Quick answers
- What is Sacubitril and valsartan used for?
- The FDA-approved label (Entresto, Novartis Pharmaceuticals Corporation, July 6, 2026) says: “ENTRESTO is a combination of sacubitril, a neprilisin inhibitor, and valsartan, an angiotensin II receptor blocker, and is indicated: to reduce the risk of cardiovascular death and hospitalization for heart failure in adult patients with chronic heart failure. Benefits are most clearly evident in patients with left ventricular ejection fraction (LVEF) below normal. …” 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 Sacubitril and valsartan?
- The “Adverse Reactions” section of the FDA label (Entresto, Novartis Pharmaceuticals Corporation, July 6, 2026) begins: “Clinically significant adverse reactions that appear in other sections of the labeling include: Angioedema [see Warnings and Precautions (5.2)] Hypotension [see Warnings and Precautions (5.3)] Impaired Renal Function [see Warnings and Precautions (5.4)] Hyperkalemia [see Warnings and Precautions (5.5)] Adverse reactions occurring greater than or equal to 5% are hypotension, hyperkalemia, cough, dizziness, and renal failure.” … 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 Sacubitril and valsartan?
- The “Drug Interactions” section of the FDA label (Entresto, Novartis Pharmaceuticals Corporation, July 6, 2026) begins: “Avoid concomitant use with aliskiren in patients with estimated glomerular filtration rate (eGFR) less than 60. (7.1) Potassium-sparing diuretics: May lead to increased serum potassium. (7.2) Nonsteroidal Anti-Inflammatory Drugs (NSAIDs): May lead to increased risk of renal impairment. (7.3) Lithium: Increased risk of lithium toxicity.” … This page is not medical advice. Talk to your doctor or pharmacist before you start, stop or change any medicine.
- Does Sacubitril and valsartan have a boxed warning?
- Yes. The FDA label for Entresto 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 Sacubitril and valsartan?
- No current shortage is listed by the FDA for the products of this medicine (FDA data from October 30, 2026).
- Has Sacubitril and valsartan been recalled?
- No recall linked to the products of this medicine appears in the FDA enforcement reports we use.
- Who makes Sacubitril and valsartan?
- 29 companies list prescription products of Sacubitril and valsartan in the FDA NDC Directory, including Aphena Pharma Solutions - Tennessee, LLC, Novartis Pharmaceuticals Corporation and AvKARE.
What Sacubitril and valsartan is used for
Quoted from the “Indications and Usage” section of the FDA-approved label.
ENTRESTO is a combination of sacubitril, a neprilisin inhibitor, and valsartan, an angiotensin II receptor blocker, and is indicated: to reduce the risk of cardiovascular death and hospitalization for heart failure in adult patients with chronic heart failure. Benefits are most clearly evident in patients with left ventricular ejection fraction (LVEF) below normal. …
— FDA label: Entresto, Novartis Pharmaceuticals Corporation, effective July 6, 2026. Read the full label on DailyMed →
Label quoted: the one for the most common form (tablet, film coated, oral), Entresto, Novartis Pharmaceuticals Corporation; it covers 7 products in the FDA NDC Directory. The side effects, interactions, dosage and pregnancy quotes below come from this same label.
The FDA has 36 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 →
35 of 36 FDA labels for this medicine have a boxed warning.
Sacubitril and valsartan boxed warning: what the label says
Quoted from the boxed warning of the FDA-approved label.
WARNING: FETAL TOXICITY When pregnancy is detected, discontinue ENTRESTO 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 ENTRESTO as soon as possible. (5.1) Drugs that act directly on the renin-angiotensin system can cause injury and death to the developing fetus.
Read more of this section
(5.1)
— FDA label: Entresto, Novartis Pharmaceuticals Corporation, effective July 6, 2026. Read the full label on DailyMed →
Sacubitril and valsartan side effects
Quoted from the “Adverse Reactions” section of the FDA-approved label. Tell your doctor about any side effect that worries you.
