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.

926–950 of 1563

  • LowFDA (Food)·F-0540-2021·2021-05-26

    Lopez Gonzalez Santana Recalls BTREX PLUS Dietary Supplement Due to Damaged Tablets

    Lopez Gonzalez Santana Corporation is recalling BTREX PLUS dietary supplement caplets due to the presence of damaged tablets, a Current Good Manufacturing Practice (CGMP) deviation.

    Product
    BTREX PLUS, Dietary Supplement 2 Caplets, UPC 05380930802 (Physician Samples)
    Category
    Drug
    Distribution
    0 states
  • SevereFDA (Drugs)·D-0361-2021·2021-04-21

    Spartan Chemical Recalls Antiseptic Hand Cleaner Due to Manufacturing Deviations

    Spartan Chemical Co Inc is recalling 400 gallons of Antiseptic Hand Cleaner due to CGMP deviations. The product was distributed nationwide in the US, Puerto Rico, and Mexico.

    Product
    ANTISEPTIC HAND CLEANER — ANTISEPTIC HAND CLEANER (CHLOROXYLENOL)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0364-2021·2021-04-21

    Spartan Chemical Recalls Lite'n Foamy Handwash Due to CGMP Deviations

    Spartan Chemical Co Inc is voluntarily recalling 960 containers of Lite'n Foamy Healthcare Personnel Handwash due to CGMP deviations. The product was distributed nationwide in the US, Puerto Rico, and Mexico.

    Product
    LITE NFOAMY HEALTHCARE PERSONNEL HANDWASH — LITE NFOAMY HEALTHCARE PERSONNEL HANDWASH (CHLOROXYLENOL)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0362-2021·2021-04-21

    Spartan Chemical Recalls Lite'n Foamy E2 Sanitizing Handwash Due to CGMP Deviations

    Spartan Chemical Co Inc is voluntarily recalling 2,152 containers of Lite'n Foamy E2 Sanitizing Handwash due to Current Good Manufacturing Practice (CGMP) deviations.

    Product
    LITE NFOAMY E2 SANITIZING HANDWASH — LITE NFOAMY E2 SANITIZING HANDWASH (BENZALKONIUM CHLORIDE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0360-2021·2021-04-21

    Spartan Chemical Recalls foamyiQ Hand Sanitizer Due to Manufacturing Deviations

    Spartan Chemical Company is voluntarily recalling 26,328 cartridges of foamyiQ Lemon Blossom Hand Sanitizer due to Current Good Manufacturing Practice (CGMP) deviations.

    Product
    foamyiQ Lemon Blossom Hand Sanitizer (benzalkonium chloride 0.1%), Net Contents: 42.27 oz/1250 ml per foam pump cartridge, For Institutional and Industrial Use Only, Spartan Chemical Company, Inc., 1110 Spartan Drive, Maumee, OH 43537 USA. UPC 7 53727 26454 4 NDC: 64009-202-06
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0327-2021·2021-04-14

    Cosette Recalls Mometasone Furoate Topical Solution Due to CGMP Deviations

    Cosette Pharmaceuticals is recalling specific lots of Mometasone Furoate Topical Solution due to Current Good Manufacturing Practice (CGMP) deviations.

    Product
    Mometasone Furoate Topical Solution, USP, 0.1%, (Lotion), a) 30 mL (NDC 0713-0701-85) and b) 60 mL (NDC 0713-0701-53), Rx Only, Distributed by: Cosette Pharmaceuticals, Inc., South Plainfield, NJ 07080
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0270-2021·2021-03-03

    Areva Pharmaceuticals Recalls Irinotecan Hydrochloride Injection Due to CGMP Deviations

    Areva Pharmaceuticals is recalling 3,287 vials of Irinotecan Hydrochloride Injection due to manufacturing quality deviations identified in a Warning Letter.

    Product
    Irinotecan Hydrochloride Injection, USP, 40 mg/2 mL (20 mg/mL), 2 mL Single-Dose Vial, Rx Only, Distributed by: Areva Pharmaceuticals, Inc., Gerogetown, IN 47122, Made in India, NDC 59923-714-02.
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0263-2021·2021-02-24

    Ascend Recalls Cephalexin Oral Suspension Due to Impurity Levels

    Ascend Laboratories is recalling Cephalexin for Oral Suspension because unidentified impurities were found at higher levels than allowed.

    Product
    CEPHALEXIN — CEPHALEXIN (CEPHALEXIN)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0264-2021·2021-02-24

    Ascend Recalls Cephalexin Oral Suspension Due to CGMP Deviations

    Ascend Laboratories LLC is recalling Cephalexin for Oral Suspension due to CGMP deviations involving unidentified impurities.

