Padagis Nystatin Cream
Nystatin Cream USP is subpotent, with low assay results from stability testing.
Failed specifications recalls
Recalls flagged for failed specifications, newest first. 103 recalls
2 recalls
Sun Pharmaceutical Fexofenadine Hydrochloride Tablets
Fexofenadine Hydrochloride Tablets failed impurities and degradation specifications.
5 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.
ConvaTec Aquacel Ag Surgical SP
Surgical dressing manufactured out of specification (greater thickness).
3 recalls
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
Zeiss Intrabeam Spherical Applicator 1.5 cm
The Zeiss Intrabeam Spherical Applicator 1.5 cm failed to meet manufacturing specifications.
Pilling Wecksorb Neurosponges and Neurosponge Strips
Pilling Wecksorb Neurosponges and Neurosponge Strips may have out-of-specification levels of endotoxins.
1 recall
Medline Urethral Catheters and Procedure Kits
Medline urethral catheters and kits may have surface irregularities or connector issues.
30 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.
VistaPharm Kerr Insta-Char Activated Charcoal
KERR INSTA-CHAR activated charcoal products did not meet the OTC Monograph.
4 products
1 recall
Golden State Medical Supply Niacin Extended-Release Tablets
Niacin extended-release tablets failed dissolution specifications during stability testing.
1 recall
Ascend Laboratories Minocycline Hydrochloride Extended-Release Tablets
Minocycline Hydrochloride Extended-Release Tablets failed dissolution specifications during testing.
1 recall
Fresenius Kabi Epinephrine Injection
Epinephrine Injection failed impurities and degradations specifications.
1 recall
Lannett Niacin Extended-Release Tablets
Niacin Extended-release Tablets failed dissolution specifications during stability testing.
2 recalls
Sato Yunker Energy & Health Herbal Supplement with Vitamins
This herbal supplement with vitamins does not meet label claim for Vitamin E.
Ascend Laboratories Amlodipine and Olmesartan Medoxomil Tablets
Amlodipine and Olmesartan Medoxomil Tablets have failed dissolution specifications, with olmesartan medoxomil content below specifications.
1 recall
AbbVie Pred Mild Ophthalmic Suspension
Pred Mild ophthalmic suspension failed stability specifications.
1 recall
Aveva Nicotine Transdermal System Patch
The patch failed impurity tests due to elevated oxidative-related impurities.
1 recall
Halyard Purezero Ultraviolet Nitrile Exam Gloves
Nitrile exam gloves failed to meet chemical permeation performance specifications.
1 recall
Sagent Pharmaceuticals Busulfan Injection
Busulfan Injection failed impurities and degradation specifications.
1 recall
Codman CerebroFlo EVD Catheter with Endexo Technology
The CerebroFlo EVD Catheter has an out-of-specification endotoxin result that did not meet acceptance criteria.
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.
2 recalls
CVS Pharmacy Lidocaine Wound Gel
Lidocaine Wound Gel failed pH specifications.
Medline Neuro Sponges
Medline Neuro Sponges may have higher-than-expected endotoxin levels.
31 products
1 recall
Hikma Pharmaceuticals Alendronate Sodium Oral Solution
This recall is being conducted due to out of specification assay results in a limited number of bottles that were stored on side.
1 recall
Oxoid Agglutinating Sera, Salmonella 9-0
Oxoid Agglutinating Sera, Salmonella 9-0 is not performing to IFU criteria, showing cross reactions.
2 recalls
Major Pharmaceuticals Omega-3-Acid Ethyl Esters Capsules
Omega-3-Acid, Ethyl Esters, Capsules, USP, 1 gram failed capsule specifications for loss on drying of capsule shells.
Teva Claravis Isotretinoin Capsules
Claravis (isotretinoin capsule, USP), 10 mg, failed impurities/degradation specifications for specific impurity Tretinoin.
3 products
1 recall
Skin Script Blemish Spot Treatment
Blemish Spot Treatment failed stability specifications.
2 recalls
Cytal Wound and Burn Matrices
Cytal Wound Matrix and Cytal Burn Matrix have an increased rate of out-of-specification endotoxin results.
5 products
React Health PHOENIX 5L Oxygen Concentrator
The React Health PHOENIX 5L Oxygen Concentrator was distributed without meeting internal quality specifications.
1 recall
1 recall
Major Pharmaceuticals Memantine Hydrochloride Extended-Release Capsules
Memantine Hydrochloride Extended-Release Capsules failed dissolution specifications.
1 recall
Viatris Xanax XR Extended-Release Tablets
Xanax XR extended-release tablets failed dissolution specifications.
1 recall
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
American Health Packaging Meclizine Hydrochloride Tablets
Meclizine Hydrochloride Tablets failed tablet specifications.
1 recall
OrthAlign Lantern Knee System Drill Plates
Drill plates manufactured out of specification can result in a bone cut in excess 00800"(2.8448mm).
2 products
1 recall
International Isotopes Gelatin Capsule Pack for Sodium Iodide I-131 Kit
The Gelatin Capsule Pack failed tablet or capsule specifications.
1 recall
Somerset Therapeutics Dexamethasone Sodium Phosphate Injection
Dexamethasone Sodium Phosphate Injection failed impurity specifications.
1 recall
Zydus Pharmaceuticals Icosapent Ethyl Capsules
Icosapent Ethyl Capsules have red dots inside and melted capsules due to oxidized active ingredient.
1 recall
Huvepharma BioCox 60 Type A Medicated Article
BioCox 60 failed to meet stability specification requirements for assay.
3 recalls
Rising Pharmaceuticals Temozolomide Capsules, 5mg
Temozolomide Capsules failed impurities and degradation specifications during stability testing.
Dermal Source Five-Star Vasocaine Spray and Maximum Zone Lidocaine Creams
Stability Data Does Not Support Expiry Date.
3 products
Mylan Amnesteem Isotretinoin Capsules
Amnesteem (Isotretinoin) Capsules, USP 40 mg failed dissolution specifications.
1 recall
Cipla Nilotinib Capsules
Failed Tablet/Capsule Specifications: Observed OOS results at 6-months long-term stability condition for Description test and Appearance by Visual Inspection test.
2 products