The Recall Desk

Hazard

Gmp Deviation 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
16
Most recent
2026-04-08

Of the 108 gmp deviation recalls we have scored against our rubric, 0 (0%) are Critical — deaths or serious injuries reported, or the agency’s own highest classification — and 16 (15%) 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 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.

76–100 of 108

  • ModerateFDA (Drugs)·D-0814-2018·2018-05-23

    Milbar Recalls MD Complete Clarifying Cleanser Due to GMP Deviations

    Milbar Laboratories is voluntarily recalling 14,491 tubes of MD Complete Clarifying Cleanser due to Good Manufacturing Practice (GMP) deviations.

    Product
    MD Complete Clarifying Cleanser (Salicylic Acid 2.0%), 3 fl oz, (88.7mL), MD Professional LLC, Minneapolis, MN
    Category
    Drug
    Distribution
    1 state
  • ModerateFDA (Drugs)·D-0813-2018·2018-05-23

    Milbar Recalls Naturmetic Sunscreen Due to Manufacturing Deviations

    Milbar Laboratories is recalling 4,815 tubes of Naturmetic SPF 50 Sunscreen due to Good Manufacturing Practice (GMP) deviations.

    Product
    Naturmetic SPF 50 Sunscreen (Octinoxate 7.5%, Zinc Oxide 10.5%), 2.0 fl oz/60mL bottles, Fortis BioPharma, Magnolia, TX 77354.
    Category
    Drug
    Distribution
    1 state
  • ModerateFDA (Drugs)·D-0624-2018·2018-04-18

    FDA Recalls Zhong Hua Jiu Menthol Patches for GMP Deviations

    United Pacific Co Ltd is recalling Zhong Hua Jiu (menthol 1%) Patches because they were produced with substandard GMP manufacturing processes.

    Product
    Zhong Hua Jiu (menthol 1%) Patch, Distributed by United Pacific Company, UPC 6 924938 100226, NDC 53614-001-02
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0218-2018·2018-01-24

    Shiseido Future Solutions LX Triple Points Bonus Recalled for GMP Deviations

    Shiseido America Inc. is recalling Shiseido Future Solutions LX Triple Points Bonus because the manufacturing of the active pharmaceutical ingredient did not meet GMP and quality requirements.

    Product
    Shiseido Future Solutions LX Triple Points Bonus contains SPF 50+ (octinoxate 4.9%, octocrylebe 3.0%, oxybenzone 1.0% and zinc oxide 15.4%), packaged in 15 mL tubes, Shiseido Americas Corporation Dist. New York, NY 10022, NDC 58411-256-60
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0217-2018·2018-01-24

    Shiseido Eye and Lip Collection Recalled for GMP Deviations

    Shiseido America Inc. is recalling the Future Solution LX Luxurious Eye & Lip Collection because the manufacturing of active pharmaceutical ingredients did not meet GMP and quality requirements.

    Product
    Shiseido Future Solution LX Luxurious Eye & Lip Collection contains SPF 50+ (octinoxate 4.9%, octocrylebe 3.0%, oxybenzone 1.0% and zinc oxide 15.4%), packaged in 15 mL tubes, Shiseido Americas Corporation Dist. New York, NY 10022
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0215-2018·2018-01-24

    Shiseido Sunscreen Recalled for Manufacturing Quality Deviations

    Shiseido America Inc. is recalling Future Solution LX Universal Defense SPF 50+ sunscreen because the manufacturing of active ingredient material did not meet GMP and quality requirements.

    Product
    Shiseido Future Solution LX Universal Defense SPF 50+ (octinoxate 4.9%, octocrylebe 3.0%, oxybenzone 1.0% and zinc oxide 15.4%), packaged in a) 2mL, b) 15 mL and c) 50 mL tubes, Shiseido Americas Corporation Dist. New York, NY 10022. NDC 58411-256-60
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0216-2018·2018-01-24

    Shiseido Future Solution LX Discovery Set Recalled for GMP Deviations

    Shiseido America Inc. is recalling the Future Solution LX Discovery Set because the manufacturing of active pharmaceutical ingredients did not meet GMP and quality requirements.

    Product
    Shiseido Future Solution LX Discovery Set contains SPF 50+ (octinoxate 4.9%, octocrylebe 3.0%, oxybenzone 1.0% and zinc oxide 15.4%), packaged in 15 mL tubes, Shiseido Americas Corporation Dist. New York, NY 10022,
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0214-2018·2018-01-24

    Shiseido Recalls bareMinerals Sunscreen Lotion Due to GMP Deviations

    Shiseido America Inc. is recalling bareMinerals Broad Spectrum SPF 50 Daily Prep Lotion because the manufacturing of active pharmaceutical ingredients did not meet GMP and quality requirements.

    Product
    bareMinerals Broad Spectrum SPF 50 Daily Prep Lotion (zinc oxide 23.8%, titanium dioxide 4.1%), 40 mL/1.35 fl. oz. bottle, Dist. by Bare Escentuals Beauty, Inc. SF, CA 94105 USA, NDC 98132-761-01
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0087-2018·2017-11-29

    FDA Recalls Extra Strength PreTAT Gel Due to Manufacturing Control Issues

    Ridge Properties, LLC is recalling Extra Strength PreTAT by TAT BALM Gel because of inadequate manufacturing control processes. The product was distributed throughout the United States.

