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Class III · Lower riskActive recall

Nortrel

Unlikely to cause harm — often a labeling or packaging issue.

Does this affect you?
Check your lot numberLot #: 100042978, Exp 7/31/2024
Where it was soldnationwide
Find the lot number printed on your box or bottle. If it matches — and you take this medicine — call your pharmacist. Don't stop a prescribed medicine on your own.

What happened

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

What to do

  1. Check the lot number and expiry on your medicine against the recall above.
  2. Talk to your pharmacist or doctor before changing anything — don't stop on your own.
  3. Report any problems to FDA MedWatch (1-800-FDA-1088 or fda.gov/medwatch).

Who makes it

Made byTeva Pharmaceuticals USA, Inc.
Brand nameNORTREL
Generic nameNORETHINDRONE AND ETHINYL ESTRADIOL
Distributed by / forTeva Pharmaceuticals USA, Inc
NDC0555-9008-67
Show the full FDA record
Full product labelNortrel (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
Recalling firmTeva Pharmaceuticals USA, Inc
Distributionnationwide
Quantity12,916 cartons
Recall initiated2024-01-25
Report date2024-02-21
Recall completed—
Recall numberD-0321-2024
ClassificationClass III
FDA statusOngoing
Origin on fileParsippany NJ United States

Related

Recent drug recallsCheck another medication

Source: U.S. FDA enforcement database (openFDA). Look this up on the official FDA recalls site ↗

This is public FDA recall information, not medical advice. A recall does not always mean your specific bottle is affected. Never stop a prescribed medicine without asking your pharmacist or doctor.