Nitrosamine (NDMA / NDEA) recalls

460 matching FDA recall record(s) · checked Aug 25, 2026

What this means

Nitrosamines — NDMA, NDEA, and NMBA — are probable human carcinogens that can form during drug manufacturing or over time in storage. Since 2018 they have driven some of the largest drug recalls on record, starting with the “sartan” blood-pressure drugs (valsartan, losartan, irbesartan), then ranitidine (Zantac), then extended-release metformin. The impurity usually traced back to the active ingredient made at overseas facilities.

Recalls with this cause

Class II2026-08-12MIRABEGRONCGMP: Due to Out of Specification (OOS) result for N-Nitroso Mirabegron impurity.Recalling firm: Zydus Pharmaceuticals (USA) IncRead what it means & check your lot →Class II2026-07-08CINACALCETcGMP Deviations: presence of N-nitroso-cinacalcet, above the acceptable daily intake (ADI).Recalling firm: Cipla USA, Inc.Read what it means & check your lot →Class II2026-07-08CINACALCETcGMP Deviations: presence of N-nitroso-cinacalcet, above the acceptable daily intake (ADI).Recalling firm: Cipla USA, Inc.Read what it means & check your lot →Class II2026-07-08CINACALCETcGMP Deviations: presence of N-nitroso-cinacalcet, above the acceptable daily intake (ADI).Recalling firm: Cipla USA, Inc.Read what it means & check your lot →Class II2026-07-01DULOXETINE D/R, a) 30 mg (NDC 61919-482-30), 30 Caps; b) 30 mg (NDC 61CGMP Deviations: Presence of N-nitroso-duloxetine impurity above FDA recommended interim limitRecalling firm: Direct RxRead what it means & check your lot →Class II2026-06-17DULOXETINECGMP Deviations: Presence of N-nitroso-duloxetine impurity above FDA recommended interim limitRecalling firm: Breckenridge Pharmaceutical, Inc.Read what it means & check your lot →Class II2026-06-17DULOXETINECGMP Deviations: Presence of N-nitroso-duloxetine impurity above FDA recommended interim limitRecalling firm: Breckenridge Pharmaceutical, Inc.Read what it means & check your lot →Class II2026-06-10DULOXETINECGMP Deviations; presence of Nitrosamine Drug Substance Related Impurity (NDSRI), N-nitroso-duloxetine, above the FDA acceptable intake limit.Recalling firm: Asclemed USA Inc.Read what it means & check your lot →Class II2026-05-27ERYTHROMYCINCGMP Deviations; presence of N-Nitroso-Desmethyl-Erythromycin above the recommended acceptable intake limitRecalling firm: Zydus Pharmaceuticals (USA) IncRead what it means & check your lot →Class II2026-05-27ERYTHROMYCINCGMP Deviations; presence of N-Nitroso-Desmethyl-Erythromycin above the recommended acceptable intake limitRecalling firm: Zydus Pharmaceuticals (USA) IncRead what it means & check your lot →Class II2026-05-13DULOXETINECGMP Deviations: Presence of N-nitroso-Duloxetine impurity above FDA recommended limit of 0.83 ppm, identified at the 12-month and 18-month long-term stability intervals.Recalling firm: Ajanta Pharma Ltd.Read what it means & check your lot →Class II2026-05-13DULOXETINECGMP Deviations: Presence of N-nitroso-Duloxetine impurity above FDA recommended limit of 0.83 ppm, identified at the 12-month and 18-month long-term stability intervals.Recalling firm: Ajanta Pharma Ltd.Read what it means & check your lot →Class II2026-05-13DULOXETINECGMP Deviations; presence of N-nitroso-duloxetine impurity above the FDA recommended limitRecalling firm: Breckenridge Pharmaceutical, Inc.Read what it means & check your lot →Class II2026-05-13DULOXETINECGMP Deviations: Presence of N-nitroso-Duloxetine impurity above FDA recommended limit of 0.83 ppm, identified at the 12-month and 18-month long-term stability intervals.Recalling firm: Ajanta Pharma Ltd.Read what it means & check your lot →Class II2026-04-29FUROSEMIDECGMP Deviations; presence of N-nitroso-Furosemide (NNF) above the recommended intake limit.Recalling