Melatonin recalls

The FDA has published 3 recalls involving Melatonin since 2014. The latest was reported on 22 Jan 2014. Most were for labeling errors. Recalls usually affect specific lots, not every bottle on the market. Check the lot number on each recall page before acting.

Total recalls3since 2014

Last 12 months0reported

Class I00% of total

Ongoing0latest 22 Jan 2014

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 3 100%Class III 0 0%

Why melatonin is recalled

Labeling Errors3100%

Companies

Aidapak Services3100%

By year

20143100%

All melatonin recalls, newest first

3 total

Reported	Class	Recall	Company	Reason	Where
22 Jan 2014Drug	CLASS II	Melatonin Tablet, 3 mg, Over The Counter recalled by Aidapak Services	Aidapak Services	Labeling Errors	4 states
22 Jan 2014Drug	CLASS II	Melatonin Tablet, 1 mg, Over The Counter recalled by Aidapak Services	Aidapak Services	Labeling Errors	4 states
22 Jan 2014Drug	CLASS II	Melatonin Tablet, 1 mg, Over The Counter recalled by Aidapak Services	Aidapak Services	Labeling Errors	4 states

Should you stop taking Melatonin?

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.