The Recall Desk

FDA (Drugs) recall action 97584

The Harvard Drug Group LLC dba Major Pharmaceuticals and Rugby Laboratories recalled 5 products on 2025-10-15

The FDA (Drugs) publishes a recall like this one as 5 separate product records. They share a firm, a date and a cause; this page is all of them in one place, so the scale of the action is visible rather than spread across 5 pages.

Products
5
Announced
2025-10-15
Critical
0
Units
6,086

Why these products were recalled

CGMP Deviations: Presence of N-Nitroso Desmethyl Chlorpromazine above the recommended intake limit

The agency’s own wording, quoted from the enforcement report.

The unit total adds up the quantities the agency stated for each product. Where a product record gave no figure, or gave a weight rather than a count, it contributes nothing — so the real total is at least this, never less.

1–5 of 5

  • HighFDA (Drugs)··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
    Distribution
    0 states
  • HighFDA (Drugs)··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
    Distribution
    0 states
  • HighFDA (Drugs)··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
    Distribution
    0 states
  • HighFDA (Drugs)··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
    Distribution
    0 states
  • HighFDA (Drugs)··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
    Distribution
    0 states