Does Atomoxetine have a boxed warning?

Yes. The FDA label for Strattera has a boxed warning (“WARNING: SUICIDAL THOUGHTS AND BEHAVIORS IN PEDIATRIC PATIENTS”), the FDA’s strongest warning. Read it on the full label and ask your pharmacist.

Is there a shortage of Atomoxetine?

No current shortage is listed by the FDA for the products of this medicine (FDA data from October 30, 2026).

Has Atomoxetine been recalled?

FDA enforcement reports list 15 recalls of products of this medicine; the newest started April 30, 2026 (Class II). A recall usually concerns specific lots, not every product.

Who makes Atomoxetine?

23 companies list prescription products of Atomoxetine in the FDA NDC Directory, including A-S Medication Solutions, Bryant Ranch Prepack and NorthStar RxLLC.

Atomoxetine (Strattera, Atoncy): uses, warnings, recalls

Quick answers

What is Atomoxetine used for?: The FDA-approved label (Strattera, Eli Lilly and Company, June 30, 2026) says: “STRATTERA is indicated for the treatment of attention-deficit/hyperactivity disorder (ADHD) in adults and pediatric patients 6 years of age and older. STRATTERA is indicated as an integral part of a total treatment program for ADHD that may include other measures (psychological, educational, social) for patients with ADHD. …” This page is not medical advice. Talk to your doctor or pharmacist before you start, stop or change any medicine.
Does Atomoxetine have a boxed warning?: Yes. The FDA label for Strattera has a boxed warning (“WARNING: SUICIDAL THOUGHTS AND BEHAVIORS IN PEDIATRIC PATIENTS”), the FDA’s strongest warning. Read it on the full label and ask your pharmacist.
Is there a shortage of Atomoxetine?: No current shortage is listed by the FDA for the products of this medicine (FDA data from October 30, 2026).
Has Atomoxetine been recalled?: FDA enforcement reports list 15 recalls of products of this medicine; the newest started April 30, 2026 (Class II). A recall usually concerns specific lots, not every product.
Who makes Atomoxetine?: 23 companies list prescription products of Atomoxetine in the FDA NDC Directory, including A-S Medication Solutions, Bryant Ranch Prepack and NorthStar RxLLC.

What Atomoxetine is used for

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

STRATTERA is indicated for the treatment of attention-deficit/hyperactivity disorder (ADHD) in adults and pediatric patients 6 years of age and older. STRATTERA is indicated as an integral part of a total treatment program for ADHD that may include other measures (psychological, educational, social) for patients with ADHD. …

— FDA label: Strattera, Eli Lilly and Company, effective June 30, 2026. Read the full label on DailyMed →

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.

ADHD

Related medical specialties

Psychiatry

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: SUICIDAL THOUGHTS AND BEHAVIORS IN PEDIATRIC PATIENTS. Read it on the full label →

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

Forms and how it is given

Dosage forms	Capsule · Solution
Route	Oral
Prescription products	137 in the FDA NDC Directory
Brand names	Strattera, Atoncy

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 Atomoxetine, by strength and form
Strength and form	Generic or brand	Pharmacies pay
atomoxetine hydrochloride 10 mg capsule	Generic	$0.3404 per capsule
atomoxetine hydrochloride 100 mg capsule	Generic	$0.5051 per capsule
atomoxetine hydrochloride 18 mg capsule	Generic	$0.3877 per capsule
atomoxetine hydrochloride 25 mg capsule	Generic	$0.3959 per capsule
atomoxetine hydrochloride 40 mg capsule	Generic	$0.4447 per capsule
atomoxetine hydrochloride 60 mg capsule	Generic	$0.5088 per capsule
atomoxetine hydrochloride 80 mg capsule	Generic	$0.5097 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.

A-S Medication Solutions15 products
Bryant Ranch Prepack13 products
NorthStar RxLLC7 products
Creekwood Pharmaceuticals LLC7 products
NorthStar Rx LLC7 products
Teva Pharmaceuticals USA, Inc.7 products
Camber Pharmaceuticals, Inc.7 products
AvKARE7 products
Dr. Reddy's Laboratories Limited7 products
Apotex Corp.7 products
Rising Pharma Holdings, Inc.7 products
Aurobindo Pharma Limited7 products
Golden State Medical Supply, Inc.7 products
Eli Lilly and Company7 products
Strides Pharma Science Limited7 products
Glenmark Pharmaceuticals Inc., USA7 products
AvPAK3 products
American Health Packaging2 products
Remedyrepack Inc.2 products
Validus Pharmaceuticals LLC1 product
Major Pharmaceuticals1 product
Zydus Pharmaceuticals USA Inc.1 product
Advagen Pharma Ltd1 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.

