The Recall Desk

Hazard

Gmp Violation recalls

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

What the numbers show

Total
823
Critical
49
Severe
376
Most recent
2026-03-04

Of the 823 gmp violation recalls we have scored against our rubric, 49 (6%) are Critical — deaths or serious injuries reported, or the agency’s own highest classification — and 376 (46%) 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 gmp violation 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.

1–25 of 823

  • HighFDA (Drugs)·D-0348-2026·2026-03-04

    Vista Meibo Tears eye drops recalled over sterility assurance failure

    Wizcure Pharmaa is recalling all lots of Vista Meibo Tears Propylene Glycol 0.6% eye drops because the products were not manufactured in conformance with current good manufacturing practices.

    Product
    VISTA MEIBO TEARS PROPYLENE GLYCOL 0.6% W/V ADVANCED DRY EYE RELIEF LUBRICATING DROPS 10 ML — VISTA MEIBO TEARS PROPYLENE GLYCOL 0.6% W/V ADVANCED DRY EYE RELIEF LUBRICATING DROPS 10 ML (PROPYLENE GLYCOL)
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0352-2026·2026-03-04

    BioGlo fluorescein ophthalmic strips recalled over sterility assurance failure

    Wizcure Pharmaa is recalling all lots of BioGlo Fluorescein Sodium Ophthalmic Strips in 100-strip packs because the products were not manufactured in conformance with current good manufacturing practices.

    Product
    BioGlo Fluorescein Sodium Ophthalmic Strips USP, 100 diagnostic strips, Manufactured by Omni Lens PVT. Ltd., 5 - Samrudhhi, Opp. Sakar-III, Navrangpura, Ahmedabad, Gujarat, India - 380014, Email:[email protected], Manufactured for & disibruted by: HUB Pharmaceuticals, LLC, 8767 E
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0351-2026·2026-03-04

    Bio Glo fluorescein strips 300-count recalled over sterility assurance failure

    Wizcure Pharmaa is recalling all lots of Bio Glo Fluorescein Sodium Ophthalmic Strips in 300-strip packs because the products were not manufactured in conformance with current good manufacturing practices.

    Product
    Bio Glo Fluorescein Sodium Ophthalmic Strips USP, 300 diagnostic strips, Manufactured Omni Lens Pvt Ltd 5 - Samruddhi, Opp. Sakar - III, Navrangpura, Ahmedabad - 380014, India, Email:[email protected], Manufactured for & distributed by: HUB Pharmaceuticals, LLC, 8767 E Via de Ven
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0346-2026·2026-03-04

    Vista Tears lubricant eye drops recalled over sterility assurance failure

    Wizcure Pharmaa is recalling all lots of Vista Tears Polyethylene Glycol 400 and Propylene Glycol eye drops because the products were not manufactured in conformance with current good manufacturing practices.

    Product
    Vista Tears Polyethylene Glycol 400 0.4% w/v, Propylene Glycol 0.3% w/v Eye Drops, Dry Eye Relief, Lubricant Drops, Sterile 10 ml (1/3 fl. oz.), Manufactured by: RA/Drugs/ MFG/2019/196283, Omni Lens Pvt. Ltd. 5, Samrudhhi, Opposite:Sakar-III, Navrangpura, Ahmedabad-380014, INDIA.
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0382-2025·2025-04-30

    Rapidol Arnica Gel topical homeopathic medicine recalled for manufacturing violations

    Pharmadel, LLC is recalling Rapidol Arnica Gel (2 oz, 57 g) distributed in Delaware due to manufacturing process deviations. The voluntary recall affects 6,048 bottles of lot EAG-01 with expiration date MAR 27.

    Product
    Rapidol Arnica Gel, Topical Gel, Homeopathic Medicine, 2 oz (57 g), Distributed by: Pharmadel, New Castle, DE 19720, NDC 55758-403-02
    Category
    Drug
    Distribution
    1 state
  • SevereFDA (Drugs)·D-1026-2016·2016-06-15

    Well Care Compounding Pharmacy Recalls Otic Solution Due to Sterility Concerns

    Well Care Compounding Pharmacy is recalling specific lots of Clotrimazole 1%/Betamethasone Dipropionate 0.05% Otic Solution because FDA inspections found GMP violations that may affect sterility.

