Quick answers
- What is Methylphenidate used for?
- The FDA-approved label (Ritalin, Sandoz Inc, February 5, 2025) says: “Ritalin is indicated for the treatment of: • Attention Deficit Hyperactivity Disorders (ADHD) in pediatric patients 6 years and older and adults • Narcolepsy Ritalin is a central nervous system (CNS) stimulant indicated for the treatment of Attention Deficit Hyperactivity Disorders (ADHD) and Narcolepsy.” This page is not medical advice. Talk to your doctor or pharmacist before you start, stop or change any medicine.
- Does Methylphenidate have a boxed warning?
- Yes. The FDA label for Ritalin has a boxed warning (“WARNING: ABUSE, MISUSE, AND ADDICTION”), the FDA’s strongest warning. Read it on the full label and ask your pharmacist.
- Is there a shortage of Methylphenidate?
- The FDA drug shortage list shows “Current shortage” for a product of this medicine (updated October 20, 2026). Ask your pharmacist about alternatives.
- Has Methylphenidate been recalled?
- FDA enforcement reports list 50 recalls of products of this medicine; the newest started June 17, 2024 (Class II). A recall usually concerns specific lots, not every product.
- Who makes Methylphenidate?
- 43 companies list prescription products of Methylphenidate in the FDA NDC Directory, including Bryant Ranch Prepack, SpecGx LLC and Lannett Company, LLC.
What Methylphenidate is used for
Quoted from the “Indications and Usage” section of the FDA-approved label.
Ritalin is indicated for the treatment of: • Attention Deficit Hyperactivity Disorders (ADHD) in pediatric patients 6 years and older and adults • Narcolepsy Ritalin is a central nervous system (CNS) stimulant indicated for the treatment of Attention Deficit Hyperactivity Disorders (ADHD) and Narcolepsy.
— FDA label: Ritalin, Sandoz Inc, effective February 5, 2025. Read the full label on DailyMed →
The FDA has 77 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: ABUSE, MISUSE, AND ADDICTION
. Read it on the full label →
74 of 77 FDA labels for this medicine have a boxed warning.
Forms and how it is given
| Dosage forms | Capsule, extended release · Tablet, extended release · Tablet · Solution · Tablet, chewable · Patch · Tablet, orally disintegrating · Capsule · Tablet, film coated, extended release · Suspension, extended release |
|---|---|
| Route | Oral · Transdermal |
| Prescription products | 245 in the FDA NDC Directory |
| Brand names | Metadate Cd, Relexxii, Methylphenidate Hydrochloride Cd, Jornay Pm Extended-Release, Ritalin La, Concerta, Quillivant XR, Methylphenidate Transdermal System, Daytrana, Quillichew ER, Ritalin, Cotempla Xr-Odt |
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 |
|---|---|---|
| methylphenidate 1.1 mg/h patch | Generic | $6.30 per patch |
| methylphenidate 1.6 mg/h patch | Generic | $6.27 per patch |
| methylphenidate 17.3 mg tablet, orally disintegrating | Brand: Cotempla XR-ODT | $17.88 per tablet |
| methylphenidate 2.2 mg/h patch | Generic | $6.16 per patch |
| methylphenidate 25.9 mg tablet, orally disintegrating | Brand: Cotempla XR-ODT | $17.94 per tablet |
| methylphenidate 27.5 mg/mg patch | Generic | $6.30 per patch |
| methylphenidate 3.3 mg/h patch | Generic | $6.61 per patch |
| methylphenidate 41.3 mg/mg patch | Generic | $6.27 per patch |
| methylphenidate 55 mg/mg patch | Generic | $6.16 per patch |
| methylphenidate 8.6 mg tablet, orally disintegrating | Brand: Cotempla XR-ODT | $18.02 per tablet |
| methylphenidate 82.5 mg/mg patch | Generic | $6.61 per patch |
| methylphenidate hydrochloride 10 mg capsule, extended release | Generic | $1.52–$2.35 per capsule 6 packages, lowest to highest |
