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
377
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 377 (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.

51–75 of 823

  • ModerateFDA (Drugs)·D-0989-2016·2016-06-15

    Well Care Compounding Pharmacy Recalls 1-HCG 2000 IU/ML Vials

    Well Care Compounding Pharmacy is recalling 1-HCG 2000 IU/ML vials due to GMP violations that may affect sterility.

    Product
    1-HCG 2000 IU/ML, packaged in 5mL vials, Rx only, Well Care Compounding Pharmacy Las Vegas, NV 89121
    Category
    Drug
    Distribution
    1 state
  • ModerateFDA (Drugs)·D-0980-2016·2016-06-15

    Well Care Compounding Pharmacy Recalls Atropine Sulfate Ophthalmic Drops

    Well Care Compounding Pharmacy is recalling Atropine Sulfate 0.5% Ophthalmic Drops due to FDA inspection findings of GMP violations that may impact sterility.

    Product
    ATROPINE SULFATE 0.5% Ophthalmic Drops, packaged in 5mL droppers, Rx only, Well Care Compounding Pharmacy Las Vegas, NV 89121
    Category
    Drug
    Distribution
    1 state
  • ModerateFDA (Drugs)·D-1021-2016·2016-06-15

    Well Care Compounding Pharmacy Recalls TRI-MIX # 6 Due to Sterility Concerns

    Well Care Compounding Pharmacy is recalling TRI-MIX # 6 vials because FDA inspections found violations that may affect product sterility.

    Product
    TRI-MIX # 6, packaged in 5mL vials, Rx only, Well Care Compounding Pharmacy Las Vegas, NV 89121
    Category
    Drug
    Distribution
    1 state
  • ModerateFDA (Drugs)·D-0999-2016·2016-06-15

    Well Care Compounding Pharmacy Recalls Methylcobalamin Vials for Sterility Concerns

    Well Care Compounding Pharmacy is recalling 869 vials of Methylcobalamin 12.5mg/mL due to FDA inspection findings of GMP violations that may impact sterility.

    Product
    METHYLCOBALAMIN 12.5MG/ML, packaged in 5mL vials, Rx only, Well Care Compounding Pharmacy Las Vegas, NV 89121
    Category
    Drug
    Distribution
    1 state
  • SevereFDA (Drugs)·D-0179-2016·2015-11-18

    B&B Pharmacy Recalls PAPA/PGE1/PHENTO Injection Due to Sterility Concerns

    Pacific Healthcare, Inc dba B&B Pharmacy is recalling PAPA/PGE1/PHENTO injection vials because an FDA inspection found GMP violations that may affect sterility.

    Product
    PAPA/PGE1/PHENTO (35mg/12mcg/1.5mg/ml), Injection, 10 mL vial, Rx, B & B Health Mart Pharmacy, Bellflower, CA
    Category
    Drug
    Distribution
    2 states
  • SevereFDA (Drugs)·D-0168-2016·2015-11-18

    Testosterone Propionate Injection Recalled for Sterility Assurance Concerns

    Pacific Healthcare, Inc dba B&B Pharmacy is recalling Testosterone Propionate Injection due to FDA inspection findings of GMP violations that may impact sterility.

    Product
    Testosterone prop. 200 mg/ml Injection, 10 mL vial, Rx, B & B Health Mart Pharmacy, Bellflower, CA
    Category
    Drug
    Distribution
    2 states
  • SevereFDA (Drugs)·D-0180-2016·2015-11-18

    PGE 25mcg/ml Injection Recalled Due to Sterility Assurance Concerns

    Pacific Healthcare, Inc dba B&B Pharmacy is recalling PGE 25mcg/ml Injection vials because an FDA inspection identified GMP violations that may impact sterility.

    Product
    PGE 25mcg/ml, Injection, 10 mL vial, Rx, B & B Health Mart Pharmacy, Bellflower, CA
    Category
    Drug
    Distribution
    2 states
  • SevereFDA (Drugs)·D-0170-2016·2015-11-18

    B&B Pharmacy Recalls PAPA/PHENTO Injection Due to Sterility Concerns

    Pacific Healthcare, Inc dba B&B Pharmacy is recalling PAPA/PHENTO Injection vials because FDA inspections identified GMP violations that may affect sterility.

