Methylphenidate recalls

The FDA has published 55 recalls involving Methylphenidate since 2012. The latest was reported on 10 Jul 2024. Most were for potency & assay. Noven Pharmaceuticals has the most recalls in this group. Recalls usually affect specific lots, not every bottle on the market. Check the lot number on each recall page before acting.

Total recalls55since 2012

Last 12 months0reported

Class I00% of total

Ongoing10latest 10 Jul 2024

Recalls per month, last 24 months

click a bar for that month

0Oct '24 0 0 0Jan '25 0 0 0Apr 0 0 0Jul 0 0 0Oct 0 0 0Jan '26 0 0 0Apr 0 0 0Jul 0 0

Severity split

Class I 0 0%Class II 50 91%Class III 5 9%

Why methylphenidate is recalled

Companies

Brands

Daytrana4276%
Methylphenidate Hydrochloride815%

By year

202412%
202359%
202247%
2021611%
2020916%
201912%
201824%
20171018%
201635%
201524%

Ongoing methylphenidate recalls

10 active

Reported	Class	Recall	Company	Reason	Where
29 Mar 2023Drug	CLASS II	Daytrana (methylphenidate transdermal system) CII, 20mg recalledDaytrana	Noven Pharmaceuticals	Potency & Assay	Nationwide
29 Mar 2023Drug	CLASS II	Daytrana (methylphenidate transdermal system) CII, 15 mg recalledDaytrana	Noven Pharmaceuticals	Potency & Assay	Nationwide
29 Mar 2023Drug	CLASS II	Daytrana (methylphenidate transdermal system) CII, 10mg recalledDaytrana	Noven Pharmaceuticals	Potency & Assay	Nationwide
29 Mar 2023Drug	CLASS II	Daytrana (methylphenidate transdermal system) CII, 30 mg recalledDaytrana	Noven Pharmaceuticals	Potency & Assay	Nationwide
7 Dec 2022Drug	CLASS II	Daytrana (methylphenidate transdermal system) recalledDaytrana	Noven Pharmaceuticals	Potency & Assay	Nationwide
6 Jul 2022Drug	CLASS II	Daytrana (methylphenidate transdermal system) Delivers recalledDaytrana	Noven Pharmaceuticals	Other	Nationwide

All methylphenidate recalls, newest first

55 total

Reported	Class	Recall	Company	Reason	Where
10 Jul 2024Drug	CLASS II	Methylphenidate Hydrochloride, Extended-release Tablets, USP, 36mg recalledMethylphenidate Hydrochloride	Trigen Laboratories	Potency & Assay	Nationwide
2 Aug 2023Drug	CLASS II	Methylphenidate Hydrochloride Tablets, USP 20mg recalledMethylphenidate Hydrochloride	Sun Pharmaceutical Industries	Foreign Material	Nationwide
29 Mar 2023Drug	CLASS II	Daytrana (methylphenidate transdermal system) CII, 20mg recalledDaytrana	Noven Pharmaceuticals	Potency & Assay	Nationwide
29 Mar 2023Drug	CLASS II	Daytrana (methylphenidate transdermal system) CII, 15 mg recalledDaytrana	Noven Pharmaceuticals	Potency & Assay	Nationwide
29 Mar 2023Drug	CLASS II	Daytrana (methylphenidate transdermal system) CII, 10mg recalledDaytrana	Noven Pharmaceuticals	Potency & Assay	Nationwide
29 Mar 2023Drug	CLASS II	Daytrana (methylphenidate transdermal system) CII, 30 mg recalledDaytrana	Noven Pharmaceuticals	Potency & Assay	Nationwide
7 Dec 2022Drug	CLASS II	Daytrana (methylphenidate transdermal system) recalledDaytrana	Noven Pharmaceuticals	Potency & Assay	Nationwide
6 Jul 2022Drug	CLASS II	Daytrana (methylphenidate transdermal system) Delivers recalledDaytrana	Noven Pharmaceuticals	Other	Nationwide
1 Jun 2022Drug	CLASS II	Daytrana (methylphenidate transdermal system) Delivers recalledDaytrana	Noven Pharmaceuticals	Other	Nationwide
2 Mar 2022Drug	CLASS II	Methylphenidate Hydrochloride Chewable Tablets, 5 mg recalledMethylphenidate Hydrochloride	Rising Pharmaceuticals	Packaging Defects	Nationwide

Should you stop taking Methylphenidate?

Not on your own. Most recalls affect specific lots from one manufacturer, and stopping a prescription suddenly can be riskier than the defect. Check your lot number and NDC against the recall, then call the pharmacy that dispensed it for a replacement.