Nitrosamine Impurity recalls

509 recalls have been issued for nitrosamine impurity, from 2012 to 12 Aug 2026. 49 of them came in the last 12 months. 2 were classified Class I.

Total recalls509since 2012

Last 12 months49reported

Class I20% of total

Ongoing296latest 12 Aug 2026

Recalls per month, last 24 months

click a bar for that month

6Nov '24 21 13 18Feb 7 7 0May 6 3 13Aug 11 5 16Nov 5 0 1Feb 0 8 6May 3 4 1Aug 0 0

Severity split

Class I 2 0%Class II 506 99%Class III 0 0%Other/pending 1

Why nitrosamine impurity is recalled

Nitrosamine Impurity509100%

Companies

Product types

Brands

By year

2026235%
202510420%
2024408%
202331%
2022224%
2021255%
20209318%
201915029%
2018459%
201610%

Ongoing nitrosamine impurity recalls

296 active

Reported	Class	Recall	Company	Reason	Where
12 Aug 2026Drug	CLASS II	Mirabegron Extended-Release Tablets, 25 mg recalledMirabegron	Zydus Pharmaceuticals	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

All nitrosamine impurity recalls, newest first

509 total

Reported	Class	Recall	Company	Reason	Where
12 Aug 2026Drug	CLASS II	Mirabegron Extended-Release Tablets, 25 mg recalledMirabegron	Zydus Pharmaceuticals	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	Nitrosamine Impurity	Nationwide
27 May 2026Drug	CLASS II	Erythromycin Tablets, USP, 500 mg recalledErythromycin	Zydus Pharmaceuticals	Nitrosamine Impurity	Nationwide
13 May 2026Drug	CLASS II	Duloxetine Delayed-Release Capsules, 60 mg recalled by Ajanta PharmaDuloxetine	Ajanta Pharma	Nitrosamine Impurity	Nationwide
13 May 2026Drug	CLASS II	Duloxetine Delayed-Release Capsules USP, 60mg recalledDuloxetine	Breckenridge Pharmaceutical	Nitrosamine Impurity	Nationwide
13 May 2026Drug	CLASS II	Duloxetine Delayed-Release Capsules, 20 mg recalled by Ajanta PharmaDuloxetine	Ajanta Pharma	Nitrosamine Impurity	Nationwide
13 May 2026Drug	CLASS II	Duloxetine Delayed-Release Capsules, 30 mg recalled by Ajanta PharmaDuloxetine	Ajanta Pharma	Nitrosamine Impurity	Nationwide
29 Apr 2026Drug	CLASS II	Furosemide Tablets, USP, 80 mg recalled by Leading PharmaFurosemide	Leading Pharma	Nitrosamine Impurity	Nationwide
22 Apr 2026Drug	CLASS II	Cinacalcet Hydrochloride Tablets, 60 mg recalled by Cipla USACinacalcet	Cipla USA	Nitrosamine Impurity	Nationwide
22 Apr 2026Drug	CLASS II	Cinacalcet Hydrochloride Tablets, 90 mg recalled by Cipla USACinacalcet	Cipla USA	Nitrosamine Impurity	Nationwide
22 Apr 2026Drug	CLASS II	Cinacalcet Hydrochloride Tablets, 30 mg recalled by Cipla USACinacalcet	Cipla USA	Nitrosamine Impurity	Nationwide
8 Apr 2026Drug	CLASS II	Prazosin Hydrochloride Capsules, USP, 5mg recalled by Appco PharmaPrazosin Hydrochloride	Appco Pharma	Nitrosamine Impurity	Nationwide
8 Apr 2026Drug	CLASS II	Prazosin Hydrochloride Capsules, USP, 2mg recalled by Appco PharmaPrazosin Hydrochloride	Appco Pharma	Nitrosamine Impurity	Nationwide
8 Apr 2026Drug	CLASS II	traMADol Hydrochloride Tablets, USP, 50 mg recalled	Amneal Pharmaceuticals	Nitrosamine Impurity	Nationwide
8 Apr 2026Drug	CLASS II	Prazosin Hydrochloride Capsules, USP, 1mg recalled by Appco PharmaPrazosin Hydrochloride	Appco Pharma	Nitrosamine Impurity	Nationwide
11 Feb 2026Drug	CLASS II	Bisoprolol Fumarate and Hydrochlorothiazide tablets recalledBisoprolol Fumarate And Hydrochlorothiazide	Unichem Pharmaceuticals USA	Nitrosamine Impurity	Nationwide
17 Dec 2025Drug	CLASS II	Cinacalcet Hydrochloride Tablets, 60 mg recalled by Cipla USACinacalcet	Cipla USA	Nitrosamine Impurity	Nationwide
17 Dec 2025Drug	CLASS II	Cinacalcet Hydrochloride Tablets, 30 mg recalled by Cipla USACinacalcet	Cipla USA	Nitrosamine Impurity	Nationwide
17 Dec 2025Drug	CLASS II	Cinacalcet Hydrochloride Tablets, 90 mg recalled by Cipla USACinacalcet	Cipla USA	Nitrosamine Impurity	Nationwide
10 Dec 2025Drug	CLASS II	Duloxetine Delayed-Release Capsules, USP, 60 mg recalledDuloxetine	Breckenridge Pharmaceutical	Nitrosamine Impurity	Nationwide
10 Dec 2025Drug	CLASS II	Duloxetine Delayed-Release Capsules, USP, 60 mg recalledDuloxetine	Breckenridge Pharmaceutical	Nitrosamine Impurity	Nationwide
12 Nov 2025Drug	CLASS II	clomiPRAMINE Hydrochloride, Capsules, USP, 75 mg recalledClomipramine Hydrochloride	Zydus Pharmaceuticals	Nitrosamine Impurity	Nationwide
12 Nov 2025Drug	CLASS II	clomiPRAMINE Hydrochloride, Capsules, USP, 50 mg recalledClomipramine Hydrochloride	Zydus Pharmaceuticals	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.