FDA Alerts Archive for 2019
January 3, 2019
January 5, 2019
January 8, 2019
- Sun Pharmaceutical Industries, Inc. Issues Voluntary Nationwide Recall of Vecuronium Bromide for Injection Due to the Presence of Particulate Matter Identified as Glass
- Happy Together, Inc. Issues Voluntary Nationwide Recall of Product Due to Presence of Undeclared Sildenafil and Tadalafil
January 18, 2019
January 22, 2019
January 29, 2019
- Nature’s Rx Issues Voluntary Nationwide Recall of Silver Bullet 10x to Undeclared PDF-5 Inhibitors in the Product
- Tris Pharma, Inc Expands Its Voluntary Nationwide Retail Recall of Ibuprofen Oral Suspension Drops, USP, 50 mg per 1.25 mL, Due to Higher Concentration of Ibuprofen
February 1, 2019
- FDA Warns Patients and Doctors About Recall of Home-Use Test Strips Used with Device to Monitor Blood Thinner Warfarin, Not Authorized for Sale in U.S.
- FDA Warns Compounders Not to Use Glutathione from Letco Medical to Compound Sterile Drugs
February 4, 2019
February 21, 2019
February 22, 2019
February 25, 2019
- Golean Detox USA Issues Voluntary Nationwide Recall of Golean DETOX Capsules Due to Presence of Undeclared Sibutramine and Phenolphthalein
- Safety Communication: Xeljanz, Xeljanz XR (tofacitinib) Safety Trial Finds Increased Risk of Blood Clots in the Lungs and Death with Higher Dose in Rheumatoid Arthritis Patients
February 28, 2019
March 1, 2019
- AurobindoPharma USA, Inc. Initiates a Voluntary Nationwide Consumer Level Recall Expansion of 38 Lots of Amlodipine/Valsartan Tablets USP and Valsartan Tablets, USP Due to the Detection of NDEA Impurity
- Updated: Torrent Pharmaceuticals Limited Issues Voluntary Nationwide Recall of Losartan Potassium Tablets, USP and Losartan Potassium /Hydrochlorothiazide Tablets, USP
March 4, 2019
March 7, 2019
March 13, 2019
March 15, 2019
- Legacy Pharmaceutical Packaging, LLC Issues Voluntary Nationwide Recall of Losartan Potassium Tablets, USP, 25mg, 50mg, And 100mg Due to The Detection of Trace Amounts Of N-Nitroso N-Methyl 4-Amino Butyric Acid (NMBA) Impurity Found in The Active Pharmaceutical Ingredient (API)
- Legacy Pharmaceutical Packaging, LLC Issues Voluntary Nationwide Recall of Losartan Potassium Tablets, USP, 50mg Due to the Detection of Trace Amounts of N-Nitroso N-Methyl 4-amino butyric acid (NMBA) Impurity found in the Active Pharmaceutical Ingredient (API)
March 18, 2019
March 19, 2019
March 21, 2019
- Ata Int. Inc. Issues Voluntary Nationwide Recall of BLUEFUSION Capsules, due to presence of Undeclared Sildenafil, Tadalafil, Desmethyl carbodenafil, Dithiodesmethyl carbodenafil, Scutellarin and Daidzein
- FDA Warns About the Risks Associated with the Investigational Use of Venclexta in Multiple Myeloma
March 25, 2019
April 3, 2019
April 9, 2019
April 18, 2019
April 19, 2019
April 27, 2019
April 29, 2019
- AmEx Pharmacy Issues Voluntary Nationwide Recall for one Lot of Bevacizumab 1.25mg/0.05mL 31 G Syringe Due to Reported Defective Delivery System
- Teva Pharmaceuticals USA, Inc. Issues Voluntary Nationwide Recall of Losartan Potassium 25 mg and 100 mg Tablets USP, Sold Exclusively to Golden State Medical Supply
April 30, 2019
May 1, 2019
May 3, 2019
- Par Pharmaceutical, Inc. Issues Voluntary Nationwide Recall of One Lot of Mycophenolate Mofetil for Injection, USP Due to the Presence of a Glass Fragment Observed in One Vial of Reconstituted Product
- Vivimed Life Sciences Pvt Ltd Issues Voluntary Nationwide Recall of Losartan Potassium 25 mg, 50 mg and 100 mg Tablets, USP Due to the Detection of Trace Amounts of N-Nitroso-N-methyl-4-aminobutyric acid (NMBA) Impurity
May 12, 2019
May 24, 2019
May 28, 2019
May 30, 2019
June 11, 2019
June 13, 2019
June 21, 2019
June 25, 2019
June 26, 2019
June 28, 2019
- FDA Warns Patients and Health Care Professionals Not to Use Sterile Products from Pacifico National Inc., dba AmEx Pharmacy
- PharMEDium Services, LLC Issues Voluntary Nationwide Recall of 0.5 mg/mL HYDROmorphone HCl in 0.9% Sodium Chloride 1 mL in 3 mL BD Syringe Due to Presence of Sulfite
July 2, 2019
July 3, 2019
- Altaire Pharmaceuticals, Inc. Issues Voluntary Recall of Multiple Ophthalmic Products
- Altaire Pharmaceuticals, Inc. Issues Voluntary Recall of Multiple Ophthalmic Products Sold at Walgreens
July 5, 2019
July 10, 2019
July 15, 2019
July 16, 2019
- Altaire Pharmaceuticals, Inc. Issues Voluntary Recall of Multiple Over-The-Counter Ophthalmic Products Sold By Accutome, Focus Laboratories, Grandall Distributing Co. Inc. And Prestige
- Altaire Pharmaceuticals, Inc. Issues Voluntary Recall of Multiple Ophthalmic Products Sold by OCuSOFT
- Altaire Pharmaceuticals, Inc. Issues Voluntary Recall of Over-The-Counter Ophthalmic Products Sold By Natural Ophthalmics And TRP Company, Inc.
