Tydemy birth control pill recall: Reason, affected lots, and all you need to know

At least two different lots of Tydemy Birth Control Pills are being recalled by Lupin Pharmaceuticals Inc. from across the country after they tested high for a known impurity and relatively low for an inactive ingredient, ascorbic acid. The unexpected differences in purity and presence of the inactive ingredient may cause the contraceptive pills to become less effective and could lead to an unwanted pregnancy.

Announced on July 28, 2023, the nationwide voluntary recall applies to "Tydemy (Drospirenone, Ethinyl Estradiol & Levomefolate Calcium Tablets 3mg/0.03mg/0.451 mg and Levomefolate Calcium Tablets 0.451 mg)" sold all across the United States. The problem with the contraceptive pills was discovered during the recent out-of-specification (OOS) tests conducted at a stability time point of 12 months.

The recalled Tydemy Birth Control Pills are feared to become less effective due to the differences in the purity and presence of the inactive ingredient (Image via FDA)

Currently, neither Lupin Pharmaceuticals Inc. nor the United States Food and Drug Administration has received reports of any adverse events linked to the recalled batches of the contraceptive pills. Still, they are recalling the pills as they may become less effective and could pose the risk of an unwanted pregnancy.

Individuals who may be using the affected pills are advised to continue using them for now but also to get in touch with their pharmacist or healthcare provider immediately to discuss other possible alternatives.

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Tydemy Birth Control Pills recall concerns contraceptive pills available for purchase between June 2022 and May 2023

According to Lupin's recall notice issued on the United States Food and Drug Administration (FDA) website, the nationwide voluntary recall only applies to two lots of Tydemy Birth Control Pills.

Feared to be less effective due to the high presence of some known impurities and the lower presence of an inactive ingredient, the recalled contraceptive pills were sold all across the United States.

Sold nationwide through drug chains, wholesalers, supermarkets, mail-order pharmacies, and other retailers, the recalled oral contraceptive pills were available for purchase between June 2022 and May 2023.

The recalled oral contraceptive pills may pose risks of unwanted pregnancy (Image via FDA)

Distributed under the name "Tydemy (Drospirenone, Ethinyl Estradiol & Levomefolate Calcium Tablets 3mg/0.03mg/0.451 mg and Levomefolate Calcium Tablets 0.451 mg)," the affected contraceptive pills were available in single-Blister packaging of 28 tablets and in cartons with 3-Blisters packaging of 28 tablets each.

Product	Lot No	Expiry	NDC(s)	UPC	Distribution Dates
Tydemy™	L200183	Jan. 2024	68180-904-71 (1 Blister of 28 tablets each)	368180904731	June 2022 to May 2023
Tydemy™	L201560	Sep. 2024	68180-904-73 (3 Blister of 28 tablets each)	368180904731	June 2022 to May 2023

Individuals who may have purchased the recalled contraceptive pills and may be using them can continue using them for the time being. However, it is best advised to get in touch with your pharmacist or healthcare provider immediately to discuss other potential treatments. Once you have an alternative treatment, you could return the recalled lots to Inmar Rx Solutions, Inc. for quick reimbursement.

Retailers, distributors, and others who sell the recalled Tydemy Birth Control Pills are also advised to cease the sale of the affected contraceptive pills with immediate effect. Those with doubts about the recall can get in touch with Inmar Rx Solutions, Inc. at (866) 480-8206. The establishment can be contacted from Monday to Friday, between 09:00 am to 05:00 pm EST.