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Class II · ModerateRecall completed

Tri-Lo-Sprintec

Could cause temporary or reversible harm; serious harm is unlikely.

Does this affect you?
Check your lot numberLot # 100039678, Exp 04/31/2024; 100038111, 100042277, Exp 07/31/2024
Where it was soldUSA nationwide.
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

Failed Dissolution Specifications

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 nameTRI-LO-SPRINTEC
Generic nameNORGESTIMATE AND ETHINYL ESTRADIOL
Distributed by / forTeva Pharmaceuticals USA, Inc
NDC0093-2140-62
Show the full FDA record
Full product labelTri-Lo-Sprintec (norgestimate and ethinyl estradiol) tablets USP - triphasic regimen, packaged in carton containing 3 Blister Cards, 28 Tablets Each, Rx only, Teva Pharmaceuticals USA, INC, North Wales, PA 19454, NDC 0093-2140-62
Recalling firmTeva Pharmaceuticals USA, Inc
DistributionUSA nationwide.
Quantity92,676 cartons
Recall initiated2024-03-07
Report date2024-04-03
Recall completed2025-03-06
Recall numberD-0428-2024
ClassificationClass II
FDA statusTerminated
Origin on fileParsippany NJ United States

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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.