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.

351–375 of 823

  • SevereFDA (Drugs)·D-1644-2015·2015-09-23

    FDA Recalls Testosterone Cypionate and Anastrazole Injection Due to Sterility Concerns

    The Compounding Pharmacy of America is recalling Testosterone Cypionate and Anastrazole Injection because FDA inspections found GMP violations that may affect sterility.

    Product
    Testosterone Cypionate 200 mg/ml Anastrazole 0.5 mg/ml Injection, Multi-Dose Vial, Sterile, Room Temperature, The Compounding Pharmacy of America, Knoxville, TN
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1737-2015·2015-09-23

    Morphine and Bupivacaine Solution Recalled for Sterility Assurance Issues

    The Compounding Pharmacy of America is recalling Morphine and Bupivacaine Solution due to FDA inspection findings of GMP violations that impact sterility.

    Product
    Morphine 40 mg/ml + Bupivacaine 8 mg/ml Solution, Sterile-Preservative Free, The Compounding Pharmacy of America, Knoxville, TN
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1569-2015·2015-09-23

    Methylcobalamin Injectable Recalled for Sterility Assurance Concerns

    The Compounding Pharmacy of America is recalling Methylcobalamin 1,000 mcg/ml Injectable due to FDA inspection findings of GMP violations that may impact sterility.

    Product
    Methylcobalamin 1,000 mcg/ml Injectable, Multi-Dose Vial, Sterile, Refrigerate, The Compounding Pharmacy of America, Knoxville, TN
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1748-2015·2015-09-23

    Testosterone Sterile Pellets Recalled for Lack of Sterility Assurance

    The Compounding Pharmacy of America is recalling Testosterone 37.5 mg sterile pellets due to FDA inspection findings of GMP violations that may impact sterility.

    Product
    Testosterone 37.5 mg, Sterile Pellet, The Compounding Pharmacy of America, Knoxville, TN
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1722-2015·2015-09-23

    Tri-Mix Injectable Recalled for Potential Sterility Issues

    The Compounding Pharmacy of America is recalling Tri-Mix injectable vials because FDA inspections found GMP violations that may affect sterility.

    Product
    Tri-Mix (15 mg/0.5 mg/20 mcg) Injectable, Multi-Dose Vial, Sterile, Keep Frozen, The Compounding Pharmacy of America, Knoxville, TN
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1718-2015·2015-09-23

    Quad-Mix 4 Injectable Recalled Due to Sterility Assurance Concerns

    The Compounding Pharmacy of America is recalling Quad-Mix 4 Injectable vials because FDA inspections found GMP violations that may affect sterility.

    Product
    Quad-Mix 4 Injectable, Multi-Dose Vial, Sterile, Keep Frozen, The Compounding Pharmacy of America, Knoxville, TN
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1581-2015·2015-09-23

    Mitomycin Ophthalmic Solution Recalled for Sterility Assurance Concerns

    The Compounding Pharmacy of America is recalling Mitomycin 0.02% Ophthalmic Solution due to FDA inspection findings of GMP violations that may impact sterility.

    Product
    Mitomycin 0.02% Ophthalmic Solution, single dose dropper, Keep Frozen, The Compounding Pharmacy of America, Knoxville, TN
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1623-2015·2015-09-23

    Phosphatidylcholine Injection Recalled for Sterility Assurance Concerns

    The Compounding Pharmacy of America is recalling Phosphatidylcholine Injection due to FDA inspection findings of GMP violations that may impact sterility.

    Product
    Phosphatidylcholine 0.1% Sodium Deoxycholate 0.089% Injection, Vial, Sterile, Refrigerate, The Compounding Pharmacy of America, Knoxville, TN
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1727-2015·2015-09-23

    Betamethasone Sodium Phosphate Injectable Recalled for Sterility Concerns

    The Compounding Pharmacy of America is recalling Betamethasone Sodium Phosphate injectable due to FDA inspection findings of GMP violations that may impact sterility.

    Product
    Betamethasone Sodium Phosphate (10 ml) 30 mg/ml Injectable, The Compounding Pharmacy of America, Knoxville, TN
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1720-2015·2015-09-23

    FDA Recalls Tri-Mix Super Injectable Due to Sterility Concerns

    The Compounding Pharmacy of America is recalling Tri-Mix Super Injectable vials because FDA inspections found violations that may affect sterility.

