Norgestimate recalls

The FDA has published 3 recalls involving Norgestimate since 2021. The latest was reported on 15 Oct 2025. Most were for manufacturing (cgmp) deviations. AvKARE 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 recalls3since 2021

Last 12 months1reported

Class I00% of total

Ongoing1latest 15 Oct 2025

Recalls per month, last 24 months

click a bar for that month

0Nov '24 0 0 0Feb 0 0 0May 0 0 0Aug 0 1 0Nov 0 0 0Feb 0 0 0May 0 0 0Aug 0 0

Severity split

Class I 0 0%Class II 3 100%Class III 0 0%

Why norgestimate is recalled

Companies

Brands

By year

2025133%
2024133%
2021133%

Ongoing norgestimate recalls

1 active

Reported	Class	Recall	Company	Reason	Where
15 Oct 2025Drug	CLASS II	Norgestimate and Ethinyl Estradiol Tablets recalled by AvKARENorgestimate And Ethinyl Estradiol	AvKARE	Other	Nationwide

All norgestimate recalls, newest first

3 total

Reported	Class	Recall	Company	Reason	Where
15 Oct 2025Drug	CLASS II	Norgestimate and Ethinyl Estradiol Tablets recalled by AvKARENorgestimate And Ethinyl Estradiol	AvKARE	Other	Nationwide
3 Apr 2024Drug	CLASS II	Tri-Lo-Sprintec (norgestimate recalled by Teva Pharmaceuticals USATri-lo-sprintec	Teva Pharmaceuticals USA	Potency & Assay	Nationwide
2 Jun 2021Drug	CLASS II	Tri-lo-marzia 0.180mg/0.025mg recalled by Cardinal HealthTri-lo-marzia	Cardinal Health	Manufacturing (CGMP) Deviations	FL, GA, SC

Should you stop taking Norgestimate?

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.