The Recall Desk

Hazard

Nitrosamine Impurity recalls

80 recalls in our database tag this hazard, drawn from FDA, USDA FSIS, CPSC, and NHTSA source notices.

What the numbers show

Total
80
Critical
0
Severe
25
Most recent
2026-06-10

Of the 80 nitrosamine impurity recalls we have scored against our rubric, 0 (0%) are Critical — deaths or serious injuries reported, or the agency’s own highest classification — and 25 (31%) are Severe.

Which agencies issued them

About this hazard tag

Hazard tags are short, machine-readable labels we attach to every recall to make cross-cutting queries possible — “all nitrosamine impurity recalls regardless of agency”, “all listeria recalls in California”, “all airbag recalls in 2025”. The tags are extracted from each recall’s source text during the LLM rewrite step and validated against a fixed schema.

A recall can carry multiple tags — a Listeria recall might also be tagged ready-to-eat and undeclared-allergen. Use the full-text search if you want to combine hazard tags with brand or category filters.

1–25 of 80

  • HighFDA (Drugs)·D-0451-2026·2026-04-22

    Cipla cinacalcet 90 mg tablets exceed the nitrosamine daily intake limit

    Cipla is recalling Cinacalcet Hydrochloride Tablets, 90 mg, over CGMP deviations and the presence of N-Nitroso Cinacalcet above the acceptable daily intake limit. 63,192 bottles are affected.

    Product
    CINACALCET — CINACALCET (CINACALCET)
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0449-2026·2026-04-22

    Cipla cinacalcet 30 mg tablets exceed the nitrosamine daily intake limit

    Cipla is recalling Cinacalcet Hydrochloride Tablets, 30 mg, over CGMP deviations and the presence of N-Nitroso Cinacalcet above the acceptable daily intake limit. 113,336 bottles are affected.

    Product
    CINACALCET — CINACALCET (CINACALCET)
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0450-2026·2026-04-22

    Cipla cinacalcet 60 mg tablets exceed the nitrosamine daily intake limit

    Cipla is recalling Cinacalcet Hydrochloride Tablets, 60 mg, over CGMP deviations and the presence of N-Nitroso Cinacalcet above the acceptable daily intake limit. 96,096 bottles are affected.

    Product
    CINACALCET — CINACALCET (CINACALCET)
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0420-2026·2026-04-08

    Prazosin hydrochloride tablets recalled over nitrosamine impurity above limits

    Five lots of Prazosin Hydrochloride tablets are being recalled after detection of the nitrosamine impurity N-nitroso-prazosin impurity C above acceptable limits.

    Product
    PRAZOSIN HYDROCHLORIDE — PRAZOSIN HYDROCHLORIDE (PRAZOSIN HYDROCHLORIDE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0419-2026·2026-04-08

    Prazosin hydrochloride 100-count bottles recalled over nitrosamine impurity

    A further quantity of Prazosin Hydrochloride tablets is being recalled after detection of the nitrosamine impurity N-nitroso-prazosin impurity C above acceptable limits.

    Product
    PRAZOSIN HYDROCHLORIDE — PRAZOSIN HYDROCHLORIDE (PRAZOSIN HYDROCHLORIDE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0408-2026·2026-04-08

    Amneal tramadol tablets failed nitrosamine impurity specification at stability

    Amneal Pharmaceuticals is recalling two lots of Tramadol Hydrochloride Tablets 50 mg after a nitrosamine impurity was found out of specification at the 24-month stability interval.

    Product
    TRAMADOL HYDROCHLORIDE — TRAMADOL HYDROCHLORIDE (TRAMADOL HYDROCHLORIDE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0421-2026·2026-04-08

    Prazosin hydrochloride further lots recalled over nitrosamine impurity levels

    A further quantity of Prazosin Hydrochloride tablets is being recalled after detection of the nitrosamine impurity N-nitroso-prazosin impurity C above acceptable limits.

    Product
    PRAZOSIN HYDROCHLORIDE — PRAZOSIN HYDROCHLORIDE (PRAZOSIN HYDROCHLORIDE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0224-2026·2025-12-17

    Cinacalcet 30 mg tablets recalled over a nitrosamine impurity above limits

    Cipla USA is recalling 63,504 bottles of Cinacalcet Hydrochloride Tablets, 30 mg, over the presence of N-nitroso-cinacalcet above the acceptable daily intake limits.

    Product
    CINACALCET — CINACALCET (CINACALCET)
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Food)·H-0284-2026·2025-12-17

    Cinacalcet 60 mg tablets recalled over a nitrosamine impurity above limits

    Cipla USA is recalling 15,744 bottles of Cinacalcet Hydrochloride Tablets, 60 mg, over the presence of N-nitroso-cinacalcet above the acceptable daily intake limits.

    Product
    Deep-brand PREMIUM Select Mixed Vegetables 4 way KEEP FROZEN a) Net Wt. 3.85 LB. (1.75 kg); b) Net Wt. 2 LB (907 g)
    Category
    Drug
    Distribution
    0 states
  • HighFDA (Drugs)·D-0226-2026·2025-12-17

    Cinacalcet 90 mg tablets recalled over a nitrosamine impurity above limits

    Cipla USA is recalling 12,576 bottles of Cinacalcet Hydrochloride Tablets, 90 mg, over the presence of N-nitroso-cinacalcet above the acceptable daily intake limits.