| methylphenidate hydrochloride 10 mg tablet | Generic | $0.1497–$0.4550 per tablet 11 packages, lowest to highest |
| methylphenidate hydrochloride 10 mg tablet | Brand: Ritalin | $1.13 per tablet |
| methylphenidate hydrochloride 10 mg tablet, chewable | Generic | $2.90 per tablet |
| methylphenidate hydrochloride 10 mg tablet, extended release | Generic | $0.4550 per tablet |
| methylphenidate hydrochloride 10 mg/5 mL solution | Generic | $0.1158 per mL |
| methylphenidate hydrochloride 10 mg/5 mL solution | Brand: Methylin | $0.2309 per mL |
| methylphenidate hydrochloride 100 mg capsule | Brand: JORNAY PM Extended-Release | $15.38 per capsule |
| methylphenidate hydrochloride 18 mg tablet, extended release | Generic | $0.6096 per tablet |
| methylphenidate hydrochloride 18 mg tablet, extended release | Brand: Concerta | $12.33 per tablet |
| methylphenidate hydrochloride 18 mg tablet, extended release | Brand: Relexxii | $10.94 per tablet |
| methylphenidate hydrochloride 18 mg tablet, film coated, extended release | Generic | $0.6096 per tablet |
| methylphenidate hydrochloride 2.5 mg tablet, chewable | Generic | $1.31 per tablet |
| methylphenidate hydrochloride 20 mg capsule | Brand: JORNAY PM Extended-Release | $15.38 per capsule |
| methylphenidate hydrochloride 20 mg capsule, extended release | Generic | $1.46–$1.62 per capsule 7 packages, lowest to highest |
| methylphenidate hydrochloride 20 mg tablet | Generic | $0.1993–$0.5103 per tablet 10 packages, lowest to highest |
| methylphenidate hydrochloride 20 mg tablet | Brand: Ritalin | $1.63 per tablet |
| methylphenidate hydrochloride 20 mg tablet, chewable, extended release | Brand: QuilliChew ER | $11.90 per tablet |
| methylphenidate hydrochloride 20 mg tablet, extended release | Generic | $0.5103 per tablet |
| methylphenidate hydrochloride 27 mg tablet, extended release | Generic | $0.7186 per tablet |
| methylphenidate hydrochloride 27 mg tablet, extended release | Brand: Concerta | $12.65 per tablet |
| methylphenidate hydrochloride 27 mg tablet, extended release | Brand: Relexxii | $11.39 per tablet |
| methylphenidate hydrochloride 27 mg tablet, film coated, extended release | Generic | $0.7186 per tablet |
| methylphenidate hydrochloride 30 mg capsule, extended release | Generic | $1.72–$1.81 per capsule 7 packages, lowest to highest |
| methylphenidate hydrochloride 30 mg tablet, chewable, extended release | Brand: QuilliChew ER | $11.88 per tablet |
| methylphenidate hydrochloride 300 mg/60 mL suspension, extended release | Brand: Quillivant XR | $5.39 per mL |
| methylphenidate hydrochloride 36 mg tablet, extended release | Generic | $0.6892 per tablet |
| methylphenidate hydrochloride 36 mg tablet, extended release | Brand: Concerta | $13.04 per tablet |
| methylphenidate hydrochloride 36 mg tablet, extended release | Brand: Relexxii | $11.87 per tablet |
| methylphenidate hydrochloride 36 mg tablet, film coated, extended release | Generic | $0.6892 per tablet |
| methylphenidate hydrochloride 40 mg capsule | Brand: JORNAY PM Extended-Release | $15.41 per capsule |
| methylphenidate hydrochloride 40 mg capsule, extended release | Generic | $1.62–$1.77 per capsule 6 packages, lowest to highest |
| methylphenidate hydrochloride 40 mg tablet, chewable, extended release | Brand: QuilliChew ER | $11.86 per tablet |
| methylphenidate hydrochloride 45 mg tablet, extended release | Generic | $17.47 per tablet |
| methylphenidate hydrochloride 5 mg tablet | Generic | $0.1218 per tablet |
| methylphenidate hydrochloride 5 mg tablet | Brand: Ritalin | $0.7935 per tablet |
| methylphenidate hydrochloride 5 mg tablet, chewable | Generic | $1.99 per tablet |