July 19, 2019
July 23, 2019
- FDA Advises Patients Not to Use Herbal Doctor Remedies’ Medicines
- Jubilant Cadista Pharmaceuticals Inc. Issues Voluntary Nationwide Recall of Drospirenone and Ethinyl Estradiol Tablets, USP, Due to Out-of-Specification Dissolution Test Results
July 26, 2019
August 8, 2019
August 13, 2019
August 15, 2019
August 28, 2019
August 30, 2019
September 5, 2019
September 6, 2019
- Vaping Illnesses: Consumers Can Help Protect Themselves by Avoiding Tetrahydrocannabinol (THC)-Containing Vaping Products
- Hospira, Inc., Issues A Voluntary Nationwide Recall for One Lot of Bacteriostatic Water for Injection, USP, due to a Potential Lack of Sterility Assurance
September 9, 2019
September 12, 2019
- KRS Global Biotechnology, Inc. Issues Voluntary Nationwide Recall of All Human and Animal Sterile Drug Products Due to Lack of Assurance of Sterility
- Darmerica LLC Issues Voluntary Nationwide Recall of Quinacrine Dihydrochloride Due to a Labeling Error
September 13, 2019
- Safety Information: Ranitidine Generics - NDMA Found in Samples of Some Ranitidine Medicines
- Drug Safety Communication: Ibrance (palbociclib), Kisqali (ribociclib), and Verzenio (abemaciclib) - Rare but Severe Lung Inflammation
September 16, 2019
September 19, 2019
September 20, 2019
September 23, 2019
September 25, 2019
October 4, 2019
October 10, 2019
October 11, 2019
October 15, 2019
October 18, 2019
October 22, 2019
- FDA, FTC Warn Company Marketing Unapproved Cannabidiol Products with Unsubstantiated Claims to Treat Teething and Ear Pain in Infants, Autism, ADHD, Parkinson’s and Alzheimer’s Disease
- GL Holdings Issues Voluntary Worldwide Recall of Green Lumber Products Due to Presence of Undeclared Tadalafil
October 23, 2019
- Dr. Reddy’s Confirms its Voluntary Nationwide Recall of All Ranitidine Products in the U.S. Market
- Sanofi Provides Update on Precautionary Voluntary Recall of Zantac OTC in U.S.
- Perrigo Company plc Issues Voluntary Worldwide Recall of Ranitidine Due to Possible Presence of Impurity, N-nitrosodimethylamine (NDMA) Impurity in the Product
October 25, 2019
- Novitium Pharma Issues Voluntary National Recall of Ranitidine Hydrochloride Capsules 150mg and 300mg Due to an Elevated Amount of Unexpected Impurity, N-Nitrosodimethylamine (NDMA)
- Lannett Issues Voluntary Nationwide Recall of Ranitidine Syrup (Ranitidine Oral Solution, USP), 15mg/mL due to an Elevated Level of the Unexpected Impurity, N-Nitrosodimethylamine (NDMA)
October 26, 2019
October 30, 2019
November 5, 2019
November 6, 2019
November 8, 2019
- Med Man Issues Voluntary Nationwide Recall of Up2 Due to Presence of Undeclared Sildenafil
- American Health Packaging Issues Voluntary Nationwide Recall of Ranitidine Syrup (Ranitidine Oral Solution USP) 150 mg/10 mL Liquid Unit Dose Cups Due to the Detection of N-nitrosodimethylamine (NDMA) Impurity
November 12, 2019
November 13, 2019
- FDA Updates on Angiotensin II Receptor Blocker (ARB) Recalls
- Nature’s Rx Issues Voluntary Nationwide Recall of Silver Bullet 10 Male Enhancement Capsules due to an Undeclared PDE-5 Inhibitor Found in The Product
November 15, 2019
November 19, 2019
December 17, 2019
December 19, 2019
- FDA Warns About Serious Breathing Problems with Seizure and Nerve Pain Medicines Gabapentin (Neurontin, Gralise, Horizant) and Pregabalin (Lyrica, Lyrica CR) in Patients with Respiratory Risk Factors
- Lannett Issues Voluntary Nationwide Recall of Levetiracetam Oral Solution, 100mg/mL Due to Microbial Contamination
December 31, 2019
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