    Product
    Tri-Mix Super Injectable, Multi-Dose Vial, Sterile, Keep Frozen, The Compounding Pharmacy of America, Knoxville, TN
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-1647-2015·2015-09-23

    Testosterone Enanthate Injection Recalled for Sterility Assurance Concerns

    The Compounding Pharmacy of America is recalling Testosterone Enanthate 200 mg/ml Injection due to FDA inspection findings of GMP violations that may impact sterility.

    Product
    Testosterone Enanthate 200 mg/ml Injection, Multi-Dose Vial, Sterile, Room Temperature, The Compounding Pharmacy of America, Knoxville, TN
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-1454-2015·2015-09-23

    Clotrimazole Otic Suspension Recalled for Sterility Assurance Concerns

    The Compounding Pharmacy of America is recalling Clotrimazole 2% Otic Suspension due to FDA inspection findings of GMP violations that may impact sterility.

    Product
    Clotrimazole 2% Otic Suspension, ml, Sterile, Room Temperature, Shake Well, The Compounding Pharmacy of America, Knoxville, TN
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-1616-2015·2015-09-23

    Nandrolone Decanoate Injection Recalled for Sterility Assurance Concerns

    The Compounding Pharmacy of America is recalling Nandrolone Decanoate 200 mg/ml Injection due to FDA inspection findings of GMP violations that may impact sterility.

    Product
    Nandrolone Decanoate 200 mg/ml Injection, ml Multi-Dose Vial, Sterile, Room Temperature, The Compounding Pharmacy of America, Knoxville, TN
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-1577-2015·2015-09-23

    Compounded Methylcobalamin Injection Recalled for Sterility Concerns

    The Compounding Pharmacy of America is recalling MIC+Methylcobalamin 4000 mcg/ml Injection due to FDA inspection findings of GMP violations that may impact sterility.

    Product
    MIC+Methylcobalamin 4000 mcg/ml Injection, Multi-Dose Vial, Sterile, Room Temperature, The Compounding Pharmacy of America, Knoxville, TN
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-1742-2015·2015-09-23

    Testosterone Pellets Recalled Due to Sterility Assurance Concerns

    The Compounding Pharmacy of America is recalling Testosterone 100 mg sterile pellets nationwide because FDA inspections found GMP violations affecting sterility.

    Product
    Testosterone 100 mg, Sterile Pellet, The Compounding Pharmacy of America, Knoxville, TN
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-1696-2015·2015-09-23

    Compounded MEGA-BURN Injection Recalled for Sterility Assurance Concerns

    The Compounding Pharmacy of America is recalling MEGA-BURN Injection due to FDA inspection findings of GMP violations that may impact sterility.

    Product
    MEGA-BURN Injection, Multi-Dose Vial, Sterile, Room Temperature, The Compounding Pharmacy of America, Knoxville, TN
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-1508-2015·2015-09-23

    Compounded HCG and B-12 Injection Recalled for Sterility Concerns

    The Compounding Pharmacy of America is recalling HCG 1,000 IU/ml + MIC B-12 Injection due to FDA inspection findings of GMP violations that may impact sterility.

    Product
    HCG 1,000 IU/ml + MIC B-12 Injection, Multi-Dose Vial, Sterile, Refrigerate, The Compounding Pharmacy of America, Knoxville, TN
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-1688-2015·2015-09-23

    Compounding Pharmacy Recalls LIPO-VITE Injection Due to Sterility Concerns

    The Compounding Pharmacy of America is recalling LIPO-VITE Injection vials because an FDA inspection found GMP violations that may affect sterility.

    Product
    LIPO-VITE Injection, Multi-Dose Vial, Sterile, Room Temperature, The Compounding Pharmacy of America, Knoxville, TN
    Category
    Drug
    Distribution
    Distributed nationwide
  • CriticalFDA (Food)·F-3027-2015·2015-08-26

    Inventure Foods Recalls Fresh Frozen Country Blend Due to Listeria Risk

    Inventure Foods is recalling Fresh Frozen Grade A Country Blend due to Listeria contamination from GMP violations. The product was distributed in 33 states.

    Product
    Fresh Frozen Grade A Country Blend, Net Wt. 32 Oz. (2 Lb.) 907g, Dist. By Fresh Frozen Foods, Inc., Jefferson, GA 30549, UPC 0-86069-20170-1
    Category
    Food
    Distribution
    32 states
  • CriticalFDA (Food)·F-3004-2015·2015-08-26

    Inventure Foods Recalls Frozen White Corn Due to Listeria Risk

    Inventure Foods is recalling specific sizes of Fresh Frozen Grade A Cut White Corn due to Listeria contamination caused by GMP violations.

