Class I โ€” Serious Health Hazard

Serious health hazard โ€” there is a reasonable probability that use of or exposure to this product will cause serious adverse health consequences or death.

Drospirenone and Ethinyl Estradiol Tablets Recalled by Jubilant Cadista Pharmaceuticals, Inc. Due to Failed dissolution specifications : failed results at the...

Date: July 9, 2019
Company: Jubilant Cadista Pharmaceuticals, Inc.
Status: Terminated
Source: FDA (Drug)

What You Should Do

Stop using this product immediately. Do not consume, use, or distribute it.

Return the product to the place of purchase for a full refund. If you have questions, contact Jubilant Cadista Pharmaceuticals, Inc. directly.

Affected Products

Drospirenone and Ethinyl Estradiol Tablets, USP, 3 mg/0.02 mg, packaged into a carton containing 3 blister cards each blister card contains 28-film coated, biconvex tablets, Rx Only, Manufactured by: Cyndea Pharma, S.L., Olvega (Soria), 42110 Spain, Distributed by: Jubilant Cadista Pharmaceuticals, Inc., Salisbury, MD, 21801 USA, NDC 59746-763-43

Quantity: 11,412 cartons/34,236 blister cards/28 tablets each card

Why Was This Recalled?

Failed dissolution specifications : failed results at the 3-month stability time point.

Where Was This Sold?

This product was distributed nationwide across all 50 states.

Affected (51 states)Not affected

About Jubilant Cadista Pharmaceuticals, Inc.

Jubilant Cadista Pharmaceuticals, Inc. has 29 total recalls tracked by RecallDetector.

Related Recalls

Data sourced from the FDA (Drug). Last updated March 26, 2026. View original report