    Product
    PAPA/PHENTO (30mg/1mg/ml) Injection, 5 mL and 10 mL vials, Rx, B & B Health Mart Pharmacy, Bellflower, CA
    Category
    Drug
    Distribution
    2 states
  • SevereFDA (Drugs)·D-0172-2016·2015-11-18

    B&B Pharmacy Recalls PAPA/PGE1/PHENTO Injection Due to Sterility Concerns

    Pacific Healthcare, Inc dba B&B Pharmacy is recalling PAPA/PGE1/PHENTO injection vials because an FDA inspection identified GMP violations that may impact product sterility.

    Product
    PAPA/PGE1/PHENTO (30mg/50mcg/0.5mg/ml), Injection, 10 mL vial, Rx, B & B Health Mart Pharmacy, Bellflower, CA
    Category
    Drug
    Distribution
    2 states
  • SevereFDA (Drugs)·D-0165-2016·2015-11-18

    Stanozolol Injection Recalled Due to Sterility Assurance Concerns

    Pacific Healthcare, Inc. is recalling Stanozolol 200 mg/ml Injection vials due to FDA inspection findings of GMP violations that may impact sterility.

    Product
    Stanozolol 200 mg/ml Injection, 20 mL vial, Rx, B & B Health Mart Pharmacy, Bellflower, CA
    Category
    Drug
    Distribution
    2 states
  • SevereFDA (Drugs)·D-0167-2016·2015-11-18

    Testosterone Cypionate Injection Recalled Due to Sterility Assurance Concerns

    Pacific Healthcare, Inc dba B&B Pharmacy is recalling Testosterone Cypionate 250 mg/mL Injection due to FDA inspection findings of GMP violations that may impact sterility.

    Product
    Testosterone Cypionate 250 mg/mL Injection, 10 mL vial, Rx, B & B Health Mart Pharmacy, Bellflower, CA
    Category
    Drug
    Distribution
    2 states
  • SevereFDA (Drugs)·D-0178-2016·2015-11-18

    B&B Pharmacy Recalls PAPA/PHENTO Injection Due to Sterility Concerns

    Pacific Healthcare, Inc dba B&B Pharmacy is recalling PAPA/PHENTO Injection vials because an FDA inspection found GMP violations that may affect sterility.

    Product
    PAPA/PHENTO (15mg/0.8333mg/ml) Injection, 5 mL vial, Rx, B & B Health Mart Pharmacy, Bellflower, CA
    Category
    Drug
    Distribution
    2 states
  • SevereFDA (Drugs)·D-0176-2016·2015-11-18

    B&B Pharmacy Recalls PAPA/PGE1/PHENTO Injection Due to Sterility Concerns

    B&B Pharmacy is recalling specific vials of PAPA/PGE1/PHENTO Injection because FDA inspections found GMP violations that may affect sterility.

    Product
    PAPA/PGE1/PHENTO (15mg/5mcg/0.5mg/ml) Injection, 5 mL and 10 mL vials, Rx, B & B Health Mart Pharmacy, Bellflower, CA
    Category
    Drug
    Distribution
    2 states
  • SevereFDA (Drugs)·D-0171-2016·2015-11-18

    PGE 20mcg/ml Injection Recalled Due to Sterility Assurance Concerns

    Pacific Healthcare, Inc dba B&B Pharmacy is recalling PGE 20mcg/ml Injection vials due to FDA inspection findings of GMP violations that may impact sterility.

    Product
    PGE 20mcg/ml Injection, 10 mL vial, Rx, B & B Health Mart Pharmacy, Bellflower, CA
    Category
    Drug
    Distribution
    2 states
  • SevereFDA (Drugs)·D-0169-2016·2015-11-18

    B&B Pharmacy Recalls PAPA+PGE1+PHENTO Injection Due to Sterility Concerns

    B&B Pharmacy is recalling PAPA+PGE1+PHENTO Injection vials because an FDA inspection found GMP violations that may affect sterility.

