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Class III Recall — Unlikely to Cause Adverse Health Consequences
Verified · FDAClass III — Low RiskMedications

NORTREL Nortrel (norethindrone and ethinyl estradiol tablets USP) 0.5/35, packaged in ca Recall 2024

NORTRELIssued January 25, 2024

NORTREL Nortrel (norethindrone and ethinyl estradiol tablets USP) 0.5/35, packaged in cartons, each carton contains 3 blister cards, each card contains 28 tablets, Rx only, TEVA PHARMACEUTICALS USA, INC., Nor — recalled per FDA on 1/25/2024. Reason: Discoloration: discolored tablets (shades of blue) mixed in with the white inert remainder tablets..

Issuing agency
FDA
Issued
Jan 25, 2024
Brand
NORTREL
Distribution
1 states

What to do right now

  1. 1

    Stop using it

    Take it out of rotation. Don't consume, wear, or operate.

  2. 2

    Verify the match

    Compare lot numbers, UPCs, and dates against your product.

  3. 3

    Return or dispose

    Follow the manufacturer's instructions to refund or safely dispose.

Verified source

U.S. Food and Drug Administration

Summary of the official FDA notice issued January 25, 2024. Last synced Apr 27, 2026. View on fda.gov

What's recalled

Nortrel (norethindrone and ethinyl estradiol tablets USP) 0.5/35, packaged in cartons, each carton contains 3 blister cards, each card contains 28 tablets, Rx only, TEVA PHARMACEUTICALS USA, INC., North Wales, PA 19454, NDC 0555-9008-67

Why it was recalled

Discoloration: discolored tablets (shades of blue) mixed in with the white inert remainder tablets.

Affected products & lot numbers
2 lots called out

Affected Lot Numbers

Check your product label — do not use if your lot number appears below.

Lot Number
Lot #: 100042978
Exp 7/31/2024
Where was it sold
1 state

nationwide

nationwide
View official FDA notice

View all questions for this recall →

More recalls like this
4 related — by brand, contaminant, and category

Frequently asked questions

Is the NORTREL recall still active?

Yes, this recall is currently active as of January 25, 2024. Do not use or consume the affected product.

What lot numbers are affected?

Affected lot numbers: Lot #: 100042978, Exp 7/31/2024. Check the label on your product.

What should I do if I have the recalled NORTREL?

Do not consume or use this product. Return it to the store for a full refund, or dispose of it safely.