Quick answers
- What is Lisdexamfetamine dimesylate used for?
- The FDA-approved label (Vyvanse, Takeda Pharmaceuticals America, Inc., April 30, 2026) says: “VYVANSE ® is indicated for the treatment of: Attention Deficit Hyperactivity Disorder (ADHD) in adults and pediatric patients 6 years and older […]. Moderate to severe binge eating disorder (BED) in adults […]. VYVANSE is a central nervous system (CNS) stimulant indicated for the treatment of …” 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 Lisdexamfetamine dimesylate?
- The “Adverse Reactions” section of the FDA label (Vyvanse, Takeda Pharmaceuticals America, Inc., April 30, 2026) begins: “The following adverse reactions are discussed in greater detail in other sections of the labeling: Known hypersensitivity to amphetamine products or other ingredients of VYVANSE [see Contraindications (4)] Hypertensive Crisis When Used Concomitantly with Monoamine Oxidase Inhibitors [see Contraindications (4) and Drug Interactions (7.1)] Abuse, Misuse, and Addiction [see Boxed Warning, Warnings and Precautions (5.1), and Drug Abuse and Dependence (9.2, 9.3)] Risks to …” … 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 Lisdexamfetamine dimesylate?
- The “Drug Interactions” section of the FDA label (Vyvanse, Takeda Pharmaceuticals America, Inc., April 30, 2026) begins: “Acidifying and Alkalinizing Agents: Agents that alter urinary pH can alter blood levels of amphetamine. Acidifying agents decrease amphetamine blood levels, while alkalinizing agents increase amphetamine blood levels. Adjust VYVANSE dosage accordingly. (2.6, 7.1) 7.1 Drugs Having Clinically Important Interactions with Amphetamines Table 5 Drugs having clinically important interactions with amphetamines.” … This page is not medical advice. Talk to your doctor or pharmacist before you start, stop or change any medicine.
- Does Lisdexamfetamine dimesylate have a boxed warning?
- Yes. The FDA label for Vyvanse has a boxed warning, the FDA’s strongest warning. Read it on the full label and ask your pharmacist.
- Is there a shortage of Lisdexamfetamine dimesylate?
- The FDA drug shortage list shows “Current shortage” for a product of this medicine (updated October 19, 2026). Ask your pharmacist about alternatives.
- Has Lisdexamfetamine dimesylate been recalled?
- FDA enforcement reports list 11 recalls of products of this medicine; the newest started October 28, 2025 (Class II). A recall usually concerns specific lots, not every product.
- Who makes Lisdexamfetamine dimesylate?
- 21 companies list prescription products of Lisdexamfetamine dimesylate in the FDA NDC Directory, including Camber Pharmaceuticals, Inc., Sun Pharmaceutical Industries, Inc. and Takeda Pharmaceuticals America, Inc.
What Lisdexamfetamine dimesylate is used for
Quoted from the “Indications and Usage” section of the FDA-approved label.
VYVANSE ® is indicated for the treatment of: Attention Deficit Hyperactivity Disorder (ADHD) in adults and pediatric patients 6 years and older […]. Moderate to severe binge eating disorder (BED) in adults […]. VYVANSE is a central nervous system (CNS) stimulant indicated for the treatment of …
— FDA label: Vyvanse, Takeda Pharmaceuticals America, Inc., effective April 30, 2026. Read the full label on DailyMed →
Label quoted: the one for the most common form (capsule, oral), Vyvanse, Takeda Pharmaceuticals America, Inc.; it covers 13 products in the FDA NDC Directory. The side effects, interactions, dosage and pregnancy quotes below come from this same label.
The FDA has 26 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. Read it on the full label →
26 of 26 FDA labels for this medicine have a boxed warning.
Lisdexamfetamine dimesylate boxed warning: what the label says
Quoted from the boxed warning of the FDA-approved label.
WARNING: ABUSE, MISUSE, AND ADDICTION VYVANSE has a high potential for abuse and misuse, which can lead to the development of a substance use disorder, including addiction. Misuse and abuse of CNS stimulants, including VYVANSE, can result in overdose and death [see Overdosage (10)], and this risk is increased with higher doses or unapproved methods of administration, such as snorting or injection.
