The Recall Desk

Hazard

Cgmp Deviation recalls

1,563 recalls in our database tag this hazard, drawn from FDA, USDA FSIS, CPSC, and NHTSA source notices.

What the numbers show

Total
1,563
Critical
1
Severe
288
Most recent
2026-09-09

Of the 1,563 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 288 (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.

1276–1300 of 1563

  • SevereFDA (Drugs)·D-0973-2018·2018-08-01

    Prinston Recalls Valsartan and Hydrochlorothiazide Tablets Due to Carcinogen Impurity

    Prinston Pharmaceutical Inc. is recalling Valsartan and Hydrochlorothiazide tablets because a carcinogen impurity was detected in the active pharmaceutical ingredient.

    Product
    VALSARTAN AND HYDROCHLOROTHIAZIDE — VALSARTAN AND HYDROCHLOROTHIAZIDE (VALSARTAN AND HYDROCHLOROTHIAZIDE)
    Category
    Drug
    Distribution
    0 states
  • SevereFDA (Drugs)·D-0975-2018·2018-08-01

    Prinston Recalls Valsartan and Hydrochlorothiazide Tablets Due to Carcinogen Impurity

    Prinston Pharmaceutical Inc. is recalling Valsartan and Hydrochlorothiazide tablets because a carcinogen impurity was detected in the active pharmaceutical ingredient.

    Product
    VALSARTAN AND HYDROCHLOROTHIAZIDE — VALSARTAN AND HYDROCHLOROTHIAZIDE (VALSARTAN AND HYDROCHLOROTHIAZIDE)
    Category
    Drug
    Distribution
    0 states
  • SevereFDA (Drugs)·D-0969-2018·2018-08-01

    Prinston Recalls Valsartan Tablets Due to Carcinogen Impurity

    Prinston Pharmaceutical Inc is recalling Valsartan tablets because a carcinogen impurity was detected in the active pharmaceutical ingredient.

    Product
    VALSARTAN — VALSARTAN (VALSARTAN)
    Category
    Drug
    Distribution
    0 states
  • SevereFDA (Drugs)·D-0966-2018·2018-08-01

    Major Pharmaceuticals Recalls Valsartan Tablets Due to Carcinogen Impurity

    Major Pharmaceuticals is recalling specific lots of 80 mg Valsartan tablets because a carcinogen impurity was detected in the active ingredient.

    Product
    Unit Dose Valsartan Tablets, USP, 80 mg. Rx only, Distributed by: Major Pharmaceuticals, Livonia, MI 48152, NDC# 0904-6594-61.
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0982-2018·2018-08-01

    Teva Recalls Valsartan and Hydrochlorothiazide Tablets Due to Carcinogen Impurity

    Teva Pharmaceuticals is recalling specific lots of Valsartan and Hydrochlorothiazide tablets because a carcinogen impurity was detected in the active pharmaceutical ingredient.

    Product
    Valsartan and Hydrochlorothiazide (HCTZ) Tablets, USP 160 mg/12.5 mg tablets, USP 90-count bottle, Rx Only, Rx Only, Manufactured by: Arrow Pharma (Malta) Ltd. India, Distributed by: Actavis Pharma, Inc. Parsippany, NJ 07054. NDC 0591-2316-19.
    Category
    Drug
    Distribution
    2 states
  • SevereFDA (Drugs)·D-0981-2018·2018-08-01

    Teva Recalls Valsartan and Hydrochlorothiazide Tablets Due to Carcinogen Impurity

    Teva Pharmaceuticals USA is recalling specific lots of Valsartan and Hydrochlorothiazide tablets because a carcinogen impurity was detected in the active pharmaceutical ingredient.

