Birth Control Pills Recalled Because They May Not Work, FDA Warns
New tests indicate that this medication could be ineffective.
Most of us trust that the medications we have been prescribed are meant to help us. But sometimes even our doctors can't foresee what problems could arise down the road—which is where the U.S. Food and Drug Administration (FDA) comes into play, as the agency continuously warns consumers about any issues affecting the medicines they may be taking. Back in February, the FDA revealed that a popular thyroid medication had been recalled due to a lower-than-listed dosage strength. Then in April, the agency alerted us to a major recall impacting over 80 prescription and over-the-counter (OTC) drugs because their safety could not be guaranteed. Now, the FDA is warning that a new prescription problem could be putting more people at risk. Read on to find out more about why certain birth control pills are being recalled because they may not work.
The FDA just alerted consumers to a new medication recall.
If you take birth control, you may want to pay attention to a new warning from the FDA. In a July 31 press release, the agency alerted consumers to a major medication recall. According to the release, Lupin Pharmaceuticals Inc. is now voluntarily recalling some of its Tydemy tablets at the consumer level.
"Tydemy is estrogen/progestin oral contraceptive (COC) indicated for use by women to prevent pregnancy and to raise folate levels in women who choose to use an oral contraceptive for contraception," the company explained in its recall announcement.
Lupin is recalling two lots of Tydemy.
Lupin Pharmaceuticals Inc. is one of the largest pharmaceutical companies in the U.S. based on total prescriptions. The company is recalling two lots of Tydemy that were distributed nationwide to "wholesalers, drug chains, mail order pharmacies, and supermarkets," according to the announcement. So it's likely that a lot of people could be affected.
"Tydemy is packaged in 28's blister," Lupin explained. "One such blister was then packed in a pouch along with one printed sleeve, one pack insert (with day label) and one oxygen absorber (Stabilox) sachet. The three pouches were packed in one carton."
The recalled birth control pills have a UPC of 368180904731 and were distributed between June 2022 to May 2023. The affected packages may include one of two lot numbers: L200183, which expires in Jan. 2024, and L201560, which expires in Sept. 2024.
These birth control pills may not work.
The two lots of Tydemy are being recalled because of out of specification (OOS) test results at the 12-month stability time point. OOS results include "all test results that fall outside the specifications or acceptance criteria established in drug applications, drug master files (DMFs), official compendia, or by the manufacturer," according to the FDA.
With its tests, it was found that one of the recalled Tydemy lots (L200183) tested low for the inactive ingredient ascorbic acid and high for a known impurity—which could make the birth control pills basically ineffective. "Lupin is recalling these two batches because if there were a significant reduction in the amount of inactive content (ascorbic acid), this could potentially impact the effectiveness of the product which could potentially result in unexpected pregnancy," the company explained in its announcement.
You should talk to your doctor if you take this medication.
Wholesalers, distributors, and retailers who have any of the recalled product lots of Tydemy are being instructed to discontinue the sale of them immediately. But if you are currently taking these birth control pills, you should still do so until you talk to your doctor.
"Patients taking Tydemy are advised to continue taking their medication and immediately contact their pharmacist, physician, or medical provider for advice regarding an alternative treatment," Lupin stated.
The company has not yet received any reports of adverse events related to either recalled batches of Tydemy. But "consumers should contact their physician or healthcare provider if they have experienced any problems that may be related to taking or using this drug product," Lupin added in its announcement.
- Source: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/lupin-pharmaceuticals-inc-issues-voluntary-nationwide-recall-2-lots-tydemytm-drospirenone-ethinyl
- Source: https://www.fda.gov/regulatory-information/search-fda-guidance-documents/investigating-out-specification-oos-test-results-pharmaceutical-production-level-2-revision