Read more of this section
Before prescribing VYVANSE, assess each patient's risk for abuse, misuse, and addiction. Educate patients and their families about these risks, proper storage of the drug, and proper disposal of any unused drug. Throughout VYVANSE treatment, reassess each patient's risk of abuse, misuse, and addiction and frequently monitor for signs and symptoms of abuse, misuse, and addiction [see Warnings and Precautions (5.1), Drug Abuse and Dependence (9.2)]. WARNING: ABUSE, MISUSE, AND ADDICTION See full prescribing information for complete boxed warning. VYVANSE has a high potential for abuse and misuse, which can lead to the development of a substance use disorder, including addiction. Misuse and abuse of CNS stimulants, including VYVANSE, can result in overdose and death (5.1, 9.2, 10): Before prescribing VYVANSE, assess each patient's risk for abuse, misuse, and addiction. Educate patients and their families about these risks, proper storage of the drug, and proper disposal of any unused drug. Throughout treatment, reassess each patient's risk and frequently monitor for signs and symptoms of abuse, misuse, and addiction.
— FDA label: Vyvanse, Takeda Pharmaceuticals America, Inc., effective April 30, 2026. Read the full label on DailyMed →
Lisdexamfetamine dimesylate 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 in greater detail in other sections of the labeling: Known hypersensitivity to amphetamine products or other ingredients of VYVANSE [see Contraindications (4)] Hypertensive Crisis When Used Concomitantly with Monoamine Oxidase Inhibitors [see Contraindications (4) and Drug Interactions (7.1)] Abuse, Misuse, and Addiction [see Boxed Warning, Warnings and Precautions (5.1), and Drug Abuse and Dependence (9.2, 9.3)] Risks to …
Table from the label
| VYVANSE (n=233) | Placebo (n=77) | |
|---|---|---|
| Decreased Appetite | 34% | 3% |
| Insomnia | 13% | 4% |
| Weight Decreased | 9% | 0% |
| Dry Mouth | 4% | 1% |
| Palpitations | 2% | 1% |
| Anorexia | 2% | 0% |
| Tremor | 2% | 0% |
— FDA label: Vyvanse, Takeda Pharmaceuticals America, Inc., effective April 30, 2026. This is part of the section. Read the full label on DailyMed →
Lisdexamfetamine dimesylate 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.
Acidifying and Alkalinizing Agents: Agents that alter urinary pH can alter blood levels of amphetamine. Acidifying agents decrease amphetamine blood levels, while alkalinizing agents increase amphetamine blood levels. Adjust VYVANSE dosage accordingly. (2.6, 7.1) 7.1 Drugs Having Clinically Important Interactions with Amphetamines Table 5 Drugs having clinically important interactions with amphetamines.