    Product
    CINACALCET — CINACALCET (CINACALCET)
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0639-2025·2025-09-17

    Chlorpromazine 200 mg tablets recalled over nitrosamine impurity above acceptable intake

    Chlorpromazine Hydrochloride Tablets, USP, 200 mg, made by Zydus for Northstar Rx, are recalled nationwide because N-Nitroso Desmethyl Chlorpromazine was found above the recommended acceptable intake limit.

    Product
    CHLORPROMAZINE HYDROCHLORIDE — CHLORPROMAZINE HYDROCHLORIDE (CHLORPROMAZINE HYDROCHLORIDE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0632-2025·2025-09-17

    Zydus chlorpromazine 25 mg tablets recalled over nitrosamine above intake limit

    Zydus Chlorpromazine Hydrochloride Tablets, USP, 25 mg, are recalled nationwide because N-Nitroso Desmethyl Chlorpromazine was found above the recommended acceptable intake limit.

    Product
    CHLORPROMAZINE HYDROCHLORIDE — CHLORPROMAZINE HYDROCHLORIDE (CHLORPROMAZINE HYDROCHLORIDE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0631-2025·2025-09-17

    Chlorpromazine 10 mg tablets recalled over N-nitroso impurity above limit

    Chlorpromazine Hydrochloride Tablets, USP, 10 mg, made by Zydus for Northstar Rx, are recalled nationwide because N-Nitroso Desmethyl Chlorpromazine was found above the recommended acceptable intake limit.

    Product
    CHLORPROMAZINE HYDROCHLORIDE — CHLORPROMAZINE HYDROCHLORIDE (CHLORPROMAZINE HYDROCHLORIDE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0630-2025·2025-09-17

    Zydus chlorpromazine 10 mg tablets recalled over N-nitroso desmethyl chlorpromazine

    Zydus Chlorpromazine Hydrochloride Tablets, USP, 10 mg, are recalled nationwide because N-Nitroso Desmethyl Chlorpromazine was found above the recommended acceptable intake limit.

    Product
    CHLORPROMAZINE HYDROCHLORIDE — CHLORPROMAZINE HYDROCHLORIDE (CHLORPROMAZINE HYDROCHLORIDE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0634-2025·2025-09-17

    Chlorpromazine 50 mg tablets recalled over nitrosamine exceeding acceptable intake limit

    Zydus Chlorpromazine Hydrochloride Tablets, USP, 50 mg, are recalled nationwide because N-Nitroso Desmethyl Chlorpromazine was found above the recommended acceptable intake limit.

    Product
    CHLORPROMAZINE HYDROCHLORIDE — CHLORPROMAZINE HYDROCHLORIDE (CHLORPROMAZINE HYDROCHLORIDE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0637-2025·2025-09-17

    Northstar chlorpromazine 100 mg tablets recalled over N-nitroso impurity level

    Chlorpromazine Hydrochloride Tablets, USP, 100 mg, made by Zydus for Northstar Rx, are recalled nationwide because N-Nitroso Desmethyl Chlorpromazine was found above the recommended acceptable intake limit.

    Product
    CHLORPROMAZINE HYDROCHLORIDE — CHLORPROMAZINE HYDROCHLORIDE (CHLORPROMAZINE HYDROCHLORIDE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0635-2025·2025-09-17

    Northstar chlorpromazine 50 mg tablets recalled over nitrosamine impurity level

    Chlorpromazine Hydrochloride Tablets, USP, 50 mg, made by Zydus for Northstar Rx, are recalled nationwide because N-Nitroso Desmethyl Chlorpromazine was found above the recommended acceptable intake limit.

    Product
    CHLORPROMAZINE HYDROCHLORIDE — CHLORPROMAZINE HYDROCHLORIDE (CHLORPROMAZINE HYDROCHLORIDE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0636-2025·2025-09-17

    Zydus chlorpromazine 100 mg tablets recalled over nitrosamine impurity above limit

    Zydus Chlorpromazine Hydrochloride Tablets, USP, 100 mg, are recalled nationwide because N-Nitroso Desmethyl Chlorpromazine was found above the recommended acceptable intake limit.

    Product
    CHLORPROMAZINE HYDROCHLORIDE — CHLORPROMAZINE HYDROCHLORIDE (CHLORPROMAZINE HYDROCHLORIDE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0638-2025·2025-09-17

    Chlorpromazine 200 mg from Zydus recalled over N-nitroso desmethyl impurity

    Zydus Chlorpromazine Hydrochloride Tablets, USP, 200 mg, are recalled nationwide because N-Nitroso Desmethyl Chlorpromazine was found above the recommended acceptable intake limit.

    Product
    CHLORPROMAZINE HYDROCHLORIDE — CHLORPROMAZINE HYDROCHLORIDE (CHLORPROMAZINE HYDROCHLORIDE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0633-2025·2025-09-17

    Northstar chlorpromazine 25 mg tablets recalled over nitrosamine above intake limit

    Chlorpromazine Hydrochloride Tablets, USP, 25 mg, made by Zydus for Northstar Rx, are recalled nationwide because N-Nitroso Desmethyl Chlorpromazine was found above the recommended acceptable intake limit.

    Product
    CHLORPROMAZINE HYDROCHLORIDE — CHLORPROMAZINE HYDROCHLORIDE (CHLORPROMAZINE HYDROCHLORIDE)
    Category
    Drug
    Distribution
    Distributed nationwide