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Norethindrone And Ethinyl Estradiol
Norethindrone And Ethinyl Estradiol recalls: 5 FDA reports
Recalls involving Norethindrone And Ethinyl Estradiol. What was wrong with each batch, and how the FDA graded the risk.
5Reports
0Class I
3Ongoing
2026-06-24Most recent
What the classes mean
The FDA sorts every recall into one of three classes. The class is the whole story. It is also the part people skip.
Class II is the bulk of every list here. That matters. A long list of Class II says something different from one Class I.
By class
By year reported
Checking whether it affects you
The lot or code number is what matters. Not the product name. A recall covers
specific lots. Yours may not be one of them.
Check the code on your package against the report. The FDA keeps the current
list at fda.gov/safety/recalls.
The reports
The text below is quoted from the FDA record word for word.
Alyacen 7/7/7, Norethindrone and Ethinyl Estradiol Tablets USP, 0.5mg/0.035mg, 0.75mg/0.035mg, 1 mg/0.0.35mg,
D-0588-2026 · Class II · reported 2026-06-24 · Ongoing
- Why it was recalled
- Failed Impurities/Degradation Specifications: This recall is being initiated due to out-of-specification results total impurities.
- Product
- Alyacen 7/7/7, Norethindrone and Ethinyl Estradiol Tablets USP, 0.5mg/0.035mg, 0.75mg/0.035mg, 1 mg/0.0.35mg, 3 Blister Cards each containing 28 tablets, 28 day regimen, Rx only, Manufactured by: Glenmark Pharmaceuticals Ltd., Colvale-Bardez, Goa 403 513, India, Manufactured for: Glenmark Pharmaceuticals Inc., Mahwah, NJ 07430, NDC 68462-556-29
- Where it went
- USA Nationwide.
Nortrel (norethindrone and ethinyl estradiol tablets USP) 0.5/35, packaged in cartons, each carton contains 3
D-0321-2024 · Class III · reported 2024-02-21 · Ongoing
- Why it was recalled
- Discoloration: discolored tablets (shades of blue) mixed in with the white inert remainder tablets.
- 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
- Where it went
- nationwide
- How much
- 12,916 cartons
Nortrel 7/7/7 (norethindrone and ethinyl estradiol tablets USP- triphasic regimen), packaged in cartons, each
D-0322-2024 · Class III · reported 2024-02-21 · Ongoing
- Why it was recalled
- Discoloration: discolored tablets (shades of blue) mixed in with the white inert remainder tablets.
- Product
- Nortrel 7/7/7 (norethindrone and ethinyl estradiol tablets USP- triphasic regimen), packaged in cartons, each carton contains 6 blister cards, each card contains 28 tablets, Rx only, TEVA PHARMACEUTICALS USA, INC., North Wales, PA 19454, NDC 0555-9012-58
- Where it went
- nationwide
- How much
- 19,824 cartons
Balziva 28 Day (norethindrone and ethinyl estradiol tablets USP) 6 Blister Card Dispensers, 28 tablets each,
D-0579-2021 · Class II · reported 2021-06-02 · Terminated
- Why it was recalled
- CGMP Deviations: Intermittent exposure to temperature excursion during storage.
- Product
- Balziva 28 Day (norethindrone and ethinyl estradiol tablets USP) 6 Blister Card Dispensers, 28 tablets each, Rx Only, Manufactured for: Teva Pharmaceuticals USA, Inc., North Wales, PA 19454, NDC 0555-9034-58
- Where it went
- FL, GA, SC
- How much
- 23 bottles
Balziva(TM) (norethindrone and ethinyl estradiol tablets, USP) 0.15 mg/0.03 mg, 28 day regimen, Rx only, Barr
D-684-2013 · Class III · reported 2013-07-17 · Terminated
- Why it was recalled
- Failed Impurity/Degradation Specification; an impurity identified as N-Butyl-Benzene Sulfonamide (NBBS) was detected during impurity testing
- Product
- Balziva(TM) (norethindrone and ethinyl estradiol tablets, USP) 0.15 mg/0.03 mg, 28 day regimen, Rx only, Barr Laboratories, Inc., Pomona, NY --- NDC 0555-9034-58
- Where it went
- Nationwide distribution. No foreign or government accounts.
- How much
- 36,708 blister packs
Read these counts with three things in mind
A firm with more recalls usually makes more products. A contract packer runs
hundreds of lines. It will out-recall a company with one product whatever either
does. This is not a safety ranking.
Most recalls here are voluntary. A firm found its own fault and pulled the stock.
That is the system working. It lands in this database looking the same as a recall
the FDA had to push for.
Terminated means the FDA considers the recall finished. It is not a verdict.
It does not mean anyone was harmed.
Source: openFDA enforcement reports, retrieved 2026-08-05. FDA dataset last updated 2026-07-29.
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