Read more of this section
MAO Inhibitors (MAOI) Clinical Impact MAOI antidepressants slow amphetamine metabolism, increasing amphetamines effect on the release of norepinephrine and other monoamines from adrenergic nerve endings causing headaches and other signs of hypertensive crisis. Toxic neurological effects and malignant hyperpyrexia can occur, sometimes with fatal results. Intervention Do not administer VYVANSE during or within 14 days following the administration of MAOI [see Contraindications (4)]. Serotonergic Drugs Clinical Impact The concomitant use of VYVANSE and serotonergic drugs increases the risk of serotonin syndrome. Intervention Initiate with lower doses and monitor patients for signs and symptoms of serotonin syndrome, particularly during VYVANSE initiation or dosage increase. If serotonin syndrome occurs, discontinue VYVANSE and the concomitant serotonergic drug(s) [see Warnings and Precautions (5.7)]. CYP2D6 Inhibitors Clinical Impact The concomitant use of VYVANSE and CYP2D6 inhibitors may increase the exposure of dextroamphetamine, the active metabolite of VYVANSE compared to the use of the drug alone and increase the risk of serotonin syndrome. Intervention Initiate with lower doses and monitor patients for signs and symptoms of serotonin syndrome particularly during VYVANSE initiation and after a dosage increase. If serotonin syndrome occurs, discontinue VYVANSE and the CYP2D6 inhibitor [see Warnings and Precautions (5.7) and Overdosage (10)]. Alkalinizing Agents Clinical Impact Urinary alkalinizing agents can increase blood levels and potentiate the action of amphetamine. Intervention Co-administration of VYVANSE and urinary alkalinizing agents should be avoided. Acidifying Agents Clinical Impact Urinary acidifying agents can lower blood levels and efficacy of amphetamines. Intervention Increase dose based on clinical response. Tricyclic Antidepressants Clinical Impact May enhance the activity of tricyclic or sympathomimetic agents causing striking and sustained increases in the concentration of d-amphetamine in the brain; cardiovascular effects can be potentiated. Intervention Monitor frequently and adjust or use alternative therapy based on clinical response. 7.2 Interference with Laboratory Test Allow for an adequate washout period between administration of VYVANSE and radioactive diagnostic agents used for dopamine transporter (DAT) visualization. VYVANSE can interfere with the test results of a radioactive diagnostic agent (ioflupane I-123) that is used for DAT visualization by binding and internalization of the DAT, which may result in lower DAT in the striatum. This may lead to false-positive diagnostic results.
— FDA label: Vyvanse, Takeda Pharmaceuticals America, Inc., effective April 30, 2026. This is part of the section. Read the full label on DailyMed →
Lisdexamfetamine dimesylate 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.
Indicated Population Initial Dose Titration Schedule Recommended Dose Maximum Dose ADHD (Adults and pediatric patients 6 years and older) (2.2) 30 mg every morning 10 mg or 20 mg weekly 30 mg to 70 mg per day 70 mg per day BED (Adults) (2.3) 30 mg every morning 20 mg weekly 50 mg to 70 mg per day 70 mg per day Prior to treatment, assess for presence of cardiac disease (2.4) Severe renal impairment: Maximum dose is 50 mg/day (2.5) End stage renal disease (ESRD): Maximum dose …
Table from the label
| Indicated Population | Initial Dose | Titration Schedule | Recommended Dose | Maximum Dose |
|---|---|---|---|---|
| ADHD (Adults and pediatric patients 6 years and older) (2.2) | 30 mg every morning | 10 mg or 20 mg weekly | 30 mg to 70 mg per day | 70 mg per day |
| BED (Adults) (2.3) | 30 mg every morning | 20 mg weekly | 50 mg to 70 mg per day | 70 mg per day |
— FDA label: Vyvanse, Takeda Pharmaceuticals America, Inc., effective April 30, 2026. This is part of the section. Read the full label on DailyMed →
Lisdexamfetamine dimesylate 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.
Pregnancy Exposure Registry There is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to ADHD medications during pregnancy. Healthcare providers are encouraged to register patients by calling the National Pregnancy Registry for Psychostimulants at 1-866-961-2388 or visiting online at https://womensmentalhealth.org/clinical-and researchprograms/pregnancyregistry/adhd-medications/.
