Hydroquinone recalls

The FDA has published 5 recalls involving Hydroquinone since 2017. The latest was reported on 6 Oct 2021. Most were for sterility. Synergy Rx 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 recalls5since 2017

Last 12 months0reported

Class I00% of total

Ongoing0latest 6 Oct 2021

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 4 80%Class III 1 20%

Why hydroquinone is recalled

Companies

Synergy Rx360%
Monarch PCM240%

By year

2021240%
2017360%

All hydroquinone recalls, newest first

5 total

Reported	Class	Recall	Company	Reason	Where
6 Oct 2021Drug	CLASS II	Hydroquinone USP, 4% Skin Bleaching Cream recalled by Monarch PCMHydroquinone	Monarch PCM	Other	TN
29 Sep 2021Drug	CLASS III	Hydroquinone, USP, 4% Skin Bleaching Cream recalled by Monarch PCMHydroquinone	Monarch PCM	Potency & Assay	OH, TN
22 Mar 2017Drug	CLASS II	Hydroquinone Cream in all strengths including recalled by Synergy Rx	Synergy Rx	Sterility	Nationwide
22 Mar 2017Drug	CLASS II	Hydroquinone Solution in all strengths including recalled by Synergy Rx	Synergy Rx	Sterility	Nationwide
22 Mar 2017Drug	CLASS II	Hydroquinone Cream in all strengths including 4% recalled by Synergy Rx	Synergy Rx	Sterility	Nationwide

Should you stop taking Hydroquinone?

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.