    Product
    PAPA+PGE1+PHENTO (30mg/20mcg/1mg/ml) Injection, 5 mL and 10 mL vials, Rx, B & B Health Mart Pharmacy, Bellflower, CA
    Category
    Drug
    Distribution
    2 states
  • SevereFDA (Drugs)·D-0173-2016·2015-11-18

    B&B Pharmacy Recalls PAPA/PGE1/PHENTO Injection Due to Sterility Concerns

    Pacific Healthcare, Inc dba B&B Pharmacy is recalling PAPA/PGE1/PHENTO Injection vials because an FDA inspection identified GMP violations that may impact sterility.

    Product
    PAPA/PGE1/PHENTO (22.5mg/8.33mcg/0.833mg/ml) Injection, 10 mL vial, Rx, B & B Health Mart Pharmacy, Bellflower, CA
    Category
    Drug
    Distribution
    2 states
  • SevereFDA (Drugs)·D-0177-2016·2015-11-18

    B&B Pharmacy Recalls PGE 30mcg/ml Injection Due to Sterility Concerns

    Pacific Healthcare, Inc dba B&B Pharmacy is recalling PGE 30mcg/ml Injection vials because an FDA inspection identified GMP violations that may impact sterility.

    Product
    PGE 30mcg/ml Injection, 10 mL vials, Rx, B & B Health Mart Pharmacy, Bellflower, CA
    Category
    Drug
    Distribution
    2 states
  • SevereFDA (Drugs)·D-0166-2016·2015-11-18

    Nandrolone Injection Recalled Due to Sterility Assurance Concerns

    Pacific Healthcare is recalling Nandrolone 200 mg/ml Injection vials because an FDA inspection found GMP violations that may impact sterility.

    Product
    Nandrolone 200 mg/ml Injection, 10 mL and 20 mL vials, Rx, B & B Health Mart Pharmacy, Bellflower, CA
    Category
    Drug
    Distribution
    2 states
  • SevereFDA (Drugs)·D-0175-2016·2015-11-18

    B&B Pharmacy Recalls PAPA/PGE1/PHENTO Injection Due to Sterility Concerns

    Pacific Healthcare, Inc dba B&B Pharmacy is recalling PAPA/PGE1/PHENTO Injection vials because an FDA inspection identified GMP violations that may impact product sterility.

    Product
    PAPA/PGE1/PHENTO (30mg/40mcg/1mg/ml) Injection, 10 mL vial, Rx, B & B Health Mart Pharmacy, Bellflower, CA
    Category
    Drug
    Distribution
    2 states
  • SevereFDA (Drugs)·D-0174-2016·2015-11-18

    B&B Pharmacy Recalls PAPA/PGE1/PHENTO Injection Due to Sterility Concerns

    Pacific Healthcare, Inc dba B&B Pharmacy is recalling PAPA/PGE1/PHENTO Injection vials because an FDA inspection found GMP violations that may affect sterility.

    Product
    PAPA/PGE1/PHENTO (30mg/10mg/1mg/ml) Injection, 5 mL and 10 mL vials, Rx, B & B Health Mart Pharmacy, Bellflower, CA
    Category
    Drug
    Distribution
    2 states
  • SevereFDA (Drugs)·D-1487-2015·2015-09-23

    Fentanyl and Bupivacaine Intrathecal Solution Recalled for Sterility Concerns

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

    Product
    Fentanyl 8,000 mcg/ml + Bupivacaine 30 mg/ml Intrathecal Solution, Sterile-Preservative Free, The Compounding Pharmacy of America, Knoxville, TN
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1467-2015·2015-09-23

    Estradiol Pellets Recalled Due to Sterility Assurance Concerns

    The Compounding Pharmacy of America is recalling Estradiol 15 mg sterile pellets nationwide because FDA inspections identified GMP violations affecting sterility.

    Product
    Estradiol 15 mg, Sterile Pellet, The Compounding Pharmacy of America, Knoxville, TN
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1673-2015·2015-09-23

    Hydromorphone and Bupivacaine Intrathecal Solution Recalled for Sterility Concerns

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

    Product
    Hydromorphone 35 mg/ml + Bupivacaine 4 mg/ml Intrathecal Solution, Sterile-Preservative Free, 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