Drug shortages

The U.S. Food and Drug Administration keeps track of drug shortages. Drug shortages can occur because of manufacturing and quality problems, delays and discontinuations. Manufacturers provide the FDA with many drug shortage concerns. Visit the FDA online for more information.

Drug recalls

The FDA keeps track of drug recalls and safety alerts. Below is a list of recalls.

2019

November 19 - Precision Dose Inc. Issues Voluntary Nationwide Recall of Ranitidine Oral Solution, USP 150 mg/10 mL Due to Possible Presence of N-nitrosodimethylamine (NDMA) Impurity | FDA

November 15 - Golden State Medical Supply, Inc. Issues a Voluntary Nationwide Recall of Ranitidine Hydrochloride 150mg and 300mg Capsules (Manufactured by Novitium Pharma LLC) Due to an Elevated Amount of Unexpected Impurity, N-Nitrosodimethylamine (NDMA) | FDA

October 25 - 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) | FDA

September 12 - Darmerica LLC Issues Voluntary Nationwide Recall of Quinacrine Dihydrochloride Due to A Labeling Error | FDA

September 12 - KRS Global Biotechnology, Inc. Issues Voluntary Nationwide Recall of All Human and Animal Sterile Drug Products Due to Lack of Assurance of Sterility | FDA

September 9 - Plastikon Healthcare Issues Voluntary Nationwide Recall of Milk of Magnesia Oral Suspension 2400 mg/30 mL due to Microbial Contamination | FDA

August 30 - Pacifico National, Inc. dba AmEx Pharmacy Issues Voluntary Nationwide Recall for all Lots of Bevacizumab | FDA

July 23 - Jubilant Cadista Pharmaceuticals Inc. Issues Voluntary Nationwide Recall of Drospirenone and Ethinyl Estradiol Tablets, USP, Due to Out-of-Specification Dissolution Test Results.

July 2 - Fresenius Kabi Issues Voluntary Nationwide Recall of Two Lots of Fluorouracil Injection Due to the Potential for Glass Particulate.

June 25 - Macleods Pharmaceutical Limited Issues Voluntary Nationwide Consumer Level Recall of Losartan Potassium 50mg and Losartan Potassium/Hydrochlorothiazide combination Tablets 50mg/12.5mg, 100mg/12.5mg and 100mg/25mg due to detection of NMBA (N-Nitroso-N­ Methyl-4-aminobutyric acid) Impurity.

June 11 - Teva Pharmaceuticals USA, Inc. Expands Voluntary Nationwide Recall of Losartan Potassium to 50 mg and 100 mg Tablets USP, Sold Exclusively to Golden State Medical Supply, Inc.

May 29 - NOVIS PR LLC Issues Voluntary Nationwide Recall of PECGEN DMX Due to a Labeling Error.

May 28 - Heritage Pharmaceuticals Inc. Issues Voluntary Nationwide Recall of Amikacin Sulfate Injection, USP 1gm/4 mL (250mg/mL) and Prochlorperazine Edisylate Injection, USP 10mg/2mL (5mg/mL) as a Result of a Sterility Test Failure.

May 11 - Novartis Issues Voluntary Nationwide Recall of Promacta® 12.5mg for Oral Suspension Due to Potential Peanut Contamination.

April 30 - Sagent Pharmaceuticals Issues Voluntary Nationwide Recall of Ketorolac Tromethamine Injection, USP, 60mg/2mL (30mg per mL) Due to Lack of Sterility Assurance.

April 29 - AmEx Pharmacy Issues Voluntary Nationwide Recall for one Lot of Bevacizumab 1.25mg/0.05mL 31 G Syringe Due to Reported Defective Delivery System.

April 26 - Teva Pharmaceuticals USA, Inc. Issues Voluntary Nationwide Recall of Losartan Potassium 25mg and 100mg Tablets USP, Sold Exclusively to Golden State Medical Supply.

April 24 - Legacy Pharmaceutical Packaging, LLC Expands 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).