    Product
    CEPHALEXIN — CEPHALEXIN (CEPHALEXIN)
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0125-2021·2020-12-16

    FDA Recalls Imatinib Mesylate Tablets Due to Manufacturing Deviations

    Shilpa Medicare Limited is recalling 4,166 bottles of Imatinib Mesylate 400 mg tablets nationwide due to Current Good Manufacturing Practice (CGMP) deviations.

    Product
    IMATINIB MESYLATE — IMATINIB MESYLATE (IMATINIB MESYLATE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0102-2021·2020-12-02

    SYP Health Hand Sanitizer Recalled for CGMP Deviations and Methanol Risk

    AA Products Inc. is recalling SYP Health Hand Sanitizer Alcohol Gel due to CGMP deviations and a history of subpotent ethanol and methanol contamination at the manufacturing facility.

    Product
    SYP Health Hand Sanitizer Alcohol Gel (ethyl alcohol) 70%, Net Wt. 16.91 FL OZ (500 mL) bottles,Biotecnologia, Educacion y Genetica, S.A. de C.V. Av. Quetra, UPC 9 780201 378624 .
    Category
    Drug
    Distribution
    1 state
  • ModerateFDA (Drugs)·D-0071-2021·2020-11-18

    H & H Remedies Recalls Union Salve Due to CGMP Deviations

    H & H Remedies, LLC is voluntarily recalling 939 jars of Union (black) salve due to Current Good Manufacturing Practice (CGMP) deviations.

    Product
    Union (black) salve packaged in a) 1/8 oz; b) 2 oz.; c) 4 oz.; d) 8 oz.; e) 16 oz.; and f) 32 oz. jars. Mfg & Sold by: H & H Remedies, LLC c/o David A. Cox, 1219 South Broadway, New Philadelphia, OH 44663
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0073-2021·2020-11-18

    H & H Remedies Recalls Vapor Ointment Due to Manufacturing Deviations

    H & H Remedies, LLC is voluntarily recalling 252 jars of Vapor Ointment due to Current Good Manufacturing Practice (CGMP) deviations.

    Product
    Vapor Ointment packaged in a) 1/8 oz; b) 2 oz.; c) 4 oz.; and d) 8 oz jars. Mfg & Sold by: H & H Remedies, LLC c/o David A. Cox, 1219 South Broadway, New Philadelphia, OH 44663
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0060-2021·2020-11-11

    PD-Rx Recalls Metformin Hydrochloride Extended Release Tablets Due to NDMA

    PD-Rx Pharmaceuticals is recalling 125 bottles of Metformin Hydrochloride Extended Release tablets because of NDMA impurity levels above acceptable limits.

    Product
    METFORMIN HYDROCHLORIDE EXTENDED RELEASE — METFORMIN HYDROCHLORIDE EXTENDED RELEASE (METFORMIN HYDROCHLORIDE)
    Category
    Drug
    Distribution
    16 states
  • SevereFDA (Drugs)·D-0061-2021·2020-11-11

    Time-Cap Labs Recalls Metformin Hydrochloride Extended-Release Tablets Due to NDMA Impurity

    Time-Cap Labs, Inc. is recalling Metformin Hydrochloride Extended-Release Tablets 500 mg because the FDA detected the impurity N-Nitrosodimethylamine (NDMA) above acceptable intake levels.

    Product
    METFORMIN HYDROCHLORIDE EXTENDED RELEASE — METFORMIN HYDROCHLORIDE EXTENDED RELEASE (METFORMIN HYDROCHLORIDE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0062-2021·2020-11-11

    Metformin Hydrochloride Extended Release Tablets Recalled for NDMA Impurity

    Marksans Pharma Limited is recalling Metformin Hydrochloride Extended Release tablets due to N-Nitrosodimethylamine (NDMA) impurity levels above acceptable intake limits.

    Product
    METFORMIN HYDROCHLORIDE EXTENDED RELEASE — METFORMIN HYDROCHLORIDE EXTENDED RELEASE (METFORMIN HYDROCHLORIDE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0059-2021·2020-11-11

    PD-Rx Recalls Metformin Hydrochloride Extended Release Due to NDMA Impurity

    PD-Rx Pharmaceuticals is recalling 1,683 bottles of Metformin Hydrochloride Extended Release 500 mg because of NDMA impurity levels above acceptable limits.