    Product
    Fresh Frozen Grade A Cut White Corn, Net Wt. 32 Oz, (2 Lb.) 907g, Dist. By Fresh Frozen Foods, Inc., Jefferson, GA 30549, UPC 0-86069-20102-2, Fresh Frozen Grade A Cut White Corn, Net Wt. 80 Oz. (5 Lb.) Dist. By Fresh Frozen Foods, Inc., Jefferson, GA 30549, UPC 0-86069-50102-3
    Category
    Food
    Distribution
    32 states
  • CriticalFDA (Food)·F-3017-2015·2015-08-26

    Inventure Foods Recalls Summer Blend Vegetables Due to Listeria Risk

    Inventure Foods is recalling two sizes of Summer Blend vegetables due to Listeria contamination caused by GMP violations.

    Product
    Fresh Frozen Grade A Summer Blend, Net Wt. 32 Oz. (2 Lb.) 907g, Dist. By Fresh Frozen Foods, Inc., Jefferson, GA 30549, UPC 0-86069-20330-9, Steamables Summer Blend, Net Wt. 12 Oz. (340.8g), Dist. By Fresh Frozen Foods, Inc., Jefferson, GA 30549, UPC 0-86069-11280-9
    Category
    Food
    Distribution
    32 states
  • CriticalFDA (Food)·F-3028-2015·2015-08-26

    Inventure Foods Recalls Frozen Strawberries Due to Listeria Contamination

    Inventure Foods is recalling 16-ounce packages of Fresh Frozen Grade A Strawberries due to Listeria contamination caused by GMP violations.

    Product
    Fresh Frozen Grade A Strawberries, Net Wt. 16 Oz. (2 Lb.) (454g), Dist. By Fresh Frozen Foods, Inc., Jefferson, GA 30549, UPC 0-86069-10180-3
    Category
    Food
    Distribution
    32 states
  • CriticalFDA (Food)·F-3016-2015·2015-08-26

    Inventure Foods Recalls California Blend Products Due to Listeria Contamination

    Inventure Foods is recalling various California Blend products due to Listeria contamination caused by GMP violations.

    Product
    Steamables California Blend, Net Wt. 10 Oz., Dist. By Fresh Frozen Foods, Inc., Jefferson, GA 30549, UPC 0-86069-11275-5, Fresh Frozen California Blend, Net Wt. 16 Oz. (1 Lb.), Dist. By Fresh Frozen Foods, Inc., Jefferson, GA 30549, UPC 86069-20013-1, Fresh Frozen Grade A Califo
    Category
    Food
    Distribution
    32 states
  • CriticalFDA (Food)·F-2995-2015·2015-08-26

    Inventure Foods Recalls Frozen Green Peas Due to Listeria Contamination

    Inventure Foods is recalling specific frozen green pea products due to Listeria contamination caused by GMP violations.

    Product
    Fresh Frozen Grade A Green Peas, Net Wt. 32 oz. (2 lb.) 907g. Dist. By Fresh Frozen Foods, Inc., Jefferson, GA 30549, UPC 0-86069-20061-2; Fresh Frozen Grade A Green Peas, Net Wt. 80 Oz. (5 Lb.) 2268g, Dist. By Fresh Frozen Foods, Inc., Jefferson, GA 30549, UPC 0-086069-50060-6,
    Category
    Food
    Distribution
    32 states
  • CriticalFDA (Food)·F-3012-2015·2015-08-26

    Inventure Foods Recalls Frozen Mustard Greens Due to Listeria Risk

    Inventure Foods is recalling specific lots of frozen mustard greens due to Listeria contamination from GMP violations. Consumers should check their freezers for the affected products.

    Product
    Fresh Frozen Chopped Mustard Greens, Net Wt. 16 Oz, (1 Lb.) 454g, Dist. By Fresh Frozen Foods, Inc., Jefferson, GA 30549, UPC 0-86069-25070-9, Fresh Frozen Mustard Greens, Net. Wt. 32 Oz.. (2 Lb.), Dist. By Fresh Frozen Foods, Inc., Jefferson, GA 39549, UPC 0-86069-25071-6
    Category
    Food
    Distribution
    32 states