April 21 - Alvogen Inc. Issues Voluntary Nationwide Recall of Fentanyl Transdermal System Due to Product Mislabeling.

April 18 - Updated: Torrent Pharmaceuticals Limited Expands Voluntary Nationwide Recall of Losartan Potassium Tablets, USP and Losartan Potassium/Hydrochlorothiazide Tablets, USP.

April 5 - Brian Richardson DBA “In Tha Pink” Issues Voluntary Nationwide Recall of Kopi Jantan Tradisional Natural Herbs Coffee Due to Presence of Undeclared Sildenafil and Tadalafil.

March 18 - Mylan Institutional LLC Initiates Voluntary Nationwide Recall of Levoleucovorin Injection Due to the Presence of Particulate Matter

March 15 - 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).

March 15 - Hospira, Inc. Issues a Voluntary Nationwide Recall of 8.4% Sodium Bicarbonate Injection, USP Due to the Presence of Particulate Matter.

March 4 - Apotex Corp. Issues Voluntary Nationwide Recall of Drospirenone and Ethinyl Estradiol Tablets, USP, 28x3 Blister Pack/Carton Due to Possibility of Missing/Incorrect Tablet Arrangement.

March 1 - Updated: Torrent Pharmaceuticals Limited Issues Voluntary Nationwide Recall of Losartan Potassium Tablets, USP and Losartan Potassium /Hydrochlorothiazide Tablets, USP.

March 1 - 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 (N-Nitrosodiethylamine) Impurity.

February 28 - Camber Pharmaceuticals, Inc. Issues Voluntary Nationwide Recall of Losartan Potassium Tablets, USP, 25 mg, 50 mg and 100 mg 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).

February 22Macleods Pharmaceuticals Limited issues voluntary nationwide consumer level recall of one lot (BLM 715A) of Losartan Potassium/Hydrochlorothiazide combination tablets 100mg/25mg due to detection of NDEA (N-Nitrosodiethylamine) impurity.

January 22 - UPDATED: Torrent Pharmaceuticals Limited issues voluntary nationwide recall of Losartan Potassium tablets, USP and Losartan Potassium and Hydrochlorothiazide tablets, USP.

January 3 - Torrent Pharmaceuticals Limited expands voluntary nationwide recall of Losartan Potassium tablets, USP.

2018

December 31 - Aurobindo Pharma USA, Inc. initiates voluntary nationwide consumer level recall of 80 lots of Amlodipine Valsartan tablets USP, Valsartan HCTZ tablets, USP and Valsartan tablets USP, due to the detection of NDEA (N-Nitrosodiethylamine) impurity.

December 4 - Mylan expands its voluntary nationwide recall of Valsartan tablets, USP, Amlodipine and Valsartan tablets, USP, and Valsartan and Hydrochlorothiazide tablets, USP, to all lots within expiry due to the detection of trace amounts of NDEA (N-Nitrosodiethylamine) impurity found in the active pharmaceutical ingredient.

November 27 - Teva Pharmaceuticals USA issues voluntary nationwide recall of all Amlodipine/Valsartan combination tablets and Amlodipine/Valsartan/Hydrochlorothiazide combination tablets that are within expiry.

August 9 - Westminster Pharmaceuticals, LLC issues voluntary nationwide recall of Levothyroxine and Liothyronine (thyroid tablets, USP) due to risk of adulteration.

July 18 - FDA recall updates on products containing valsartan.

March 2 - FDA working with manufacturers to withdraw Zinbryta from the market in the United States.

2017

August 10 - Voluntary Nationwide Recall of all Liquid Products Manufactured by Pharmatech LLC and Distributed by Leader Brand, Major Pharmaceuticals, and Rugby Laboratories.

August 2 - Rugby Laboratories Issues Voluntary Nationwide Recall of Diocto Liquid and Diocto Syrup Manufactured by PharmaTech, LLC due to possible product contamination. This includes Diocto Liquid 50 mg/5 mL NDC 0536-0590-85 or Diocto Syrup 60mg/15mL NDC 0536-1001-85.

2016

No recalls.