Hyoscyamine recalls

The FDA has published 6 recalls involving Hyoscyamine since 2014. The latest was reported on 19 Jun 2019. Most were for potency & assay. Virtus Pharmaceuticals Opco II L 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 recalls6since 2014

Last 12 months0reported

Class I350% of total

Ongoing0latest 19 Jun 2019

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 3 50%Class II 3 50%Class III 0 0%

Why hyoscyamine is recalled

Companies

By year

2019117%
2016350%
2014233%

All hyoscyamine recalls, newest first

6 total

Reported	Class	Recall	Company	Reason	Where
19 Jun 2019Drug	CLASS II	Hyoscyamine Oral Drops 0.125 mg/mL recalled by Torrent Pharma	Torrent Pharma	Sterility	Nationwide
28 Dec 2016Drug	CLASS I	Hyoscyamine Sulfate, USP Tablets recalled by Virtus Pharmaceuticals Opco	Virtus Pharmaceuticals Opco II L	Potency & Assay	Nationwide
28 Dec 2016Drug	CLASS I	Hyoscyamine Sulfate, Sublingual Tablets, 0.125 mg recalled	Virtus Pharmaceuticals Opco II L	Potency & Assay	Nationwide
28 Dec 2016Drug	CLASS I	Hyoscyamine Sulfate, Orally Disintegrating Tablets, 0.125 mg recalled	Virtus Pharmaceuticals Opco II L	Potency & Assay	Nationwide
29 Jan 2014Drug	CLASS II	Hyoscyamine Sulfate ODT, Tablet, 0.125 mg recalled by Aidapak Services	Aidapak Services	Labeling Errors	4 states
22 Jan 2014Drug	CLASS II	Hyoscyamine Sulfate ER, Tablet, 0.375 mg recalled by Aidapak Services	Aidapak Services	Labeling Errors	4 states

Should you stop taking Hyoscyamine?

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.