The Recall Desk

Hazard

Nitrosamine recalls

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

What the numbers show

Total
93
Critical
0
Severe
44
Most recent
2026-08-12

Of the 93 nitrosamine recalls we have scored against our rubric, 0 (0%) are Critical — deaths or serious injuries reported, or the agency’s own highest classification — and 44 (47%) are Severe.

About this hazard tag

Hazard tags are short, machine-readable labels we attach to every recall to make cross-cutting queries possible — “all nitrosamine 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 93

  • SevereFDA (Drugs)·D-0745-2026·2026-08-12

    FDA Recalls Mirabegron Tablets Over Nitrosamine Impurity

    Zydus Pharmaceuticals is recalling Mirabegron extended-release tablets, 25 mg, due to an out-of-specification result for the N-Nitroso Mirabegron impurity. The recall affects nationwide distribution in the USA.

    Product
    MIRABEGRON — MIRABEGRON (MIRABEGRON)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0301-2026·2026-02-11

    Bisoprolol and hydrochlorothiazide tablets recalled over a nitrosamine impurity

    Unichem Pharmaceuticals USA is recalling a lot of Bisoprolol Fumarate and Hydrochlorothiazide tablets, 2.5 mg/6.25 mg, for not meeting the N-Nitroso Bisoprolol impurity specification limits.

    Product
    BISOPROLOL FUMARATE AND HYDROCHLOROTHIAZIDE — BISOPROLOL FUMARATE AND HYDROCHLOROTHIAZIDE (BISOPROLOL FUMARATE AND HYDROCHLOROTHIAZIDE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0153-2026·2025-11-12

    Clomipramine 50 mg capsules recalled over nitrosamine above the intake limit

    Zydus Pharmaceuticals is recalling clomiPRAMINE Hydrochloride Capsules USP 50 mg after N-Nitroso Desmethyl-Clomipramine was found above the FDA acceptable intake limit.

    Product
    CLOMIPRAMINE HYDROCHLORIDE — CLOMIPRAMINE HYDROCHLORIDE (CLOMIPRAMINE HYDROCHLORIDE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0154-2026·2025-11-12

    Clomipramine 75 mg capsules recalled over nitrosamine above the intake limit

    Zydus Pharmaceuticals is recalling clomiPRAMINE Hydrochloride Capsules USP 75 mg after N-Nitroso Desmethyl-Clomipramine was found above the FDA acceptable intake limit.

    Product
    CLOMIPRAMINE HYDROCHLORIDE — CLOMIPRAMINE HYDROCHLORIDE (CLOMIPRAMINE HYDROCHLORIDE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0152-2026·2025-11-12

    Clomipramine 25 mg capsules recalled over nitrosamine above the intake limit

    Zydus Pharmaceuticals is recalling clomiPRAMINE Hydrochloride Capsules USP 25 mg after N-Nitroso Desmethyl-Clomipramine was found above the FDA acceptable intake limit.

    Product
    CLOMIPRAMINE HYDROCHLORIDE — CLOMIPRAMINE HYDROCHLORIDE (CLOMIPRAMINE HYDROCHLORIDE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0107-2026·2025-11-05

    Desipramine tablets recalled over nitrosamine impurity above acceptable daily intake

    Heritage Pharmaceuticals is recalling 6,979 bottles of Desipramine Hydrochloride Tablets USP 10 mg because N-Nitroso Desipramine exceeded the permissible acceptable daily intake level.

    Product
    DESIPRAMINE HYDROCHLORIDE — DESIPRAMINE HYDROCHLORIDE (DESIPRAMINE HYDROCHLORIDE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0111-2026·2025-11-05

    Desipramine 100 mg tablets recalled over nitrosamine impurity above intake limit

    Heritage Pharmaceuticals is recalling 5,882 bottles of Desipramine Hydrochloride Tablets USP 100 mg because N-Nitroso Desipramine exceeded the permissible acceptable daily intake level.