| methylphenidate hydrochloride 5 mg/5 mL solution | Generic | $0.0795 per mL |
| methylphenidate hydrochloride 5 mg/5 mL solution | Brand: Methylin | $0.1615 per mL |
| methylphenidate hydrochloride 50 mg capsule, extended release | Generic | $1.73 per capsule |
| methylphenidate hydrochloride 54 mg tablet, extended release | Generic | $0.8220 per tablet |
| methylphenidate hydrochloride 54 mg tablet, extended release | Brand: Concerta | $14.18 per tablet |
| methylphenidate hydrochloride 54 mg tablet, extended release | Brand: Relexxii | $12.78 per tablet |
| methylphenidate hydrochloride 54 mg tablet, film coated, extended release | Generic | $0.8220 per tablet |
| methylphenidate hydrochloride 60 mg capsule | Brand: JORNAY PM Extended-Release | $15.40 per capsule |
| methylphenidate hydrochloride 60 mg capsule, extended release | Generic | $1.89–$10.03 per capsule 5 packages, lowest to highest |
| methylphenidate hydrochloride 600 mg/120 mL suspension, extended release | Brand: Quillivant XR | $2.70 per mL |
| methylphenidate hydrochloride 63 mg tablet, extended release | Generic | $19.00 per tablet |
| methylphenidate hydrochloride 63 mg tablet, extended release | Brand: Relexxii | $21.34 per tablet |
| methylphenidate hydrochloride 72 mg tablet, extended release | Generic | $16.09 per tablet |
| methylphenidate hydrochloride 72 mg tablet, extended release | Brand: Relexxii | $21.85 per tablet |
| methylphenidate hydrochloride 750 mg/150 mL suspension, extended release | Brand: Quillivant XR | $2.16 per mL |
| methylphenidate hydrochloride 80 mg capsule | Brand: JORNAY PM Extended-Release | $15.40 per capsule |
| methylphenidate hydrochloride 900 mg/180 mL suspension, extended release | Brand: Quillivant XR | $1.80 per mL |
NADAC list of November 4, 2026; these prices took effect between March 18, 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.
- Bryant Ranch Prepack19 products
- SpecGx LLC14 products
- Lannett Company, LLC12 products
- Actavis Pharma, Inc.11 products
- Sandoz Inc11 products
- XLCare Pharmaceuticals, Inc.10 products
- Amneal Pharmaceuticals of New York LLC9 products
- Lannett Company, Inc.8 products
- Lupin Pharmaceuticals, Inc.8 products
- NextWave Pharmaceuticals, Inc7 products
- Granules Pharmaceuticals Inc.7 products
- KVK-Tech, Inc.7 products
- Rhodes Pharmaceuticals LLC7 products
- Vertical Pharmaceuticals, LLC7 products
- Camber Pharmaceuticals, Inc.7 products
- Trigen Laboratories, LLC7 products
- Golden State Medical Supply, Inc.6 products
- American Health Packaging6 products
- Aytu BioPharma, Inc.6 products
- Ironshore Pharmaceuticals Inc.5 products
- Ascend Laboratories, LLC5 products
- Dr. Reddy's Laboratories Inc.5 products
- Novartis Pharmaceuticals Corporation4 products
- Janssen Pharmaceuticals, Inc.4 products
- Sun Pharmaceutical Industries, Inc.4 products
- Padagis US LLC4 products
- Noven Therapeutics, LLC4 products
- Mylan Pharmaceuticals Inc.4 products
- Solco Healthcare US, LLC3 products
- Camber Pharmaceutical Inc3 products
- Nivagen Pharmaceuticals, Inc.3 products
- Accord Healthcare Inc.3 products
- Aurolife Pharma, LLC3 products
- Rising Pharma Holdings, Inc.3 products
- Neos Therapeutics, LP3 products
- Neos Therapeutics Brands, LLC3 products
- Eywa Pharma Inc2 products
- Cranbury Pharmaceuticals, LLC2 products
- Patrin Pharma, Inc.2 products
- Shionogi Inc.2 products
- Quagen Pharmaceuticals LLC2 products
- Ascent Pharmaceuticals Inc2 products
- NorthStar Rx 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 |
|---|---|---|---|
| NDA010187 RITALIN | Sandoz | December 5, 1955 | 57, latest February 4, 2025 2025: Labeling · 2023: Labeling · 2023: Labeling |