Read more of this section
Risk Summary The limited available data from published literature and postmarketing reports on use of VYVANSE in pregnant women are not sufficient to inform a drug-associated risk for major birth defects and miscarriage. Adverse pregnancy outcomes, including premature delivery and low birth weight, have been seen in infants born to mothers dependent on amphetamines [see Clinical Considerations]. In animal reproduction studies, lisdexamfetamine dimesylate (a prodrug of d-amphetamine) had no effects on embryo-fetal morphological development or survival when administered orally to pregnant rats and rabbits throughout the period of organogenesis. Pre- and postnatal studies were not conducted with lisdexamfetamine dimesylate. However, amphetamine (d- to l- ratio of 3:1) administration to pregnant rats during gestation and lactation caused a decrease in pup survival and a decrease in pup body weight that correlated with a delay in developmental landmarks at clinically relevant doses of amphetamine. In addition, adverse effects on reproductive performance were observed in pups whose mothers were treated with amphetamine. Long-term neurochemical and behavioral effects have also been reported in animal developmental studies using clinically relevant doses of amphetamine [see Data]. 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 Fetal/Neonatal Adverse Reactions Amphetamines, such as VYVANSE, cause vasoconstriction and thereby may decrease placental perfusion. In addition, amphetamines can stimulate uterine contractions increasing the risk of premature delivery. Infants born to amphetamine-dependent mothers have an increased risk of premature delivery and low birth weight. Monitor infants born to mothers taking amphetamines for symptoms of withdrawal such as feeding difficulties, irritability, agitation, and excessive drowsiness. Data Animal Data Lisdexamfetamine dimesylate had no apparent effects on embryo-fetal morphological development or survival when administered orally to pregnant rats and rabbits throughout the period of organogenesis at doses of up to 40 and 120 mg/kg/day, respectively. These doses are approximately 5.5 and 33 times, respectively, the maximum recommended human dose (MRHD) of 70 mg/day given to adults, on a mg/m 2 body surface area basis.
— FDA label: Vyvanse, Takeda Pharmaceuticals America, Inc., effective April 30, 2026. This is part of the section. Read the full label on DailyMed →
When Lisdexamfetamine dimesylate should not be used
Quoted from the “Contraindications” section of the FDA-approved label.
VYVANSE is contraindicated in patients with: Known hypersensitivity to amphetamine products or other ingredients of VYVANSE. Anaphylactic reactions, Stevens-Johnson Syndrome, angioedema, and urticaria have been observed in postmarketing reports [see Adverse Reactions (6.2)].
Read more of this section
Patients taking monoamine oxidase inhibitors (MAOIs), or within 14 days of stopping MAOIs (including MAOIs such as linezolid or intravenous methylene blue), because of an increased risk of hypertensive crisis [see Warnings and Precautions (5.7) and Drug Interactions (7.1)]. Known hypersensitivity to amphetamine products or other ingredients in VYVANSE (4) Use with monoamine oxidase (MAO) inhibitor, or within 14 days of the last MAO inhibitor dose (4, 7.1)
— FDA label: Vyvanse, Takeda Pharmaceuticals America, Inc., effective April 30, 2026. Read the full label on DailyMed →
Lisdexamfetamine dimesylate 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).
Clinical Effects of Overdose Overdose of CNS stimulants is characterized by the following sympathomimetic effects: Cardiovascular effects including tachyarrhythmias, and hypertension or hypotension. Vasospasm, myocardial infarction, or aortic dissection may precipitate sudden cardiac death. Takotsubo cardiomyopathy may develop. CNS effects including psychomotor agitation, confusion, and hallucinations.
Read more of this section
Serotonin syndrome, seizures, cerebral vascular accidents, and coma may occur. Life-threatening hyperthermia (temperatures greater than 104°F) and rhabdomyolysis may develop. Overdose Management Consider the possibility of multiple drug ingestion. The pharmacokinetic profile of VYVANSE should be considered when treating patients with overdose. Lisdexamfetamine and d-amphetamine are not dialyzable. Consider contacting the Poison Help line (1-800-222-1222) or a medical toxicologist for additional overdose management recommendations.
