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 · 5 months ago
Safecor Health, LLC Atomoxetine Capsules HCL, 10 mg Capsules in unit dose foil strip recall: Labeling: Label Mix-Up: Atomoxetine HCl 25mg Capsule incorrectly labeled
Labeling: Label Mix-Up: Atomoxetine HCl 25mg Capsule incorrectly labeled as Atomoxetine HCl 10mg Capsule.
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Class II · 5 months ago
Ascend Laboratories, LLC, Metoprolol Succinate Extended-Release recall: Failed Dissolution Specifications
Failed Dissolution Specifications
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Class II · 5 months ago
ENDO USA, Inc. Buprenorphine Hydrochloride, Injection, 0.3mg/mL recall: Crystallization; identified as Buprenorphine free base
Crystallization; identified as Buprenorphine free base
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Class II · 5 months ago
Oasis Tears PF, Preservative-Free Lubricant Eye Drops recall: Lack of Assurance of Sterility: The recall is being initiated
Lack of Assurance of Sterility: The recall is being initiated out of an abundance of caution following FDA observations noted during a recent…
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Class II · 6 months ago
Ajanta Pharma Ltd. Duloxetine Delayed-Release Capsules, 60 mg recall: CGMP Deviations: Presence of N-nitroso-Duloxetine impurity above FDA
CGMP Deviations: Presence of N-nitroso-Duloxetine impurity above FDA recommended limit of 0.83 ppm, identified at the 12-month and 18-month long-term…
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Class II · 6 months ago
Fresenius Medical Care Holdings, Inc. Delflex, Dextrose Peritoneal Dialysis Solution recall: Lack of Assurance of Sterility: Potential leaks from perforations in bags
Lack of Assurance of Sterility: Potential leaks from perforations in bags.
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Class II · 6 months ago
Teva Pharmaceuticals USA, Inc Octreotide Acetate for Injectable Suspension recall: Lack of Assurance of Sterility: Quality system deficiencies identified during
Lack of Assurance of Sterility: Quality system deficiencies identified during a routine U.S Food and Drug Administration (FDA) inspection at the…
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Class II · 6 months ago
Fresenius Medical Care Holdings, Inc. Delflex, Dextrose Peritoneal Dialysis Solution recall: Lack of Assurance of Sterility: Potential leaks from perforations in bags
Lack of Assurance of Sterility: Potential leaks from perforations in bags.
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Class I · 6 months ago
B Braun Medical Inc Lactated Ringer's Injection USP, 1000 mL container recall: Presence of Particulate Matter
Presence of Particulate Matter.
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Class II · 6 months ago
Breckenridge Pharmaceutical, Inc. Duloxetine Delayed-Release Capsules USP, 60mg recall: CGMP Deviations; presence of N-nitroso-duloxetine impurity above the FDA
CGMP Deviations; presence of N-nitroso-duloxetine impurity above the FDA recommended limit
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Class III · 6 months ago
Unichem Pharmaceuticals USA Inc. busPIRone Hydrochloride Tablets, USP recall: Subpotent drug
Subpotent drug
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Class II · 6 months ago
Ajanta Pharma Ltd. Duloxetine Delayed-Release Capsules, 20 mg recall: CGMP Deviations: Presence of N-nitroso-Duloxetine impurity above FDA
CGMP Deviations: Presence of N-nitroso-Duloxetine impurity above FDA recommended limit of 0.83 ppm, identified at the 12-month and 18-month long-term…
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Class II · 6 months ago
JB Chemicals and Pharmaceuticals Ltd Enalapril Maleate Tablets, USP recall: Failed Impurities/Degradation Specifications:Out of specification result
Failed Impurities/Degradation Specifications:Out of specification result occurred in Organic Impurities Test
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Class II · 6 months ago
Acella Pharmaceuticals, LLC Naproxen Oral Suspension, USP, 125 mg/5mL recall: Chemical contamination; presence of lead and lithium above specification
Chemical contamination; presence of lead and lithium above specification
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Class II · 6 months ago
Ajanta Pharma Ltd. Duloxetine Delayed-Release Capsules, 30 mg recall: CGMP Deviations: Presence of N-nitroso-Duloxetine impurity above FDA
CGMP Deviations: Presence of N-nitroso-Duloxetine impurity above FDA recommended limit of 0.83 ppm, identified at the 12-month and 18-month long-term…
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Class II · 6 months ago
CareFusion 213, LLC BD PurPrep, Povidone-iodine 8.3% w/w with isopropyl alcohol 72.5% recall: Lack of assurance of Sterility: potential product contamination
Lack of assurance of Sterility: potential product contamination
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Class II · 6 months ago
CareFusion 213, LLC BD PurPrep, Povidone-iodine 8.3% w/w with isopropyl alcohol 72.5% recall: Lack of assurance of Sterility: potential product contamination
Lack of assurance of Sterility: potential product contamination
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Class II · 6 months ago
Central Admixture Pharmacy Services, Inc Los Angeles TPN bag recall: Incorrect Product Formulation: product did not contain insulin as listed
Incorrect Product Formulation: product did not contain insulin as listed in the label.
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Class II · 6 months ago
Wells Pharma of Houston LLC fentaNYL Citrate Injectable Solution in 0.9% Sodium recall: cGMP deviations
cGMP deviations.
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Class III · 6 months ago
American Regent, Inc. Levocarnitine Injection, USP, 1 g/5 mL , 5 mL Single-Dose Vial recall: Labeling: Missing Label
Labeling: Missing Label
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Class II · 6 months ago
Wells Pharma of Houston LLC Phenylephrine Hydrochloride Injectable Solution, 40mg recall: cGMP deviations
cGMP deviations.
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Class II · 6 months ago
Alcon Research LLC Systane, Lubricant Eye Gel, Night Gel, Sterile, 10g recall: Lack of Assurance of Sterility: Due to FDA inspection observations that it
Lack of Assurance of Sterility: Due to FDA inspection observations that it believes may impact product quality.
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Class III · 6 months ago
Water-Jel Technologies, LLC Lidocaine Wound Gel recall: Failed PH Specifications
Failed PH Specifications
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Class II · 6 months ago
Wells Pharma of Houston LLC fentaNYL Citrate Injectable Solution, Narcotic, CII recall: cGMP deviations
cGMP deviations.