| NDA021121 CONCERTA | Janssen Pharms | August 1, 2000 | 30, latest April 10, 2026 2026: Labeling · 2026: Labeling · 2026: Labeling |
| NDA021259 METADATE CD | Lannett | April 3, 2001 | 24, latest September 23, 2025 2025: Labeling · 2023: Labeling · 2022: Labeling |
| NDA021284 RITALIN LA | Sandoz | June 5, 2002 | 24, latest September 23, 2025 2025: Labeling · 2023: Labeling · 2023: Labeling |
| NDA021419 METHYLIN | Specgx LLC | December 19, 2002 | 11, latest October 13, 2023 2023: Labeling · 2021: Labeling · 2021: Labeling |
| NDA021514 DAYTRANA | Noven Pharms Inc | April 6, 2006 | 26, latest September 23, 2025 2025: Labeling · 2024: Labeling · 2023: Labeling |
| NDA202100 QUILLIVANT XR | Nextwave | September 27, 2012 | 13, latest March 9, 2026 2026: Labeling · 2025: Labeling · 2023: Labeling |
| NDA205489 COTEMPLA XR-ODT | Neos Theraps Inc | June 19, 2017 | 4, latest September 23, 2025 2025: Labeling · 2024: Manufacturing (CMC) · 2023: Labeling |
| NDA205831 APTENSIO XR | Rhodes Pharms | April 17, 2015 | 6, latest September 23, 2025 2025: Labeling · 2023: Labeling · 2021: Labeling |
| NDA207960 QUILLICHEW ER | Nextwave Pharms | December 4, 2015 | 6, latest March 10, 2026 2026: Labeling · 2025: Labeling · 2023: Labeling |
| NDA209311 JORNAY PM | Ironshore Pharms | August 8, 2018 | 5, latest August 20, 2026 2026: Manufacturing (CMC) · 2025: Labeling · 2023: Labeling |
| NDA216117 RELEXXII | Osmotica Pharm Us | June 23, 2022 | 2, latest September 23, 2025 2025: Labeling · 2023: Labeling |
Generic approvals (40)
- ANDA040300Specgx LLC · November 27, 1998
- ANDA075629Specgx LLC · May 9, 2000
- ANDA091601Tris Pharma Inc · July 23, 2010
- ANDA078458DR Reddys Labs SA · December 1, 2011
- ANDA090710Sun Pharm Inds Inc · March 15, 2012
- ANDA202608Specgx LLC · December 28, 2012
- ANDA091695Lannett Co Inc · July 9, 2013
- ANDA091159Mountain · March 12, 2014
- ANDA204115Novel Labs Inc · February 25, 2015
- ANDA207488Abhai LLC · June 9, 2015
- ANDA204602Novel Labs Inc · August 14, 2015
- ANDA207416Ascent Pharms Inc · September 22, 2015
- ANDA203583Specgx LLC · September 29, 2015
- ANDA207884Novel Labs Inc · November 13, 2015
- ANDA205105Impax Labs Inc · July 28, 2016
- ANDA205756Rising · November 7, 2016
- ANDA207485Abhai LLC · November 18, 2016
- ANDA206932Abhai LLC · May 11, 2017
- ANDA205327Osmotica Pharm Us · July 28, 2017
- ANDA210354Ascent Pharms Inc · December 29, 2017
- ANDA200886DR Reddys Labs SA · February 26, 2018
- ANDA076655Actavis Labs Fl · March 21, 2018
- ANDA076772Actavis Labs Fl · March 22, 2018
- ANDA210139Adaptis · October 3, 2018
- ANDA209276Aurolife Pharma LLC · October 25, 2018
- ANDA210992Granules · November 21, 2018
- ANDA208861Actavis Elizabeth · December 13, 2018
- ANDA208737Cediprof Inc · February 1, 2019
- ANDA211918Andor Pharms · April 24, 2019
- ANDA211796Granules · May 23, 2019
- ANDA211009Ascent Pharms Inc · September 3, 2019
- ANDA211779Alkem Labs Ltd · October 4, 2019
- ANDA211647Alkem Labs Ltd · March 30, 2020
- ANDA210764Anda Repository · April 10, 2020
- ANDA213567Quagen · June 4, 2020
- ANDA212697Prinston Inc · July 23, 2020
- ANDA213936Accord Hlthcare · October 28, 2020
- ANDA207417Ascent Pharms Inc · January 29, 2021
- ANDA206497Mylan Tech Viatris · March 14, 2022
- ANDA217229Sun Pharm Inds Inc · August 25, 2023
Shortage status
Current shortage · updated October 20, 2026 · first posted July 26, 2023
| Product | Concerta, Tablet, Extended Release, 18 mg (NDC 50458-585-01) |
|---|---|
| Availability | Available |
| Company | Janssen Pharmaceuticals |
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.