firm: Leading Pharma, LLCRead what it means & check your lot →Class II2026-04-22CINACALCETCGMP Deviations; presence N-Nitroso Cinacalcet above the acceptable daily intake limitRecalling firm: Cipla USA, Inc.Read what it means & check your lot →Class II2026-04-22CINACALCETCGMP Deviations; presence N-Nitroso Cinacalcet above the acceptable daily intake limitRecalling firm: Cipla USA, Inc.Read what it means & check your lot →Class II2026-04-22CINACALCETCGMP Deviations; presence N-Nitroso Cinacalcet above the acceptable daily intake limitRecalling firm: Cipla USA, Inc.Read what it means & check your lot →Class II2026-04-08PRAZOSIN HYDROCHLORIDEcGMP deviation: detection of Nitrosamine Drug Substance-Related Impurities, N-nitroso-prazosin impurity C (NNP) above acceptable limits.Recalling firm: Appco Pharma LLCRead what it means & check your lot →Class II2026-04-08TRAMADOL HYDROCHLORIDEFailed Impurities/Degradation Specifications: N-nitroso-desmethyl-tramadol impurity (NDSRI) was found out of the specification at 24-month stability interval during Long term stabiRecalling firm: Amneal Pharmaceuticals, LLCRead what it means & check your lot →Class II2026-04-08PRAZOSIN HYDROCHLORIDEcGMP deviation: detection of Nitrosamine Drug Substance-Related Impurities, N-nitroso-prazosin impurity C (NNP) above acceptable limits.Recalling firm: Appco Pharma LLCRead what it means & check your lot →Class II2026-04-08PRAZOSIN HYDROCHLORIDEcGMP deviation: detection of Nitrosamine Drug Substance-Related Impurities, N-nitroso-prazosin impurity C (NNP) above acceptable limits.Recalling firm: Appco Pharma LLCRead what it means & check your lot →Class II2026-02-11BISOPROLOL FUMARATE AND HYDROCHLOROTHIAZIDEcGMP Deviations: recall due to not meeting the N-Nitroso Bisoprolol impurity specification limits.Recalling firm: Unichem Pharmaceuticals USA Inc.Read what it means & check your lot →Class II2025-12-17CINACALCETCGMP Deviations: the presence of a nitrosamine impurity, N-nitroso-cinacalcet, above the acceptable daily intake (ADI) limits.Recalling firm: Cipla USA, Inc.Read what it means & check your lot →Class II2025-12-17CINACALCETCGMP Deviations: the presence of a nitrosamine impurity, N-nitroso-cinacalcet, above the acceptable daily intake (ADI) limits.Recalling firm: Cipla USA, Inc.Read what it means & check your lot →Class II2025-12-17CINACALCETCGMP Deviations: the presence of a nitrosamine impurity, N-nitroso-cinacalcet, above the acceptable daily intake (ADI) limits.Recalling firm: Cipla USA, Inc.Read what it means & check your lot →Class II2025-12-10DULOXETINECGMP Deviations; presence of N-nitroso-duloxetine impurity above the FDA recommended limitRecalling firm: Breckenridge Pharmaceutical, Inc.Read what it means & check your lot →Class II2025-12-10DULOXETINECGMP Deviations; presence of N-nitroso-duloxetine impurity above the FDA recommended limitRecalling firm: Breckenridge Pharmaceutical, Inc.Read what it means & check your lot →Class II2025-11-12CLOMIPRAMINE HYDROCHLORIDEcGMP deviations: an observed Out of Specification of Nitrosamine Drug Substance-Related Impurities (NDSRIs), N-Nitroso Desmethyl-Clomipramine, above the FDA acceptable intake limitRecalling firm: Zydus Pharmaceuticals (USA) IncRead what it means & check your lot →Class II2025-11-12CLOMIPRAMINE HYDROCHLORIDEcGMP deviations: an observed Out of Specification of Nitrosamine Drug Substance-Related Impurities (NDSRIs), N-Nitroso Desmethyl-Clomipramine, above the FDA acceptable intake limitRecalling firm: Zydus Pharmaceuticals (USA) IncRead what it means & check your lot →Class II2025-11-12CLOMIPRAMINE HYDROCHLORIDEcGMP deviations: an observed Out of Specification of Nitrosamine Drug Substance-Related Impurities (NDSRIs), N-Nitroso Desmethyl-Clomipramine, above the FDA acceptable intake limitRecalling