The Recall Desk

Hazard

Cgmp Deviation recalls

1,552 recalls in our database tag this hazard, drawn from FDA, USDA FSIS, CPSC, and NHTSA source notices.

What the numbers show

Total
1,552
Critical
1
Severe
283
Most recent
2026-09-02

Of the 1,552 cgmp deviation recalls we have scored against our rubric, 1 (0%) are Critical — deaths or serious injuries reported, or the agency’s own highest classification — and 283 (18%) 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 cgmp deviation 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.

176–200 of 1552

  • HighFDA (Drugs)·D-0124-2026·2025-11-05

    Testosterone 50 mg pellets recalled over potential presence of metal particulate

    FarmaKeio Outsourcing is recalling 829 sterile Testosterone 50 mg pellets from one lot over the potential presence of metal particulate matter.

    Product
    Testosterone 50MG, 1 PELLET (STERILE) FOR SUBCUTANEOUS INSERTION, RX ONLY, FarmaKeio Outsourcing, 920 S Kimball Ave, Ste 100, Southlake, TX 76092. NDC 73693-0387-01
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0126-2026·2025-11-05

    Testosterone 87.5 mg pellets recalled over potential metal particulate matter

    FarmaKeio Outsourcing is recalling 529 sterile Testosterone 87.5 mg pellets from one lot over the potential presence of metal particulate matter.

    Product
    Testosterone 87.5 MG, 1 PELLET (STERILE) FOR SUBCUTANEOUS INSERTION, RX ONLY, FarmaKeio Outsourcing, 920 S Kimball Ave, Ste 100, Southlake, TX 76092. NDC 73693-0386-01
    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-0022-2026·2025-10-22

    Sunscreen lotion recalled after failing total aerobic microbial count testing

    SV Labs Prescott is recalling 11,386 tubes of Aloe Up Sport Performance Sunscreen Lotion SPF 30 after the firm released and distributed product that failed total aerobic microbial count testing.

    Product
    Aloe Up Sport Performance Sunscreen Lotion SPF 30, 1 FL OZ (30 mL) per tube, Mfd. for: ALOE UP, 9700 W. 76th St., Ste 112, Eden Prairie, Minnesota 55344
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0027-2026·2025-10-22

    Sucralfate tablets recalled after bankruptcy left quality program unmonitored

    Amerisource Health Services is recalling 27,868 blister packs of Sucralfate Tablets USP 1 gram because, after a Chapter 11 filing, the firm cannot monitor its quality program.

    Product
    Sucralfate Tablets, USP 1 gram, 100 Tablets, (10x10), Rx Only, Distributed by: American Health Packaging, Columbus, Ohio 43217, NDC 60687-695-01 - Carton NDC [60687-695-11- Unit Dose]
    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-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-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-0004-2026·2025-10-15

    Ethanol hand sanitizer recalled because methanol risk could not be excluded

    Acuity Specialty Products is recalling Wyandotte Sanifect E3 ethanol-based hand sanitizer because required receipt testing of incoming alcohol was not performed, so methanol risk could not be excluded.

    Product
    Wyandotte, Sanifect E3, Hand Sanitizer (Ethanol-Based, Product 5511), Ethyl Alcohol 60.1%, Manufacture By: AFCO, 550 Development Avenue, Chambersburg, PA 17210, Toll Free: 800-345-1329, Package Configurations: a) 6x1000mL Case, b) 4x1 Gallon Case, c) 5 Gallon Pail, d) 55 Gallon D
    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-0005-2026·2025-10-15

    Isopropyl hand sanitizer recalled because methanol risk could not be excluded

    Acuity Specialty Products is recalling AFCO isopropyl alcohol-based hand sanitizer because required receipt testing of incoming alcohol was not performed, so methanol risk could not be excluded.

    Product
    AFCO, Hand Sanitizer (Isopropyl Alcohol-Based, Product 5515), Manufactured by: AFCO, 550 Development Avenue, Chambersburg, PA 17201, Toll Free: 800-345-1329, Package Configuration: a) 4x1 Gallon Case, 5 Gallon Pail, 55 Gallon Drum.
    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
  • ModerateFDA (Drugs)·D-0659-2025·2025-10-01

    Alcohol prep pads recalled over current good manufacturing practice deviations

    Quick Touch Alcohol Prep Pads containing 70% isopropyl alcohol, lot 20240610, are recalled for current good manufacturing practice deviations. 500 cases are affected.

    Product
    Quick Touch Alcohol Prep Pads(Isopropyl Alcohol 70%), 100 Sterile Pads per carton, AUM Pharmaceuticals, 320 Oser Ave., Hauppauge, NY 11788.
    Category
    Drug
    Distribution
    0 states
  • ModerateFDA (Drugs)·D-0662-2025·2025-10-01

    Azelaic acid gel recalled after complaints of gritty texture in tubes

    Glenmark Azelaic Acid Gel, 15%, 50 gram tubes from batch 19252524, is recalled nationwide after market complaints of a gritty or grainy texture. 13,824 tubes are affected.

    Product
    AZELAIC ACID — AZELAIC ACID (AZELAIC ACID)
    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-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
  • 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-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-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-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-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-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-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