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.

1551–1563 of 1563

  • SevereFDA (Drugs)·D-508-2013·2013-06-12

    TG United Recalls AMBI Antitussive Due to CGMP Deviations

    TG United, Inc. is recalling 348 bottles of AMBI 25CPD/200GFN antitussive and expectorant due to CGMP deviations involving incorrect dosage.

    Product
    AMBI 25CPD/200GFN, Antitussive, Expectorant, Berry Vanilla Flavor, 16 fl oz. bottle, OTC, Manufactured for: AMBI Pharmaceuticals, Brooksville, FL 34604, NDC 66870-0221-16.
    Category
    Drug
    Distribution
    5 states
  • SevereFDA (Drugs)·D-509-2013·2013-06-12

    TG United Recalls Underdosed AMBI Antihistamine Nasal Decongestant Syrup

    TG United, Inc. is recalling 355 bottles of AMBI antihistamine and nasal decongestant syrup due to CGMP deviations resulting in underdosed products.

    Product
    AMBI 2CPM/15DM/5PEH, Antihistamine, Nasal Decongestant, Fruit Candy Flavor, 16 fl oz. bottle, OTC, Manufactured for: AMBI Pharmaceuticals, Brooksville, FL 34604, NDC 66870-0228-16.
    Category
    Drug
    Distribution
    5 states
  • ModerateFDA (Drugs)·D-506-2013·2013-06-12

    TG United Recalls Underdosed AMBI Cough Syrup Bottles

    TG United, Inc. is recalling 348 bottles of AMBI cough syrup due to CGMP deviations resulting in underdosed products.

    Product
    AMBI 12.5 CPD/100GFN/30PSE, Antitussive, Expectorant, Nasal Decongestant, Raspberry Flavor, 16 fl oz. bottle, OTC, Manufactured for: AMBI Pharmaceuticals, Brooksville, FL 34604, NDC 66870-0223-16
    Category
    Drug
    Distribution
    5 states
  • ModerateFDA (Drugs)·D-507-2013·2013-06-12

    TG United Recalls Underdosed AMBI Cough Suppressant and Expectorant

    TG United, Inc. is recalling 348 bottles of AMBI cough suppressant and expectorant due to CGMP deviations resulting in underdosed products.

    Product
    AMBI 12.5 CPD/120GFN/5PEH, Cough Suppressant, Expectorant, Nasal Decongestant, Berry Vanilla Flavor, 16 fl oz. bottle, OTC, Manufactured for: AMBI Pharmaceuticals, Brooksville, FL 34604, NDC 66870-0224-16
    Category
    Drug
    Distribution
    5 states
  • ModerateFDA (Drugs)·D-307-2013·2013-05-08

    Benjamins Infants Gripe Mixture Recalled for Manufacturing Violations

    Carib Import & Export is recalling 480 bottles of Benjamins Infants Gripe Mixture because FDA inspections found it was not manufactured under current good manufacturing practices.

    Product
    Benjamins Infants Gripe Mixture, Each 5 mL contains: Light Magnesium Carbonate BP, 200.0 mg; Sodium Bicarbonate BP, 100.0 mg; Sucrose, 487.5 mg; Alcohol, 0.362 mL; Fennel Oil BP, 0.004 mL; Dill Oil BP, 0.005 mL), 120 mL bottle, Manufactured by: P.A. Benjamin Manufacturing Co. Ltd
    Category
    Drug
    Distribution
    Distributed nationwide
  • LowFDA (Drugs)·D-215-2013·2013-04-03

    Hospira Recalls Lactated Ringer's Injection Due to CGMP Deviations

    Hospira is recalling 1,296 units of Lactated Ringer's Injection, USP, 1000 mL, because the product was shipped without approval for release.

    Product
    Lactated Ringer's Injection, USP, 1000 mL, Rx only, Manufactured by Hospira, Inc., Lake Forest, IL 60045, NDC 0409-7953-09
    Category
    Drug
    Distribution
    1 state
  • SevereFDA (Drugs)·D-191-2013·2013-03-20

    RX3 Pharmacy Recalls Medi-bolic Booster Injectable Due to Manufacturing Deviations

    RX3 Pharmacy is recalling 126 vials of Medi-bolic Booster Injectable because the product was not manufactured according to Good Manufacturing Procedures.

