The Recall Desk

Hazard

Cgmp Deviation recalls

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

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.

1–25 of 547

  • SevereFDA (Drugs)·D-0544-2026·2026-05-27

    Erythromycin Tablets Recalled for Impurity Above Acceptable Limits

    Zydus Pharmaceuticals is recalling Erythromycin Tablets, 250 mg, nationwide because certain lots contain N-Nitroso-Desmethyl-Erythromycin above the recommended acceptable intake limit due to CGMP deviations.

    Product
    ERYTHROMYCIN — ERYTHROMYCIN (ERYTHROMYCIN)
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0545-2026·2026-05-27

    Erythromycin 500 mg Tablets Recalled for Impurity Above Limits

    Zydus Pharmaceuticals is recalling erythromycin 500 mg tablets nationwide due to the presence of N-Nitroso-Desmethyl-Erythromycin above the recommended acceptable intake limit, resulting from manufacturing deviations.

    Product
    ERYTHROMYCIN — ERYTHROMYCIN (ERYTHROMYCIN)
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Food)·H-0806-2026·2026-05-27

    Liposomal D3+B12 Spray Recalled for Manufacturing Practice Deviations

    Wellnov Supplements is recalling Liposomal D3+B12 Spray due to manufacturing practice deviations that could allow bacterial pathogens including C. Botulinum to contaminate the product. No illnesses have been reported.

    Product
    Liposomal D3+B12 Spray. Dosage: 3 sprays Liquid. Packaging: Aluminum bottle. 30 ml. Firm Address: VitaminAlly LLC Chandler, AZ 85225.
    Category
    Food
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0501-2026·2026-05-06

    Similasan iVIZIA Sterile Lubricant Eye Drops Recall Due to Sterility Assurance

    Thea Pharma, Inc. is recalling Similasan iVIZIA Sterile Lubricant Eye Drops due to the lack of assurance of sterility caused by manufacturing deviations found by the FDA.

    Product
    Similasan, iVIZIA, Sterile Lubricant Eye Drops (Povidone 0.5%), 0.33 Fl oz (10 mL), Made in France, Distributed by: Thea Pharma Inc., Waltham, MA 02451, NDC 59262-700-11
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0503-2026·2026-05-06

    Fentanyl Citrate Injectable Solution Recalled for cGMP Deviations

    Wells Pharma is recalling fentanyl citrate injectable solution (1000 mcg/100 mL, 10 mcg per mL) distributed nationwide due to current good manufacturing practice (cGMP) deviations. The recall affects 4,030 IV bags with various lot numbers and expiration dates between April and June 2026.

    Product
    fentaNYL Citrate Injectable Solution, NARCOTIC, Cii, 1000 mcg/100 mL (10 mcg per mL), 100 mL bag, Wells Pharma in Houston, NDC 73702-202-02.
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0504-2026·2026-05-06

    Fentanyl Citrate Injectable Solution Recalled for cGMP Deviations

    Wells Pharma of Houston is voluntarily recalling 2,940 IV bags of fentanyl citrate injectable solution due to cGMP (current good manufacturing practice) deviations. The product was distributed nationwide.

    Product
    fentaNYL Citrate injectable Solution in 0.9% Sodium Chloride, Narcotic, (2500 mcg/ 250 mL) (10 mcg per mL), 250 mL bag, wells pharma of Houston, NDC 73702-202-03.
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0507-2026·2026-05-06

    Ketamine Hydrochloride Injectable Solution Recalled for cGMP Deviations

    Wells Pharma of Houston LLC is recalling 4,975 syringes of Ketamine Hydrochloride Injectable Solution (50 mg/mL) distributed nationwide due to current Good Manufacturing Practice (cGMP) deviations.

    Product
    Ketamine Hydrochloride Injectable Solution, 50mg/ml, (50 mg per mL) Volume: 1 mL, 5265 Kitty Drive, Houston, TX 77054, NDC 73702-302-31.
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0502-2026·2026-05-06

    Injectable Phenylephrine Hydrochloride Solution Recall Due to cGMP Deviations

    Wells Pharma of Houston LLC is recalling Phenylephrine Hydrochloride Injectable Solution, 40 mg, 250 mL IV bags nationwide due to cGMP deviations. The recall affects 13,070 IV bags with multiple lot numbers and expiration dates through July 2026.

