Lupin Pharma recalls birth control pills deemed possibly ineffective

Lupin Pharmaceuticals, the U.S. unit of India’s Lupin Limited, issued a voluntary recall of two lots of birth control pills due to the potential that they may not be effective in preventing pregnancy.

The company is pulling two lots of Tydemy tablets due to out-of-specification test results at the 12-month stability time point, the company said in a July 31 press release.

Testing on one of the lots found low levels of ascorbic acid and high levels of a “known impurity,” Lupin said. The company didn’t identify the impurity.

“Regardless, Lupin is recalling two lots 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 said in the release.

No adverse effects related to the recall have been reported to date, the company said.

The lots were distributed nationwide in the U.S. from June 2022 to May 2023 through wholesalers, drug chains, mail-order pharmacies and supermarkets.

The company is advising patients taking the drug to continue doing so and for them to immediately contact their physician, pharmacist or medical provider to discuss alternative treatments.

Lupin is no stranger to recalls and run-ins with the FDA. Last November, the company disclosed it received a Form 483 at its active pharmaceutical ingredients plant in Mandideep, India, marking the fourth such admonition it received from the regulatory agency in a nine-week period.

That same month, Lupin said it was suspending production of U.S.-bound drugs from a troubled drug ingredients plant in Tarapur, India, where the FDA asked the company to provide notification “before resuming operations.”