    Product
    Valsartan and Hydrochlorothiazide (HCTZ) Tablets, USP 80 mg/12.5 mg tablets, 90 count-count bottle, Rx Only, Manufactured by: Arrow Pharma (Malta) Ltd. India, Distributed by: Actavis Pharma, Inc. Parsippany, NJ 07054, NDC 0591-2315-19.
    Category
    Drug
    Distribution
    2 states
  • SevereFDA (Drugs)·D-0984-2018·2018-08-01

    Teva Recalls Valsartan and Hydrochlorothiazide Tablets Due to Carcinogen Impurity

    Teva Pharmaceuticals USA is recalling specific lots of Valsartan and Hydrochlorothiazide tablets because a carcinogen impurity was detected in the active pharmaceutical ingredient.

    Product
    Valsartan and Hydrochlorothiazide (HCTZ) Tablets, USP 320 mg/12.5 mg tablets, USP, 90-count bottle, Rx Only, Rx Only, Manufactured by: Arrow Pharma (Malta) Ltd. India, Distributed by: Actavis Pharma, Inc. Parsippany, NJ 07054. NDC 0591-2318-19
    Category
    Drug
    Distribution
    2 states
  • SevereFDA (Drugs)·D-0970-2018·2018-08-01

    Prinston Recalls Valsartan Tablets Due to Carcinogen Impurity

    Prinston Pharmaceutical Inc is recalling Valsartan tablets because a carcinogen impurity was detected in the active pharmaceutical ingredient.

    Product
    VALSARTAN — VALSARTAN (VALSARTAN)
    Category
    Drug
    Distribution
    0 states
  • SevereFDA (Drugs)·D-0968-2018·2018-08-01

    Prinston Recalls Valsartan Tablets Due to Carcinogen Impurity

    Prinston Pharmaceutical Inc. is recalling Valsartan 40 mg tablets because a carcinogen impurity was detected in the active pharmaceutical ingredient.

    Product
    VALSARTAN — VALSARTAN (VALSARTAN)
    Category
    Drug
    Distribution
    0 states
  • SevereFDA (Drugs)·D-0972-2018·2018-08-01

    Prinston Recalls Valsartan and Hydrochlorothiazide Tablets Due to Carcinogen Impurity

    Prinston Pharmaceutical Inc is recalling Valsartan and Hydrochlorothiazide tablets because a carcinogen impurity was detected in the active pharmaceutical ingredient.

    Product
    VALSARTAN AND HYDROCHLOROTHIAZIDE — VALSARTAN AND HYDROCHLOROTHIAZIDE (VALSARTAN AND HYDROCHLOROTHIAZIDE)
    Category
    Drug
    Distribution
    0 states
  • SevereFDA (Drugs)·D-0987-2018·2018-08-01

    Teva Recalls Valsartan Tablets Due to Carcinogen Impurity

    Teva Pharmaceuticals USA is recalling specific lots of Valsartan Tablets 80 mg because a carcinogen impurity was detected in the active pharmaceutical ingredient.

    Product
    Valsartan Tablets, USP 80 mg, 90-count bottle (NDC 0591-2168-19), 1000-count bottle (NDC 0591-2168-10), Rx Only, Rx Only, Manufactured by: Arrow Pharma (Malta) Ltd. India, Distributed by: Actavis Pharma, Inc. Parsippany, NJ 07054
    Category
    Drug
    Distribution
    2 states
  • SevereFDA (Drugs)·D-0989-2018·2018-08-01

    Teva Recalls Valsartan Tablets Due to Carcinogen Impurity in API

    Teva Pharmaceuticals USA is recalling specific lots of Valsartan Tablets 320 mg because a carcinogen impurity was detected in the active pharmaceutical ingredient.

    Product
    Valsartan Tablets, USP 320 mg, 90-count bottle (NDC 0591-2170-19), 500-count bottle (NDC 0591-2170-05), Rx Only, Rx Only, Manufactured by: Arrow Pharma (Malta) Ltd. India, Distributed by: Actavis Pharma, Inc. Parsippany, NJ 07054.
    Category
    Drug
    Distribution
    2 states
  • SevereFDA (Drugs)·D-0974-2018·2018-08-01

    Prinston Recalls Valsartan and Hydrochlorothiazide Tablets Due to Carcinogen Impurity

    Prinston Pharmaceutical Inc is recalling Valsartan and Hydrochlorothiazide tablets because a carcinogen impurity was detected in the active pharmaceutical ingredient.

