The Recall Desk

Hazard

Cgmp Deviation recalls

1,552 recalls in our database tag this hazard, drawn from FDA, USDA FSIS, CPSC, and NHTSA source notices.

What the numbers show

Total
1,552
Critical
1
Severe
283
Most recent
2026-09-02

Of the 1,552 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 283 (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.

501–525 of 1552

  • ModerateFDA (Drugs)·D-1138-2022·2022-06-22

    Syphilinum homeopathic drug recalled for manufacturing practice deviations

    Washington Homeopathic Products is recalling Syphilinum homeopathic products in multiple potencies due to current good manufacturing practice deviations. The affected products were distributed nationwide.

    Product
    Syphilinum, Potency: 9C, 30C, 200C, 10X, 12X, Liquid Pellets, Rx only, Washington Homeopathic Products, 260 JR Hawvermale Way, Berkeley Springs, WV 25411
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-1139-2022·2022-06-22

    Homeopathic Tuberculinum Drug Recalled for Manufacturing Practice Deviations

    Washington Homeopathic Products is recalling Tuberculinum homeopathic drug in multiple potencies due to manufacturing practice deviations. The voluntary recall affects product distributed nationwide.

    Product
    Tuberculinum, Potency: 1X, 12X, 24X, 30X, 1M, Liquid Pellets, Rx only, Washington Homeopathic Products, 260 JR Hawvermale Way, Berkeley Springs, WV 25411
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-1132-2022·2022-06-22

    Medorrhinum homeopathic drug recalled for manufacturing process deviations

    Washington Homeopathic Products recalled Medorrhinum liquid pellets nationwide due to deviations from manufacturing standards. The product was distributed in 49 glass amber bottles.

    Product
    Medorrhinum, Potency:12C, 30C, 200C, 1M, Liquid Pellets, Rx only, Washington Homeopathic Products, 260 JR Hawvermale Way, Berkeley Springs, WV 25411
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-1110-2022·2022-06-15

    FDA Recalls Metoprolol Tablets Due to Temperature Abuse During Manufacturing

    McKesson Medical-Surgical is recalling Metoprolol 50 mg tablets nationwide due to temperature abuse during manufacturing that may compromise medication stability. Patients should contact their pharmacist or physician.

    Product
    Metoprolol tablets 50 mg, 100-count botte, Rx only, MFG: Sun Pharmaceuticals, NDC 57664-0477-52
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-1060-2022·2022-06-15

    FDA Recalls Medroxyprogesterone Acetate Injectable Suspension for Temperature Abuse

    McKesson Medical-Surgical recalls 780 vials of medroxyprogesterone acetate injectable suspension nationwide due to temperature exposure during distribution that may affect medication stability.

    Product
    Medroxyprogesterone acetate injectable suspension, 150 mg/mL, 1 mL single dose vial, Rx only, MFG: NorthStarRx/Teva Pharma USA , NDC 16714-981-01
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-1038-2022·2022-06-15

    Glucagen Injectable Medication Recalled Nationwide for Temperature Abuse

    McKesson Medical-Surgical is recalling Glucagen (glucagon) 1 mg injection vials nationwide due to temperature abuse during manufacturing and distribution, a cGMP deviation.

    Product
    Glucagen (glucagon) for injection, packaged in a 10-count box, (10 vials each containing 1 mg per vial), Rx only, MFG: Boehringer Mannheim, NDC 0597-0053-45
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-1004-2022·2022-06-15

    Lidocaine Patch 5% Recalled for Temperature Exposure During Distribution

    McKesson Medical-Surgical is recalling Lidocaine Patch 5% due to temperature abuse during storage and distribution. Affected patches may not function properly. Patients should consult their healthcare provider.

    Product
    Lidocaine Patch, 5%, 30-count box, Rx only, Manufacturer: Rhodes Pharmaceuticals, NDC 42858-0118-30
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-1100-2022·2022-06-15

    Verapamil HCL injection recalled due to temperature abuse during manufacturing

    McKesson Medical-Surgical is recalling Verapamil HCL injection ampules (NDC 04094-011-01) distributed nationwide due to temperature abuse during manufacturing.

    Product
    Verapamil HCL, ampule, 2.5 mg/ML 2ML (5/pack), Rx only, MFG: Pfizer, NDC 04094-011-01
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-1119-2022·2022-06-15

    Intralipid Intravenous Fat Emulsion Recalled for Temperature Abuse

    McKesson Medical-Surgical is recalling Intralipid intravenous fat emulsion distributed nationwide due to cGMP deviations involving temperature abuse that could compromise product safety.

