A recent FDA announcement has brought attention to a nationwide recall of two lots of Tydemy, a popular oral contraceptive. The voluntary recall was issued after the manufacturer, Lupin Pharmaceuticals, discovered that the affected batches contained lower-than-expected levels of ascorbic acid (vitamin C) — a component that may alter the medication’s effectiveness.

While no adverse health events have been reported so far, the recall serves as a precautionary measure to prevent possible contraceptive failure or unexpected pregnancy among users.

Details Of The Tydemy Recall

According to the U.S. Food and Drug Administration (FDA), the two recalled lots were distributed across the United States between June 3, 2022, and May 31, 2023.

The affected lots include:

  • Lot L200183 – Expiration Date: January 2024

  • Lot L201560 – Expiration Date: September 2024

The recall notice, issued on July 29, states that these products were distributed to mail-order pharmacies, wholesalers, retail chains, and supermarkets.

Lupin Pharmaceuticals confirmed that the recall was initiated out of an abundance of caution after internal quality checks revealed abnormalities. Specifically, Lot L200183 tested low for ascorbic acid and high for a known impurity.

What Consumers Should Do

Consumers currently taking Tydemy should not immediately stop taking their birth control pills without consulting a healthcare provider. Instead, Lupin advises them to contact their doctor or pharmacist as soon as possible to obtain an alternative prescription or guidance on next steps.

The affected products were sold in 28-tablet blister packs, packaged in sets of one or three blister cards. The lot numbers are printed on the side of each carton or blister pack.

If you’re unsure whether your medication is affected, you can:

  • Check the packaging for the listed lot numbers.

  • Contact your pharmacy, which can verify your prescription’s lot information.

Dr. Chelsea Thibodeau, an assistant professor of family medicine at the University of Minnesota Medical School, told Health that reaching out to your pharmacy or healthcare provider is the best first step.

“Find the birth control package you have at home,” she said. “If you don’t have it, your pharmacy should be able to tell you if your batch was part of the recall.”

Why The Recall Was Necessary

The issue with Tydemy lies not in its primary hormones but in the reduced levels of ascorbic acid, also known as vitamin C.

According to Dr. Thibodeau, the Tydemy formula contains three main components:

  1. Ethinyl estradiol (estrogen)

  2. Drospirenone (progestin)

  3. Folate (a type of vitamin B)

Ascorbic acid (vitamin C) helps stabilize hormone levels in the pill. When vitamin C levels are lower than intended, it can influence estrogen concentration in the body.

“The thought is that if vitamin C levels are not consistent with what was tested, estrogen levels may fluctuate,” Thibodeau explained. “This could reduce the overall effectiveness of birth control and lead to a higher risk of unintended pregnancy.”

While the vitamin C deficiency itself poses no direct health hazard, the concern lies in possible contraceptive failure and menstrual irregularities such as breakthrough bleeding or spotting.

FDA’s Statement And Safety Advice

As of the recall announcement, the FDA reported no adverse events linked to Tydemy. Still, the agency urges all distributors and retailers to halt sales and distribution immediately and return the affected products to Lupin or its recall partner, Inmar Rx Solutions.

Consumers can reach Inmar Rx Solutions at 866-480-8206 for questions about returns or reimbursement during normal business hours.

Lupin also emphasized that users should report any health problems or unexpected pregnancies related to the recalled product to the FDA’s MedWatch Adverse Event Reporting Program.

Despite the recall, medical experts stress that there is no cause for panic. “Issuing the recall was the safest course of action,” said Dr. Thibodeau. “It’s precautionary. If you’re using an affected batch, contact your healthcare provider right away.”

How Reduced Vitamin C Affects Hormonal Birth Control

Vitamin C interacts with hormones in the bloodstream, particularly estrogen. If an oral contraceptive contains insufficient ascorbic acid, the stability of the estrogen component may be compromised.

In hormonal birth control, the delicate balance between estrogen and progestin is critical to:

  • Prevent ovulation.

  • Thicken cervical mucus (to block sperm).

  • Maintain uterine lining stability.

Low vitamin C levels might make the estrogen less effective in performing these tasks, resulting in:

  • Reduced pregnancy protection.

  • Unexpected bleeding or spotting.

  • Cycle irregularities.

However, unlike toxic impurities that may cause direct harm, this issue relates mainly to effectiveness, not safety.

What To Do If You’ve Taken Recalled Tydemy

If you discover your Tydemy package matches one of the recalled lot numbers, follow these steps:

  1. Continue taking your pills until you speak with your healthcare provider to avoid a sudden drop in hormone levels.

  2. Contact your doctor or pharmacist as soon as possible to confirm whether your lot is affected and discuss alternative contraception.

  3. Use backup protection (such as condoms) until you obtain a replacement or new prescription.

  4. Report any irregular symptoms—like abnormal bleeding or pregnancy signs—to your provider.

Your healthcare provider can quickly prescribe an equivalent alternative, such as Yasmin or its generic versions, which contain the same hormones (ethinyl estradiol and drospirenone). You can also take a separate folate supplement to match Tydemy’s formula.

Switching To A Safe Alternative

Transitioning from Tydemy to another contraceptive is straightforward.

“If someone was taking the recalled medication, it should be easy to switch to an equivalent pill,” said Dr. Thibodeau. “Your doctor can write a new prescription immediately. The next day you’re due for your pill, you just start the new one.”

If you prefer to continue using Tydemy, contact your pharmacy to check whether they can supply non-recalled batches. Many pharmacies keep records of product lot numbers and can confirm if your refill is safe.

Understanding Tydemy’s Composition

Tydemy is an oral contraceptive that combines hormonal regulation with nutritional support. Each tablet contains:

  • Ethinyl Estradiol (0.02 mg) – a synthetic form of estrogen.

  • Drospirenone (3 mg) – a synthetic form of progesterone that prevents ovulation.

  • Levomefolate Calcium (0.451 mg) – a folate supplement that supports healthy red blood cell production and may lower neural tube defect risks in future pregnancies.

  • Ascorbic Acid (Vitamin C) – helps stabilize hormonal potency.

Because the vitamin C levels in some Tydemy lots fell below approved limits, hormonal balance and contraceptive reliability may be compromised.

What Makes This Recall Different From Others

Unlike medication recalls that involve contamination or toxic compounds, this recall concerns reduced potency, not safety hazards.

That means users of recalled Tydemy are not at risk of poisoning or organ damage. The main concern is contraceptive failure—leading to unintended pregnancy.

“Low ascorbic acid isn’t dangerous on its own,” Dr. Thibodeau clarified. “The recall is purely precautionary because it could alter hormone stability, not because it’s unsafe to consume.”

How To Report Problems Or Seek Reimbursement

If you experience any unexpected health issues while taking recalled Tydemy, you can report them directly through the FDA MedWatch program:

For refund or replacement assistance, contact Inmar Rx Solutions at 866-480-8206 during normal business hours.

Retailers, distributors, and pharmacies should immediately cease sales and return existing inventory of affected lots to Lupin Pharmaceuticals.

The Bottom Line

The recall of Tydemy birth control pills serves as a reminder of the importance of routine quality testing and consumer vigilance.

While the issue does not pose a direct health risk, the lower ascorbic acid levels could reduce hormonal stability—potentially leading to decreased contraceptive effectiveness and unplanned pregnancy.

If you’re currently using Tydemy, don’t panic. Simply check your lot number, continue taking your pills, and contact your healthcare provider for safe alternatives or new prescriptions.

Reliable birth control depends on consistent hormone balance—and switching to an unaffected or equivalent option ensures you stay protected without interruption.