Norethindrone recalls

The FDA has published 5 recalls involving Norethindrone since 2013. The latest was reported on 24 Jun 2026. Most were for packaging defects. Teva Pharmaceuticals USA has the most recalls in this group. Recalls usually affect specific lots, not every bottle on the market. Check the lot number on each recall page before acting.

Total recalls5since 2013

Last 12 months1reported

Class I00% of total

Ongoing3latest 24 Jun 2026

Recalls per month, last 24 months

click a bar for that month

0Oct '24 0 0 0Jan '25 0 0 0Apr 0 0 0Jul 0 0 0Oct 0 0 0Jan '26 0 0 0Apr 0 1 0Jul 0 0

Severity split

Class I 0 0%Class II 2 40%Class III 3 60%

Why norethindrone is recalled

Companies

Brands

By year

2026120%
2024240%
2021120%
2013120%

Ongoing norethindrone recalls

3 active

Reported	Class	Recall	Company	Reason	Where
24 Jun 2026Drug	CLASS II	Alyacen 7/7/7, Norethindrone recalled by Glenmark PharmaceuticalsAlyacen 1/35	Glenmark Pharmaceuticals Inc., U	Potency & Assay	Nationwide
21 Feb 2024Drug	CLASS III	Nortrel 7/7/7 (norethindrone recalled by Teva Pharmaceuticals USANortrel 7/7/7	Teva Pharmaceuticals USA	Packaging Defects	Nationwide
21 Feb 2024Drug	CLASS III	Nortrel (norethindrone and ethinyl estradiol tablets USP) 5/35 recalledNortrel	Teva Pharmaceuticals USA	Packaging Defects	Nationwide

All norethindrone recalls, newest first

5 total

Reported	Class	Recall	Company	Reason	Where
24 Jun 2026Drug	CLASS II	Alyacen 7/7/7, Norethindrone recalled by Glenmark PharmaceuticalsAlyacen 1/35	Glenmark Pharmaceuticals Inc., U	Potency & Assay	Nationwide
21 Feb 2024Drug	CLASS III	Nortrel 7/7/7 (norethindrone recalled by Teva Pharmaceuticals USANortrel 7/7/7	Teva Pharmaceuticals USA	Packaging Defects	Nationwide
21 Feb 2024Drug	CLASS III	Nortrel (norethindrone and ethinyl estradiol tablets USP) 5/35 recalledNortrel	Teva Pharmaceuticals USA	Packaging Defects	Nationwide
2 Jun 2021Drug	CLASS II	Balziva 28 Day (norethindrone recalled by Cardinal HealthBalziva	Cardinal Health	Manufacturing (CGMP) Deviations	FL, GA, SC
17 Jul 2013Drug	CLASS III	Balziva(TM) (norethindrone and ethinyl estradiol tablets recalledBalziva	Teva Pharmaceuticals USA	Benzene	Nationwide

Should you stop taking Norethindrone?

Not on your own. Most recalls affect specific lots from one manufacturer, and stopping a prescription suddenly can be riskier than the defect. Check your lot number and NDC against the recall, then call the pharmacy that dispensed it for a replacement.