    Product
    Extra Strength PreTAT by TAT BALM Gel, (lidocaine HCL 4%), 1/2 oz Gel (NDC 69804-018-09), 1 oz Gel (NDC 69804-018-10) , 2 oz Gel (NDC 69804-018-11), and 4 oz Gel (NDC 69804-018-12) jars, Manufactured by Pain Relief Naturally, www.Naturally HL.com
    Category
    Drug
    Distribution
    0 states
  • ModerateFDA (Drugs)·D-0090-2018·2017-11-29

    FDA Recalls Naturally HL Hemorrhoid Balm for Manufacturing Control Issues

    Ridge Properties, LLC is recalling Naturally HL Hemorrhoid Numbing Balm due to inadequate manufacturing control processes. The product was distributed throughout the United States.

    Product
    Extra Strength Naturally HL Hemorrhoid Numbing with Lidocaine, (lidocaine HCL 4%), 1/2 oz Balm (NDC 69804-014-06), and 2 oz Balm(NDC 69804-014-03), Manufactured by Pain Relief Naturally, www.Naturally HL.com
    Category
    Drug
    Distribution
    0 states
  • ModerateFDA (Drugs)·D-0089-2018·2017-11-29

    Ridge Properties Recalls Naturally HL Hemorrhoid Gel Due to Manufacturing Issues

    Ridge Properties, LLC is recalling Naturally HL Liquid Hemorrhoid Relief Gel due to inadequate manufacturing control processes. The product was distributed throughout the United States.

    Product
    Extra Strength Naturally HL Liquid Hemorrhoid Relief Gel, (lidocaine HCL 4%), 1/2 oz Liquid Gel (NDC 69804-024-13), 1 oz Liquid Gel (NDC 69804-024-14), 2 oz Liquid Gel (NDC 69804-024-15), 4 oz Liquid Gel (NDC 69804-024-16) bottles, Manufactured by Pain Relief Naturally, www.Natu
    Category
    Drug
    Distribution
    0 states
  • ModerateFDA (Drugs)·D-0088-2018·2017-11-29

    FDA Recalls Naturally HL Hemorrhoid Spray for Manufacturing Control Issues

    Ridge Properties, LLC is recalling Naturally HL Hemorrhoid Numbing Spray due to inadequate manufacturing control processes. The product was distributed throughout the United States.

    Product
    Extra Strength Naturally HL Hemorrhoid Numbing Spray with Lidocaine, (lidocaine HCL 4%), 1/2 oz Spray (NDC 69804-015-08), 1 oz Spray (NDC 69804-015-07), 2 oz Spray (NDC 69804-015-01) and 4 oz Spray (NDC 69804-015-04) bottles, Manufactured by Pain Relief Naturally, www.Naturally H
    Category
    Drug
    Distribution
    0 states
  • ModerateFDA (Drugs)·D-0086-2018·2017-11-29

    Ridge Properties Recalls Bed Sore Cream Due to Manufacturing Control Issues

    Ridge Properties, LLC is recalling Extra Strength Naturally HL Bed Sore Relief Cream with Added Lidocaine due to inadequate manufacturing control processes.

    Product
    Extra Strength Naturally HL Bed Sore Relief Cream with Added Lidocaine, (lidocaine HCL 4%), 1/2 oz Balm(NDC 69804-008-06), 1 oz Balm (NDC 69804-008-05), 2 oz Balm(NDC 69804-008-02), and 4 oz Balm(NDC 69804-008-03), Manufactured by Pain Relief Naturally, www.Naturally HL.com
    Category
    Drug
    Distribution
    0 states
  • SevereFDA (Drugs)·D-0002-2018·2017-10-11

    Inopak Recalls Antibacterial Hand Wash Due to Potential Bacterial Contamination

    Inopak Ltd is recalling Option Systems and STYLE Antibacterial Hand Wash due to GMP deviations and potential bacterial contamination from a pump.

    Product
    Option Systems Antibacterial Foaming Hand Wash, 0.3% P.C.M.X., 8 fl oz and 18 fl oz. bottles and 500, mL 800 mL, and 1000 mL pouches, ALSO labeled as STYLE Antibacterial Hand Soap, Inopak Ltd Ringwood, NJ --- NDC 5031-431-02
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0004-2018·2017-10-11

    Inopak Choice Antibacterial Hand Soap Recalled for Potential Bacterial Contamination

    Inopak Ltd is recalling Choice Antibacterial Hand Soap due to GMP deviations and potential bacterial contamination from a pump.

    Product
    Choice Antibacterial Hand Soap, (ethyl alcohol 61%) 800 ml/ 27 fl oz, Universal Valve, Inopak LTD, Ringwood, NJ
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0003-2018·2017-10-11

    Inopak Recalls Mild Healthcare Antibacterial Hand Soap Due to Contamination Risk

    Inopak Ltd is recalling specific batches of Mild Healthcare Antibacterial Hand Soap due to potential bacterial contamination from a defective pump.

