetotoxicity only at maternally toxic doses (see Data). When pregnancy is detected, discontinue MICARDIS 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% to 4% and 15% to 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 Telmisartan Use of drugs that act on the RAS in the second and third trimesters of pregnancy can result in the following: oligohydramnios, reduced fetal renal function leading to anuria and renal failure, fetal lung hypoplasia, skeletal deformations, including skull hypoplasia, hypotension, and death. In the unusual case that there is no appropriate alternative to therapy with drugs affecting the renin-angiotensin system for a particular patient, apprise the mother of the potential risk to the fetus. In patients taking MICARDIS HCT during pregnancy, perform serial ultrasound examinations to assess the intra-amniotic environment. Fetal testing may be appropriate, based on the week of gestation. If oligohydramnios is observed, discontinue MICARDIS HCT, unless it is considered lifesaving for the mother. Patients and physicians should be aware, however, that oligohydramnios may not appear until after the fetus has sustained irreversible injury. Closely observe infants with histories of in utero exposure to MICARDIS HCT for hypotension, oliguria, and hyperkalemia. 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 [see Use in Specific Populations (8.4)].

— FDA label: Micardis HCT, Boehringer Ingelheim Pharmaceuticals, Inc., effective December 31, 2024. This is part of the section. Read the full label on DailyMed →

When Telmisartan and hydrochlorothiazide should not be used

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

MICARDIS HCT is contraindicated: In patients who are hypersensitive to any component of this product [see Warnings and Precautions (5.5)]. In patients with anuria. For co-administration with aliskiren in patients with diabetes [see Drug Interactions (7.4)]. Hypersensitivity to telmisartan or any component (4) Anuria (4) Co-Administration with aliskiren in patients with diabetes (4)

— FDA label: Micardis HCT, Boehringer Ingelheim Pharmaceuticals, Inc., effective December 31, 2024. Read the full label on DailyMed →

Telmisartan 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).

Telmisartan Limited data are available with regard to overdosage of telmisartan in humans. The most likely manifestations of overdosage with telmisartan are hypotension, dizziness, and tachycardia; bradycardia could occur from parasympathetic (vagal) stimulation. If symptomatic hypotension should occur, supportive treatment should be instituted. Telmisartan is not removed by hemofiltration and is not dialyzable.

Read more of this section

Hydrochlorothiazide The most common signs and symptoms observed in patients with a hydrochlorothiazide overdose 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. The degree to which hydrochlorothiazide is removed by hemodialysis has not been established. The oral LD 50 of hydrochlorothiazide is greater than 10 g/kg in both mice and rats.

— FDA label: Micardis HCT, Boehringer Ingelheim Pharmaceuticals, Inc., effective December 31, 2024. Read the full label on DailyMed →

Forms and how it is given

Dosage formsTablet
RouteOral
Prescription products27 in the FDA NDC Directory
Brand namesMicardis Hct

What pharmacies pay (NADAC)

The National Average Drug Acquisition Cost (NADAC) is the average price U.S. retail pharmacies paid to buy one unit of a medicine (one tablet, one mL or one gram), from a monthly survey of pharmacy invoices by the Centers for Medicare & Medicaid Services (CMS). State Medicaid programs use it to pay pharmacies.

This is not the price you pay. What you pay depends on your insurance (copay or coinsurance), your pharmacy and any discounts, and pharmacies also charge for filling a prescription. Ask your pharmacist or your health plan what your price will be.

NADAC per unit for Telmisartan and hydrochlorothiazide, by strength and form
Strength and formGeneric or brandPharmacies pay
hydrochlorothiazide 12.5 mg · telmisartan 40 mg
tablet
Generic $0.3483 per tablet
hydrochlorothiazide 12.5 mg · telmisartan 40 mg
tablet
Brand: Micardis HCT $4.48 per tablet
hydrochlorothiazide 12.5 mg · telmisartan 80 mg
tablet
Generic $0.3329 per tablet
hydrochlorothiazide 12.5 mg · telmisartan 80 mg
tablet
Brand: Micardis HCT $4.47 per tablet
hydrochlorothiazide 25 mg · telmisartan 80 mg
tablet
Generic $0.3438 per tablet
hydrochlorothiazide 25 mg · telmisartan 80 mg
tablet
Brand: Micardis HCT $4.48 per tablet

NADAC list of November 4, 2026; these prices took effect between January 21, 2026 and October 21, 2026. Shown only where a package’s NDC code matches the NADAC list exactly, and only for that exact strength and form: nothing is averaged across strengths. Strengths and forms not listed here have no NADAC price.

Source: NADAC (National Average Drug Acquisition Cost) 2026, data.medicaid.gov (CMS) →

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.

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.
Brand and biologic applications
ApplicationSponsorApprovedLater changes approved
NDA021162
MICARDIS HCT
Boehringer IngelheimNovember 17, 2000 15, latest December 19, 2022
2022: Labeling · 2020: Labeling · 2018: Labeling

Generic approvals (6)

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. June 29, 2022 · Class II · Terminated · D-1306-2022

    Defective Container: Recall of these batches has been initiated due to complaints of difficult to open blister and tablet breaks while opening the blister .

    Telmisartan and Hydrochlorothiazide Tablets USP, 80 mg/12.5 mg, 30 Tablets, Rx Only, Manufactured by: Glenmark Pharmaceuticals Ltd., Plot no 2, Phase-2, Pharma Zone, SEZ Pithampur, District Dhar, Madhya Pradesh 454775, I — Glenmark Pharmaceuticals Inc., USA

  2. June 29, 2022 · Class II · Terminated · D-1305-2022

    Defective Container: Recall of these batches has been initiated due to complaints of difficult to open blister and tablet breaks while opening the blister .

    Telmisartan and Hydrochlorothiazide Tablets USP, 80 mg/25 mg, 30 Tablets, Rx Only, Manufactured by: Glenmark Pharmaceuticals Ltd., Plot no 2, Phase-2, Pharma Zone, SEZ Pithampur, District Dhar, Madhya Pradesh 454775, Ind — Glenmark Pharmaceuticals Inc., USA

What do the recall classes mean?

Class I: The most serious type: there is a reasonable chance that using the product will cause serious health problems or death.
Class II: Using the product may cause temporary or medically reversible health problems, or the chance of serious problems is remote.
Class III: Using the product is not likely to cause health problems (for example a labeling or packaging issue).

Official identifiers

RxCUI (RxNorm)283316, 283317, 477130, 749833, 749837, 749841
SPL set ID of the quoted labelb078dae2-664d-4144-847a-3b9d9b557402
FDA labels (SPL)7
FDA applicationsNDA021162, 6 ANDA
Active ingredients (FDA)HYDROCHLOROTHIAZIDE / TELMISARTAN

Next steps

Sources

  1. FDA-approved label on DailyMed (National Library of Medicine) — Micardis HCT, Boehringer Ingelheim Pharmaceuticals, Inc., effective December 31, 2024; 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 →

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