    Product
    Phenylephrine Hydrochloride Injectable Solution, 40mg, 250*mL Bag, wells pharma of Houston, NDC 73702-122-03
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0450-2026·2026-04-22

    FDA Recalls Cinacalcet Tablets for N-Nitroso Impurity Exceeding Limits

    Cipla USA is recalling Cinacalcet Hydrochloride tablets nationwide due to N-Nitroso Cinacalcet impurity exceeding acceptable daily intake limits. No illnesses have been reported.

    Product
    CINACALCET — CINACALCET (CINACALCET)
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0449-2026·2026-04-22

    Cinacalcet tablets recalled due to N-nitroso impurity above acceptable limits

    Cipla USA recalls Cinacalcet 30 mg tablets nationwide due to manufacturing deviations that resulted in N-nitroso Cinacalcet above acceptable daily intake limits. No illnesses have been reported.

    Product
    CINACALCET — CINACALCET (CINACALCET)
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0368-2026·2026-03-11

    Hand sanitizing wipes recalled due to manufacturing practice deviations

    ACME UNITED CORPORATION has voluntarily recalled Wipes Plus hand sanitizing wipes due to CGMP deviations. No illnesses have been reported.

    Product
    Wipes Plus, Hand Sanitizing Alcohol Free BZK Wipes (Benzalkonium Chloride 0.13%), Manufactured for: CFS Brands DBA WipesPlus, 4711 E. Heiner Rd. Oklahoma City, OK 73331, NDC 67151-333-01.
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0380-2026·2026-03-11

    Semaglutide compounding ingredient recalled for unvalidated manufacturing processes

    Harbin Jixianglong Biotech is recalling semaglutide raw ingredient used for pharmacy compounding due to incomplete process and endotoxin testing validation before distribution.

    Product
    Semaglutide, For Rx compounding use only, packaged in a) 1g, NDC 84385-106-01; b) 5g, NDC 84385-106-02; c) 10g, NDC 84385-106-06; d) 25g, NDC 84385-106-03; d) 50g, NDC 84385-106-04; e) 100g, NDC 84385-106-05Manufacturer: Harbin Jixianglong Biotech Co., Ltd., North of Baoan Road,
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0374-2026·2026-03-11

    Green Guard Antiseptic Wipes recalled for manufacturing quality deviations

    Green Guard Antiseptic Wipes are being recalled due to manufacturing quality deviations. The firm initiated the recall voluntarily.

    Product
    GREEN GUARD ANTISEPTIC WIPES — GREEN GUARD ANTISEPTIC WIPES (BENZALKONIUM CHLORIDE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0371-2026·2026-03-11

    OTC Antiseptic Towelettes Recalled for Manufacturing Practice Violations

    Med-Nap Cleansing Towelettes containing benzalkonium chloride are being recalled nationwide by Acme United Corporation due to Current Good Manufacturing Practice (CGMP) deviations.

    Product
    MED NAP CLEANSING TOWELETTE — MED NAP CLEANSING TOWELETTE (BENZALKONIUM CHLORIDE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0367-2026·2026-03-11

    Benzalkonium Chloride Antiseptic Towelettes Recalled Due to Manufacturing Deviations

    Acme United Corporation is voluntarily recalling Med-Nap Benzalkonium Chloride Antiseptic Towelettes nationwide due to manufacturing quality deviations. The recall affects multiple lot numbers with expiration dates through October 2028.

    Product
    MED NAP BENZALKONIUM CHLORIDE ANTISEPTIC — MED NAP BENZALKONIUM CHLORIDE ANTISEPTIC (BENZALKONIUM CHLORIDE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0364-2026·2026-03-11

    Drug Recall: Savannah Antibacterial Towelettes Due to Manufacturing Deviations

    ACME UNITED CORPORATION is recalling Savannah Antibacterial Towelettes nationwide due to Good Manufacturing Practice deviations. No illnesses have been reported.