    Product
    METFORMIN HYDROCHLORIDE EXTENDED RELEASE — METFORMIN HYDROCHLORIDE EXTENDED RELEASE (METFORMIN HYDROCHLORIDE)
    Category
    Drug
    Distribution
    16 states
  • SevereFDA (Drugs)·D-0056-2021·2020-11-11

    Denton Pharma Recalls Metformin Hydrochloride Tablets Due to NDMA Impurity

    Denton Pharma, Inc. is recalling Metformin Hydrochloride Extended-Release Tablets 750 mg due to the detection of N-Nitrosodimethylamine (NDMA) impurity above acceptable intake levels.

    Product
    Metformin Hydrochloride Extended-Release Tablets USP 750 mg, 30 Tablets bottle, Rx Only, Time-Cap Labs, Inc., Repackaged By: Northwind Pharmaceuticals North Blenheim NY 12131 NDC 70934-334-30
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0039-2021·2020-10-28

    Genesis Hand Sanitizer Gel Recalled for CGMP Deviations

    Genesis Partnership Company SA is recalling 5,040 bottles of hand sanitizer gel due to manufacturing deviations in a facility that produced sub-potent products.

    Product
    Genesis Hand Sanitizer Gel, Topical Solution, Non Sterile Solution, 1 gallon (3785 mL) bottle, Manufactured by Genesis Partnership Company S.A., Guatemala, NDC 74484-002-04, UPC 7401037203427.
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0038-2021·2020-10-28

    Genesis Hand Sanitizer Gel Recalled for CGMP Deviations

    Genesis Partnership Company SA is recalling 15,000 bottles of Genesis Hand Sanitizer Gel due to manufacturing deviations in a facility that produced sub-potent products.

    Product
    Genesis Hand Sanitizer Gel, Topical Solution, Non Sterile Solution, 240 mL (8 FL OZ.) bottle, Manufactured by Genesis Partnership Company S.A., Guatemala, NDC 74484-002-02, UPC 7401037205773.
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0037-2021·2020-10-28

    Panagel Hand Sanitizer Recalled for CGMP Deviations and Sub-Potent Ethanol Risk

    Genesis Partnership Company SA is recalling 33,480 bottles of Panagel Hand Sanitizer due to CGMP deviations and potential sub-potent ethanol levels.

    Product
    Panagel Hand Sanitizer, 70% Alcohol,16 Fl. Oz. (472 mL) bottle, Made in Guatemala, Distributed by Central Med Distribution, 6100 Hollywood Blvd, Hollywood FL 33024, NDC 78384-001-04, UPC 378384000016.
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0005-2021·2020-10-14

    PD-Rx Recalls Nature-Throid Tablets Due to CGMP Deviations and Sub-Potency Risk

    PD-Rx Pharmaceuticals is recalling 20 bottles of Nature-Throid 1 GR tablets due to CGMP deviations and potential sub-potency. The product was distributed in Arizona and Oklahoma.

    Product
    Nature-Throid 1 GR (65 mg), Each Tablet Contains: Thyroid USP 1 GR (65 mg), Liothyronine (T3) 9 mcg, Levothyroxine (T4) 38 mcg, 100 Tablets per bottle, Rx Only, Pkg By PD-Rx Pharmaceuticals Incorporated, Oklahoma City, OK 73127, NDC 43063-819-01.
    Category
    Drug
    Distribution
    2 states
  • SevereFDA (Drugs)·D-0022-2021·2020-10-07

    Blumen Hand Sanitizer Recalled for CGMP Deviations and Methanol Risk

    4e Brands North America is recalling Blumen Advanced Instant Hand Sanitizer due to manufacturing in a facility associated with methanol contamination.

    Product
    blumen ADVANCED INSTANT HAND SANITIZER Clear ETHYL ALCOHOL 70% Natural Boost with Tea Tree Oil, (70% ethyl alcohol), Packaged as a) 18 fl oz / 532 ml bottle, UPC 8 14266 02408 9 b) 33.8 fl oz / 1L bottle, UPC 8 14266 02374 7, Distributed in USA and Canada BY: 4e Brands Northamer
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0025-2021·2020-10-07

    Blumen Aloe Hand Sanitizer Recalled for CGMP Deviations and Methanol Risk

    4e Brands North America is recalling Blumen Aloe Advanced Hand Sanitizer because it was manufactured in a facility associated with methanol contamination, representing poor manufacturing practices.

    Product
    blumen Aloe ADVANCED HAND SANITIZER 70% ALCOHOL CONTENT (70% ethyl alcohol v/v), 3.4 fl. oz./100 mL bottle, Distributed in USA and Canada By: 4e Brands Northamerica LLC, 17806 IH-10W, Suite 300, San Antonio, Texas, 78257, Made in Mexico. UPC 8 14266 02358 7
    Category
    Drug
    Distribution
    Distributed nationwide