ADHD and stimulant medication recalls
36 FDA-recorded recalls of adhd and stimulant medications, most recent Jun 2026 — newest first, straight from the FDA's own database.
Two things drive the recalls we hold in this class, and neither is a safety problem with the drug. The largest group by far is a nitrosamine impurity found in atomoxetine — the same family of probable-carcinogen manufacturing by-products behind the blood-pressure and metformin recalls — and the second is failed dissolution, meaning the tablet did not release its dose the way it should. Most of these medicines are Schedule II controlled substances, so a replacement usually needs a new prescription rather than a swap at the counter: check the lot, then call the prescriber, not just the pharmacy.
Dextroamphetamine Saccharate
Class IILabeling: Label Mix-up: Capsules contain only immediate-release (IR) pellets while labeled as ER capsules.
Lannett Company Inc. · Jul 8, 2026
Focalin XR (dexmethylphenidate HCl) 5 mg
Class IIILabeling: Incorrect or Missing Lot and/or Exp Date
Sandoz Inc · Jun 24, 2026
Atomoxetine Capsules HCL
Class IILabeling: Label Mix-Up: Atomoxetine HCl 25mg Capsule incorrectly labeled as Atomoxetine HCl 10mg Capsule.
Safecor Health, LLC · May 27, 2026
Lisdexamfetamine Dimesylate Capsules
Class IIFailed 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.
SUN PHARMACEUTICAL INDUSTRIES INC · Nov 5, 2025
Lisdexamfetamine Dimesylate Capsules
Class IIFailed 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.
SUN PHARMACEUTICAL INDUSTRIES INC · Nov 5, 2025
Lisdexamfetamine Dimesylate Capsules
Class IIFailed 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.
SUN PHARMACEUTICAL INDUSTRIES INC · Nov 5, 2025
Lisdexamfetamine Dimesylate Capsules
Class IIFailed 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.
SUN PHARMACEUTICAL INDUSTRIES INC · Nov 5, 2025
Lisdexamfetamine Dimesylate Capsules
Class IIFailed 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.
SUN PHARMACEUTICAL INDUSTRIES INC · Nov 5, 2025
Lisdexamfetamine Dimesylate Capsules
Class IIFailed 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.
SUN PHARMACEUTICAL INDUSTRIES INC · Nov 5, 2025
Lisdexamfetamine Dimesylate Capsules
Class IIFailed 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.
SUN PHARMACEUTICAL INDUSTRIES INC · Nov 5, 2025
Dextroamphetamine Saccharate
Class IIIFailed Impurities/Degradation Specifications:
Granules Pharmaceuticals Inc. · Oct 1, 2025
Dextroamphetamine Saccharate
Class IIIFailed Impurities/Degradation Specifications:
Granules Pharmaceuticals Inc. · Oct 1, 2025
Dextroamphetamine Saccharate
Class IIIFailed Impurities/Degradation Specifications:
Granules Pharmaceuticals Inc. · Oct 1, 2025
Dextroamphetamine Saccharate
Class IIIFailed Impurities/Degradation Specifications:
Granules Pharmaceuticals Inc. · Oct 1, 2025
Dextroamphetamine Saccharate
Class IIIFailed Impurities/Degradation Specifications:
Granules Pharmaceuticals Inc. · Oct 1, 2025
Dextroamphetamine Saccharate
Class IIPresence of Foreign Tablet/Capsule: Two (2) bottles labeled as Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate and Amphetamine Sulfate Tablets, 10mg, 100ct, contained one (1) tablet of Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate and Amphetamine Sulfate Tablets, 5 mg.
Lannett Company Inc. · Sep 17, 2025
Lisdexamfetamine Dimesylate Capsules
Class IILabeling: Label Mix-up. A bottle labeled as Lisdexamphetamine Dimesylate Capsules 40mg, contained Lisdexamphetamine Dimesylate Capsules 30mg.
Lannett Company Inc. · Sep 3, 2025
Lisdexamfetamine Dimesylate Capsules
Class IIFailed Dissolution Specifications: An out of specification results observed in dissolution test during analysis at 9 month long term stability station (25¿C, 60%RH).
SUN PHARMACEUTICAL INDUSTRIES INC · Jul 23, 2025
Atomoxetine Capsules
Class IICGMP Deviations: presence of N-Nitroso Atomoxetine Impurity above the FDA recommended limit.
Glenmark Pharmaceuticals Inc., USA · Feb 26, 2025
Atomoxetine Capsules
Class IICGMP Deviations: presence of N-Nitroso Atomoxetine Impurity above the FDA recommended limit.
