Medications & Supplements/Prescription Drugs

Nortrel Birth Control Tablets Recalled for Discoloration

Agency Publication Date: February 12, 2024

Summary

Teva Pharmaceuticals USA, Inc. is recalling 32,740 cartons of Nortrel (norethindrone and ethinyl estradiol) birth control tablets. The recall was initiated because discolored blue tablets were found mixed in with the white inert (reminder) tablets in the blister cards. The affected products include Nortrel 0.5/35 and Nortrel 7/7/7, which were distributed nationwide in the United States.

Risk

The presence of discolored blue tablets in the remainder/inert portion of the birth control regimen could lead to consumer confusion. If a user takes the wrong tablet or is confused by the sequence, it may disrupt the intended dosing schedule, though the risk of serious health consequences is low.

What You Should Do

This recall affects Nortrel 0.5/35 (NDC 0555-9008-67) and Nortrel 7/7/7 (NDC 0555-9012-58) birth control tablets packaged in cartons of blister cards.
Check your medication packaging for lot number 100042978 (Nortrel 0.5/35) or lot number 100040731 (Nortrel 7/7/7), both with an expiration date of 7/31/2024.
Inspect your blister cards for any blue-colored tablets that appear where white remainder tablets should be.
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 for 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: Nortrel (norethindrone and ethinyl estradiol tablets USP) 0.5/35

Variants: 0.5/35 strength, 28 tablets per blister card, 3 blister cards per carton

Lot Numbers:

100042978 (Exp 7/31/2024)

NDC:

0555-9008-67

Rx only

Product: Nortrel 7/7/7 (norethindrone and ethinyl estradiol tablets USP- triphasic regimen)

Variants: 7/7/7 strength, 28 tablets per blister card, 6 blister cards per carton

Lot Numbers:

100040731 (Exp 7/31/2024)

NDC:

0555-9012-58

Rx only

Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 93867

Status: Active

Manufacturer: Teva Pharmaceuticals USA, Inc

Sold By: Pharmacies

Manufactured In: United States

Units Affected: 2 products (12,916 cartons; 19,824 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 · 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 Nortrel 0.5/35 (NDC 0555-9008-67) and Nortrel 7/7/7 (NDC 0555-9012-58) birth control tablets packaged in cartons of blister cards.

Check your medication packaging for lot number 100042978 (Nortrel 0.5/35) or lot number 100040731 (Nortrel 7/7/7), both with an expiration date of 7/31/2024.

Inspect your blister cards for any blue-colored tablets that appear where white remainder tablets should be.

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 for 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: Nortrel (norethindrone and ethinyl estradiol tablets USP) 0.5/35

Variants: 0.5/35 strength, 28 tablets per blister card, 3 blister cards per carton

Lot Numbers:

100042978 (Exp 7/31/2024)

NDC:

0555-9008-67

Rx only

Product: Nortrel 7/7/7 (norethindrone and ethinyl estradiol tablets USP- triphasic regimen)

Variants: 7/7/7 strength, 28 tablets per blister card, 6 blister cards per carton

Lot Numbers:

100040731 (Exp 7/31/2024)

NDC:

0555-9012-58

Rx only