Zydus Hydrocortisone Sodium Succinate for Injection
Hydrocortisone Sodium Succinate for Injection failed impurities and degradation specifications.
Drug recalls
Drug recalls from FDA, newest first.
1 recall
1 recall
Sun Pharmaceutical Industries Tretinoin Cream
Tretinoin Cream USP, 0.05% failed impurities and degradation specifications.
3 products
1 recall
Cipla USA Fosfomycin Tromethamine Granules for Oral Solution
Fosfomycin Tromethamine Granules for Oral Solution failed impurities and degradation specifications.
1 recall
Macleods Olanzapine Tablets
Olanzapine Tablets, USP 5 mg, failed impurities and degradation specifications.
1 recall
Amneal Phytonadione Injectable Emulsion
Phytonadione Injectable Emulsion failed impurities and degradation specifications.
1 recall
Ajanta Pharma Fluphenazine Hydrochloride Tablets
Fluphenazine Hydrochloride Tablets failed impurity specifications during stability testing.
1 recall
Exelan Pharmaceuticals Ramipril Capsules USP
Ramipril Capsules USP, 10 mg, failed impurity specifications.
1 recall
Zydus Mirabegron Extended-Release Tablets
Mirabegron Extended-Release Tablets contain an impurity above specification.
1 recall
Ascend Laboratories Dabigatran Etexilate Capsules
Dabigatran Etexilate Capsules failed impurity and degradation specifications.
4 products
1 recall
Precision Dose Glycopyrrolate Oral Solution
Glycopyrrolate Oral Solution failed impurities and degradation specifications due to an unidentified impurity.
3 products
1 recall
Ascend Laboratories Dabigatran Etexilate Capsules
Dabigatran etexilate capsules failed impurity and degradation specifications during stability testing.
2 products1 recall
Sun Pharmaceutical Fexofenadine Hydrochloride Tablets
Fexofenadine Hydrochloride Tablets failed impurities and degradation specifications.
2 recalls
QuVa Pharma Methohexital Sodium
Methohexital Sodium failed impurities and degradation specifications.
Avet Methohexital Sodium for Injection
Methohexital Sodium for Injection failed impurities and degradation specifications.
1 recall
Cipla Cinacalcet Hydrochloride Tablets
CGMP Deviations: presence of N-nitroso-cinacalcet, above the acceptable daily intake (ADI).
3 products
1 recall
Direct Rx Duloxetine and Cymbalta Capsules
Duloxetine D/R contains an impurity above the FDA recommended interim limit.
1 recall
Glenmark Alyacen 7/7/7 and Norethindrone and Ethinyl Estradiol Tablets
Failed Impurities/Degradation Specifications: This recall is being initiated due to out-of-specification results total impurities.
1 recall
Breckenridge Duloxetine Delayed-Release Capsules
Duloxetine Delayed-Release Capsules contain an impurity above the FDA recommended interim limit.
2 products
1 recall
Fresenius Kabi Epinephrine Injection
Epinephrine Injection failed impurities and degradations specifications.
1 recall
Asclemed USA Duloxetine DR Capsules
Duloxetine DR Capsules contain a nitrosamine impurity above the acceptable limit.
1 recall
Aveva Nicotine Transdermal System Patch
The patch failed impurity tests due to elevated oxidative-related impurities.
1 recall
Zydus Erythromycin Tablets
Reason given by FDA: CGMP Deviations; presence of N-Nitroso-Desmethyl-Erythromycin above the recommended acceptable intake limit.
2 products
1 recall
Sagent Pharmaceuticals Busulfan Injection
Busulfan Injection failed impurities and degradation specifications.
1 recall
Breckenridge Pharmaceutical Duloxetine Delayed-Release Capsules
Duloxetine Delayed-Release Capsules contain an impurity above the recommended limit.
1 recall
Rising Pharma Enalapril Maleate Tablets
Enalapril Maleate Tablets failed impurities/degradation specifications due to an out-of-specification result in organic impurities test.
1 recall
Ajanta Pharma Duloxetine Delayed-Release Capsules
Duloxetine Delayed-Release Capsules contain an impurity above the FDA recommended limit.
3 products
1 recall
Leading Pharma Furosemide Tablets
CGMP Deviations; presence of N-nitroso-Furosemide (NNF) above the recommended intake limit.
1 recall
Teva Claravis Isotretinoin Capsules
Claravis (isotretinoin capsule, USP), 10 mg, failed impurities/degradation specifications for specific impurity Tretinoin.
3 products
1 recall
Cipla Cinacalcet Hydrochloride Tablets
Reason given by FDA: CGMP Deviations; presence N-Nitroso Cinacalcet above the acceptable daily intake limit.
3 products
2 recalls
Biocon Prazosin Hydrochloride Capsules
Prazosin Hydrochloride Capsules contain a nitrosamine impurity above acceptable limits.
3 products
Alembic Pharmaceuticals Bromfenac Ophthalmic Solution 0.07%
Bromfenac Ophthalmic Solution 0.07% failed impurities and degradation specifications at the 20th month stability testing.
1 recall
Amneal Tramadol Hydrochloride Tablets
TraMADol Hydrochloride Tablets contain an impurity that failed specifications.
1 recall
Somerset Therapeutics Dexamethasone Sodium Phosphate Injection
Dexamethasone Sodium Phosphate Injection failed impurity specifications.
1 recall
Rising Pharmaceuticals Temozolomide Capsules, 5mg
Temozolomide Capsules failed impurities and degradation specifications during stability testing.
1 recall
Unichem Bisoprolol Fumarate and Hydrochlorothiazide Tablets
Bisoprolol Fumarate and Hydrochlorothiazide tablets fail to meet impurity specification limits.
