Cyclopentolate recalls

The FDA has published 8 recalls involving Cyclopentolate since 2016. The latest was reported on 9 Oct 2019. Most were for sterility. KRS Global Biotechnology 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 recalls8since 2016

Last 12 months0reported

Class I00% of total

Ongoing0latest 9 Oct 2019

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 7 88%Class III 1 13%

Why cyclopentolate is recalled

Companies

KRS Global Biotechnology788%
Bausch & Lomb113%

By year

2019563%
2018225%
2016113%

All cyclopentolate recalls, newest first

8 total

Reported	Class	Recall	Company	Reason	Where
9 Oct 2019Drug	CLASS II	Cyclopentolate HCl 1% (5 mg/ / Phenylephrine HCl recalled	KRS Global Biotechnology	Sterility	Nationwide
9 Oct 2019Drug	CLASS II	Cyclopentolate HCl 1% (10 mg/mL) / Phenylephrine HCl recalled	KRS Global Biotechnology	Sterility	Nationwide
9 Oct 2019Drug	CLASS II	Cyclopentolate HCl 1% (5 mg/ / Phenylephrine HCl recalled	KRS Global Biotechnology	Sterility	Nationwide
9 Oct 2019Drug	CLASS II	Cyclopentolate HCl 1% (10 mg/mL) / Phenylephrine HCl recalled	KRS Global Biotechnology	Sterility	Nationwide
9 Oct 2019Drug	CLASS II	Cyclopentolate HCl 1% (10 mg/mL) / Phenylephrine HCl recalled	KRS Global Biotechnology	Sterility	Nationwide
17 Jan 2018Drug	CLASS II	Cyclopentolate HCl/ Phenylephrine HCl/ Tropicamide recalled	KRS Global Biotechnology	Other	Nationwide
17 Jan 2018Drug	CLASS II	Cyclopentolate HCl/ Phenylephrine HCl/ Tropicamide recalled	KRS Global Biotechnology	Other	Nationwide
3 Feb 2016Drug	CLASS III	Cyclopentolate Hydrochloride Ophthalmic Solution recalledCyclopentolate Hydrochloride	Bausch & Lomb	Packaging Defects	Nationwide

Should you stop taking Cyclopentolate?

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.