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.

501–525 of 1563

  • ModerateFDA (Drugs)·D-1343-2022·2022-08-24

    Rifampin Capsules Recalled Due to Manufacturing Control Deviation

    Lupin Pharmaceuticals is recalling Rifampin 150 mg capsules (lot #A200170) nationwide due to a Current Good Manufacturing Practice deviation with an out-of-specification impurity detected during manufacturing.

    Product
    RIFAMPIN — RIFAMPIN (RIFAMPIN)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-1324-2022·2022-08-17

    Asthmanefrin Racephinephrine Inhalation Solution Recalled Due to Improper Storage

    Asthmanefrin Racephinephrine Inhalation Solution is being recalled because batches were stored outside the conditions specified on the drug label. The recall affects products distributed nationwide.

    Product
    Asthmanefrin Racephinephrine Inhalation Solution Bronchodilator, For temporary relief of mild symptoms of intermittent asthma, Preservative Free, Sterile, For Oral Inhalation Only, 30 vials per box, Nephron Pharmaceuticals Corporation, NDC 0487-2784-01.
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-1318-2022·2022-08-17

    Earwax Removal Aid Debrox Recalled Nationwide for Improper Storage Conditions

    Debrox earwax removal aid is recalled nationwide because 131 boxes of the product were stored outside label-specified conditions. Consumers should discontinue use and consult a healthcare provider if needed.

    Product
    DEBROX — DEBROX (CARBAMIDE PEROXIDE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-1322-2022·2022-08-17

    FDA Recalls A&D Original Ointment due to improper storage conditions

    A&D Original Ointment 16 oz jars are being recalled nationwide because products were stored outside manufacturer specifications. The recall affects all NDC 11523-0096-3 units distributed in the USA.

    Product
    A&D Original Ointment, Diaper Rash Ointment & Skin Protectant, 16 oz. Jar, Bayer Healthcare Pharmaceutica, NDC 11523-0096-3.
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-1316-2022·2022-08-17

    Eye Drops Recalled for Improper Storage Outside Specifications

    SYSTANE BALANCE lubricant eye drops (12 boxes, nationwide) are being recalled because they were stored outside the manufacturer's label specifications. The FDA classified this as a Class II recall.

    Product
    SYSTANE BALANCE — SYSTANE BALANCE (PROPYLENE GLYCOL)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-1180-2022·2022-07-13

    Prescription Drug Recall: Enalapril Maleate Due to Manufacturing Deviations

    Golden State Medical Supply Inc. is recalling 1,424 bottles of Enalapril Maleate 20 mg tablets due to Current Good Manufacturing Practice deviations. The affected lot numbers have expiration dates ranging from March 2022 to December 2022.

    Product
    ENALAPRIL MALEATE — ENALAPRIL MALEATE (ENALAPRIL MALEATE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-1177-2022·2022-07-13

    Prescription drug Enalapril Maleate recalled for manufacturing deviations

    Golden State Medical Supply Inc. is recalling Enalapril Maleate 2.5 mg tablets due to Current Good Manufacturing Practice (CGMP) deviations. Approximately 1,471 bottles were distributed nationwide.

    Product
    ENALAPRIL MALEATE — ENALAPRIL MALEATE (ENALAPRIL MALEATE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-1178-2022·2022-07-13

    Enalapril Maleate Tablets Recalled Due to Manufacturing Practice Deviations

    Golden State Medical Supply Inc. is recalling Enalapril Maleate Tablets due to manufacturing practice deviations. The voluntary recall involves 9,058 units distributed nationwide.

    Product
    ENALAPRIL MALEATE — ENALAPRIL MALEATE (ENALAPRIL MALEATE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-1164-2022·2022-07-06

    FDA Recalls Losartan-Hydrochlorothiazide Tablets for Manufacturing Quality Deviations

    Macleods Pharma USA is recalling Losartan Potassium and Hydrochlorothiazide tablets (100 mg/25 mg) due to CGMP deviations and azido impurity levels exceeding acceptable limits. The affected lot is BLM2114A (expiration 07/2023) distributed nationwide.

    Product
    LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE — LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE (LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-1171-2022·2022-07-06

    Desmopressin Acetate Tablets recalled for manufacturing process deviations

    Glenmark Pharmaceuticals voluntarily recalls 36 bottles of Desmopressin Acetate Tablets (0.2 mg) due to manufacturing process deviations. The recall affected one distributor in Texas.

    Product
    Desmopressin Acetate Tablets, 0.2 mg, 100-count bottles, Rx Only, Manufactured for: Northstar Rx LLC, Memphis, TN 38141, Manufactured by: Glenmark Pharmaceuticals Ltd., Colvale-Bardez, Goa 403513, India, NDC 16714-884-01
    Category
    Drug
    Distribution
    1 state
  • 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
  • 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-1133-2022·2022-06-22

    Homeopathic Drug Morbillinum Recalled for Manufacturing Practice Deviations

    Washington Homeopathic Products is recalling Morbillinum in multiple potencies due to manufacturing practice deviations. No illnesses have been reported.

    Product
    Morbillinum, Potency:7C, 8C, 9C, 10C 12C, 13C, 15C, 20C, 21C, 30C, 200 C,Liquid Pellets, OTC, Washington Homeopathic Products, 260 JR Hawvermale Way, Berkeley Springs, WV 25411
    Category
    Drug
    Distribution
    Distributed nationwide
  • 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
  • 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-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-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-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
  • 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
  • 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
  • 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
  • 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