Methylphenidate recalls

The FDA has published 54 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 recalls54since 2012

Last 12 months0reported

Class I00% of total

Ongoing10latest 10 Jul 2024

Recalls per month, last 24 months

click a bar for that month

0Nov '24 0 0 0Feb 0 0 0May 0 0 0Aug 0 0 0Nov 0 0 0Feb 0 0 0May 0 0 0Aug 0 0

Severity split

Class I 0 0%Class II 50 93%Class III 4 7%

Why methylphenidate is recalled

Companies

Brands

Daytrana4278%
Methylphenidate Hydrochloride815%

By year

202412%
202359%
202247%
2021611%
2020917%
201824%
20171019%
201636%
201524%
201436%

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

54 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, 2.5 mg recalledMethylphenidate Hydrochloride	Rising Pharmaceuticals	Packaging Defects	Nationwide
2 Jun 2021Drug	CLASS II	Daytrana (methylphenidate transdermal system) recalledDaytrana	Noven Pharmaceuticals	Other	Nationwide
2 Jun 2021Drug	CLASS II	Daytrana (methylphenidate transdermal system) recalledDaytrana	Noven Pharmaceuticals	Other	Nationwide
10 Mar 2021Drug	CLASS II	Daytrana (methylphenidate transdermal system) Delivers recalledDaytrana	Noven Pharmaceuticals	Potency & Assay	Nationwide
10 Mar 2021Drug	CLASS II	Daytrana (methylphenidate transdermal system) recalledDaytrana	Noven Pharmaceuticals	Potency & Assay	Nationwide
10 Mar 2021Drug	CLASS II	Daytrana (methylphenidate transdermal system) recalledDaytrana	Noven Pharmaceuticals	Potency & Assay	Nationwide
10 Mar 2021Drug	CLASS II	Daytrana (methylphenidate transdermal system) Delivers recalledDaytrana	Noven Pharmaceuticals	Potency & Assay	Nationwide
29 Apr 2020Drug	CLASS II	Daytrana (methylphenidate transdermal system) Delivers recalledDaytrana	Noven Therapeutics	Potency & Assay	Nationwide
29 Apr 2020Drug	CLASS II	Daytrana (methylphenidate transdermal system) Delivers recalledDaytrana	Noven Therapeutics	Potency & Assay	Nationwide
29 Apr 2020Drug	CLASS II	Daytrana (methylphenidate transdermal system) Delivers recalledDaytrana	Noven Therapeutics	Potency & Assay	Nationwide
25 Mar 2020Drug	CLASS II	Daytrana (methylphenidate transdermal system) patches recalledDaytrana	Noven Therapeutics	Potency & Assay	Nationwide
25 Mar 2020Drug	CLASS II	Daytrana (methylphenidate transdermal system) patches recalledDaytrana	Noven Therapeutics	Potency & Assay	Nationwide
25 Mar 2020Drug	CLASS II	Daytrana (methylphenidate transdermal system) patches recalledDaytrana	Noven Therapeutics	Potency & Assay	Nationwide
25 Mar 2020Drug	CLASS II	Daytrana (methylphenidate transdermal system) patches recalledDaytrana	Noven Therapeutics	Potency & Assay	Nationwide
19 Feb 2020Drug	CLASS II	Methylphenidate hydrochloride Extended-Release ablets recalledMethylphenidate Hydrochloride	Teva Pharmaceuticals USA	Manufacturing (CGMP) Deviations	Nationwide
19 Feb 2020Drug	CLASS II	Methylphenidate hydrochloride Extended-Release ablets recalledMethylphenidate Hydrochloride	Teva Pharmaceuticals USA	Manufacturing (CGMP) Deviations	Nationwide
25 Apr 2018Drug	CLASS II	Daytrana (methylphenidate transdermal system) Delivers recalledDaytrana	Noven Pharmaceuticals	Potency & Assay	Nationwide
14 Mar 2018Drug	CLASS III	Methylphenidate Hydrochloride Extended-release Tablets, USP, 36 mg recalledMethylphenidate Hydrochloride	Osmotica Pharmaceutical	Potency & Assay	Nationwide
27 Dec 2017Drug	CLASS III	Methylphenidate Hydrochloride Extended-release Tablets, USP 54 mg recalledMethylphenidate Hydrochloride	Osmotica Pharmaceutical	Potency & Assay	Nationwide
27 Dec 2017Drug	CLASS III	Methylphenidate Hydrochloride Extended-release Tablets, USP 27 mg recalledMethylphenidate Hydrochloride	Osmotica Pharmaceutical	Potency & Assay	Nationwide
1 Nov 2017Drug	CLASS III	Methylphenidate Hydrochloride Tablets USP, 20 mg recalled	Teva Pharmaceuticals USA	Potency & Assay	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.