firm: Zydus Pharmaceuticals (USA) IncRead what it means & check your lot →Class II2025-11-05PRAZOSIN HYDROCHLORIDECGMP Deviations-Test results for N-nitroso Prazosin impurity C that are above the Carcinogenic Potency Categorization Approach (CPCA) acceptable intake limit for the above specifieRecalling firm: Teva Pharmaceuticals USA, IncRead what it means & check your lot →Class II2025-11-05PRAZOSIN HYDROCHLORIDECGMP Deviations-Test results for N-nitroso Prazosin impurity C that are above the Carcinogenic Potency Categorization Approach (CPCA) acceptable intake limit for the above specifieRecalling firm: Teva Pharmaceuticals USA, IncRead what it means & check your lot →Class II2025-11-05DESIPRAMINE HYDROCHLORIDECGMP Deviations: N-Nitroso Desipramine impurity exceeding the permissible acceptable daily intake level.Recalling firm: Heritage Pharmaceuticals IncRead what it means & check your lot →Class II2025-11-05DESIPRAMINE HYDROCHLORIDECGMP Deviations: N-Nitroso Desipramine impurity exceeding the permissible acceptable daily intake level.Recalling firm: Heritage Pharmaceuticals IncRead what it means & check your lot →Class II2025-11-05PRAZOSIN HYDROCHLORIDEFailed Impurities/Degradation Specification: presence of N-nitroso Prazosin impurity C above the Carcinogenic Potency Categorization Approach (CPCA) acceptable intake limitRecalling firm: Amerisource Health Services LLCRead what it means & check your lot →Class II2025-11-05PRAZOSIN HYDROCHLORIDEFailed Impurities/Degradation Specification: presence of N-nitroso Prazosin impurity C above the Carcinogenic Potency Categorization Approach (CPCA) acceptable intake limitRecalling firm: Amerisource Health Services LLCRead what it means & check your lot →Class II2025-11-05DESIPRAMINE HYDROCHLORIDECGMP Deviations: N-Nitroso Desipramine impurity exceeding the permissible acceptable daily intake level.Recalling firm: Heritage Pharmaceuticals IncRead what it means & check your lot →Class II2025-11-05PRAZOSIN HYDROCHLORIDEFailed Impurities/Degradation Specification: presence of N-nitroso Prazosin impurity C above the Carcinogenic Potency Categorization Approach (CPCA) acceptable intake limitRecalling firm: Amerisource Health Services LLCRead what it means & check your lot →Class II2025-11-05DESIPRAMINE HYDROCHLORIDECGMP Deviations: N-Nitroso Desipramine impurity exceeding the permissible acceptable daily intake level.Recalling firm: Heritage Pharmaceuticals IncRead what it means & check your lot →Class II2025-11-05DESIPRAMINE HYDROCHLORIDECGMP Deviations: N-Nitroso Desipramine impurity exceeding the permissible acceptable daily intake level.Recalling firm: Heritage Pharmaceuticals IncRead what it means & check your lot →Class II2025-11-05PRAZOSIN HYDROCHLORIDECGMP Deviations-Test results for N-nitroso Prazosin impurity C that are above the Carcinogenic Potency Categorization Approach (CPCA) acceptable intake limit for the above specifieRecalling firm: Teva Pharmaceuticals USA, IncRead what it means & check your lot →Class II2025-11-05DULOXETINECGMP Deviations: N-nitroso-duloxetine impurity above the safety assessment limit of 12.5ppm.Recalling firm: Breckenridge Pharmaceutical, Inc.Read what it means & check your lot →Class II2025-11-05DESIPRAMINE HYDROCHLORIDECGMP Deviations: N-Nitroso Desipramine impurity exceeding the permissible acceptable daily intake level.Recalling firm: Heritage Pharmaceuticals IncRead what it means & check your lot →Class II2025-10-15Major ChlorproMAZINE Hydrochloride Tablets, USP, 200 mg, 100 Tablets (CGMP Deviations: Presence of N-Nitroso Desmethyl Chlorpromazine above the recommended intake limitRecalling firm: The Harvard Drug Group LLC dba Major Pharmaceuticals and Rugby LaboratoriesRead what it means & check your lot →Class II2025-10-15Major ChlorproMAZINE