    Product
    DESIPRAMINE HYDROCHLORIDE — DESIPRAMINE HYDROCHLORIDE (DESIPRAMINE HYDROCHLORIDE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0112-2026·2025-11-05

    Desipramine 150 mg tablets recalled over nitrosamine impurity above intake limit

    Heritage Pharmaceuticals is recalling 3,750 bottles of Desipramine Hydrochloride Tablets USP 150 mg because N-Nitroso Desipramine exceeded the permissible acceptable daily intake level.

    Product
    DESIPRAMINE HYDROCHLORIDE — DESIPRAMINE HYDROCHLORIDE (DESIPRAMINE HYDROCHLORIDE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0108-2026·2025-11-05

    Desipramine 25 mg tablets recalled over nitrosamine impurity above intake limit

    Heritage Pharmaceuticals is recalling 8,754 bottles of Desipramine Hydrochloride Tablets USP 25 mg because N-Nitroso Desipramine exceeded the permissible acceptable daily intake level.

    Product
    DESIPRAMINE HYDROCHLORIDE — DESIPRAMINE HYDROCHLORIDE (DESIPRAMINE HYDROCHLORIDE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0106-2026·2025-11-05

    Prazosin 5 mg capsules recalled over nitrosamine impurity above intake limit

    Teva Pharmaceuticals USA is recalling 107,673 units of Prazosin Hydrochloride Capsules 5 mg because test results for N-nitroso Prazosin impurity C exceeded the acceptable intake limit.

    Product
    PRAZOSIN HYDROCHLORIDE — PRAZOSIN HYDROCHLORIDE (PRAZOSIN HYDROCHLORIDE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0109-2026·2025-11-05

    Desipramine 50 mg tablets recalled over nitrosamine impurity above intake limit

    Heritage Pharmaceuticals is recalling 5,880 bottles of Desipramine Hydrochloride Tablets USP 50 mg because N-Nitroso Desipramine exceeded the permissible acceptable daily intake level.

    Product
    DESIPRAMINE HYDROCHLORIDE — DESIPRAMINE HYDROCHLORIDE (DESIPRAMINE HYDROCHLORIDE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0102-2026·2025-11-05

    Unit dose prazosin 2 mg cartons recalled over nitrosamine impurity

    Amerisource Health Services is recalling 1,818 unit dose cartons of Prazosin Hydrochloride Capsules 2 mg over N-nitroso Prazosin impurity C above the acceptable intake limit.

    Product
    PRAZOSIN HYDROCHLORIDE — PRAZOSIN HYDROCHLORIDE (PRAZOSIN HYDROCHLORIDE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0110-2026·2025-11-05

    Desipramine 75 mg tablets recalled over nitrosamine impurity above intake limit

    Heritage Pharmaceuticals is recalling 2,418 bottles of Desipramine Hydrochloride Tablets USP 75 mg because N-Nitroso Desipramine exceeded the permissible acceptable daily intake level.

    Product
    DESIPRAMINE HYDROCHLORIDE — DESIPRAMINE HYDROCHLORIDE (DESIPRAMINE HYDROCHLORIDE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0104-2026·2025-11-05

    Prazosin 1 mg capsules recalled over nitrosamine impurity above intake limit

    Teva Pharmaceuticals USA is recalling 181,659 bottles of Prazosin Hydrochloride Capsules 1 mg because test results for N-nitroso Prazosin impurity C exceeded the acceptable intake limit.

    Product
    PRAZOSIN HYDROCHLORIDE — PRAZOSIN HYDROCHLORIDE (PRAZOSIN HYDROCHLORIDE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0103-2026·2025-11-05

    Unit dose prazosin 5 mg cartons recalled over nitrosamine impurity

    Amerisource Health Services is recalling 3,410 unit dose cartons of Prazosin Hydrochloride Capsules 5 mg over N-nitroso Prazosin impurity C above the acceptable intake limit.

    Product
    PRAZOSIN HYDROCHLORIDE — PRAZOSIN HYDROCHLORIDE (PRAZOSIN HYDROCHLORIDE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0101-2026·2025-11-05

    Unit dose prazosin 1 mg cartons recalled over nitrosamine impurity

    Amerisource Health Services is recalling 1,970 unit dose cartons of Prazosin Hydrochloride Capsules 1 mg over N-nitroso Prazosin impurity C above the acceptable intake limit.

