Nitrosamine Impurity recalls

513 recalls have been issued for nitrosamine impurity, from 2012 to 26 Aug 2026. 51 of them came in the last 12 months. 3 were classified Class I.

Total recalls513since 2012

Last 12 months51reported

Class I31% of total

Ongoing301latest 26 Aug 2026

Recalls per month, last 24 months

click a bar for that month

1Oct '24 6 21 13Jan '25 18 7 7Apr 0 6 3Jul 13 11 6Oct 16 5 0Jan '26 1 0 8Apr 6 3 4Jul 2 0

Severity split

Class I 3 1%Class II 509 99%Class III 0 0%Other/pending 1

Why nitrosamine impurity is recalled

Nitrosamine Impurity513100%

Companies

Product types

Brands

By year

2026245%
202510520%
2024408%
202331%
2022234%
2021255%
20209318%
201915029%
2018459%
201610%

Ongoing nitrosamine impurity recalls

301 active

Reported	Class	Recall	Company	Reason	Where
26 Aug 2026Device	CLASS II	Arvis Surgical Navigation System Gen recalled by Kico Knee Innovation	Kico Knee Innovation	Nitrosamine Impurity	19 states
12 Aug 2026Drug	CLASS II	Mirabegron Extended-Release Tablets, 25 mg recalledMirabegron	Zydus Pharmaceuticals (USA)	Nitrosamine Impurity	Nationwide
8 Jul 2026Drug	CLASS II	Cinacalcet Hydrochloride Tablets, 60 mg recalled by Cipla USACinacalcet	Cipla USA	Nitrosamine Impurity	Nationwide
8 Jul 2026Drug	CLASS II	Cinacalcet Hydrochloride Tablets, 90 mg recalled by Cipla USACinacalcet	Cipla USA	Nitrosamine Impurity	Nationwide
8 Jul 2026Drug	CLASS II	Cinacalcet Hydrochloride Tablets, 30 mg recalled by Cipla USACinacalcet	Cipla USA	Nitrosamine Impurity	Nationwide
1 Jul 2026Drug	CLASS II	Duloxetine D/R, a) 30 mg recalled by Direct Rx	Direct Rx	Nitrosamine Impurity	Nationwide

All nitrosamine impurity recalls, newest first

513 total

Reported	Class	Recall	Company	Reason	Where
26 Aug 2026Device	CLASS II	Arvis Surgical Navigation System Gen recalled by Kico Knee Innovation	Kico Knee Innovation	Nitrosamine Impurity	19 states
12 Aug 2026Drug	CLASS II	Mirabegron Extended-Release Tablets, 25 mg recalledMirabegron	Zydus Pharmaceuticals (USA)	Nitrosamine Impurity	Nationwide
8 Jul 2026Drug	CLASS II	Cinacalcet Hydrochloride Tablets, 60 mg recalled by Cipla USACinacalcet	Cipla USA	Nitrosamine Impurity	Nationwide
8 Jul 2026Drug	CLASS II	Cinacalcet Hydrochloride Tablets, 90 mg recalled by Cipla USACinacalcet	Cipla USA	Nitrosamine Impurity	Nationwide
8 Jul 2026Drug	CLASS II	Cinacalcet Hydrochloride Tablets, 30 mg recalled by Cipla USACinacalcet	Cipla USA	Nitrosamine Impurity	Nationwide
1 Jul 2026Drug	CLASS II	Duloxetine D/R, a) 30 mg recalled by Direct Rx	Direct Rx	Nitrosamine Impurity	Nationwide
17 Jun 2026Drug	CLASS II	Duloxetine Delayed-Release Capsules, USP, 30mg recalledDuloxetine	Breckenridge Pharmaceutical	Nitrosamine Impurity	Nationwide
17 Jun 2026Drug	CLASS II	Duloxetine Delayed-Release Capsules, USP, 60mg recalledDuloxetine	Breckenridge Pharmaceutical	Nitrosamine Impurity	Nationwide
10 Jun 2026Drug	CLASS II	Duloxetine DR Capsules, 30 mg, Rx, Relabeled recalled by Asclemed USADuloxetine	Asclemed USA	Nitrosamine Impurity	Nationwide
27 May 2026Drug	CLASS II	Erythromycin Tablets, USP, 250 mg recalledErythromycin	Zydus Pharmaceuticals (USA)	Nitrosamine Impurity	Nationwide

About this list

Records come from FDA enforcement reports and USDA FSIS notices, grouped by normalised name. A company operating under several names may appear more than once.