Medications & Supplements/Prescription Drugs

Tri-Lo-Sprintec Birth Control Recalled for Failed Dissolution

Agency Publication Date: March 28, 2024

Summary

Teva Pharmaceuticals USA, Inc. is recalling 92,676 cartons of Tri-Lo-Sprintec (norgestimate and ethinyl estradiol) tablets USP because they failed dissolution tests. This means the medication may not release the active ingredients into the body at the correct rate. Because the tablets may not dissolve properly, the medication could be less effective in its primary purpose of preventing pregnancy.

Risk

If the medication fails to release its active ingredients as intended, it may not provide the necessary hormone levels to prevent pregnancy, potentially leading to an unintended pregnancy.

What You Should Do

This recall affects Tri-Lo-Sprintec (norgestimate and ethinyl estradiol) tablets USP, a triphasic regimen birth control packaged in cartons containing three 28-day blister cards (NDC 0093-2140-62).
Check your medication packaging for lot number 100039678 with an expiration date of 04/31/2024, or lot numbers 100038111 and 100042277 with an expiration date of 07/31/2024.
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: Tri-Lo-Sprintec (norgestimate and ethinyl estradiol) tablets USP

Variants: triphasic regimen, 28 Tablets Each, 3 Blister Cards per carton

Lot Numbers:

100039678 (Exp 04/31/2024)

100038111 (Exp 07/31/2024)

100042277 (Exp 07/31/2024)

NDC:

0093-2140-62

Quantity affected: 92,676 cartons

Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 94183

Status: Resolved

Manufacturer: Teva Pharmaceuticals USA, Inc

Sold By: pharmacies

Manufactured In: United States

Units Affected: 92,676 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

This recall affects Tri-Lo-Sprintec (norgestimate and ethinyl estradiol) tablets USP, a triphasic regimen birth control packaged in cartons containing three 28-day blister cards (NDC 0093-2140-62).

Check your medication packaging for lot number 100039678 with an expiration date of 04/31/2024, or lot numbers 100038111 and 100042277 with an expiration date of 07/31/2024.

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.