— FDA label: Vyvanse, Takeda Pharmaceuticals America, Inc., effective April 30, 2026. Read the full label on DailyMed →
Forms and how it is given
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 |
|---|---|---|
| lisdexamfetamine dimesylate 10 mg capsule | Generic | $2.54 per capsule |
| lisdexamfetamine dimesylate 10 mg capsule | Brand: Vyvanse | $12.35 per capsule |
| lisdexamfetamine dimesylate 10 mg tablet, chewable | Generic | $3.79 per tablet |
| lisdexamfetamine dimesylate 10 mg tablet, chewable | Brand: Vyvanse | $12.35 per tablet |
| lisdexamfetamine dimesylate 20 mg capsule | Generic | $2.49 per capsule |
| lisdexamfetamine dimesylate 20 mg capsule | Brand: Vyvanse | $12.35 per capsule |
| lisdexamfetamine dimesylate 20 mg tablet, chewable | Generic | $4.32 per tablet |
| lisdexamfetamine dimesylate 20 mg tablet, chewable | Brand: Vyvanse | $12.34 per tablet |
| lisdexamfetamine dimesylate 30 mg capsule | Generic | $2.88 per capsule |
| lisdexamfetamine dimesylate 30 mg capsule | Brand: Vyvanse | $12.34 per capsule |
| lisdexamfetamine dimesylate 30 mg tablet, chewable | Generic | $3.87 per tablet |
| lisdexamfetamine dimesylate 30 mg tablet, chewable | Brand: Vyvanse | $12.35 per tablet |
| lisdexamfetamine dimesylate 40 mg capsule | Generic | $2.66 per capsule |
| lisdexamfetamine dimesylate 40 mg capsule | Brand: Vyvanse | $12.35 per capsule |
| lisdexamfetamine dimesylate 40 mg tablet, chewable | Generic | $4.17 per tablet |
| lisdexamfetamine dimesylate 40 mg tablet, chewable | Brand: Vyvanse | $12.35 per tablet |
| lisdexamfetamine dimesylate 50 mg capsule | Generic | $2.73 per capsule |
| lisdexamfetamine dimesylate 50 mg capsule | Brand: Vyvanse | $12.35 per capsule |
| lisdexamfetamine dimesylate 50 mg tablet, chewable | Generic | $3.68 per tablet |
| lisdexamfetamine dimesylate 50 mg tablet, chewable | Brand: Vyvanse | $12.35 per tablet |
| lisdexamfetamine dimesylate 60 mg capsule | Generic | $2.61 per capsule |
| lisdexamfetamine dimesylate 60 mg capsule | Brand: Vyvanse | $12.35 per capsule |
| lisdexamfetamine dimesylate 60 mg tablet, chewable | Generic | $3.58 per tablet |
| lisdexamfetamine dimesylate 60 mg tablet, chewable | Brand: Vyvanse | $12.36 per tablet |
| lisdexamfetamine dimesylate 70 mg capsule | Generic | $2.61 per capsule |
| lisdexamfetamine dimesylate 70 mg capsule | Brand: Vyvanse | $12.35 per capsule |
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.
- Camber Pharmaceuticals, Inc.13 products
- Sun Pharmaceutical Industries, Inc.13 products
- Takeda Pharmaceuticals America, Inc.13 products
- Granules Pharmaceuticals Inc.13 products
- SpecGx LLC13 products
- Teva Pharmaceuticals, Inc.13 products
- Bryant Ranch Prepack8 products
- Rhodes Pharmaceuticals LLC7 products
- Solco Healthcare US, LLC7 products
- Alvogen Inc.7 products
- Apotex Corp.7 products
- Hikma Pharmaceuticals USA Inc.7 products
- Lannett Company, LLC7 products
- Mylan Pharmaceuticals Inc.7 products
- Elite Laboratories, Inc.7 products
- Sandoz Inc7 products
- Novadoz Pharmaceuticals LLC6 products
- AvKARE6 products
- American Health Packaging6 products
- Amneal Pharmaceuticals LLC6 products
- Azurity 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.
