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Tydemy contraceptive recall overview:
- Who: Lupin recalled two batches of Tydemy contraceptive pills.
- Why: The batches may contain low levels of inactive content, which could impact the effectiveness of the contraceptive pill, potentially resulting in unexpected pregnancy.
- Where: The Tydemy calcium recall is active in the United States.
Lupin recalled two batches of Tydemy contraceptive pills as they may contain low levels of inactive content, which could impact the effectiveness of the pill, the company says.
The U.S. Food & Drug Administration (FDA) website published the recall July 31. It applies to two batches of Tydemy (drospirenone, ethinyl estradiol and levomefolate calcium tablets 3 mg/0.03 mg/0.451 mg and levomefolate calcium tablets 0.451 mg) with UPC 368180904731 distributed from June 2022 through May 2023.
According to the recall, one lot of the pills tested low for ascorbic acid (an inactive ingredient) and high for a known impurity.
“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 Tydemy contraceptive recall claims.
Lupin received no reports of adverse events related to either recalled batches, the recall states. The company is not facing legal action over the recall, but Top Class Actions follows recalls closely as they sometimes end in class action lawsuits.
Continue taking pill, contact physician, Tydemy recall says
Tydemy is an estrogen/progestin oral contraceptive used to prevent pregnancy and raise folate levels in women who choose to use an oral contraceptive for contraception, the recall states.
Lupin distributed the recalled pills nationwide in the United States to wholesalers, drug chains, mail order pharmacies and supermarkets.
Lupin is notifying these entities by phone and through recall notification and arranging for the return of the recalled product lots.
“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,” the contraception recall states.
Last year, Lupin also voluntarily recalled four lots of quinapril tablets as they contain a nitrosamine impurity, N-nitroso-quinapril, with levels higher than those approved for daily intake.
Are you affected by this Tydemy calcium recall? Let us know in the comments.
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