    Product
    VALSARTAN AND HYDROCHLOROTHIAZIDE — VALSARTAN AND HYDROCHLOROTHIAZIDE (VALSARTAN AND HYDROCHLOROTHIAZIDE)
    Category
    Drug
    Distribution
    0 states
  • SevereFDA (Drugs)·D-0971-2018·2018-08-01

    Prinston Recalls Valsartan Tablets Due to Carcinogen Impurity

    Prinston Pharmaceutical Inc. is recalling Valsartan tablets because a carcinogen impurity was detected in the active pharmaceutical ingredient.

    Product
    VALSARTAN — VALSARTAN (VALSARTAN)
    Category
    Drug
    Distribution
    0 states
  • SevereFDA (Drugs)·D-0983-2018·2018-08-01

    Teva Recalls Valsartan and Hydrochlorothiazide Tablets Due to Carcinogen Impurity

    Teva Pharmaceuticals USA is recalling specific lots of Valsartan and Hydrochlorothiazide tablets because a carcinogen impurity was detected in the active pharmaceutical ingredient.

    Product
    Valsartan and Hydrochlorothiazide (HCTZ) Tablets, USP 160 mg/25 mg tablets, USP 90-count bottle, Rx Only, Rx Only, Manufactured by: Arrow Pharma (Malta) Ltd. India, Distributed by: Actavis Pharma, Inc. Parsippany, NJ 07054. NDC 0591-2317-19.
    Category
    Drug
    Distribution
    2 states
  • ModerateFDA (Drugs)·D-0917-2018·2018-07-18

    Medgyn Recalls Monsel's Solution for Manufacturing Practice Deviations

    Medgyn Products, Inc. is recalling 2,750 boxes of Monsel's Solution because the product was not manufactured under current good manufacturing practices.

    Product
    Monsel's Solution (Ferric Subsulfate), 20%, packaged as 12 single application vials and 12 applicators, 8 mL per box, Manufactured For: MedGyn Products, Inc., 100 W. Industrial Rd., Addison, IL 60101 USA; Manufactured By: BioDiagnostics Intl, 555 West Lambert Road Unit-C, Brea, C
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0874-2018·2018-06-20

    BioDiagnostic International Recalls Monsel's Solution for CGMP Deviations

    BioDiagnostic International is recalling 1,000 boxes of Monsel's Solution (Ferric Subsulfate) 20% because the product was not manufactured under current good manufacturing practices.

    Product
    Monsel's Solution (Ferric Subsulfate), 20%, packaged as 12 single application vials and 12 applicators, 8 mL per box, Manufactured For: MedGyn Products, Inc., 100 W. Industrial Rd., Addison, IL 60101 USA; Manufactured By: BioDiagnostics Intl, 555 West Lambert Road Unit-C, Brea,
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0851-2018·2018-06-20

    RIJ Pharmaceutical Recalls Senna Syrup Due to Microbial Count Deviation

    RIJ Pharmaceutical LLC is recalling Senna Syrup (Sennosides A and B) due to an out-of-specification total aerobic microbial count in a water sample.

    Product
    SENNA SYRUP — SENNA SYRUP (SENNOSIDES A AND B)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0843-2018·2018-06-20

    RIJ Pharmaceutical Recalls Preferred Plus Pharmacy Antacid Due to Microbial Count

    RIJ Pharmaceutical LLC is recalling Preferred Plus Pharmacy Antacid because a water sample used in manufacturing showed an out-of-specification total aerobic microbial count.

