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Low RiskFDA Drug
Medications & Supplements/Prescription Drugs

Tydemy Birth Control Tablets Recalled for Being Subpotent

Agency Publication Date: December 1, 2021
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Summary

Lupin Pharmaceuticals Inc. has recalled 4,113 cartons of Tydemy (drospirenone, ethinyl estradiol, and levomefolate calcium) tablets because testing showed the medication is subpotent. This means the drug may not contain the full required amount of its active ingredients, which can reduce its effectiveness in preventing pregnancy. No incidents or injuries have been reported to date.

Risk

Subpotent birth control medication may fail to prevent pregnancy as intended, leading to an increased risk of unintended pregnancy.

What You Should Do

  1. The recalled products are Tydemy (drospirenone, ethinyl estradiol, and levomefolate calcium) tablets packaged in cartons containing three 28-tablet wallets (NDC 68180-904-13) and individual 28-tablet wallets (NDC 68180-904-11).
  2. Check your medication packaging for lot numbers L000784 and L000785 with an expiration date of May 2022.
  3. If you have health concerns, contact your healthcare provider or pharmacist for guidance. Return any unused product to the place of purchase for a refund, throw it away, or contact Lupin Pharmaceuticals Inc. for further instructions.
  4. Call the FDA Consumer Complaint hotline at 1-888-723-3332 for additional questions regarding this recall.

Your Remedy Options

You have 2 options:

๐Ÿ’ฐOption 1: Full Refund
How to: Contact your healthcare provider or pharmacist for guidance, or return any unused product to the place of purchase for a refund
๐Ÿ—‘๏ธOption 2: Dispose of Product
How to: Throw the product away. For prescription medications, a DEA take-back location or pharmacy mail-back program is preferred when available.

Affected Products

Product: Tydemy (drospirenone, ethinyl estradiol & levomefolate calcium tablets, 3 mg/0.03 mg/0.451 mg and levomefolate calcium tablets, 0.451 mg)
Variants: 3 mg/0.03 mg/0.451 mg, 0.451 mg, 28 Tablets per wallet, 3 wallets per carton
Lot Numbers:
L000784 (Exp. May 2022)
L000785 (Exp. May 2022)
NDC:
68180-904-11
68180-904-13

Rx Only. Distributed by Lupin Pharmaceuticals, Inc., Baltimore, Maryland. Manufactured by Lupin Limited, India.

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 89085
Status: Resolved
Manufacturer: Lupin Pharmaceuticals Inc.
Manufactured In: United States, India
Units Affected: 4113 cartons
Distributed To: Nationwide

AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.

Sources: FDA iRES ยท Raw API Response

openFDA Disclaimer: This recall information is sourced from the openFDA API. Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Refer to the openFDA terms of service for more information.