    Product
    CLOTRIMAZOLE 1%/ BETAMETHASONE DIPROPIONATE 0.05% OTIC SOLUTION, 15mL dropper, Rx only, Well Care Compounding Pharmacy Las Vegas, NV 89121
    Category
    Drug
    Distribution
    1 state
  • SevereFDA (Drugs)·D-1016-2016·2016-06-15

    Well Care Compounding Pharmacy Recalls TRI-MIX # 1 Due to Sterility Concerns

    Well Care Compounding Pharmacy is recalling TRI-MIX # 1 vials because FDA inspections found violations that may affect product sterility.

    Product
    TRI-MIX # 1, packaged in 5mL vials, Rx only, Well Care Compounding Pharmacy Las Vegas, NV 89121
    Category
    Drug
    Distribution
    1 state
  • SevereFDA (Drugs)·D-0990-2016·2016-06-15

    FDA Recalls Compounded HCG and Vitamin Injections for Sterility Concerns

    Well Care Compounding Pharmacy is recalling compounded HCG, methylcobalamin, and folic acid injections due to FDA inspection findings regarding sterility assurance.

    Product
    HCG/METHYLCOBALAMIN/FOLIC ACID,1000IU/5MG/0.4MG/ML; packaged in 5 mL vials, Rx only, Well Care Compounding Pharmacy Las Vegas, NV 89121
    Category
    Drug
    Distribution
    1 state
  • SevereFDA (Drugs)·D-1007-2016·2016-06-15

    Well Care Compounding Pharmacy Recalls QUAD-MIX #2 Due to Sterility Concerns

    Well Care Compounding Pharmacy is recalling QUAD-MIX #2 vials due to FDA inspection findings of GMP violations that may impact sterility.

    Product
    QUAD-MIX #2, packaged in 5mL vial, Rx only, Well Care Compounding Pharmacy Las Vegas, NV 89121
    Category
    Drug
    Distribution
    1 state
  • SevereFDA (Drugs)·D-0988-2016·2016-06-15

    FDA Recalls 1-HCG 1000 IU/ML Due to Sterility Concerns

    Well Care Compounding Pharmacy is recalling 1-HCG 1000 IU/ML vials because FDA inspections identified GMP violations that may impact product sterility.

    Product
    1-HCG 1000 IU/ML, packaged in 5mL and 10mL vials, Rx only, Well Care Compounding Pharmacy Las Vegas, NV 89121
    Category
    Drug
    Distribution
    1 state
  • SevereFDA (Drugs)·D-1002-2016·2016-06-15

    Well Care Compounding Pharmacy Recalls Methylcobalamin/Folic Acid Vials

    Well Care Compounding Pharmacy is recalling Methylcobalamin/Folic Acid vials due to GMP violations that may impact sterility.

    Product
    METHYLCOBALAMIN/FOLIC ACID; 10MG/0.8MG/ML, packaged in 1mL and 5mL vials, Rx only, Well Care Compounding Pharmacy Las Vegas, NV 89121
    Category
    Drug
    Distribution
    1 state
  • SevereFDA (Drugs)·D-0978-2016·2016-06-15

    FDA Recalls 17-0H Progesterone Vials Due to Sterility Concerns

    Well Care Compounding Pharmacy is recalling 17-0H Progesterone vials because FDA inspections found GMP violations that may affect sterility.

    Product
    17-0H PROGESTERONE 250MG/ML, packaged in 5mL vials, Rx only, Well Care Compounding Pharmacy Las Vegas, NV 89121
    Category
    Drug
    Distribution
    1 state
  • SevereFDA (Drugs)·D-1019-2016·2016-06-15

    Well Care Compounding Pharmacy Recalls TRI-MIX # 4 Due to Sterility Concerns

    Well Care Compounding Pharmacy is recalling 869 vials of TRI-MIX # 4 in Nevada due to GMP violations that may impact sterility.

