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.

1251–1275 of 1563

  • SevereFDA (Drugs)·D-1114-2018·2018-08-29

    Hetero Labs Recalls Valsartan Tablets Due to Carcinogen Impurity

    Hetero Labs Limited is recalling Valsartan tablets because a carcinogen impurity was detected in the active pharmaceutical ingredient.

    Product
    VALSARTAN — VALSARTAN (VALSARTAN)
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1107-2018·2018-08-29

    Preferred Pharmaceuticals Recalls Valsartan Tablets Due to Carcinogen Impurity

    Preferred Pharmaceuticals is recalling Valsartan Tablets USP 320 mg because a carcinogen impurity was detected in the active pharmaceutical ingredient.

    Product
    Valsartan Tablets USP 320 mg, 90-count, plastic child resistant bottle, Rx Only, Preferred Pharmaceuticals, Inc., 1250 N. Lakeview Ave., Suite O, Anaheim, CA 92807, NDC 68788-6882-9
    Category
    Drug
    Distribution
    1 state
  • SevereFDA (Drugs)·D-1115-2018·2018-08-29

    Hetero Labs Recalls Valsartan Tablets Due to Carcinogen Impurity

    Hetero Labs Limited is recalling Valsartan tablets because a carcinogen impurity was detected in the active pharmaceutical ingredient.

    Product
    VALSARTAN — VALSARTAN (VALSARTAN)
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1110-2018·2018-08-29

    A-S Medication Solutions Recalls Valsartan and Hydrochlorothiazide Tablets

    A-S Medication Solutions LLC is recalling Valsartan and Hydrochlorothiazide Tablets because a carcinogen impurity was detected in the active pharmaceutical ingredient.

    Product
    Valsartan and Hydrochlorothiazide Tablets, Valsartan 160 MG and Hydrochlorothiazide 12.5 MG, 90 tablets per bottle, Rx Only, MFG: Arrow Pharm (Malta) LTD, Birzebbugia, BBG 3000 Malta. NDC: 54569-6480-0
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1109-2018·2018-08-29

    A-S Medication Solutions Recalls Valsartan Tablets Due to Carcinogen Impurity

    A-S Medication Solutions LLC is recalling 178 bottles of Valsartan Tablets, 80 MG, because a carcinogen impurity was detected in the active pharmaceutical ingredient.

    Product
    Valsartan Tablets, 80 MG, 30-count bottle (NDC 54569-6582-0, 90-count bottle (NDC 54569-6582-1), Rx Only, MFG: Zhejiang Huahai Pharma, Linhai, Zhejiang 317024 China
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1113-2018·2018-08-29

    Hetero Labs Recalls Valsartan Tablets Due to Carcinogen Impurity

    Hetero Labs Limited is recalling Valsartan tablets because a carcinogen impurity was detected in the active pharmaceutical ingredient.

    Product
    VALSARTAN — VALSARTAN (VALSARTAN)
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1100-2018·2018-08-22

    RemedyRepack Recalls Valsartan 80 mg Tablets Due to Carcinogen Impurity

    RemedyRepack Inc. is recalling Valsartan 80 mg tablets because a carcinogen impurity was detected in the active pharmaceutical ingredient used to manufacture the product.

    Product
    Valsartan 80 mg Tablet,s HDPE 90 cc bottles in cardboard trays, Rx Only, RemedyRepack, Inc., 625 Kolter Drive, Suite 4, Indiana, PA 15701, NDC 61786-0791-19
    Category
    Drug
    Distribution
    2 states
  • SevereFDA (Drugs)·D-1095-2018·2018-08-22

    Northwind Pharmaceuticals Recalls Valsartan Tablets Due to Carcinogen Impurity

    Northwind Pharmaceuticals is recalling specific lots of Valsartan 160 mg tablets because a carcinogen impurity was detected in the active pharmaceutical ingredient.

    Product
    Valsartan, 160 mg, 30 tablets per bottle, Rx Only, Repackaged By: Northwind Pharmaceuticals, Indianapolis, IN 46256. NDC: 51655-460-52
    Category
    Drug
    Distribution
    1 state
  • SevereFDA (Drugs)·D-1102-2018·2018-08-22

    RemedyRepack Recalls Valsartan 320 mg Tablets Due to Carcinogen Impurity

    RemedyRepack Inc. is recalling specific lots of Valsartan 320 mg tablets because a carcinogen impurity was detected in the active pharmaceutical ingredient.

    Product
    Valsartan 320 mg Tablets, HDPE 90 cc bottles in cardboard trays, Rx Only, RemedyRepack, Inc., 625 Kolter Drive, Suite 4, Indiana, PA 15701, NDC 61786-0793-19
    Category
    Drug
    Distribution
    2 states
  • SevereFDA (Drugs)·D-1098-2018·2018-08-22

    Northwind Pharmaceuticals Recalls Valsartan 320mg Due to Carcinogen Impurity

    Northwind Pharmaceuticals is recalling 14 bottles of Valsartan 320mg tablets distributed in Indiana because a carcinogen impurity was detected in the active pharmaceutical ingredient.