-
June 17, 2024 · Class II · Terminated · D-0579-2024
Failed dissolution specifications: this product is being recalled due to this batch not meeting dissolution specifications.
Methylphenidate Hydrochloride, Extended-release Tablets, USP, 36mg, 100-count Bottle, Rx Only, Manufactured for: Trigen Laboratories, LLC, Alpharetta, GA 30005, NDC 13811-708-10 — Trigen Laboratories
-
July 13, 2023 · Class II · Terminated · D-0940-2023
Presence of Foreign Substance: Metal embedded in a tablet.
Methylphenidate Hydrochloride Tablets, USP 20mg, Rx Only, 100 Tablets per bottle, Manufactured by: Ohm Laboratories Inc., New Brunswick, NJ 08901, Distributed by: Sun Pharmaceutical Industries Inc., Cranbury, NJ 08512, N — SUN PHARMACEUTICAL INDUSTRIES INC
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March 10, 2023 · Class II · Ongoing · D-0471-2023
Defective Delivery System: Out of specification for shear.
Daytrana (methylphenidate transdermal system) CII, 15 mg, 30-count carton, Rx only, Manufactured for Noven Therapeutics, LLC., Miami by Noven Pharmaceuticals, Inc., NDC 68968-5553-3 — Noven Pharmaceuticals Inc
-
March 10, 2023 · Class II · Ongoing · D-0473-2023
Defective Delivery System: Out of specification for shear.
Daytrana (methylphenidate transdermal system) CII, 30 mg, 30-count carton, Rx only, Manufactured for Noven Therapeutics, LLC., Miami by Noven Pharmaceuticals, Inc., NDC 68968-5555-3 — Noven Pharmaceuticals Inc
-
March 10, 2023 · Class II · Ongoing · D-0470-2023
Defective Delivery System: Out of specification for shear.
Daytrana (methylphenidate transdermal system) CII, 10mg, 30-count carton, Rx only, Manufactured for Noven Therapeutics, LLC., Miami by Noven Pharmaceuticals, Inc., NDC 68968-5552-3. — Noven Pharmaceuticals Inc
-
March 10, 2023 · Class II · Ongoing · D-0472-2023
Defective Delivery System: Out of specification for shear.
Daytrana (methylphenidate transdermal system) CII, 20mg, 30-count carton, Rx only, Manufactured for Noven Therapeutics, LLC., Miami by Noven Pharmaceuticals, Inc., NDC 68968-5554-3. — Noven Pharmaceuticals Inc
-
November 16, 2022 · Class II · Ongoing · D-0071-2023
Defective Delivery System: Recalled lot was found to be out of specification for shear. Shear is an attribute related to the adhesive properties of the transdermal patches.
Daytrana (methylphenidate transdermal system), Delivers 15 mg over 9 hours, (1.6 mg/hr), 30 patches per box, Rx only, Manufactured for Noven Therapeutics, LLC, Miami, FL 33186; By Noven Pharmaceuticals, Inc., Miami, FL 3 — Noven Pharmaceuticals Inc
-
June 24, 2022 · Class II · Ongoing · D-1169-2022
Defective Delivery System: Customer complaints received for ripping patches and tight release/adhesive transfer.
Daytrana (methylphenidate transdermal system) Delivers 10 mg over 9 hours (1.1 mg/hr) Contains: 30 Patches, Rx only, Manufactured for Noven Therapeutics, LLC, Miami, FL 33186 By Noven Pharmaceuticals, Inc., Miami, FL 331 — Noven Pharmaceuticals Inc
-
May 6, 2022 · Class II · Ongoing · D-0889-2022
Defective Delivery System: customer complaints exceeded respective action limits.
