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
3 recalls
Preferred Pharmaceuticals Lidocaine Ointment
Lidocaine Ointment USP, 5% failed content uniformity specifications.
Cipla USA Fosfomycin Tromethamine Granules for Oral Solution
Fosfomycin Tromethamine Granules for Oral Solution failed impurities and degradation specifications.
BioSpectra Tris/Tromethamine
Biospectra Tris/Tromethamine failed stability specifications.
1 recall
American National Red Cross Apheresis Platelets
Apheresis Platelets, PAS, Leukocytes Reduced were not tested for pH or platelet yield.
1 recall
Omni Gold Anti-Marks Cream Extra Brightening and Orbi 20
Orbi 20 Whitening Cream is contaminated with mercury.
2 products
1 recall
Apotex Paroxetine Extended-Release Tablets
Paroxetine Extended-Release Tablets failed dissolution specifications.
1 recall
Ajanta Pharma Ranolazine Extended-Release Tablets
Ranolazine Extended-Release Tablets fail dissolution specifications.
1 recall
Macleods Olanzapine Tablets
Olanzapine Tablets, USP 5 mg, failed impurities and degradation specifications.
1 recall
American Red Cross Apheresis Platelets
Apheresis Platelets were distributed without testing for pH or platelet yield.
1 recall
Inventia Healthcare Chlorthalidone Tablets
Chlorthalidone Tablets failed dissolution specifications.
2 recalls
Amneal Phytonadione Injectable Emulsion
Phytonadione Injectable Emulsion failed impurities and degradation specifications.
1 recall
Safecor Health Fluphenazine HCl Oral Elixir
Fluphenazine HCl Elixir failed stability specifications.
12 products
2 recalls
Centric Compounding Glutathione, Myers Cocktail and Tri-Immune Boost Injections
Glutathione, Myer's Cocktail, and Tri-Immune Boost injectable vials may contain elevated endotoxin levels, which could cause significant medical events.
3 products
Taro Lidocaine Ointment
Lidocaine Ointment USP, 5%, Speermint Flavor failed content uniformity specifications and assay specifications.
1 recall
Ajanta Pharma Fluphenazine Hydrochloride Tablets
Fluphenazine Hydrochloride Tablets failed impurity specifications during stability testing.
2 recalls
Trokendi XR (Topiramate) Extended-Release Capsules
Trokendi XR extended-release capsules failed dissolution specifications.
Mylan Mycophenolate Mofetil for Injection
Mycophenolate Mofetil for injection fails dissolution specifications.
1 recall
Vitalant Pooled Cryoprecipitated AHF
Pooled Cryoprecipitated AHF was not prepared in accordance with specifications.
4 recalls
Revcovi (Elapegademase-Lvlr) Injection
Revcovi injection failed stability specifications for protein concentration profile.
Mylan Prasugrel Tablets
Prasugrel Tablets, USP, 10mg failed dissolution specifications and stability testing.
American National Red Cross Blood Services Apheresis Platelets
Apheresis Platelets, PAS, Leukocytes Reduced, Pathogen Reduced were not tested for pH and were distributed.
1 recall
Apotex Paxil CR, Paroxetine, Extended-Release Tablets
Paxil CR tablets failed dissolution specifications and stability testing acceptance criteria.
2 recalls
Exelan Pharmaceuticals Ramipril Capsules USP
Ramipril Capsules USP, 10 mg, failed impurity specifications.
Lupin Clobetasol Propionate Cream
Clobetasol Propionate Cream USP, 0.05%, 60 g tube failed content uniformity specifications.
2 recalls
Optimal Balance Pharmacy Glutathione Injection
Glutathione 200 mg/mL sterile multidose vials have elevated bacterial endotoxin levels, which could cause significant medical events.
Mylan Acamprosate Calcium, Delayed-Release Tablets
Acamprosate Calcium, Delayed-Release Tablets failed dissolution specifications.
1 recall
Novartis Diovan Tablets
Diovan (valsartan) 160 mg tablets failed dissolution specifications.
1 recall
Zydus Mirabegron Extended-Release Tablets
Mirabegron Extended-Release Tablets contain an impurity above specification.
2 recalls
Victory Medical Center Pharmacy Glutathione Injection
Compounded glutathione vials have elevated bacterial endotoxin levels, which could cause fever, hypotension, inflammatory reactions, anaphylactic shock.
American Red Cross Apheresis Platelets
Apheresis Platelets, PAS, Leukocytes Reduced, Pathogen Reduced were distributed without platelet yield testing.
2 recalls
Proin ER, Phenylpropanolamine Hydrochloride Extended-Release Tablets
Proin ER tablets failed dissolution specifications, which can affect drug release.
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
4 recalls
Ascend Laboratories Amlodipine and Olmesartan Medoxomil Tablets
Amlodipine and Olmesartan Medoxomil Tablets failed dissolution specifications, with Olmesartan Medoxomil content below specifications.
Trokendi XR, Topiramate Extended-Release Capsules
Trokendi XR, topiramate extended-release capsules failed dissolution specifications.
3 productsAscend Laboratories Dabigatran Etexilate Capsules
Dabigatran etexilate capsules failed impurity and degradation specifications during stability testing.
2 productsLifeSouth Apheresis Platelets, Leukocytes Reduced, Irradiated
Apheresis Platelets, Leukocytes Reduced, Irradiated did not meet platelet yield specifications.
2 recalls
Padagis Nystatin Cream
Nystatin Cream USP is subpotent, with low assay results from stability testing.
Sun Pharmaceutical Fexofenadine Hydrochloride Tablets
Fexofenadine Hydrochloride Tablets failed impurities and degradation specifications.
4 recalls
Vitalant Apheresis Platelets, Leukocytes Reduced, Irradiated
Apheresis Platelets, Leukocytes Reduced, Irradiated were labeled as leukocytes reduced but were not tested to verify white blood cell count.
QuVa Pharma Methohexital Sodium
Methohexital Sodium failed impurities and degradation specifications.
Medline Remedy Specialized Silicone Cream (Hydraguard-D)
Medline Remedy Specialized Silicone Cream has formaldehyde levels exceeding specification.
Avet Methohexital Sodium for Injection
Methohexital Sodium for Injection failed impurities and degradation specifications.
1 recall
Lupin Pharmaceuticals Glucagon Emergency Kit for Low Blood Sugar
CGMP deviation: OOS result observed for the Gliding Force functionality test during 12-month long term stability testing.
3 products
3 recalls
Inventia Healthcare Chlorthalidone Tablets
Chlorthalidone Tablets fail dissolution specifications.
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.
