The Recall Desk

Hazard

Cgmp Violation recalls

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

What the numbers show

Total
108
Critical
0
Severe
3
Most recent
2026-07-08

Of the 108 cgmp violation recalls we have scored against our rubric, 0 (0%) are Critical — deaths or serious injuries reported, or the agency’s own highest classification — and 3 (3%) are Severe.

Which agencies issued them

About this hazard tag

Hazard tags are short, machine-readable labels we attach to every recall to make cross-cutting queries possible — “all cgmp 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.

76–100 of 108

  • ModerateFDA (Drugs)·D-0516-2022·2022-02-09

    REMfresh Advanced Ion-Powered Melatonin Caplets Recalled for cGMP Deviations

    Ultra Seal Corporation is voluntarily recalling REMfresh Advanced Ion-Powered Melatonin 2 mg Caplets nationwide due to current Good Manufacturing Practice (cGMP) deviations. The recall affects 12-count and 36-count blister packages distributed across the United States.

    Product
    REMfresh Advanced Ion-Powered Melatonin (Melatonin 2 mg) Caplets, packaged in a) 12-count blisters b) 36-count blisters Physician's Seal LLC, Boca Raton, FL 33487
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0468-2022·2022-02-09

    Drug Recall: CHLORESIN Cold and Cough Medication Due to Manufacturing Violations

    Ultra Seal Corporation is voluntarily recalling CHLORESIN, a combination cold and cough medication, due to current Good Manufacturing Practice (cGMP) deviations. The recall affects 225,350 packets distributed nationwide.

    Product
    CHLORESIN (acetaminophen 325mg, dextromethorphan HBr 15mg, Guaifenesin 200mg, Phenylephrine HCl 5mg) 2 tablet packets, Manufactured For Afassco Inc. Minden NV 89423, NDC 51532-0107-2
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0431-2022·2022-02-02

    FDA Recalls CSF Otic Insufflation Capsule for CGMP Deviations

    Edge Pharma, LLC is recalling 1055 bottles of CSF Otic Insufflation Capsule containing Sulfacetamide Sodium, Ciprofloxacin, and Amphotericin B nationwide due to CGMP manufacturing deviations.

    Product
    CSF Otic Insufflation Capsule, Sulfacetamide Sodium/ Ciprofloxacin/ Amphotericin B Otic Powder, 50mg / 30mg / 5mg, 5 count bottle, For Otic Use with Insufflator, Edge Pharma, LLC 856 Hercules Dr., Colchester, VT 05446, NDC 05446-1633-05
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0432-2022·2022-02-02

    CSF-HC Otic Powder Drug Recalled for Manufacturing Deviations

    Edge Pharma, LLC is recalling CSF-HC Otic Insufflation Capsule nationwide due to Current Good Manufacturing Practice (CGMP) deviations. The recall affects 440 cartons of this antibiotic and steroid combination powder.

    Product
    CSF-HC Otic Insufflation Capsule, Sulfacetamide Sodium/Ciprofloxacin/Hydrocortisone/Amphotericin B Otic Powder, 50mg/ 30mg/ 25mg/ 5mg, 5 count bottle, Edge Pharma, LLC, 856 Hercules Dr., Colchester, VT 05446, NDC 05446-1634-01
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0015-2022·2021-10-27

    Coppertone Pure & Simple 50 Sunscreen Spray Recall for cGMP Deviations

    Beiersdorf Inc. is recalling Coppertone Pure & Simple 50 Sunscreen Spray due to manufacturing practice deviations. Approximately 36,660 cans were distributed nationwide.

    Product
    Coppertone Pure & Simple 50 Sunscreen Spray (To Deliver) Zinc Oxide 24.08%, NET WT 5 OZ (142 g) can, Beiersdorf Inc., Wilton, CT 06897 UPC 0 72140 02880 0
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0842-2021·2021-10-06

    Neutrogena COOLDRY SPORT Sunscreen Spray Recalled for cGMP Deviations

    Johnson & Johnson Consumer, Inc. is recalling Neutrogena COOLDRY SPORT WITH MICROMESH SUNSCREEN SPRAY (5.5 oz, SPF 50) due to cGMP (current Good Manufacturing Practice) deviations. Approximately 1.4 million cans distributed nationwide are affected.

    Product
    Neutrogena COOLDRY SPORT WITH MICROMESH SUNSCREEN SPRAY Broad Spectrum SPF 50, Avobenzone 2.7%, Homosalate 5%, Octisalate 4.5%, Octocrylene 6%, Oxybenzone 4.5%. NET WT. 5.5 OZ. (155 g) aerosol can, Distributed by: JOHNSON & JOHNSON CONSUMER, INC. Skillman, NJ 08858, UPC 0 86800 1
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0825-2021·2021-09-29

    Zonisamide Capsules Recalled for Manufacturing Deviations

    Glenmark Pharmaceuticals is recalling Zonisamide Capsules 50 mg nationwide due to manufacturing deviations. The recall affects approximately 15,936 bottles across multiple lots with expiration dates in May 2022.

