The product pack of Tydemy. Credit: PRNewsfoto/Lupin Pharmaceuticals, Inc.

Lupin Pharmaceuticals has announced the voluntary recall of two lots of the pregnancy prevention drug Tydemy (drospirenone, ethinyl estradiol and levomefolate calcium tablets 3mg/0.03mg/0.451mg and levomefolate calcium tablets 0.451mg) in the US.

Tydemy is an estrogen/progestin oral contraceptive (COC) intended for women who wish to prevent pregnancy and for increasing folate levels in those who choose an oral contraceptive.

Go deeper with GlobalData

Premium Insights

The gold standard of business intelligence.

Find out more

Related Company Profiles

View all

The tablets have been recalled because of out-of-specification (OOS) test results at the 12-month stability time point. 

One lot in particular, L200183, tested low for ascorbic acid (an inactive ingredient), and also high for a known impurity.

Lupin is recalling the two lots due to a significant reduction in their inactive content (ascorbic acid), which may potentially impact the product’s effectiveness and result in unexpected pregnancies.

See Also:

Tydemy is delivered in blister packs containing 28 tablets each. A single blister was packed into a pouch, along with a printed sleeve, a pack insert labelled with the day and an oxygen absorber sachet (Stabilox).

How well do you really know your competitors?

Access the most comprehensive Company Profiles on the market, powered by GlobalData. Save hours of research. Gain competitive edge.

Company Profile – free sample

Thank you!

Your download email will arrive shortly

Not ready to buy yet? Download a free sample

We are confident about the unique quality of our Company Profiles. However, we want you to make the most beneficial decision for your business, so we offer a free sample that you can download by submitting the below form

By GlobalData
Visit our Privacy Policy for more information about our services, how we may use, process and share your personal data, including information of your rights in respect of your personal data and how you can unsubscribe from future marketing communications. Our services are intended for corporate subscribers and you warrant that the email address submitted is your corporate email address.

The three pouches were packed in a single carton. The lots were then supplied across the US to wholesalers, mail-order pharmacies, drug chains and supermarkets.

Adverse reactions or quality problems with this product can be reported to the US Food and Drug Administration (FDA) MedWatch Adverse Event Reporting Programme online by regular mail or by fax.

So far, Lupin has not received any reports of adverse events associated with the recalled lots.