| Application | Sponsor | Approved | Later changes approved |
|---|---|---|---|
| NDA021977 VYVANSE | Takeda Pharms USA | February 23, 2007 | 43, latest April 23, 2026 2026: Labeling · 2025: Labeling · 2023: Labeling |
| NDA208510 VYVANSE | Takeda Pharms USA | January 28, 2017 | 8, latest April 23, 2026 2026: Labeling · 2025: Labeling · 2023: Labeling |
| NDA219847 ARYNTA | Azurity | June 16, 2025 | 1, latest December 22, 2025 2025: Labeling |
Generic approvals (21)
- ANDA202802Actavis Elizabeth · August 25, 2023
- ANDA202827Hikma · August 25, 2023
- ANDA202830Amneal · August 25, 2023
- ANDA202835Mylan · August 25, 2023
- ANDA211840Specgx LLC · August 25, 2023
- ANDA214134Sun Pharm Inds Inc · August 25, 2023
- ANDA214484Sun Pharm Inds Inc · August 25, 2023
- ANDA214547Norwich · August 25, 2023
- ANDA215330Rhodes Pharms · August 25, 2023
- ANDA215415Teva Pharms · August 25, 2023
- ANDA215802Lannett Co Inc · August 25, 2023
- ANDA216266Prinston Inc · August 25, 2023
- ANDA216944Apotex · August 25, 2023
- ANDA217068Ascent Pharms Inc · August 25, 2023
- ANDA217442Ascent Pharms Inc · August 25, 2023
- ANDA218306Msn · February 2, 2024
- ANDA202836Sandoz · July 26, 2024
- ANDA218604Elite Labs Inc · November 15, 2024
- ANDA219258Granules · December 16, 2024
- ANDA218850Specgx LLC · December 17, 2024
- ANDA218987Granules · January 29, 2025
Shortage status
Current shortage · updated October 19, 2026 · first posted July 14, 2023
| Product | Lisdexamfetamine Dimesylate, Capsule, 30 mg (NDC 0378-6856-77) |
|---|---|
| Availability | Available |
| Company | Mylan Pharmaceuticals Inc., a Viatris Company |
Ask your pharmacist whether your product is affected and what the options are.
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.
-
October 28, 2025 · Class II · Ongoing · D-0148-2026
Failed Dissolution Specifications: An out of specification results observed in dissolution test during analysis at 12-month long term stability station (25¿C, 60%RH) for Lisdexamfetamine dimesylate capsules.
Lisdexamfetamine Dimesylate Capsules, 50 mg, CII, 100-count bottle, Rx only, Manufactured by: OHM Laboratories, New Brunswick, NJ 08901, Distributed by: Sun Pharmaceutical Industries, Inc., Cranbury, NJ 08512, NDC 57664- — SUN PHARMACEUTICAL INDUSTRIES INC
-
October 28, 2025 · Class II · Ongoing · D-0150-2026
Failed Dissolution Specifications: An out of specification results observed in dissolution test during analysis at 12-month long term stability station (25¿C, 60%RH) for Lisdexamfetamine dimesylate capsules.
Lisdexamfetamine Dimesylate Capsules, 70 mg, CII, 100-count bottle, Rx only, Manufactured by: OHM Laboratories, New Brunswick, NJ 08901, Distributed by: Sun Pharmaceutical Industries, Inc., Cranbury, NJ 08512, NDC 57664- — SUN PHARMACEUTICAL INDUSTRIES INC
-
October 28, 2025 · Class II · Ongoing · D-0145-2026
Failed Dissolution Specifications: An out of specification results observed in dissolution test during analysis at 12-month long term stability station (25¿C, 60%RH) for Lisdexamfetamine dimesylate capsules.
Lisdexamfetamine Dimesylate Capsules, 20 mg, CII, 100-count bottle, Rx only, Manufactured by: OHM Laboratories, New Brunswick, NJ 08901, Distributed by: Sun Pharmaceutical Industries, Inc., Cranbury, NJ 08512, NDC 57664- — SUN PHARMACEUTICAL INDUSTRIES INC
-
October 28, 2025 · Class II · Ongoing · D-0146-2026
Failed Dissolution Specifications: An out of specification results observed in dissolution test during analysis at 12-month long term stability station (25¿C, 60%RH) for Lisdexamfetamine dimesylate capsules.
Lisdexamfetamine Dimesylate Capsules, 30 mg, CII, 100-count bottle, Rx only, Manufactured by: OHM Laboratories, New Brunswick, NJ 08901, Distributed by: Sun Pharmaceutical Industries, Inc., Cranbury, NJ 08512, NDC 57664- — SUN PHARMACEUTICAL INDUSTRIES INC
-
October 28, 2025 · Class II · Ongoing · D-0144-2026
Failed Dissolution Specifications: An out of specification results observed in dissolution test during analysis at 12-month long term stability station (25¿C, 60%RH) for Lisdexamfetamine dimesylate capsules.