    Product
    INTRALIPID — INTRALIPID (I.V. FAT EMULSION)
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-1042-2022·2022-06-15

    FDA Recalls Olanzapine Tablets Due to Temperature Abuse in Manufacturing

    McKesson Medical-Surgical is recalling Olanzapine Orally Disintegrating Tablets 10 mg nationwide due to temperature abuse during manufacturing that may have affected product stability. Patients should consult their healthcare provider about their medication.

    Product
    Olanzapine Orally Disintegrating Tablets, USP 10 mg, 30-count box unit dose tablets (3 blister cards each containing 10 tablets), Rx only, MFG: PAR PHARMA, NDC 49884-321-55
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-1058-2022·2022-06-15

    Sodium Bicarbonate Antacid Tablets Recalled for Manufacturing Temperature Abuse

    McKesson Medical-Surgical is recalling Sodium Bicarbonate Antacid Tablets nationwide due to temperature abuse during manufacturing. Consumers should consult their healthcare provider about continued use.

    Product
    SODIUM BICARBONATE ANTACID — SODIUM BICARBONATE ANTACID (SODIUM BICARBONATE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-1049-2022·2022-06-15

    Nitrostat Nitroglycerin Tablets Recalled Due to Temperature Abuse During Manufacturing

    McKesson Medical-Surgical is recalling Nitrostat (nitroglycerin sublingual tablets) 0.4 mg due to manufacturing deviations involving temperature abuse that may affect product quality. The affected product was distributed nationwide.

    Product
    Nitrostat (Nitroglycerin Sublingual Tablets, USP) 0.4 mg/tablet, 25-count bottle, Rx only, Distributed by: Pfizer Parke-Davis, Division of Pfizer Inc., NDC 0071-0418-13
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-1083-2022·2022-06-15

    FDA Recalls Transderm Scop Scopolamine Transdermal Patches for Temperature Deviation

    McKesson Medical-Surgical is recalling Transderm Scop (scopolamine) transdermal patches nationwide due to Good Manufacturing Practice (cGMP) deviations involving temperature abuse during manufacturing. No illnesses have been reported.

    Product
    TRANSDERM SCOP — TRANSDERM SCOP (SCOPOLAMINE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0974-2022·2022-06-08

    Losartan Potassium Tablets Recalled for CGMP Deviations and Elevated Impurity

    Strides Pharma Inc. is recalling Losartan Potassium 100 mg tablets nationwide due to CGMP deviations with AZIDO impurity levels above acceptable limits. Patients should contact their healthcare provider to verify if they are affected.

    Product
    LOSARTAN POTASSIUM — LOSARTAN POTASSIUM (LOSARTAN POTASSIUM)
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0971-2022·2022-06-08

    Blood Pressure Medication Losartan-HCTZ Recalled for Impurity Deviation

    Direct Rx is recalling 81 bottles of Losartan Potassium and Hydrochlorothiazide 100/12.5 mg due to AZIDO impurity exceeding acceptable manufacturing standards. Affected bottles were distributed in Alabama, Georgia, Florida, and Louisiana.

    Product
    LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE — LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE (LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE)
    Category
    Drug
    Distribution
    4 states
  • HighFDA (Drugs)·D-0892-2022·2022-06-01

    Losartan Potassium and HCTZ Tablets Recalled for AZIDO Impurity Deviations

    Preferred Pharmaceuticals is recalling specific lots of Losartan Potassium & HCTZ Tablets due to AZIDO impurity levels exceeding acceptable manufacturing standards. The recalled tablets were distributed in Florida and California.

    Product
    Losartan Potassium & HCTZ Tablets 50mg/12.5 mg, hydrochlorothiazide USP 12.5 mg, Pkg Size: 30, NDC: 68788-7758-03.
    Category
    Drug
    Distribution
    2 states
  • HighFDA (Drugs)·D-0886-2022·2022-06-01

    Losartan HCTZ drug recall due to azido impurity levels above limits

    RemedyRepack Inc. is recalling Losartan HCTZ 100/25 mg tablets distributed in Florida, South Carolina, and Virginia due to azido impurity levels exceeding acceptable manufacturing limits.

    Product
    Losartan HCTZ 100/25 mg, 90 count bottles NDC# 70518-2578-00 Repackaged NDC Original NDC # 68180-0217-09
    Category
    Drug
    Distribution
    3 states
  • ModerateFDA (Drugs)·D-0888-2022·2022-06-01

    Zonisamide Capsules USP recalled for quality control system deviation

    Direct Rx is recalling Zonisamide Capsules USP 100 mg, lot 23JY2124, nationwide due to gaps in the quality control microbiology laboratory that could affect product verification.