    Product
    Valsartan, 320mg, 30 tablets per bottle, Rx Only, Repackaged By: Northwind Pharmaceuticals, Indianapolis, IN 46256. NDC: 51655-0654-52
    Category
    Drug
    Distribution
    1 state
  • SevereFDA (Drugs)·D-1097-2018·2018-08-22

    Northwind Pharmaceuticals Recalls Valsartan 80mg Due to Carcinogen Impurity

    Northwind Pharmaceuticals is recalling Valsartan 80mg tablets because a carcinogen impurity was detected in the active pharmaceutical ingredient.

    Product
    Valsartan, 80mg, 30 tablets per bottle, Rx Only, Repackaged By: Northwind Pharmaceuticals, Indianapolis, IN 46256. NDC: 51655-0652-52
    Category
    Drug
    Distribution
    1 state
  • SevereFDA (Drugs)·D-1101-2018·2018-08-22

    RemedyRepack Recalls Valsartan 160 mg Tablets Due to Carcinogen Impurity

    RemedyRepack Inc. is recalling Valsartan 160 mg tablets because a carcinogen impurity was detected in the active pharmaceutical ingredient.

    Product
    Valsartan 160 mg Tablets, HDPE 90 cc bottles in cardboard trays, Rx Only, RemedyRepack, Inc., 625 Kolter Drive, Suite 4, Indiana, PA 15701, NDC: 61786-0792-19
    Category
    Drug
    Distribution
    2 states
  • SevereFDA (Drugs)·D-1038-2018·2018-08-15

    NuCare Recalls Valsartan/HCTZ Tablets Due to Carcinogen Impurity

    NuCare Pharmaceuticals is recalling specific lots of Valsartan/HCTZ 160/25mg tablets because a carcinogen impurity was detected in the active pharmaceutical ingredient.

    Product
    Valsartan/HCTZ 160/25mg Tablets, 30-count jar, Rx Only, Packaged by NuCare Pharmaceuticals, Inc., Orange, CA 92867,
    Category
    Drug
    Distribution
    2 states
  • SevereFDA (Drugs)·D-1048-2018·2018-08-15

    Longbow Recalls Emergency First Aid Eyewash Due to Manufacturing Deviations

    Longbow First Aid Products Manufactory is recalling 30,000 bottles of Emergency First Aid Eyewash due to CGMP deviations. The product was distributed in New York and California.

    Product
    Emergency First Aid Eyewash (Purified Water 98.3%), packaged in a) 4fl oz. (118 ml) NDC 7110500002, and b) 0.67 fl (20 ml) NDC 71150000) bottles, Manufactured for: Redicare LLC, Congers, NY
    Category
    Drug
    Distribution
    2 states
  • SevereFDA (Drugs)·D-1037-2018·2018-08-15

    NuCare Recalls Valsartan/HCTZ Tablets Due to Carcinogen Impurity

    NuCare Pharmaceuticals is recalling specific lots of Valsartan/HCTZ tablets because a carcinogen impurity was detected in the active pharmaceutical ingredient.

    Product
    Valsartan/HCTZ 160/12.5 mg Tablets, 90-count jar, Rx Only, Packaged by NuCare Pharmaceuticals, Inc., Orange, CA 92867, NDC 68071-4311-9
    Category
    Drug
    Distribution
    2 states
  • ModerateFDA (Drugs)·D-1043-2018·2018-08-15

    PharMEDium Recalls Fentanyl Citrate IV Bags Due to CGMP Deviations

    PharMEDium Services is recalling specific lots of Fentanyl Citrate IV bags because they were released while a hood certification discrepancy was under investigation.

    Product
    10 mcg/mL Fentanyl Citrate (Preservative Free) in 0.9% Sodium Chloride 250 mL in 250 mL Intravia Bag and 10 mcg/mL Fentanyl Citrate (Preservative Free) in 0.9% Sodium Chloride 100 mL in 150 mL Intravia Bag, PharMEDium Services, LLC.
    Category
    Drug
    Distribution
    0 states
  • ModerateFDA (Drugs)·D-1049-2018·2018-08-15

    Longbow Eyewash Solution Recalled for CGMP Deviations

    Longbow First Aid Products Manufactory is voluntarily recalling 14,400 bottles of Eyewash Purified water 98.3% Ophthalmic Solution due to CGMP deviations.