Hydrochloride Tablets, USP, 50 mg, 100 Tablets, (CGMP Deviations: Presence of N-Nitroso Desmethyl Chlorpromazine above the recommended intake limitRecalling firm: The Harvard Drug Group LLC dba Major Pharmaceuticals and Rugby LaboratoriesRead what it means & check your lot →Class II2025-10-15Major ChlorproMAZINE Hydrochloride Tablets, USP, 25 mg, 100 Tablets (1CGMP Deviations: Presence of N-Nitroso Desmethyl Chlorpromazine above the recommended intake limitRecalling firm: The Harvard Drug Group LLC dba Major Pharmaceuticals and Rugby LaboratoriesRead what it means & check your lot →Class II2025-10-15Major ChlorproMAZINE Hydrochloride Tablets, USP, 25 mg, 50 Tablets (5xCGMP Deviations: Presence of N-Nitroso Desmethyl Chlorpromazine above the recommended intake limitRecalling firm: The Harvard Drug Group LLC dba Major Pharmaceuticals and Rugby LaboratoriesRead what it means & check your lot →Class II2025-10-15Major ChlorproMAZINE Hydrochloride Tablets, USP, 100 mg, 100 Tablets (CGMP Deviations: Presence of N-Nitroso Desmethyl Chlorpromazine above the recommended intake limitRecalling firm: The Harvard Drug Group LLC dba Major Pharmaceuticals and Rugby LaboratoriesRead what it means & check your lot →Class II2025-09-17CHLORPROMAZINE HYDROCHLORIDECGMP Deviations: presence of N-Nitroso Desmethyl Chlorpromazine above the recommended acceptable intake limitRecalling firm: Zydus Pharmaceuticals (USA) IncRead what it means & check your lot →Class II2025-09-17CHLORPROMAZINE HYDROCHLORIDECGMP Deviations: presence of N-Nitroso Desmethyl Chlorpromazine above the recommended acceptable intake limitRecalling firm: Zydus Pharmaceuticals (USA) IncRead what it means & check your lot →Class II2025-09-17CHLORPROMAZINE HYDROCHLORIDECGMP Deviations: presence of N-Nitroso Desmethyl Chlorpromazine above the recommended acceptable intake limitRecalling firm: Zydus Pharmaceuticals (USA) IncRead what it means & check your lot →Class II2025-09-17CHLORPROMAZINE HYDROCHLORIDECGMP Deviations: presence of N-Nitroso Desmethyl Chlorpromazine above the recommended acceptable intake limitRecalling firm: Zydus Pharmaceuticals (USA) IncRead what it means & check your lot →Class II2025-09-17CHLORPROMAZINE HYDROCHLORIDECGMP Deviations: presence of N-Nitroso Desmethyl Chlorpromazine above the recommended acceptable intake limitRecalling firm: Zydus Pharmaceuticals (USA) IncRead what it means & check your lot →Class II2025-09-17CHLORPROMAZINE HYDROCHLORIDECGMP Deviations: presence of N-Nitroso Desmethyl Chlorpromazine above the recommended acceptable intake limitRecalling firm: Zydus Pharmaceuticals (USA) IncRead what it means & check your lot →Class II2025-09-17CHLORPROMAZINE HYDROCHLORIDECGMP Deviations: presence of N-Nitroso Desmethyl Chlorpromazine above the recommended acceptable intake limitRecalling firm: Zydus Pharmaceuticals (USA) IncRead what it means & check your lot →Class II2025-09-17CHLORPROMAZINE HYDROCHLORIDECGMP Deviations: presence of N-Nitroso Desmethyl Chlorpromazine above the recommended acceptable intake limitRecalling firm: Zydus Pharmaceuticals (USA) IncRead what it means & check your lot →Class II2025-09-17CHLORPROMAZINE HYDROCHLORIDECGMP Deviations: presence of N-Nitroso Desmethyl Chlorpromazine above the recommended acceptable intake limitRecalling firm: Zydus Pharmaceuticals (USA) IncRead what it means & check your lot →Class II2025-09-17DULOXETINECGMP deviations: N-nitroso-duloxetine impurity above the proposed interim limit.Recalling firm: Breckenridge Pharmaceutical, Inc.Read what it means & check your lot →Class II2025-09-17CHLORPROMAZINE HYDROCHLORIDECGMP Deviations: presence of N-Nitroso Desmethyl Chlorpromazine above the recommended acceptable intake limitRecalling firm: Zydus Pharmaceuticals (USA) IncRead what it means & check your lot →

By cause