Daytrana (methylphenidate transdermal system) Delivers 10 mg over 9 hours (1.1 mg/hr) Contains: 30 Patches, Rx only, Manufactured for Noven Therapeutics, LLC, Miami, FL 33186, By Noven Pharmaceuticals, Inc., Miami, FL, 3 — Noven Pharmaceuticals Inc
-
February 7, 2022 · Class II · Ongoing · D-0573-2022
Failed Tablet Specifications: Recall of this drug product was voluntarily initiated by the manufacturer due to a market complaint, which stated that a tablet in the sealed bottle was twice larger in size when compared to the remaining tablets. This complaint is second of its kind.
Methylphenidate Hydrochloride Chewable Tablets, 2.5 mg, 100-count bottle, Rx Only, Manufactured for: Rising Pharmaceuticals Inc., Saddle Brook, NJ 07863, NDC 64980-221-01 — RISING PHARMACEUTICALS
-
May 20, 2021 · Class II · Ongoing · D-0393-2021
Defective Delivery System: The number of customer complaints for ripping patches and tight release/adhesive transfer have exceeded the action limits.
Daytrana (methylphenidate transdermal system), Delivers 10 mg over 9 hours (1.1 mg/hr), 30 Patches (NDC 68968-5552-1) per box (NDC 68968-5552-3), Rx only, Manufactured for Noven Therapeutics, LLC., Miami, FL 33186; By No — Noven Pharmaceuticals Inc
-
May 20, 2021 · Class II · Ongoing · D-0394-2021
Defective Delivery System: The number of customer complaints for ripping patches and tight release/adhesive transfer have exceeded the action limits.
Daytrana (methylphenidate transdermal system), Delivers 15 mg over 9 hours (1.6 mg/hr), 30 Patches (NDC 68968-5553-1) per box (NDC 68968-5553-3), Rx only, Manufactured for Noven Therapeutics, LLC., Miami, FL 33186; By No — Noven Pharmaceuticals Inc
-
February 19, 2021 · Class II · Terminated · D-0296-2021
Defective Delivery System: Out of specification for mechanical peel.
Daytrana (methylphenidate transdermal system) Delivers 30 mg over 9 hours (3.3 mg/hr) Contains: 30 Patches in a foil-sealed polypropylene tray, packed in a paper carton, Rx only, Manufactured for Noven Therapeutics, LLC, — Noven Pharmaceuticals Inc
-
February 19, 2021 · Class II · Terminated · D-0295-2021
Defective Delivery System: Out of specification for mechanical peel.
Daytrana (methylphenidate transdermal system) Delivers 20 mg over 9 hours (2.2 mg/hr) Contains: 30 Patches in a foil-sealed polypropylene tray, packed in a paper carton, Rx only, Manufactured for Noven Therapeutics, LLC, — Noven Pharmaceuticals Inc
-
February 19, 2021 · Class II · Terminated · D-0294-2021
Defective Delivery System: Out of specification for mechanical peel.
Daytrana (methylphenidate transdermal system), Delivers 15 mg over 9 hours (1.6 mg/hr), Contains: 30 Patches in in a foil-sealed polypropylene tray, packed in a paper carton, Rx only, Manufactured for Noven Therapeutics, — Noven Pharmaceuticals Inc
-
February 19, 2021 · Class II · Terminated · D-0293-2021
Defective Delivery System: Out of specification for mechanical peel.
Daytrana (methylphenidate transdermal system), Delivers 10 mg over 9 hours (1.1 mg/hr), Contains: 30 Patches in a foil-sealed polypropylene tray, packed in a paper carton, Rx only, Manufactured for Noven Therapeutics, LL — Noven Pharmaceuticals Inc
-
March 31, 2020 · Class II · Terminated · D-1248-2020
Defective Delivery System: Out of specification for mechanical peel and shear.