    Product
    ZONISAMIDE — ZONISAMIDE (ZONISAMIDE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0782-2021·2021-09-08

    MEDICALLY MINDED Hand Sanitizer Gel Recalled for Methanol Contamination

    Global Sanitizers LLC is recalling MEDICALLY MINDED Hand Sanitizer Gel (Ethyl Alcohol 70% v/v, 8.5 FL OZ / 250 mL) distributed nationwide due to manufacturing conditions that led to methanol contamination in product lots.

    Product
    MEDICALLY MINDED Hand Sanitizer Gel, ANTIMICROBIAL FORMULA, (Ethyl Alcohol 70% v/v), 8.5 FL OZ / 250 mL bottle, Made in Mexico, Distributed by SBL Brands, LLC Las Vegas, NV 89119. UPC: 6 76753 00359 1 ,
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0723-2021·2021-08-18

    Ethosuximide Oral Solution Recalled Due to Lack of CGMP Compliance

    PAI Holdings is recalling Ethosuximide Oral Solution 250 mg/5 mL (Lot C9BC, expiration 31 October 2022) distributed nationwide due to potential carry-over contamination from Senna Syrup related to lack of current good manufacturing practices.

    Product
    ETHOSUXIMIDE — ETHOSUXIMIDE (ETHOSUXIMIDE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0722-2021·2021-08-18

    Cimetidine Hydrochloride Oral Solution Recalled for CGMP Violation

    Pharmaceutical Associates Inc. is recalling Cimetidine Hydrochloride Oral Solution 300 mg/5 mL due to a lack of Current Good Manufacturing Practice (CGMP) and potential carryover of Senna Syrup.

    Product
    Cimetidine Hydrochloride Oral Solution 300 mg/5 mL, 8 fl oz (237 mL) Rx ONLY, Pharmaceutical Associates, Inc. Greenville, SC 29605, NDC 0121-0649-08
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0696-2021·2021-08-04

    Azelaic Acid 99.0+% Micro 500G Drug Recalled for cGMP Deviations

    API Solutions Inc. is voluntarily recalling Azelaic Acid 99.0+% Micro 500 Grams (Lot #AZA181105, Exp 11/09/2021) distributed in five states due to current Good Manufacturing Practice (cGMP) deviations identified during manufacturing.

    Product
    Azelaic Acid 99.0+% Micro 500 Grams, Distributed By: A.P.I. Solutions Daphne Alabama Manufactured by: Yicheng Chemicals Corp. China Distributed by: Syntec Pharma Corp New York
    Category
    Drug
    Distribution
    5 states
  • SevereFDA (Drugs)·D-0117-2021·2020-12-16

    FDA Recalls Protz Antibacterial Hand Sanitizer for CGMP Violations

    Asiaticon, SA de CV is recalling 111,500 units of Protz Antibacterial Hand Sanitizer distributed in Texas due to a lack of Current Good Manufacturing Practices (CGMPs).

    Product
    Protz real protection Antibacterial Hand Sanitizer, Ethyl Alcohol 70%, 13.5 FL OZ (400 mL), Distributed by: Safety-Med Products, Inc. Burlington, WI 53105 Made in Mexico by Asiaticon S.A. de C.V. Conkal No. 62, Mexico, Ciudad de Mexico 14200, Mexico NDC: 75192-600-02 UPC 7 503019
    Category
    Drug
    Distribution
    1 state
  • ModerateFDA (Drugs)·D-0116-2021·2020-12-16

    V-Klean Hand Sanitizer Gel Recalled for CGMP Violations

    Asiaticon, SA de CV is voluntarily recalling V-Klean Hand Sanitizer Gel Alcohol 70% due to a lack of Current Good Manufacturing Practices (CGMPs).

    Product
    V-Klean Hand Sanitizer Gel Alcohol 70% packaged as a)8.5 fl oz (250 ml), UPC 7 16053 70499 3; b) 16.9 fl oz (500 ml), UPC 7 16053 70499 3; c) 33.8 fl. oz. (1000 ml) bottles: 716053704993; Manufactured by: Asiaticon S.A. de C.V. Conkar 62, Jardines del Ajusco. Tlalpan Cuidad de
    Category
    Drug
    Distribution
    1 state
  • ModerateFDA (Drugs)·D-0113-2021·2020-12-09

    CVS Healing Ointment Recalled for Low Weight Fill Tubes

    US Pharmaceuticals is recalling CVS Health Hydrating Healing Ointment due to low weight fill tubes identified in one lot.

