RecallRadar

FDA Drug recall D-0321-2024

Nortrel (norethindrone and ethinyl estradiol tablets USP) 0.5/35, packaged in cartons, each carton contains 3 blister cards, each card cont…

On 2024-02-21 the FDA classified a Class III recall of Nortrel (norethindrone and ethinyl estradiol tablets USP) 0.5/35, packaged in cartons, each carton contains 3 blister cards, each card cont… by Teva Pharmaceuticals Usa, citing discoloration: discolored tablets (shades of blue) mixed in with the white inert remainder tablets.

Read the official FDA Drug notice

AgencyFDA Drug
Recall numberD-0321-2024
ClassificationClass III
Statusongoing
Initiated2024-01-25
Published2024-02-21
Last updated2026-09-13 11:52 UTC
CompanyTeva Pharmaceuticals Usa
DistributionUS

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

Reason

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

Identifiers

ndc0555-9009-80
ndc0555-9009-42
ndc0555-9010-79
ndc0555-9010-58
ndc0555-9008-79
ndc0555-9008-67
code_infoLot #: 100042978, Exp 7/31/2024

Status history

No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:52 UTC. Current status: ongoing.

Source

Official record: https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0321-2024%22

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