    Product
    Savannah Antibacterial Towelettes (Benzalkonium Chloride 0.13%), 1 towelette, 4 x 7, R&R Enterprise, NDC 59647-749-02
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0366-2026·2026-03-11

    Antiseptic towelettes recalled due to manufacturing practice deviations

    Med Nap Benzalkonium Chloride Antiseptic towelettes are being recalled nationwide due to manufacturing practice deviations. This voluntary recall was initiated by Acme United Corporation with no reported adverse events.

    Product
    MED NAP BENZALKONIUM CHLORIDE ANTISEPTIC — MED NAP BENZALKONIUM CHLORIDE ANTISEPTIC (BENZALKONIUM CHLORIDE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0369-2026·2026-03-11

    FDA Recalls BZK Pads Benzalkonium Chloride Cleanser for Manufacturing Deviations

    Acme United Corporation is recalling BZK Pads (Benzalkonium Chloride 0.13%) obstetrical towelettes nationwide due to manufacturing process deviations. No illnesses or injuries have been reported.

    Product
    BZK PADS — BZK PADS (BENZALKONIUM CHLORIDE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0360-2026·2026-03-11

    OTC Drug Topical Antiseptic Recalled for Manufacturing Quality Violations

    ACME United Corporation is recalling BZK Antiseptic Towelettes nationwide due to Current Good Manufacturing Practice (CGMP) violations. The firm initiated this voluntary recall to address manufacturing process deviations.

    Product
    BZK TOWELETTE — BZK TOWELETTE (BENZALKONIUM CHLORIDE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0362-2026·2026-03-11

    FDA Recalls BZK Antiseptic Towelettes Due to Manufacturing Deviations

    ACME UNITED CORPORATION is recalling multiple brands of BZK Antiseptic Towelettes nationwide due to manufacturing compliance deviations. The firm initiated this voluntary recall on January 20, 2026.

    Product
    1) BZK Antiseptic Towelettes (Benzalkonium Chloride 0.13%) 5"x7" Piedmont Sanitizing Hand Wipes, 1,000 ea Bulk, Made in USA for: Food Service Resources, Flowery Branch, GA 30542, NDC 0924-7130-00. 2) BZK Antiseptic Towelettes (Benzalkonium Chloride 0.13%) 5" x 7" Touchpoint, 1
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0281-2026·2026-01-21

    Personal Care Ice Gel Recalled Due to Insanitary Conditions and Rodent Exposure

    Gold Star Distribution Inc is recalling Personal Care Ice Gel (8oz, 12 count) distributed nationwide due to insanitary conditions and rodent exposure in its distribution center.

    Product
    Personal Care, Ice Gel, 8oz, 12 count, UPC 048155903463
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0279-2026·2026-01-21

    TUMS Antacid Tablets Recalled Due to Insanitary Conditions in Distribution Center

    TUMS antacids manufactured by Gold Star Distribution Inc are being recalled due to insanitary conditions including rodent exposure in the distribution center. No illnesses have been reported.

    Product
    TUMS a) Assorted, 12 Ct.; b) Extra Strength (EX) Assorted Berries, 12-count #1194A *05/27; c)Extra Strength (EX) Assorted Fruit, 12-count, #1194C *03/27
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0253-2026·2026-01-14

    ORL Kids Natural Toothpaste Recalled for Manufacturing Deviations

    Signature Formulations is recalling ORL Kids Natural Toothpaste in Bubblegum flavor due to manufacturing compliance deviations. The recall affects 1,458 containers distributed only in Arizona.

    Product
    ORL Kids Natural Toothpaste, Bubblegum Flavor, 4 oz (120ml), ORL Labs, LLC, Scottsdale, Arizona USA
    Category
    Drug
    Distribution
    1 state
  • HighFDA (Drugs)·D-0205-2026·2025-12-10

    Zinc Oxide Ointment Recalled Due to Manufacturing Practice Deviations

    Blossom Pharmaceuticals is recalling Zinc Oxide Ointment nationwide due to Current Good Manufacturing Practice (cGMP) deviations at its production facility. The recall affects 2,592 bottles distributed across the USA.

    Product
    ZINC OXIDE — ZINC OXIDE (ZINC OXIDE OINTMENT)
    Category
    Drug
    Distribution
    Distributed nationwide