    Product
    CVS Health Hydrating Healing Ointment (Petrolatum 41%), Net Wt 3 OZ (85g), Distributed by CVS Pharmacy, Inc. One CVS Drive, Woonsocket, RI 02895 UPC 0 50428 53642 1
    Category
    Drug
    Distribution
    1 state
  • ModerateFDA (Food)·F-0179-2020·2019-11-27

    Basic Reset Recalls AquaLyte Dietary Supplement for CGMP Violations

    Basic Reset Inc. is recalling AquaLyte dietary supplements because they do not conform to Dietary Supplement CGMP regulations. The product was distributed to all 50 states and several foreign countries.

    Product
    AquaLyte, 30g pkg./foil pouch, SKU: 1023
    Category
    Food
    Distribution
    0 states
  • ModerateFDA (Food)·F-0173-2020·2019-11-27

    Basic Reset Recalls Vibrant Energy Drink Pouches for CGMP Violations

    Basic Reset Inc. is recalling 6,887 cases of Vibrant Energy Drink 15 g foil pouches because the products do not conform to Dietary Supplement CGMP regulations.

    Product
    Vibrant ENERGY DRINK 15 g foil pouches (15 pack case) 100-4A and 100-4B
    Category
    Food
    Distribution
    0 states
  • ModerateFDA (Food)·F-0181-2020·2019-11-27

    Basic Reset Recalls GH-C Dietary Supplement for CGMP Violations

    Basic Reset Inc. is recalling GH-C dietary supplements because they do not conform to Dietary Supplement CGMP regulations. The product was shipped to all 50 states and several foreign countries.

    Product
    GH-C, 60 capsules per plastic bottle, SKU: 100-4F
    Category
    Food
    Distribution
    0 states
  • ModerateFDA (Food)·F-0176-2020·2019-11-27

    Basic Reset Recalls Mello-Tonin Dietary Supplement for CGMP Violations

    Basic Reset Inc. is recalling Mello-Tonin dietary supplements because they do not conform to Dietary Supplement CGMP regulations. The product was distributed to all 50 states and several foreign countries.

    Product
    Mello-Tonin 2 fl. oz. glass bottle, SKU: 100-5C
    Category
    Food
    Distribution
    0 states
  • ModerateFDA (Food)·F-0171-2020·2019-11-27

    Basic Reset Recalls Trim Up Dietary Supplement for CGMP Violations

    Basic Reset Inc. is recalling Trim Up dietary supplement bottles because they do not conform to Dietary Supplement CGMP regulations.

    Product
    TRIM UP DIETARY SUPPLEMENT 80 capsules per plastic bottle, SKU: 100-5A
    Category
    Food
    Distribution
    0 states
  • ModerateFDA (Food)·F-0172-2020·2019-11-27

    Basic Reset Recalls Vibrant Energy Drink for CGMP Violations

    Basic Reset Inc. is recalling 1,980 canisters of Vibrant Energy Drink because the products do not conform to Dietary Supplement CGMP regulations.

    Product
    Vibrant ENERGY DRINK 450 g plastic canister 100-4A
    Category
    Food
    Distribution
    0 states
  • ModerateFDA (Food)·F-0170-2020·2019-11-27

    Basic Reset Recalls Beta Factor Dietary Supplement for CGMP Violations

    Basic Reset Inc. is recalling 262 bottles of Beta Factor dietary supplement because the product does not conform to Dietary Supplement CGMP regulations.

    Product
    BETA FACTOR DIETARY SUPPLEMENT 60 capsules per plastic bottle, SKU: 100-4F
    Category
    Food
    Distribution
    0 states
  • SevereFDA (Drugs)·D-1507-2019·2019-07-31

    Pharma-Natural Recalls Workvie Pain Roll-On for Manufacturing Violations

    Pharma-Natural Inc. is recalling Workvie Instant Pain Relieving Roll On due to current good manufacturing practice deviations, including lack of process and cleaning validation.

    Product
    Workvie Instant Pain Relieving Roll On (Lidocaine HCL 4% + Menthol 1% & Arnica), 2.5oz (71 g) roll on bottle, Exclusively Distributed by: Marketite, LLC., Coral Gables, FL 33134, NDC 72393-201-25.
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-1495-2019·2019-07-31

    FDA Recalls Oliver's Harvest CBD+Lidocaine Cream for Manufacturing Violations

    Pharma-Natural Inc. is recalling Oliver's Harvest CBD+Lidocaine HCL 4% Pain Relief Cream due to current good manufacturing practice violations, including lack of process and cleaning validation.

    Product
    Oliver's Harvest CBD+Lidocaine HCL 4% Pain Relief (Lidocaine HCL 4%) Topical Analgesic Cream, 4 OZ (113.4 g) bottle with pump, Distributed by: Coast to Coast Natural, Inc., Wellington, FL 33414, NDC 63766-119-04.
    Category
    Drug
    Distribution
    Distributed nationwide