Clinically significant adverse reactions that appear in other sections of the labeling include: Angioedema [see Warnings and Precautions (5.2)] Hypotension [see Warnings and Precautions (5.3)] Impaired Renal Function [see Warnings and Precautions (5.4)] Hyperkalemia [see Warnings and Precautions (5.5)] Adverse reactions occurring greater than or equal to 5% are hypotension, hyperkalemia, cough, dizziness, and renal failure.
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 trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice. A total of 6,622 heart failure patients were treated with ENTRESTO in the PARADIGM-HF (vs. enalapril) and PARAGON-HF (vs. valsartan) clinical trials. Of these, 5,085 were exposed for at least 1 year. Adult Heart Failure In PARADIGM-HF, patients were required to complete sequential enalapril and ENTRESTO run-in periods of (median) 15 and 29 days, respectively, prior to entering the randomized double-blind period comparing ENTRESTO and enalapril. During the enalapril run-in period, 1,102 patients (10.5%) were permanently discontinued from the study, 5.6% because of an adverse event, most commonly renal dysfunction (1.7%), hyperkalemia (1.7%) and hypotension (1.4%). During the ENTRESTO run-in period, an additional 10.4% of patients permanently discontinued treatment, 5.9% because of an adverse event, most commonly renal dysfunction (1.8%), hypotension (1.7%) and hyperkalemia (1.3%). Because of this run-in design, the adverse reaction rates described below are lower than expected in practice. In the double-blind period, safety was evaluated in 4,203 patients treated with ENTRESTO and 4,229 treated with enalapril. In PARADIGM-HF, patients randomized to ENTRESTO received treatment for up to 4.3 years, with a median duration of exposure of 24 months; 3,271 patients were treated for more than one year. Discontinuation of therapy because of an adverse event during the double-blind period occurred in 450 (10.7%) of ENTRESTO-treated patients and 516 (12.2%) of patients receiving enalapril. Adverse reactions occurring at an incidence of greater than or equal to 5% in patients who were treated with ENTRESTO in the double-blind period of PARADIGM-HF are shown in Table 3. In PARADIGM-HF, the incidence of angioedema was 0.1% in both the enalapril and ENTRESTO run-in periods. In the double-blind period, the incidence of angioedema was higher in patients treated with ENTRESTO than enalapril (0.5% and 0.2%, respectively). The incidence of angioedema in Black patients was 2.4% with ENTRESTO and 0.5% with enalapril [see Warnings and Precautions (5.2)]. Orthostasis was reported in 2.1% of patients treated with ENTRESTO compared to 1.1% of patients treated with enalapril during the double-blind period of PARADIGM-HF.
Table from the label
| ENTRESTO (n = 4,203) % | Enalapril (n = 4,229) % | |
|---|---|---|
| Hypotension | 18 | 12 |
| Hyperkalemia | 12 | 14 |
| Cough | 9 | 13 |
| Dizziness | 6 | 5 |
| Renal failure/acute renal failure | 5 | 5 |
— FDA label: Entresto, Novartis Pharmaceuticals Corporation, effective July 6, 2026. This is part of the section. Read the full label on DailyMed →
Sacubitril and valsartan 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.
Avoid concomitant use with aliskiren in patients with estimated glomerular filtration rate (eGFR) less than 60. (7.1) Potassium-sparing diuretics: May lead to increased serum potassium. (7.2) Nonsteroidal Anti-Inflammatory Drugs (NSAIDs): May lead to increased risk of renal impairment. (7.3) Lithium: Increased risk of lithium toxicity.
