Medications & Supplements/Prescription Drugs

AvKARE Birth Control Tablets Recalled for Failed Content Uniformity

Agency Publication Date: October 6, 2025

Summary

AvKARE is voluntarily recalling 2,192 cartons of Norgestimate and Ethinyl Estradiol Tablets (0.18 mg/0.025 mg, 0.215 mg/0.025 mg, and 0.25 mg/0.025 mg). The recall was initiated because the medication failed to meet content uniformity specifications, meaning the dosage of the active ingredients may not be consistent across all tablets. These prescription birth control tablets were distributed nationwide in cartons containing three blister cards each.

Risk

Inconsistent levels of active hormones in birth control tablets can lead to decreased effectiveness, potentially resulting in unintended pregnancy or unexpected hormonal side effects.

What You Should Do

Identify if you have the affected birth control by checking for Norgestimate and Ethinyl Estradiol Tablets (USP) in cartons of 3 blister cards (3x28 tablets).
Check the packaging for Lot # LF41138A with an expiration date of 06/30/2027.
Look for Carton NDC: 42291-565-84 or Blister NDC: 42291-565-28 to confirm if your medication is part of the recall.
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) if you have additional questions regarding this recall.

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: Norgestimate and Ethinyl Estradiol Tablets, USP

Variants: 0.18 mg/0.025 mg, 0.215 mg/0.025 mg, 0.25 mg/0.025 mg, 3 Units, 3x28 tablets blister cards per carton

Lot Numbers:

LF41138A (Exp 06/30/2027)

NDC:

42291-565-84

42291-565-28

Recall #: D-0007-2026; Quantity: 2192 cartons

Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 97542

Status: Active

Manufacturer: AvKARE

Sold By: Pharmacies

Manufactured In: United States

Units Affected: 2192 cartons

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

Identify if you have the affected birth control by checking for Norgestimate and Ethinyl Estradiol Tablets (USP) in cartons of 3 blister cards (3x28 tablets).

Check the packaging for Lot # LF41138A with an expiration date of 06/30/2027.

Look for Carton NDC: 42291-565-84 or Blister NDC: 42291-565-28 to confirm if your medication is part of the recall.

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) if you have additional questions regarding this recall.