The FDA is alerting patients of a recent recall of drospirenone/ethinyl estradiol tablets. This generic birth control medication is manufactured by Jubilant Cadista Pharmaceuticals, which issued the voluntary recall.
The drug is still considered safe, but testing done by the manufacturer identified that the drug’s active ingredients have become less effective.
What is this medication for?
Drospirenone/ethinyl estradiol is an estrogen/progestin combination oral contraceptive. It is used to prevent pregnancy, treat symptoms of premenstrual dysphoric disorder (PMDD), and treat moderate acne.
Why was it recalled?
This medication is being voluntarily recalled by its manufacturer due to “out-of-specification (OOS) dissolution results.” This means that the active ingredients in the drug might not be absorbed by the body as intended.
Fortunately, there have been no reports of harmful events related to the recall.
What products were recalled?
Only 1 batch of drugs was affected by this recall. Batches are identified by their lot number, which designates a time frame in which the medication was manufactured. Here’s the information for the recalled products.
| Name and strength | Drospirenone/ethinyl estradiol, 3 mg/0.02 mg |
| National Drug Code (NDC) | 59746-763-43 |
| Lot number | 183222 |
| Expiration date | November 2020 |
Why do medications get recalled?
Drugs are recalled when their quality or safety has been compromised. These recalls can be voluntarily initiated by a manufacturer if they identify an issue, or mandated by the FDA. Medications and medical devices are frequently recalled for reasons ranging from minor to life threatening.
The manufacturer or FDA will notify patients of a recall through telephone, mail, fax, or email. The FDA also publicly announces all recalls via news or media. You can check all recalls through the FDA’s Twitter profile, @FDArecalls.
How do I know if my medication was recalled?
To find out if your medication has been recalled, check if the recalled drug name and associated manufacturer match those on the label of your prescription. Then, check to see if your drug’s NDC and lot number match as well. If you can’t find the information on your medication, contact your pharmacy.
Additionally, keep an eye out for a recall notification email from Jubilant Cadista. They will be notifying customers and arranging returns of all recalled products.
If you have a recalled product, you can return it to your pharmacy. The pharmacy will send the medication back to the wholesaler and give you a replacement medication.
How can I contact my drug manufacturer?
If you have more questions about this recall, you can contact Jubilant Cadista at 1-800-308-3985.
You can learn more about what to do when your medication is recalled here.
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