    Product
    Preferred Plus Pharmacy Antacid (Aluminum Hydroxide 200mg, Magnesium Hydroxide 200mg Simethicone 20mg, packaged in 12 FL. OZ. (355 mL) bottles, Manufactured By: RIJ PHARMACEUTICAL CORPORATION 40 Commercial Avenue Middletown, NY 10941, Distributed by: Kinray Inc. Whitestone, NY
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0846-2018·2018-06-20

    RIJ Pharmaceutical Recalls Gericare Acetaminophen Due to Microbial Count

    RIJ Pharmaceutical LLC is recalling Gericare Liquid Pain Relief Acetaminophen due to out-of-specification microbial counts in a water sample.

    Product
    Gericare Liquid Pain Relief Acetaminophen Cherry Flavor 160mg/5mL, packaged in 16 FL OZ (473 mL), Dist. By Gericare Pharmaceuticals 1650 63rd Street Brooklyn, NY 11204, NDC 5789618016, UPC 357896180164
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0849-2018·2018-06-20

    RIJ Pharmaceutical Recalls Ritussin DM Due to Microbial Count Deviation

    RIJ Pharmaceutical is recalling 9,240 bottles of Ritussin DM because a water sample showed an out-of-specification total aerobic microbial count.

    Product
    Ritussin DM Dextromethorphan Hydrobormide (Dextromethorphan HBr, USP 10 mg, Guaifenesin, USP 100mg), packaged in 4 FL.OZ. (118 mL), RIJ PHARMACEUTICAL CORPORATION 40 COMMERCIAL AVENUE, MIDDLETOWN, NY 10941, NDC 5380740904, UPC 35380740941
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0834-2018·2018-05-30

    Ideaz Recalls Screamin' Hot Pain Gel Due to Benzene Levels

    Ideaz LLC is recalling Screamin' Hot Pain Relieving Gel because it was manufactured with benzene levels exceeding FDA limits.

    Product
    screamin' hot (capsaicin) Pain Relieving Gel, 0.03%, packaged in a) 2 OZ (57g) tubes, UPC 7 50263 80072 4; b) 5 oz. (141g) tubes, UPC 7 50263 80007 6; and c) 16 oz. (454g) bottles, UPC 7 50263 80076 2; MFD FOR: Toast Products, 400 Sproul Street, Pittsburgh, PA 15136; NDC 52099-80
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0825-2018·2018-05-30

    Mylan Recalls Loxapine Capsules Due to Manufacturing Deviations

    Mylan Pharmaceuticals is voluntarily recalling 11,650 bottles of Loxapine Capsules 50 mg due to Current Good Manufacturing Practice (CGMP) deviations.

    Product
    Loxapine Capsules, USP 50 mg, Rx Only, 100-count bottles, NDC 0378-7050-01
    Category
    Drug
    Distribution
    1 state
  • ModerateFDA (Drugs)·D-0831-2018·2018-05-30

    Mylan Recalls Prednisolone Sodium Phosphate Tablets Due to Manufacturing Deviations

    Mylan Pharmaceuticals is voluntarily recalling specific lots of Prednisolone Sodium Phosphate tablets due to Current Good Manufacturing Practice (CGMP) deviations.

    Product
    PrednisoLONE Sodium Phosphate Orally Disintegrating Tablets, 30 mg, Rx Only, 48-count bottle, NDC 00378-4730-22
    Category
    Drug
    Distribution
    1 state
  • ModerateFDA (Drugs)·D-0830-2018·2018-05-30

    Mylan Recalls Prednisolone Sodium Phosphate Orally Disintegrating Tablets

    Mylan Pharmaceuticals Inc. is voluntarily recalling PrednisoLONE Sodium Phosphate Orally Disintegrating Tablets due to CGMP deviations.

    Product
    PrednisoLONE Sodium Phosphate Orally Disintegrating Tablets 15 mg, Rx Only, 48-count bottle, NDC 00378-4715-22
    Category
    Drug
    Distribution
    1 state