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(7.4) 7.1 Dual Blockade of the Renin-Angiotensin-Aldosterone System Concomitant use of ENTRESTO with an ACE inhibitor is contraindicated because of the increased risk of angioedema [see Contraindications (4)]. Avoid use of ENTRESTO with an ARB, because ENTRESTO contains the angiotensin II receptor blocker valsartan. The concomitant use of ENTRESTO with aliskiren is contraindicated in patients with diabetes [see Contraindications (4)]. Avoid use with aliskiren in patients with renal impairment (eGFR less than 60 mL/min/1.73 m 2). 7.2 Potassium-Sparing Diuretics As with other drugs that block angiotensin II or its effects, concomitant use of potassium-sparing diuretics (e.g., spironolactone, triamterene, amiloride), potassium supplements, or salt substitutes containing potassium may lead to increases in serum potassium [see Warnings and Precautions (5.5)]. 7.3 Nonsteroidal Anti-Inflammatory Drugs (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, concomitant use of NSAIDs, including COX-2 inhibitors, with ENTRESTO may result in worsening of renal function, including possible acute renal failure. These effects are usually reversible. Monitor renal function periodically. 7.4 Lithium Increases in serum lithium concentrations and lithium toxicity have been reported during concomitant administration of lithium with angiotensin II receptor antagonists. Monitor serum lithium levels during concomitant use with ENTRESTO.
— FDA label: Entresto, Novartis Pharmaceuticals Corporation, effective July 6, 2026. Read the full label on DailyMed →
Sacubitril and valsartan 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.
The recommended starting dosage for adults is 49 mg/51 mg orally twice daily. The target maintenance dose is 97 mg/103mg orally twice daily. (2.2) Adjust adult doses every 2 to 4 weeks to the target maintenance dose, as tolerated by the patient. (2.2) For pediatric patients, see the Full Prescribing Information for recommended dosage, titrations, preparation and administration instructions.
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(2.3, 2.4, 2.5) Reduce starting dose to half the usually recommended starting dosage for: patients not currently taking an angiotensin-converting enzyme (ACE) inhibitor or angiotensin II receptor blocker (ARB) or previously taking a low dose of these agents. (2.6) patients with severe renal impairment. (2.7) patients with moderate hepatic impairment. (2.8) 2.1 General Considerations ENTRESTO is contraindicated with concomitant use of an angiotensin-converting enzyme (ACE) inhibitor. If switching from an ACE inhibitor to ENTRESTO allow a washout period of 36 hours between administration of the two drugs [see Contraindications (4) and Drug Interactions (7.1)]. 2.2 Adult Heart Failure The recommended starting dose of ENTRESTO is 49/51 mg orally twice-daily. Double the dose of ENTRESTO after 2 to 4 weeks to the target maintenance dose of 97/103 mg twice daily, as tolerated by the patient. 2.3 Pediatric Heart Failure For the recommended dosage for pediatric patients aged 1 year and older, refer to Table 1 if using the tablets, or Table 2 if using the oral pellets. Take the recommended dose orally twice daily. Adjust pediatric patient doses every 2 weeks, as tolerated by the patient. Table 1: Recommended Dose and Titration for Pediatric Patients Using Tablets † Use of the oral suspension or oral pellets (see Table 2) is recommended in these patients. Recommended mg/kg doses are of the combined amount of both sacubitril and valsartan [see Dosage and Administration (2.4, 2.5)]. ‡ Doses of 72 mg/78 mg can be achieved using three 24 mg/26 mg tablets [see Dosage Forms and Strengths (3)]. Titration Step Dose (twice daily) Weight (kg) Starting Second Final Less than 40 kg † 1.6 mg/kg 2.3 mg/kg 3.1 mg/kg At least 40 kg, less than 50 kg 24 mg/26 mg 49 mg/51 mg 72 mg/78 mg ‡ At least 50 kg 49 mg/51 mg 72 mg/78 mg ‡ 97 mg/103 mg Table 2: Recommended Dose and Titration for Pediatric Patients using ENTRESTO SPRINKLE † † When using capsules, more than one capsule may be needed to achieve recommended doses. Oral pellets are contained within each capsule. Use the entire contents of the capsules to achieve the dose. ‡ Recommended mg/kg doses are of the combined amount of sacubitril and valsartan [see Dosage and administration (2.4)]. * For patients 50 kg or more, see Table 1.