Daytrana (methylphenidate transdermal system) Delivers 20 mg over 9 hours (2.2 mg/hr) 30-count box, Rx only, Manufactured for Noven Therapeutics, LLC Miami, FL 33186, NDC 68968-5554-3 — Noven Therapeutics, LLC
-
March 31, 2020 · Class II · Terminated · D-1249-2020
Defective Delivery System: Out of specification for mechanical peel and shear.
Daytrana (methylphenidate transdermal system) Delivers 30 mg over 9 hours (3.3 mg/hr) 30-count box, Rx only, Manufactured for Noven Therapeutics, LLC Miami, FL 33186, NDC 68968-5555-3 — Noven Therapeutics, LLC
-
March 31, 2020 · Class II · Terminated · D-1247-2020
Defective Delivery System: Out of specification for mechanical peel and shear.
Daytrana (methylphenidate transdermal system) Delivers 10 mg over 9 hours (1.1 mg/hr), 30-count box, Rx only, Manufactured for Noven Therapeutics, LLC Miami, FL 33186, NDC 68968-5552-3 — Noven Therapeutics, LLC
-
March 2, 2020 · Class II · Terminated · D-1045-2020
Defective Delivery System: Out of specification for mechanical peel and shear.
Daytrana (methylphenidate transdermal system) patches, Delivers 30 mg over 9 hours (3.3 mg/hr), 30-count box, Rx only, Manufactured for Noven Therapeutics, LLC. Miami, FL 33186, NDC 68968-5555-3 — Noven Therapeutics, LLC
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March 2, 2020 · Class II · Terminated · D-1044-2020
Defective Delivery System: Out of specification for mechanical peel and shear.
Daytrana (methylphenidate transdermal system) patches, Delivers 20 mg over 9 hours (2.2 mg/hr), 30-count box, Rx only, Manufactured for Noven Therapeutics, LLC. Miami, FL 33186, NDC 68968-5554-3 — Noven Therapeutics, LLC
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March 2, 2020 · Class II · Terminated · D-1042-2020
Defective Delivery System: Out of specification for mechanical peel and shear.
Daytrana (methylphenidate transdermal system) patches, Delivers 10 mg over 9 hours (1.1 mg/hr), 30-count box, Rx only, Manufactured for Noven Therapeutics, LLC. Miami, FL 33186, NDC 68968-5552-3 — Noven Therapeutics, LLC
-
March 2, 2020 · Class II · Terminated · D-1043-2020
Defective Delivery System: Out of specification for mechanical peel and shear.
Daytrana (methylphenidate transdermal system) patches, Delivers 15 mg over 9 hours (1.6 mg/hr), 30-count box, Rx only, Manufactured for Noven Therapeutics, LLC. Miami, FL 33186, NDC 68968-5553-3 — Noven Therapeutics, LLC
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January 27, 2020 · Class II · Terminated · D-0837-2020
CGMP deviations: Product bottle may be absent of desiccant.
Methylphenidate hydrochloride Extended-Release ablets USP (CII), 27 mg, 100-count bottle, Rx only, Teva Pharmaceuticals USA, Inc., North Wales, PA 19454, NDC 62037-734-01 — Teva Pharmaceuticals USA
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January 27, 2020 · Class II · Terminated · D-0836-2020
CGMP deviations: Product bottle may be absent of desiccant.
Methylphenidate hydrochloride Extended-Release ablets USP (CII), 18 mg, 100-count bottle, Rx only, Teva Pharmaceuticals USA, Inc., North Wales, PA 19454, NDC 62037-725-01 — Teva Pharmaceuticals USA
Showing the newest 25 of 50.
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) | 753436, 753437, 753438, 753439, 753440, 753441, 753442, 753443, 1091133, 1091135 … (+10) |
|---|---|
| SPL set ID of the quoted label | d6fb2750-cdab-4749-ba0d-7534840a5892 |
| FDA labels (SPL) | 77 |
| FDA applications | NDA010187, NDA021121, NDA021259, NDA021284, NDA021419, NDA021514, NDA202100, NDA205489, NDA205831, NDA207960, NDA209311, NDA216117, 40 ANDA |
| Active ingredients (FDA) | METHYLPHENIDATE |
Sources
- FDA-approved label on DailyMed (National Library of Medicine) — Ritalin, Sandoz Inc, effective February 5, 2025; 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 →