The Recall Registry
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Food & drug recall · FDAJanuary 25, 2024Labelling issue

Teva Pharmaceuticals USA, Inc — 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

Do not stop taking this without speaking to your pharmacist or doctor.

What’s wrong

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

The Recall Registry rates this labelling issue — FDA Class III: unlikely to cause harm.

What to do

Check the lot numbers below against what you have. Do not stop taking a prescription medicine because of a recall without speaking to your pharmacist or doctor first — for many medicines stopping is more harmful than continuing, and they can tell you whether yours is affected and what to do about it.

Who to contact: Recalling firm: Teva Pharmaceuticals USA, Inc

The product

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

Details

Units affected
12,916 cartons
Recall date
January 25, 2024
Brand
Teva Pharmaceuticals USA, Inc
Model, lot or SKU numbers
Lot #: 100042978, Exp 7/31/2024
Where it was distributed

Nationwide

The official notice

This recall was issued by the U.S. Food and Drug Administration. The Recall Registry summarises it — always confirm the details at the source.

Their exact wording: “Teva Pharmaceuticals USA, Inc — 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”

Read it on FDA →

Worried about the other things in your house? You can write down what you have and be told if one is recalled — or, if you sell second-hand, check your whole stock at once.

Filed under: Prescription medicine

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