— FDA label: Entresto, Novartis Pharmaceuticals Corporation, effective July 6, 2026. This is part of the section. Read the full label on DailyMed →
Sacubitril and valsartan 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 ENTRESTO 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. In animal reproduction studies, ENTRESTO treatment during organogenesis resulted in increased embryo-fetal lethality in rats and rabbits and teratogenicity in rabbits (see Data). When pregnancy is detected, consider alternative drug treatment and discontinue ENTRESTO. However, if there is no appropriate alternative to therapy with drugs affecting the renin-angiotensin system, and if the drug is considered lifesaving for the mother, advise a pregnant woman of the potential risk to the fetus. The 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 Fetal/Neonatal Adverse Reactions 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 ENTRESTO for hypotension, oliguria, and hyperkalemia. In neonates with a history of in utero exposure to ENTRESTO, 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. Data Animal Data ENTRESTO treatment during organogenesis resulted in increased embryo-fetal lethality in rats at doses greater than or equal to 49 mg sacubitril/51 mg valsartan/kg/day (less than or equal to 0.06 [LBQ657, the active metabolite] and 0.72 [valsartan]-fold the maximum recommended human dose [MRHD] of 97/103 mg twice-daily on the basis of the area under the plasma drug concentration-time curve [AUC]) and rabbits at doses greater than or equal to 5 mg sacubitril/5 mg valsartan/kg/day (2-fold and 0.03-fold the MRHD on the basis of valsartan and LBQ657 AUC, respectively).
— FDA label: Entresto, Novartis Pharmaceuticals Corporation, effective July 6, 2026. This is part of the section. Read the full label on DailyMed →
When Sacubitril and valsartan should not be used
Quoted from the “Contraindications” section of the FDA-approved label.
ENTRESTO is contraindicated: in patients with hypersensitivity to any component in patients with a history of angioedema related to previous ACE inhibitor or ARB therapy [see Warnings and Precautions (5.2)] with concomitant use of ACE inhibitors. Do not administer within 36 hours of switching from or to an ACE inhibitor [see Drug Interactions (7.1)] with concomitant use of aliskiren in patients with diabetes [see Drug Interactions (7.1)] Hypersensitivity to any component.
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(4) History of angioedema related to previous ACEi or ARB therapy. (4) Concomitant use with ACE inhibitors. (4, 7.1) Concomitant use with aliskiren in patients with diabetes. (4, 7.1)
— FDA label: Entresto, Novartis Pharmaceuticals Corporation, effective July 6, 2026. Read the full label on DailyMed →
Sacubitril and valsartan 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 with regard to overdosage in human subjects with ENTRESTO. In healthy volunteers, a single dose of ENTRESTO 583 mg sacubitril/617 mg valsartan, and multiple doses of 437 mg sacubitril/463 mg valsartan (14 days) have been studied and were well tolerated. Hypotension is the most likely result of overdosage due to the blood pressure lowering effects of ENTRESTO. Symptomatic treatment should be provided.
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ENTRESTO is unlikely to be removed by hemodialysis because of high protein binding.
— FDA label: Entresto, Novartis Pharmaceuticals Corporation, effective July 6, 2026. Read the full label on DailyMed →
Forms and how it is given
| Dosage forms | Tablet, film coated · Tablet · Pellet |
|---|---|
| Route | Oral |
| Prescription products | 103 in the FDA NDC Directory |
| Brand names | Entresto |
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.
| Strength and form | Generic or brand | Pharmacies pay |
|---|---|---|
| sacubitril 15 mg · valsartan 16 mg pellet | Brand: Entresto | $11.61 per unit |
| sacubitril 24 mg · valsartan 26 mg tablet | Generic | $0.5020 per tablet |
| sacubitril 24 mg · valsartan 26 mg tablet, film coated | Generic | $0.5020 per tablet |
| sacubitril 24 mg · valsartan 26 mg tablet, film coated | Brand: Entresto | $11.59 per tablet |
| sacubitril 49 mg · valsartan 51 mg tablet | Generic | $0.5427 per tablet |
| sacubitril 49 mg · valsartan 51 mg tablet, film coated | Generic | $0.5427 per tablet |
| sacubitril 49 mg · valsartan 51 mg tablet, film coated | Brand: Entresto | $11.56 per tablet |
| sacubitril 6 mg · valsartan 6 mg pellet | Brand: Entresto | $11.62 per unit |
| sacubitril 97 mg · valsartan 103 mg tablet | Generic | $0.5804 per tablet |
| sacubitril 97 mg · valsartan 103 mg tablet, film coated | Generic | $0.5804 per tablet |
| sacubitril 97 mg · valsartan 103 mg tablet, film coated | Brand: Entresto | $11.59 per tablet |
NADAC list of November 4, 2026; these prices took effect on 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.