Lisdexamfetamine Dimesylate Capsules, 10 mg, CII, 100-count bottle, Rx only, Manufactured by: OHM Laboratories, New Brunswick, NJ 08901, Distributed by: Sun Pharmaceutical Industries, Inc., Cranbury, NJ 08512, NDC 57664- — SUN PHARMACEUTICAL INDUSTRIES INC
-
October 28, 2025 · Class II · Ongoing · D-0149-2026
Failed Dissolution Specifications: An out of specification results observed in dissolution test during analysis at 12-month long term stability station (25¿C, 60%RH) for Lisdexamfetamine dimesylate capsules.
Lisdexamfetamine Dimesylate Capsules, 60 mg, CII, 100-count bottle, Rx only, Manufactured by: OHM Laboratories, New Brunswick, NJ 08901, Distributed by: Sun Pharmaceutical Industries, Inc., Cranbury, NJ 08512, NDC 57664- — SUN PHARMACEUTICAL INDUSTRIES INC
-
October 28, 2025 · Class II · Ongoing · D-0147-2026
Failed Dissolution Specifications: An out of specification results observed in dissolution test during analysis at 12-month long term stability station (25¿C, 60%RH) for Lisdexamfetamine dimesylate capsules.
Lisdexamfetamine Dimesylate Capsules, 40 mg, CII, 100-count bottle, Rx only, Manufactured by: OHM Laboratories, New Brunswick, NJ 08901, Distributed by: Sun Pharmaceutical Industries, Inc., Cranbury, NJ 08512, NDC 57664- — SUN PHARMACEUTICAL INDUSTRIES INC
-
August 11, 2025 · Class II · Terminated · D-0599-2025
Labeling: Label Mix-up. A bottle labeled as Lisdexamphetamine Dimesylate Capsules 40mg, contained Lisdexamphetamine Dimesylate Capsules 30mg.
Lisdexamfetamine Dimesylate Capsules, 40 mg, 100-count bottles, Rx Only, Distributed by: Lannett Company, Inc., Philadelphia, PA 19136. NDC 0527-4664-37 — Lannett Company Inc.
-
June 16, 2025 · Class II · Ongoing · D-0516-2025
Failed Dissolution Specifications: An out of specification results observed in dissolution test during analysis at 9 month long term stability station (25¿C, 60%RH).
Lisdexamfetamine Dimesylate Capsules, 60 mg, CII, 100-count bottles, Rx only, Manufactured by: OHM Laboratories, New Brunswick, NJ 08901, Distributed by: Sun Pharmaceuticals, Inc., Cranbury, NJ 08512, NDC 57664-051-88 — SUN PHARMACEUTICAL INDUSTRIES INC
-
October 25, 2024 · Class II · Terminated · D-0112-2025
Failed Content Uniformity Specifications: Product failed to meet the action limits for stratified content uniformity.
Lisdexamfetamine Dimesylate Capsules, 10 mg, 100 Capsules per bottle, Rx only, Distributed by: Lannet Company, Philadelphia, PA 19136, NDC: 0527-4661-37 — Lannett Company Inc.
-
September 2, 2016 · Class III · Terminated · D-0006-2017
Presence of Foreign Tablets/Capsules
Vyvanse (lisdexamfetamine dimesylate) Capsules 30 mg, 100 count bottle, Rx Only, Manufactured for: Shire US, Inc., Lexington, MA 02421, NDC 59417-103-10 — Shire
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
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
- VyvanseBrand page: products, maker and price
- AryntaBrand page: products, maker and price
- ADHDCondition named on the label: hospitals that treat it
- Binge Eating DisorderCondition named on the label: hospitals that treat it
- Camber Pharmaceuticals, Inc.Maker or distributor
- Sun Pharmaceutical Industries, Inc.Maker or distributor
- Takeda Pharmaceuticals America, Inc.Maker or distributor
- All prescription drugs A to ZSearch by generic, brand or Spanish name
Sources
- FDA-approved label on DailyMed (National Library of Medicine) — Vyvanse, Takeda Pharmaceuticals America, Inc., effective April 30, 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 →