    Product
    TRI-MIX # 4, packaged in 5 mL vials, Rx only, Well Care Compounding Pharmacy Las Vegas, NV 89121
    Category
    Drug
    Distribution
    1 state
  • SevereFDA (Drugs)·D-1024-2016·2016-06-15

    Well Care Compounding Pharmacy Recalls Vitamin B Complex Due to Sterility Concerns

    Well Care Compounding Pharmacy is recalling Vitamin B Complex # 3 vials because FDA inspections found GMP violations that may affect sterility.

    Product
    VITAMIN B COMPLEX # 3, packaged in 5mL vials, Rx only, Well Care Compounding Pharmacy Las Vegas, NV 89121
    Category
    Drug
    Distribution
    1 state
  • SevereFDA (Drugs)·D-0983-2016·2016-06-15

    Estradiol Valerate Recall Due to Sterility Assurance Concerns

    Well Care Compounding Pharmacy is recalling Estradiol Valerate 20mg/mL vials due to GMP violations affecting sterility.

    Product
    ESTRADIOL VALERATE 20MG/ML, packaged in 5mL vials, Rx only, Well Care Compounding Pharmacy Las Vegas, NV 89121
    Category
    Drug
    Distribution
    1 state
  • SevereFDA (Drugs)·D-1006-2016·2016-06-15

    Well Care Compounding Pharmacy Recalls QUAD-MIX #1 Due to Sterility Concerns

    Well Care Compounding Pharmacy is recalling QUAD-MIX #1 vials because FDA inspections found violations that may affect sterility.

    Product
    QUAD-MIX #1, packaged in 5mL vials, Rx only, Well Care Compounding Pharmacy Las Vegas, NV 89121
    Category
    Drug
    Distribution
    1 state
  • SevereFDA (Drugs)·D-1009-2016·2016-06-15

    Well Care Compounding Pharmacy Recalls SUPER TRI-MIX #1 Due to Sterility Concerns

    Well Care Compounding Pharmacy is recalling 869 vials of SUPER TRI-MIX #1 because FDA inspections found violations that may affect sterility.

    Product
    SUPER TRI-MIX #1, packaged in 5mL vials, Rx only, Well Care Compounding Pharmacy Las Vegas, NV 89121
    Category
    Drug
    Distribution
    1 state
  • SevereFDA (Drugs)·D-1025-2016·2016-06-15

    Well Care Compounding Pharmacy Recalls QUAD-MIX #3 Due to Sterility Concerns

    Well Care Compounding Pharmacy is recalling QUAD-MIX #3 vials because FDA inspections found violations that may affect product sterility.

    Product
    QUAD-MIX #3, packaged in 5mL vials, Rx only, Well Care Compounding Pharmacy Las Vegas, NV 89121
    Category
    Drug
    Distribution
    1 state
  • SevereFDA (Drugs)·D-1010-2016·2016-06-15

    Well Care Compounding Pharmacy Recalls SUPER TRI-MIX #4 Due to Sterility Concerns

    Well Care Compounding Pharmacy is recalling 869 vials of SUPER TRI-MIX #4 because FDA inspections found violations that may affect sterility.

    Product
    SUPER TRI-MIX #4, packaged in 5mL vials, Rx only, Well Care Compounding Pharmacy Las Vegas, NV 89121
    Category
    Drug
    Distribution
    1 state
  • SevereFDA (Drugs)·D-0985-2016·2016-06-15

    Gentamicin Ophthalmic Solution Recalled for Sterility Assurance Concerns

    Well Care Compounding Pharmacy is recalling Gentamicin 15 mg/ml Ophthalmic Solution due to FDA inspection findings regarding sterility assurance.

    Product
    GENTAMICIN 15 MG/ML Ophthalmic Solution, Sterile Droppers, Rx only, Well Care Compounding Pharmacy Las Vegas, NV 89121
    Category
    Drug
    Distribution
    1 state