- Aphena Pharma Solutions - Tennessee, LLC9 products
- Novartis Pharmaceuticals Corporation7 products
- AvKARE6 products
- Ascend Laboratories, LLC5 products
- Torrent Pharmaceuticals Limited5 products
- Novugen Pharma (USA) LLC4 products
- Camber Pharmaceuticals, Inc.3 products
- AvPAK3 products
- American Health Packaging3 products
- Alembic Pharmaceuticals Inc.3 products
- Zydus Pharmaceuticals USA Inc.3 products
- Zydus Lifesciences Limited3 products
- Major Pharmaceuticals3 products
- Umedica Laboratories USA Inc.3 products
- Amneal Pharmaceuticals NY LLC3 products
- ANI Pharmaceuticals, Inc.3 products
- XLCare Pharmaceuticals, Inc.3 products
- Macleods Pharmaceuticals Limited3 products
- Golden State Medical Supply, Inc.3 products
- Somerset Therapeutics, LLC3 products
- Novadoz Pharmaceuticals LLC3 products
- NorthStar RxLLC3 products
- Laurus Labs Limited3 products
- Dr. Reddy's Laboratories Inc.3 products
- Aurobindo Pharma Limited3 products
- Alembic Pharmaceuticals Limited3 products
- Lupin Pharmaceuticals, Inc.3 products
- Biocon Pharma Inc.3 products
- Coupler LLC1 product
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.
| Application | Sponsor | Approved | Later changes approved |
|---|---|---|---|
| NDA207620 ENTRESTO | Novartis Pharms Corp | July 7, 2015 | 8, latest April 12, 2024 2024: Efficacy · 2023: Manufacturing (CMC) · 2021: Efficacy |
| NDA218591 ENTRESTO SPRINKLE | Novartis | April 12, 2024 | — |
Generic approvals (16)
- ANDA213605Crystal · May 28, 2024
- ANDA213676Laurus · May 28, 2024
- ANDA213682Alembic · May 28, 2024
- ANDA213719Zydus Pharms · July 9, 2024
- ANDA213604Torrent · August 22, 2024
- ANDA213680Biocon Pharma · August 30, 2024
- ANDA213764Alkem Labs Ltd · September 16, 2024
- ANDA213728Macleods Pharms · October 16, 2024
- ANDA213808Lupin · January 8, 2025
- ANDA213627DR Reddys · January 13, 2025
- ANDA213611Novugen Pharma Sdn · July 16, 2025
- ANDA213748Msn · July 16, 2025
- ANDA213668Hetero Labs Ltd III · July 17, 2025
- ANDA219983Somerset Theraps LLC · January 20, 2026
- ANDA219946Umedica · August 4, 2026
- ANDA213631Aurobindo Pharma Ltd · September 2, 2026
Shortage status
The FDA drug shortage list does not show these products.
Recalls
No recall linked to these products (by their NDC code) appears in the FDA enforcement reports.
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
- EntrestoBrand page: products, maker and price
- Heart failureCondition named on the label: hospitals that treat it
- Aphena Pharma Solutions - Tennessee, LLCMaker or distributor
- Novartis Pharmaceuticals CorporationMaker or distributor
- AvKAREMaker or distributor
- All prescription drugs A to ZSearch by generic, brand or Spanish name
Sources
- FDA-approved label on DailyMed (National Library of Medicine) — Entresto, Novartis Pharmaceuticals Corporation, effective July 6, 2026; via openFDA, FDA data exported October 30, 2026, retrieved October 31, 2026
- NDC Directory (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
- Drugs@FDA (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
- Drug recall enforcement reports (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 27, 2026, retrieved October 31, 2026
- 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 →