    Product
    Mild Healthcare Antibacterial Hand Soap, 6% P.C.M.X., 1000 mL and 2000 mL Disc Pump, 800 mL Universal Valve, and 1 gallon bottles, Inopak. Ltd, Ringwood, NJ 07456
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-1060-2017·2017-08-16

    AtHome Medical Recalls Liquid Oxygen Due to GMP Deviations

    AtHome Medical, Inc. is recalling 80 lbs of Oxygen Refrigerated Liquid USP due to a lack of standard operating procedures for testing out-of-specification products.

    Product
    Oxygen Refrigerated Liquid USP UN 1073, Rx only, At Home Medical 200 American Road, Morris Plains, NJ 07950,973-538-0485.
    Category
    Drug
    Distribution
    1 state
  • SevereFDA (Drugs)·D-0951-2017·2017-07-12

    Phillips Recalls StaphWash Skin Protectant Due to Manufacturing Deviations

    Phillips Co. is recalling StaphWash+Plus+ Skin Protectant because FDA inspections found manufacturing practices that question the product's safety and quality.

    Product
    StaphWash+Plus+ Skin Protectant, Zinc acetate (.1% by volume), 0.3 fl. oz. (3 mL) bottle, Phillips Company, Millerton, OK -- NDC 43074-101-01
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0948-2017·2017-07-12

    TetraStem Topical Antibiotic Ointment Recalled for Manufacturing Deviations

    Phillips Co. is recalling TetraStem Topical Ointment First Aid Antibiotic because FDA inspections found significant manufacturing deviations that raise questions about product safety and quality.

    Product
    TetraStem brand Topical Ointment First Aid Antibiotic, tetracycline (3%), 3 mL in a 5 mL bottle, sold over the counter Phillips Company, Millerton, OK -- NDC 04307-301-11
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0947-2017·2017-07-12

    Phillips Tetracycline Ointment Recalled for Manufacturing Quality Concerns

    Phillips Co. is recalling Tetracycline-ABC Brand Topical Ointment because FDA inspections found significant manufacturing deviations that raise questions about product safety and quality.

    Product
    Tetracycline-ABC Brand Topical ointment First Aid Antibiotic, tetracycline (3%), 3 mL in a 5 mL bottle, sold over the counter Phillips Company, Millerton, OK -- NDC 4307410201
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0952-2017·2017-07-12

    Phillips Co. Recalls VenomX Zinc Acetate Skin Protectant Due to GMP Deviations

    Phillips Co. is recalling VenomX Zinc Acetate Skin Protectant because FDA inspections found manufacturing practices that question the product's safety and quality.

    Product
    VenomX, Zinc acetate (.1% by volume), 0.3 fl. oz. (3 mL) bottles, Skin Protectant Phillips Company, Millerton, OK -- NDC 43074-207-01
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0898-2017·2017-06-21

    Hospira Recalls Levophed Injection Due to Foreign Stopper Observation

    Hospira is recalling specific lots of Levophed (norepinephrine bitartrate) injection after a foreign stopper was observed during packaging.

    Product
    LEVOPHED — LEVOPHED (NOREPINEPHRINE BITARTRATE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0866-2017·2017-05-31

    Gentell Recalls Moisture Barrier Cream Due to Manufacturing Deviations

    Gentell, Inc. is recalling 65 gallons of Shield and Protect Moisture Barrier Cream because it may not meet cGMP requirements.

    Product
    Shield and Protect Moisture Barrier Cream, 1.1% Clotrimazole, Net Weight 4 oz - 115 g Anti-Fungal, Gentell, Inc., Bristol, PA NDC 61554-232-40
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0779-2016·2016-03-30

    AGA Gas Recalls Bulk Liquid Oxygen Due to GMP Deviations

    AGA Gas Inc is recalling 1,500 gallons of bulk liquid oxygen because the delivery trailer may not have met GMP requirements prior to filling.

    Product
    Oxygen, USP, 99.0%, Bulk Cryogenic Liquid, Rx, Airgas Merchant Gases, LLC, Independence, OH --- NDC 33237-001-01
    Category
    Drug
    Distribution
    1 state
  • SevereFDA (Drugs)·D0384-2015·2015-02-18

    AnazaoHealth Recalls Compounded Plaquex Intravenous Injection Due to Unapproved Ingredient Source

    AnazaoHealth Corporation is recalling 51 vials of Compounded Plaquex intravenous injection nationwide because the product contains an active pharmaceutical ingredient from an unapproved source.

    Product
    Compounded Plaquex, intravenous injection, 50 ML vial. Each ml contains: Phosphatidyl Choline 50 mg, Sodium Deoxycholate 25 mg, Benzyl Alcohol 0.9%, Ethanol (95%) 2.4 mg di Alpha Tocopheryl Acetate 0.2 mg in Sterile Water for injection.
    Category
    Drug
    Distribution
    Distributed nationwide