    Product
    Medi-bolic Booster Injectable (methionine 8.3 mg/mL, choline chloride 16.6 mg/mL, inositol 16.6 mg/mL, cyanocobalamin USP [Vit B12] 0.33 mg/mL, chromium chloride 2.6 mg/mL), 30 mL multi-dose vials, Rx3 Compounding Pharmacy, 12230 Ironbridge Rd., Suite C, Chester, VA 23831.
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-181-2013·2013-03-13

    Bristol Myers Squibb Recalls Abilify Tablets Due to Manufacturing Error

    Bristol Myers Squibb is recalling specific Abilify 30 mg tablets because rejected material was inadvertently shipped. The affected product was distributed in LA, TN, and CA.

    Product
    ABILIFY — ABILIFY (ARIPIPRAZOLE)
    Category
    Drug
    Distribution
    3 states
  • LowFDA (Drugs)·D-056-2013·2012-11-21

    ITW Dymon Recalls Lemon Hand Sanitizing Wipes for CGMP Deviations

    ITW Dymon is recalling specific lots of Lemon Hand Sanitizing Wipes because they were manufactured with raw material containing unknown particles believed to be water and dirt.

    Product
    Lemon Hand Sanitizing Wipes [n-alkyl dimethyl benzyl ammonium chloride (0.1%) and n-alkyl dimethyl ethyl benzyl ammonium chloride (0.1%)], labeled as a) Genuine Joe Cleaning Supplies, Lemon Scent, Anti-microbial Hand Sanitizing Wipes, 120-count premoistened wipes per bucket, 6 bu
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • LowFDA (Drugs)·D-1667-2012·2012-09-05

    Apotex Recalls Azelastine Hydrochloride Nasal Solution Due to CGMP Deviations

    Apotex Corp. is recalling Azelastine Hydrochloride Nasal Solution because tubing used for filling may interact with the nasal formulation.

    Product
    AZELASTINE HYDROCHLORIDE — AZELASTINE HYDROCHLORIDE (AZELASTINE HYDROCHLORIDE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-1431-2012·2012-08-08

    Mallinckrodt Recalls Hydrocodone and Acetaminophen Oral Solution Due to Expired Flavoring

    Mallinckrodt Inc. is recalling specific lots of Hydrocodone Bitartrate and Acetaminophen Oral Solution because expired flavoring was used during manufacturing.

    Product
    Hydrocodone Bitartrate and Acetaminophen Oral Solution, 7.5 mg/500 mg per 15 mL, 16 fl oz (473 mL) bottle, Rx only, Mallinckrodt Inc., Hazelwood, MO 63042 USA, NDC 0406-0375-16, UPC 3 0406-0375-16 1.
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-1407-2012·2012-07-11

    Sanofi Recalls Eloxatin Injection Due to Manufacturing Practice Deviations

    Sanofi-aventis is recalling 196,355 vials of Eloxatin (oxaliplatin) injection nationwide because the contract manufacturer failed to meet Good Manufacturing Practices.

    Product
    Eloxatin (OXALIplatin injection) 5 mg/mL Injection, 50 mg, Rx only, Mfd. for: sanofi aventis US LLC Bridgewater, NJ 08807, NDC 0024-0590-10
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-1408-2012·2012-07-11

    Sanofi-aventis Recalls Eloxatin Injection Due to Manufacturing Issues

    Sanofi-aventis is recalling Eloxatin (oxaliplatin) injection vials because the contract manufacturer had significant Good Manufacturing Practice issues.

    Product
    Eloxatin (OXALIplatin injection) 5 mg/mL injection, 100 mg, Rx only, Mfd. for: sanofi aventis US LLC Bridgewater, NJ 08807, NDC 0024-0591-20
    Category
    Drug
    Distribution
    Distributed nationwide