Brand and biologic applications
Application	Sponsor	Approved	Later changes approved
NDA021411 STRATTERA	Lilly	November 26, 2002	36, latest June 29, 2026 2026: Labeling · 2022: Labeling · 2020: Labeling
NDA220320 ATONCY	MAP77	March 20, 2026	—

Generic approvals (9)

ANDA079017Zydus Pharms USA Inc · September 16, 2010
ANDA078983Apotex · May 30, 2017
ANDA079016Aurobindo Pharma · May 30, 2017
ANDA079019Glenmark Pharms Ltd · May 30, 2017
ANDA079022Teva Pharms USA · May 30, 2017
ANDA090609DR Reddys · February 23, 2018
ANDA079021Strides Pharma · February 18, 2021
ANDA202682Hetero Labs Ltd V · March 11, 2021
ANDA218875Pharmazone · June 16, 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.

April 30, 2026 · Class II · Ongoing · D-0538-2026

Labeling: Label Mix-Up: Atomoxetine HCl 25mg Capsule incorrectly labeled as Atomoxetine HCl 10mg Capsule.

Atomoxetine Capsules HCL, 10 mg Capsules in unit dose foil strip, strips are packed in cartons of 100, Rx Only, Pkg by: Safecor, Columbus, OH 43204. NDC: 64380-474-01 — Safecor Health, LLC
January 29, 2025 · Class II · Ongoing · D-0240-2025

CGMP Deviations: presence of N-Nitroso Atomoxetine Impurity above the FDA recommended limit.

Atomoxetine Capsules, USP, 25 mg, 30 capsule bottles, Rx Only, Manufactured for: Northstar Rx LLC., Memphis, TN 38141, Manufactured by: Glenmark Pharmaceuticals Ltd., Goa, India, NDC 16714-757-01. — Glenmark Pharmaceuticals Inc., USA
January 29, 2025 · Class II · Ongoing · D-0242-2025

CGMP Deviations: presence of N-Nitroso Atomoxetine Impurity above the FDA recommended limit.

Atomoxetine Capsules, USP, 60 mg, 30 capsule bottles, Rx Only, Manufactured for: Northstar Rx LLC., Memphis, TN 38141, Manufactured by: Glenmark Pharmaceuticals Ltd., Goa, India, NDC 16714-759-01. — Glenmark Pharmaceuticals Inc., USA
January 29, 2025 · Class II · Ongoing · D-0239-2025

CGMP Deviations: presence of N-Nitroso Atomoxetine Impurity above the FDA recommended limit.

Atomoxetine Capsules, USP, 18 mg, 30 capsule bottles, Rx Only, Manufactured for: Northstar Rx LLC., Memphis, TN 38141, Manufactured by: Glenmark Pharmaceuticals Ltd., Goa, India, NDC 16714-756-01. — Glenmark Pharmaceuticals Inc., USA
January 29, 2025 · Class II · Ongoing · D-0238-2025

CGMP Deviations: presence of N-Nitroso Atomoxetine Impurity above the FDA recommended limit.

Atomoxetine Capsules, USP, 10 mg, 30 capsule bottles, Rx Only, Manufactured for: Northstar Rx LLC., Memphis, TN 38141, Manufactured by: Glenmark Pharmaceuticals Ltd., Goa, India, NDC 16714-755-01. — Glenmark Pharmaceuticals Inc., USA
January 29, 2025 · Class II · Ongoing · D-0241-2025

CGMP Deviations: presence of N-Nitroso Atomoxetine Impurity above the FDA recommended limit.

Atomoxetine Capsules, USP, 40 mg, 30 capsule bottles, Rx Only, Manufactured for: Northstar Rx LLC., Memphis, TN 38141, Manufactured by: Glenmark Pharmaceuticals Ltd., Goa, India, NDC 16714-758-01. — Glenmark Pharmaceuticals Inc., USA
January 29, 2025 · Class II · Ongoing · D-0244-2025

CGMP Deviations: presence of N-Nitroso Atomoxetine Impurity above the FDA recommended limit.