    Product
    PRAZOSIN HYDROCHLORIDE — PRAZOSIN HYDROCHLORIDE (PRAZOSIN HYDROCHLORIDE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0105-2026·2025-11-05

    Prazosin capsules recalled over nitrosamine impurity above the acceptable intake limit

    Teva Pharmaceuticals USA is recalling 291,512 bottles of Prazosin Hydrochloride Capsules 2 mg because test results for N-nitroso Prazosin impurity C exceeded the acceptable intake limit.

    Product
    PRAZOSIN HYDROCHLORIDE — PRAZOSIN HYDROCHLORIDE (PRAZOSIN HYDROCHLORIDE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0012-2026·2025-10-15

    Chlorpromazine tablets recalled over nitrosamine impurity above recommended intake limit

    Major Pharmaceuticals is recalling 866 blister packs of Chlorpromazine Hydrochloride Tablets USP 100 mg because N-Nitroso Desmethyl Chlorpromazine was present above the recommended intake limit.

    Product
    Major ChlorproMAZINE Hydrochloride Tablets, USP, 100 mg, 100 Tablets (10x10) blister package, Rx Only, Packaged and Distributed by Major Pharmaceuticals, Indianapolis, IN 46268, USA, NDC 0904-7132-61, UPC (01)00309047132614
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0010-2026·2025-10-15

    Chlorpromazine 25 mg tablets recalled over nitrosamine above recommended intake limit

    Major Pharmaceuticals is recalling 1,256 blister packs of Chlorpromazine Hydrochloride Tablets USP 25 mg because N-Nitroso Desmethyl Chlorpromazine was present above the recommended intake limit.

    Product
    Major ChlorproMAZINE Hydrochloride Tablets, USP, 25 mg, 100 Tablets (10x10) blister package, Rx Only, Packaged and Distributed by Major Pharmaceuticals, Indianapolis, IN 46268, USA, NDC 0904-7130-61, UPC (01)00309047130610
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0011-2026·2025-10-15

    Chlorpromazine 50 mg tablets recalled over nitrosamine above recommended intake limit

    Major Pharmaceuticals is recalling 506 blister packs of Chlorpromazine Hydrochloride Tablets USP 50 mg because N-Nitroso Desmethyl Chlorpromazine was present above the recommended intake limit.

    Product
    Major ChlorproMAZINE Hydrochloride Tablets, USP, 50 mg, 100 Tablets, (10x10) blister package, Rx Only, Packaged and Distributed by Major Pharmaceuticals, Indianapolis, IN 46268, USA, NDC 0904-7131-61, UPC (01)00309047131617
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0013-2026·2025-10-15

    Chlorpromazine 200 mg tablets recalled over nitrosamine above recommended intake limit

    Major Pharmaceuticals is recalling 1,394 blister packs of Chlorpromazine Hydrochloride Tablets USP 200 mg because N-Nitroso Desmethyl Chlorpromazine was present above the recommended intake limit.

    Product
    Major ChlorproMAZINE Hydrochloride Tablets, USP, 200 mg, 100 Tablets (10x10) blister package, Rx Only, Packaged and Distributed by Major Pharmaceuticals, Indianapolis, IN 46268, USA, NDC 0904-7133-61, UPC (01)00309047133611 NDC 0904-7133-61
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0009-2026·2025-10-15

    Chlorpromazine 25 mg fifty count packs recalled over nitrosamine impurity

    Major Pharmaceuticals is recalling 2,064 fifty-tablet blister packs of Chlorpromazine Hydrochloride Tablets USP 25 mg because a nitrosamine impurity exceeded the recommended intake limit.

    Product
    Major ChlorproMAZINE Hydrochloride Tablets, USP, 25 mg, 50 Tablets (5x10) blister package, Rx Only, Packaged and Distributed by Major Pharmaceuticals, Indianapolis, IN 46268, USA, NDC 0904-7130-06, UPC (01)00309047130061
    Category
    Drug
    Distribution
    Distributed nationwide