    Product
    Zonisamide Capsules USP, 100 mg, 90-count bottle, Rx Only, Packaged and Distributed By: Direct Rx Dawsonville, GA 30534, Manufactured for: Glenmark Pharmaceuticals Inc., USA Mahwah, NJ 07430, NDC 61919-775-90
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0870-2022·2022-05-25

    Milk of Magnesia Institutional Units Recalled for Manufacturing Quality Deviation

    Plastikon Healthcare LLC is recalling 5,400 unit doses of Milk of Magnesia USP (Lot 20041A, exp. May 2022) due to failure to properly investigate failed microbial testing during manufacturing. The product was distributed in Indiana for further distribution nationwide.

    Product
    MILK OF MAGNESIA USP, (Magnesium Hydroxide), 2400 mg/30 mL, 30 mL cup, packaged in 10 cups per tray, 10 trays per carton, For Institutional Use Only, Distributed by Major Pharmaceuticals, Livonia, MI 48152, NDC 0904-6846-73.
    Category
    Drug
    Distribution
    1 state
  • HighFDA (Drugs)·D-0874-2022·2022-05-25

    Pfizer Accupril Blood Pressure Tablets Recalled for Nitrosamine Contamination

    Pfizer is recalling specific lots of Accupril (quinapril HCl) 40 mg tablets distributed nationwide and in Puerto Rico because the product contains N-nitrosoquinapril above acceptable limits, a manufacturing deviation.

    Product
    Accupril (Quinapril HCl Tablets) 40 mg, 90 Tablets, Rx only NDC 0071-0535-23 Distributed by: Parke-Davis Division of Pfizer Inc. NY, NY 10017
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0847-2022·2022-05-11

    Halobetasol Propionate Ointment 0.05% Recalled Due to Manufacturing Practice Deviations

    McKesson Corporation is recalling Halobetasol Propionate Ointment 0.05% nationwide after the manufacturer discontinued its stability study program, creating CGMP deviations. Over 13,200 tubes distributed in the United States, Guam, and the Northern Mariana Islands are affected.

    Product
    Halobetasol Propionate Ointment 0.05% Net Wt., 50 gram tube, Rx Only, Manufactured by: Teligent Pharma, Inc. Buena, NJ 08310, Distributed by: McKesson Corporation dba Sky Packaging 4071 Southridge Blvd., Suite 101 Memphis, TN 38141, NDC 63739-998-67
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0848-2022·2022-05-11

    Lidocaine Hydrochloride Topical Solution Recalled for Manufacturing Quality Deviations

    McKesson Corporation is recalling Lidocaine Hydrochloride Topical Solution due to manufacturing deviations related to discontinuation of the stability study program. Approximately 81,757 bottles distributed nationwide are affected.

    Product
    Lidocaine Hydrochloride Topical Solution USP 4% (40 mg/mL), 50 mL bottle, Rx only, Manufactured by: Teligent Pharma, Inc. Buena, NJ 08310 Distributed by: McKesson Corporation dba Sky Packaging 4071 Southridge Blvd., Suite 101 Memphis, TN 38141, NDC 63739-977-64
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0849-2022·2022-05-11

    FDA Recalls Lidocaine Prilocaine Cream Due to Manufacturing Compliance Issue

    McKesson Corporation has recalled Lidocaine Prilocaine Cream 2.5%/2.5% because the manufacturer, Teligent Pharma, Inc., discontinued its stability study program, a deviation from manufacturing standards.

    Product
    Lidocaine Prilocaine Cream USP, 2.5%/2.5% Net Wt. 30 gram tube, Rx Only, Distributed by: McKesson Corporation dba Sky Packaging 4971 Southridge Blvd., Suite 101 Memphis, TN 38141 Manufactured by: Teligent Pharma, Inc., Buena, NJ 08310, NDC 63739-054-66
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0830-2022·2022-05-11

    Drug recall: fentanyl and bupivacaine injectable solution manufacturing deviations

    SCA Pharmaceuticals voluntarily recalled 424 bags of fentanyl and bupivacaine injectable solution due to manufacturing control deviations. The product was distributed nationwide in the United States.

    Product
    Fentanyl 2mcg/ml and Bupivacaine 0.125% in 0.9% Sodium Chloride 100 mL bags, Rx only, SCA Pharmaceuticals Windsor, CT 06095, NDC 70004-0231-32
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0831-2022·2022-05-11

    Drug recall: Vancomycin HCl injection bags for manufacturing deviations

    SCA Pharmaceuticals has recalled Vancomycin HCl 1.5g injection bags due to manufacturing process deviations. The product was distributed nationwide.

    Product
    Vancomycin HCl 1.5 g in 0.9% Sodium Chloride, 500 mL bags, Rx only, SCA Pharmaceuticals Windsor, CT 06095, NDC 70004-0924-44
    Category
    Drug
    Distribution
    Distributed nationwide