Atomoxetine Capsules, USP, 100 mg, 30 capsule bottles, Rx Only, Manufactured for: Northstar Rx LLC., Memphis, TN 38141, Manufactured by: Glenmark Pharmaceuticals Ltd., Goa, India, NDC 16714-761-01. — Glenmark Pharmaceuticals Inc., USA
January 29, 2025 · Class II · Ongoing · D-0232-2025

CGMP Deviations: presence of N-Nitroso Atomoxetine Impurity above the FDA recommended limit.

Atomoxetine Capsules, USP, 18 mg, 30 capsule bottles, Rx Only, Manufactured for: Glenmark Pharmaceuticals Inc., NJ, USA, Product of India, NDC 68462-266-30. — Glenmark Pharmaceuticals Inc., USA
January 29, 2025 · Class II · Ongoing · D-0243-2025

CGMP Deviations: presence of N-Nitroso Atomoxetine Impurity above the FDA recommended limit.

Atomoxetine Capsules, USP, 80 mg, 30 capsule bottles, Rx Only, Manufactured for: Northstar Rx LLC., Memphis, TN 38141, Manufactured by: Glenmark Pharmaceuticals Ltd., Goa, India, NDC 16714-760-01. — Glenmark Pharmaceuticals Inc., USA
January 29, 2025 · Class II · Ongoing · D-0235-2025

CGMP Deviations: presence of N-Nitroso Atomoxetine Impurity above the FDA recommended limit.

Atomoxetine Capsules, USP, 60 mg, 30 capsule bottles, Rx Only, Manufactured for: Glenmark Pharmaceuticals Inc., NJ, USA, Product of India, NDC 68462-269-30. — Glenmark Pharmaceuticals Inc., USA
January 29, 2025 · Class II · Ongoing · D-0236-2025

CGMP Deviations: presence of N-Nitroso Atomoxetine Impurity above the FDA recommended limit.

Atomoxetine Capsules, USP, 80 mg, 30 capsule bottles, Rx Only, Manufactured for: Glenmark Pharmaceuticals Inc., NJ, USA, Product of India, NDC 68462-270-30. — Glenmark Pharmaceuticals Inc., USA
January 29, 2025 · Class II · Ongoing · D-0231-2025

CGMP Deviations: presence of N-Nitroso Atomoxetine Impurity above the FDA recommended limit.

Atomoxetine Capsules, USP, 10 mg, 30 capsule bottles, Rx Only, Manufactured for: Glenmark Pharmaceuticals Inc., NJ, USA, Product of India, NDC 68462-265-30. — Glenmark Pharmaceuticals Inc., USA
January 29, 2025 · Class II · Ongoing · D-0233-2025

CGMP Deviations: presence of N-Nitroso Atomoxetine Impurity above the FDA recommended limit.

Atomoxetine Capsules, USP, 25 mg, 30 capsule bottles, Rx Only, Manufactured for: Glenmark Pharmaceuticals Inc., NJ, USA, Product of India, NDC 68462-267-30. — Glenmark Pharmaceuticals Inc., USA
January 29, 2025 · Class II · Ongoing · D-0234-2025

CGMP Deviations: presence of N-Nitroso Atomoxetine Impurity above the FDA recommended limit.

Atomoxetine Capsules, USP, 40 mg, 30 capsule bottles, Rx Only, Manufactured for: Glenmark Pharmaceuticals Inc., NJ, USA, Product of India, NDC 68462-268-30. — Glenmark Pharmaceuticals Inc., USA
January 29, 2025 · Class II · Ongoing · D-0237-2025

CGMP Deviations: presence of N-Nitroso Atomoxetine Impurity above the FDA recommended limit.

Atomoxetine Capsules, USP, 100 mg, 30 capsule bottles, Rx Only, Manufactured for: Glenmark Pharmaceuticals Inc., NJ, USA, Product of India, NDC 68462-271-30. — 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)	349591, 349592, 349593, 349594, 349595, 352317, 352318, 352319, 352320, 352321 … (+6)
SPL set ID of the quoted label	309de576-c318-404a-bc15-660c2b1876fb
FDA labels (SPL)	47
FDA applications	NDA021411, NDA220320, 9 ANDA
Active ingredients (FDA)	ATOMOXETINE

Sources

FDA-approved label on DailyMed (National Library of Medicine) — Strattera, Eli Lilly and Company, effective June 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 →

Report an error → · Information for medicine makers

Atomoxetine

Official FDA data, not advice

At a glance