    Product
    Eyewash Purified water 98.3%, Ophthalmic Solution, packaged in a) 4 FL OZ (NDC 6910-3218-07) and b) 8 Fl OZ (NDC 6910-3218-08) bottles, 77656 Flora Rd, Palm Desert, CA 92211.
    Category
    Drug
    Distribution
    2 states
  • ModerateFDA (Drugs)·D-1045-2018·2018-08-15

    PharMEDium Recalls Rocuronium Bromide Syringes Due to CGMP Deviations

    PharMEDium Services, LLC is recalling 575 syringes of 10 mg/mL Rocuronium Bromide because the product was released while a hood certification discrepancy was under investigation.

    Product
    10 mg/mL Rocuronium Bromide (Preservative Free) 5 mL BD Syringe, PharMEDium Services, LLC.
    Category
    Drug
    Distribution
    0 states
  • ModerateFDA (Drugs)·D-1044-2018·2018-08-15

    PharMEDium Recalls Ephedrine Sulfate Syringes Due to CGMP Deviations

    PharMEDium Services is recalling 450 syringes of Ephedrine Sulfate because the product was released while a hood certification discrepancy was under investigation.

    Product
    5 mg/mL Ephedrine Sulfate (Preservative Free) in 0.9% Sodium Chloride 5 mL in 5 mL BD Syringe Kit Check Tagged, PharMEDium Services, LLC.
    Category
    Drug
    Distribution
    0 states
  • SevereFDA (Drugs)·D-1029-2018·2018-08-08

    Bryant Ranch Recalls Valsartan Tablets Due to Carcinogen Impurity

    Bryant Ranch Prepack Inc. is recalling specific lots of Valsartan 320 mg tablets because a carcinogen impurity was detected in the active pharmaceutical ingredient.

    Product
    VALSARTAN — VALSARTAN (VALSARTAN)
    Category
    Drug
    Distribution
    3 states
  • SevereFDA (Drugs)·D-1028-2018·2018-08-08

    Bryant Ranch Recalls Valsartan 320 mg Tablets Due to Carcinogen Impurity

    Bryant Ranch Prepack Inc. is recalling Valsartan 320 mg tablets because a carcinogen impurity was detected in the active pharmaceutical ingredient.

    Product
    Valsartan 320 mg tablets, 30-count bottles ( NDC 63629-6905-1), 90-count bottles (NDC 63629-6905-2), 28-count bottles (NDC 6362-96905-3), Rx Only, Packaged by Bryant Ranch, Burbank, CA 91504.
    Category
    Drug
    Distribution
    3 states
  • SevereFDA (Drugs)·D-1027-2018·2018-08-08

    Bryant Ranch Recalls Valsartan 80 mg Tablets Due to Carcinogen Impurity

    Bryant Ranch Prepack Inc. is recalling specific lots of Valsartan 80 mg tablets because a carcinogen impurity was detected in the active pharmaceutical ingredient.

    Product
    Valsartan 80 mg tablets, 90-count bottles (NDC 63629-6922-2), 60-count bottles ( 63629-6922-3), 28-count bottles (63629-6922-4), Rx Only, Packaged by Bryant Ranch, Burbank, CA 91504.
    Category
    Drug
    Distribution
    3 states
  • SevereFDA (Drugs)·D-1020-2018·2018-08-08

    RemedyRepack Recalls Valsartan/HCTZ Tablets Due to Carcinogen Impurity

    RemedyRepack Inc. is recalling Valsartan/HCTZ 160 mg/12.5 mg tablets because a carcinogen impurity was detected in the active pharmaceutical ingredient.

    Product
    Valsartan/HCTZ 160 mg/12.5 mg tablet, 90-count bottle, Rx only, RemedyRepack, 625 Kolter Drive, Suite 4, Indiana, PA 15701
    Category
    Drug
    Distribution
    1 state
  • SevereFDA (Drugs)·D-0986-2018·2018-08-01

    Teva Recalls Valsartan Tablets Due to Carcinogen Impurity in API

    Teva Pharmaceuticals USA is recalling specific lots of Valsartan Tablets 40 mg because a carcinogen impurity was detected in the active pharmaceutical ingredient.

    Product
    Valsartan Tablets, USP 40 mg, 30-count bottle (NDC 0591-2167-30), 90-count bottle (NDC 0591-2167-19), 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-0988-2018·2018-08-01

    Teva Recalls Valsartan Tablets Due to Carcinogen Impurity in API

    Teva Pharmaceuticals USA is recalling specific lots of Valsartan Tablets 160 mg because a carcinogen impurity was detected in the active pharmaceutical ingredient.

    Product
    Valsartan Tablets, USP 160 mg, 90-count bottle (NDC 0591-2169-19), 1000-count bottle (NDC 0591-2169-10), Rx Only, Rx Only, Manufactured by: Arrow Pharma (Malta) Ltd. India, Distributed by: Actavis Pharma, Inc. Parsippany, NJ 07054
    Category
    Drug
    Distribution
    2 states