Prescription & OTC drugs recalls
Every prescription & otc drugs recall on file, newest first, each one linked back to the federal notice it came from.
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Class II · 4 months ago
Inventia Healthcare Limited Chlorthalidone Tablets, USP, 25 mg recall: Failed Dissolution Specifications
Failed Dissolution Specifications
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Class II · 4 months ago
IntegraDose Compounding Services LLC Vasopressin 2 Units/2 mL in 0.9% Sodium recall: Subpotent Drug
Subpotent Drug
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Class II · 4 months ago
Dabur India Limited Med Pride, Bacitracin Zinc Ointment, 1oz per tube recall: CGMP Deviations; deficiencies observed during FDA inspection
CGMP Deviations; deficiencies observed during FDA inspection
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Class II · 4 months ago
Dabur India Limited Lucky Super Soft, First Aid Triple Antibiotic Ointment recall: CGMP Deviations; deficiencies observed during FDA inspection
CGMP Deviations; deficiencies observed during FDA inspection
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Class II · 4 months ago
Dabur India Limited Med Pride, Triple Antibiotic Ointment, Bacitracin Zinc recall: CGMP Deviations; deficiencies observed during FDA inspection
CGMP Deviations; deficiencies observed during FDA inspection
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Class II · 4 months ago
Dabur India Limited Rapidol, Triple Antibiotic First Aid Ointment recall: CGMP Deviations; deficiencies observed during FDA inspection
CGMP Deviations; deficiencies observed during FDA inspection
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Class II · 4 months ago
Keystone Industries PureLife, Topical Anesthetic GEL, Benzocaine 20%, 1 oz recall: Defective container:may contain bottles with incomplete seals
Defective container:may contain bottles with incomplete seals
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Class II · 4 months ago
Dabur India Limited Med Pride, Hydrocortisone Cream 1% recall: CGMP Deviations; deficiencies observed during FDA inspection
CGMP Deviations; deficiencies observed during FDA inspection
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Class II · 4 months ago
Keystone Industries DHP Topical Anesthetic Gel, Benzocaine 20%, Strawberry Flavor recall: Defective container:may contain bottles with incomplete seals
Defective container:may contain bottles with incomplete seals
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Class II · 4 months ago
Golden State Medical Supply Inc. Gsms Incorporated recall: Failed Dissolution Specifications: During 12-month long-term stability
Failed Dissolution Specifications: During 12-month long-term stability testing, subject lot was out of specification (low) for stage 3 dissolution at…
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Class III · 4 months ago
Amneal Pharmaceuticals, LLC Primidone Tablets, USP, 50 mg, 100 Tablets per Bottle recall: Cross Contamination with Other Products: due to a potential
Cross Contamination with Other Products: due to a potential for cross-contamination with Acemetacin API due to an issue at the API manufacturer.
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Class II · 4 months ago
Breckenridge Pharmaceutical, Inc. Duloxetine Delayed-Release Capsules, USP recall: CGMP Deviations: Presence of N-nitroso-duloxetine impurity above FDA
CGMP Deviations: Presence of N-nitroso-duloxetine impurity above FDA recommended interim limit
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Class I · 4 months ago
Sun Pharmaceutical Industries Inc DOXOrubin Hydrochloride Liposome injection recall: Presence of Particulate matter: Particulate matter identified as glass
Presence of Particulate matter: Particulate matter identified as glass.
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Class III · 4 months ago
Fresenius Kabi USA, LLC Epinephrine Injection, USP, 1mg/mL, 1 mL single-dose vial recall: Failed Impurities/Degradations Specifications
Failed Impurities/Degradations Specifications
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Class II · 4 months ago
Breckenridge Pharmaceutical, Inc. Duloxetine Delayed-Release Capsules, USP, 60mg recall: CGMP Deviations: Presence of N-nitroso-duloxetine impurity above FDA
CGMP Deviations: Presence of N-nitroso-duloxetine impurity above FDA recommended interim limit
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Class II · 4 months ago
Zep, Alcohol Sanitizer Spray, Ethanol 70% recall: Microbial contamination of sterile products
Microbial contamination of sterile products
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Class II · 4 months ago
Sun Pharmaceutical Industries Inc Budesonide Inhalation Suspension, 1mg/2mL recall: Presence of Foreign Substance:This recall has been initiated in response
Presence of Foreign Substance:This recall has been initiated in response to a product quality complaint reported for black/brown specs and particles…
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Class I · 4 months ago
Beekeeper's Naturals USA Inc. Beekeeper's Naturals Saline Nasal Spray recall: Microbial Contamination of Non-Sterile Products
Microbial Contamination of Non-Sterile Products
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Class I · 4 months ago
Haleon US Holdings LLC Gas-X Extra Strength, Simethicone 125 mg/Antigas recall: Chemical Contamination: contamination with a diluted propylene glycol-based
Chemical Contamination: contamination with a diluted propylene glycol-based coolant from a machine leakage during the packaging process.
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Class II · 4 months ago
Ascend Laboratories, LLC Minocycline Hydrochloride Extended-Release Tablets, USP recall: Failed Dissolution Specifications: An out-of-specification (OOS) result
Failed Dissolution Specifications: An out-of-specification (OOS) result was observed during the 9th month of dissolution test analysis
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Class II · 5 months ago
Guardian Drug Co. Inc. Kirkland Signature, Ultra Strength Antacid, Calcium Carbonate recall: Presence of foreign substance: small metallic particles in chewable tablets
Presence of foreign substance: small metallic particles in chewable tablets.
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Class II · 5 months ago
Guardian Drug Co. Inc. Family Wellness, Ultra Strengt, Antacid Tablets recall: Presence of foreign substance: small metallic particles in chewable tablets
Presence of foreign substance: small metallic particles in chewable tablets.
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Class II · 5 months ago
Lannett Company Inc. Niacin Extended-release Tablets, USP, 1,000 mg, 90-count bottles recall: Failed Dissolution Specifications: during 12M LT stability testing OOS low
Failed Dissolution Specifications: during 12M LT stability testing OOS low for Stage 3 dissolution at the 24-hour timepoint.
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Class II · 5 months ago
Guardian Drug Co. Inc. Good Neighbor Pharmacy, extra strength Antacid Calcium recall: Presence of foreign substance: small metallic particles in chewable tablets
Presence of foreign substance: small metallic particles in chewable tablets.