Medications & Supplements/Prescription Drugs

Viorele Birth Control Tablets Recalled for Failed Impurity Specifications

Agency Publication Date: October 15, 2025

Summary

Glenmark Pharmaceuticals Inc., USA is recalling 26,928 packs of Viorele (desogestrel and ethinyl estradiol) birth control tablets. The recall was initiated because the product failed to meet specifications for impurities and degradation during testing. Consumers should consult their healthcare provider or pharmacist regarding their medication and return any unused product to the place of purchase for a refund.

Risk

The failure to meet impurity and degradation specifications means the medication may not be as effective or safe as intended, potentially impacting the reliability of the birth control regimen.

What You Should Do

Check your medication packaging for Viorele (desogestrel and ethinyl estradiol, 0.15 mg/0.02 mg and 0.01 mg) in 28-day regimen blister packs.
Identify if your pack is affected by checking for batch number 20230733 with an expiration date of October 2025 and NDC 68462-318-29.
If you have health concerns, contact your healthcare provider or pharmacist. Return any unused product to the place of purchase for a refund, throw it away, or contact the manufacturer for further instructions.
Call the FDA Consumer Complaint hotline at 1-888-723-3332 (1-888-SAFEFDA) for additional questions.

Your Remedy Options

You have 2 options:

Option 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

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: Viorele (desogestrel and ethinyl estradiol, USP, 0.15 mg/0.02 mg and ethinyl estradiol tablets, USP, 0.01 mg)

Variants: 28 day Regimen, 3 Blisters each containing 28 Tablets

Lot Numbers:

20230733 (Exp October 2025)

NDC:

68462-318-29

Rx only; Manufactured by Glenmark Pharmaceuticals Limited, India.

Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 97547

Status: Active

Manufacturer: Glenmark Pharmaceuticals Inc., USA

Sold By: Retail Pharmacies

Manufactured In: India, United States

Units Affected: 26,928 packs

Distributed To: Nationwide

Were You Affected by This Recall?

If you or a family member were harmed by this recalled product, you may have legal rights. Consider consulting a consumer protection attorney to understand your options for compensation.

Find an Attorney

This is general information, not legal advice. Go Backs is not a law firm and does not provide legal services.

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 · 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.

Summary

What You Should Do

Check your medication packaging for Viorele (desogestrel and ethinyl estradiol, 0.15 mg/0.02 mg and 0.01 mg) in 28-day regimen blister packs.

Identify if your pack is affected by checking for batch number 20230733 with an expiration date of October 2025 and NDC 68462-318-29.

If you have health concerns, contact your healthcare provider or pharmacist. Return any unused product to the place of purchase for a refund, throw it away, or contact the manufacturer for further instructions.

Call the FDA Consumer Complaint hotline at 1-888-723-3332 (1-888-SAFEFDA) for additional questions.

Your Remedy Options

You have 2 options:

Option 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

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: Viorele (desogestrel and ethinyl estradiol, USP, 0.15 mg/0.02 mg and ethinyl estradiol tablets, USP, 0.01 mg)

Variants: 28 day Regimen, 3 Blisters each containing 28 Tablets

Lot Numbers:

20230733 (Exp October 2025)

NDC:

68462-318-29

Rx only; Manufactured by Glenmark Pharmaceuticals Limited, India.