Glenmark Pharmaceuticals Inc., USA · Feb 26, 2025
Atomoxetine Capsules
Class IICGMP Deviations: presence of N-Nitroso Atomoxetine Impurity above the FDA recommended limit.
Glenmark Pharmaceuticals Inc., USA · Feb 26, 2025
Atomoxetine Capsules
Class IICGMP Deviations: presence of N-Nitroso Atomoxetine Impurity above the FDA recommended limit.
Glenmark Pharmaceuticals Inc., USA · Feb 26, 2025
Atomoxetine Capsules
Class IICGMP Deviations: presence of N-Nitroso Atomoxetine Impurity above the FDA recommended limit.
Glenmark Pharmaceuticals Inc., USA · Feb 26, 2025
Atomoxetine Capsules
Class IICGMP Deviations: presence of N-Nitroso Atomoxetine Impurity above the FDA recommended limit.
Glenmark Pharmaceuticals Inc., USA · Feb 26, 2025
Atomoxetine Capsules
Class IICGMP Deviations: presence of N-Nitroso Atomoxetine Impurity above the FDA recommended limit.
Glenmark Pharmaceuticals Inc., USA · Feb 26, 2025
Atomoxetine Capsules
Class IICGMP Deviations: presence of N-Nitroso Atomoxetine Impurity above the FDA recommended limit.
Glenmark Pharmaceuticals Inc., USA · Feb 26, 2025
Atomoxetine Capsules
Class IICGMP Deviations: presence of N-Nitroso Atomoxetine Impurity above the FDA recommended limit.
Glenmark Pharmaceuticals Inc., USA · Feb 26, 2025
Atomoxetine Capsules
Class IICGMP Deviations: presence of N-Nitroso Atomoxetine Impurity above the FDA recommended limit.
Glenmark Pharmaceuticals Inc., USA · Feb 26, 2025
Atomoxetine Capsules
Class IICGMP Deviations: presence of N-Nitroso Atomoxetine Impurity above the FDA recommended limit.
Glenmark Pharmaceuticals Inc., USA · Feb 26, 2025
Atomoxetine Capsules
Class IICGMP Deviations: presence of N-Nitroso Atomoxetine Impurity above the FDA recommended limit.
Glenmark Pharmaceuticals Inc., USA · Feb 26, 2025
Atomoxetine Capsules
Class IICGMP Deviations: presence of N-Nitroso Atomoxetine Impurity above the FDA recommended limit.
Glenmark Pharmaceuticals Inc., USA · Feb 26, 2025
Atomoxetine Capsules
Class IICGMP Deviations: presence of N-Nitroso Atomoxetine Impurity above the FDA recommended limit.
Glenmark Pharmaceuticals Inc., USA · Feb 26, 2025
Xelstrym (dextroamphetamine) transdermal system
Class IIDefective Delivery System: The product does not meet predetermined specifications for Coldflow (adhesive).
Noven Pharmaceuticals Inc · Nov 27, 2024
Lisdexamfetamine Dimesylate Capsules
Class IIFailed Content Uniformity Specifications: Product failed to meet the action limits for stratified content uniformity.
Lannett Company Inc. · Dec 11, 2024
Methylphenidate Hydrochloride
Class IIFailed dissolution specifications: this product is being recalled due to this batch not meeting dissolution specifications.
Trigen Laboratories · Jul 10, 2024
Zenzedi (Dextroamphetamine Sulfate) CII Tablets
Class ILabeling: Label Mix-up
Azurity Pharmaceuticals, Inc. · Feb 7, 2024
How to use this page
A drug appearing here does not mean your prescription is unsafe. Recalls name specific lots and manufacturers — open the recall to see the affected lot numbers, and match them against your bottle. Never stop a blood-pressure, cholesterol, diabetes, antidepressant or antibiotic medicine on your own because of a recall; confirm your lot, then ask your pharmacist for a replacement if it is affected.
Other categories: Blood pressure medication · Eye drop and ophthalmic · Cholesterol medication · Diabetes medication · Antidepressant · Antibiotic · Thyroid medication · Allergy and antihistamine · Hormonal and contraceptive · Opioid and pain medication · Seizure and epilepsy medication · Asthma and inhaler · Heartburn and acid-reflux medication. See also the full recalls tracker and the recall report.
Source: the openFDA drug Enforcement (recall) database. Recalls are matched to this category by the drug names in the FDA’s product description; a small number of category recalls may be missed if the description omits the ingredient. Figures are recall events, not units, and reflect our copy of the FDA data, refreshed daily. This is public regulatory data, not medical advice.