Drug news and alerts
Get the latest news on drug recalls, safety alerts, new therapies and other important updates.
Get the latest news on drug recalls, safety alerts, new therapies and other important updates.
The Harvard Drug Group, LLC is voluntarily recalling one lot (lot #T04769) of Dronabinol Capsules, USP, 2.5 mg and Ziprasidone Hydrochloride Capsules, 20 mg. Ziprasidone is used for the treatment of schizophrenia or bipolar disorder. Dronabinol is used for anorexia associated with weight loss in patients with Acquired Immune Deficiency Syndrome (AIDS), and/or nausea and vomiting. The drugs are being recalled due to a potential product labelling mix-up.
The U.S. Food and Drug Administration (FDA) announced on July 28,2023 that Lupin Pharmaceuticals Inc. is voluntarily recalling two (2) lots of Tydemy (Drospirenone, Ethinyl Estradiol and Levomefolate Calcium Tablets 3mg/0.03mg/0.451 mg and Levomefolate Calcium Tablets 0.451 mg), because tests showed the medication has decreased levels of ascorbic acid (an inactive ingredient) that could result in reduced effectiveness which could lead to potentially unexpected pregnancy.
On July 6, 2023 Cipla Limited announced it is voluntarily recalling six batches of Albuterol Sulfate Inhalers, 90 mcg (200 Metered Inhalation). Albuterol Sulfate is indicated for the treatment of acute asthma exacerbations. The drugs are being recalled due to a potential container defect that may result in the recommended dose of albuterol not being delivered, which may result in life-threatening consequences.
The U.S. Food and Drug Administration (FDA) has announced that Camber Pharmaceuticals, Inc. is voluntarily recalling one (1) lot of Atovaquone Oral Suspension, USP 750mg/5m due to potential bacterial contamination in the product.
The U.S. Food and Drug Administration (FDA) announced on April 6, 2023 the final decision to withdraw approval of Makena and its generic. As a result of this withdrawal of approval, Makena and its generics are now unapproved products. Approvals of the medications have been withdrawn because Makena and its generics are no longer shown to be effective, and the benefits do not outweigh the risks for the indication for which they were approved.
The U.S. Food and Drug Administration (FDA) has announced on April 26, 2023 that Akorn Operating Company LLC is voluntarily recalling all its drug products as the company has shut down operations due to bankruptcy, and is unable to guarantee the quality of the products.
Ascend Laboratories LLC is voluntarily recalling one (1) lot of Dabigatran Etcxilate Capsules, USP 75 mg and 150 mg, prescribed as an oral anticoagulant to lower the risk of stroke and blood clots. This drug is being recalled due to the presence of a nitrosamine impurity being above the established Acceptable Daily Intake (ADI) level.
IBSA Pharma, Inc. is voluntarily recalling 27 lots of TIROSINT®-SOL (levothyroxine sodium) Oral Solution, which is indicated to treat hypothyroidism and pituitary thyrotropin suppression. This drug is being recalled due to tests showing slight decrease below 95.0% of its labeled amount in levothyroxine sodium (T4) for some lots.
Apotex Corp. is voluntarily recalling six (6) lots of Brimonidine Tartrate Ophthalmic Solution, 0.15%, which is indicated for the reduction of elevated intraocular pressure (IOP) in patients with openangle glaucoma or ocular hypertension. This drug is being recalled due to potential cracks in the bottle caps, which may impact sterility and cause side effects.
Mylan Pharmaceuticals Inc. is voluntarily recalling one (1) lot of Octreotide Acetate Injection, 500 mcg/mL, which are packaged in a carton of ten 1mL syringes. It is used to reduce blood levels of growth hormone (GH) and insulin growth factor-1 (IGF-1; somatomedin C) in acromegaly patients. The injection is also indicated for certain symptomatic treatment of patients with metastatic carcinoid tumors. This drug is being recalled due to a product complaint of the presence of glass particles in a syringe.
Mylan Pharmaceuticals Inc. is voluntarily recalling two (2) lots of quinapril and hydrochlorothiazide tablets USP 20mg/ 12.5mg, prescribed for the treatment of hypertension i.e. to lower blood pressure. This drug is being recalled due to the presence of a nitrosamine impurity, a substance that could cause cancer in amounts above acceptable levels.
Mylan Pharmaceuticals Inc. is recalling a single batch (Lot # BF21002895) of Insulin Glargine (Insulin glargine-yfgn) Injection, 100 units/mL (U-100), 3 mL prefilled pens, which are packaged in cartons of five pens. This drug is being recalled due to the potential for the label to be missing on some pens.
The U.S. Food and Drug Administration (FDA) announced that TG Therapeutics has withdrawn Ukoniq tablets from the market due to safety concerns. This decision was made because there was an increased risk of death seen in clinical trials with this drug, and so the FDA determined the risks of treatment with Ukoniq outweigh its benefits. This means that Ukoniq is no longer available effective June 1, 2022.
Teva Pharmaceuticals is recalling a single lot of Anagrelide Capsules, USP 0.5 mg (Lot Number GD01090). This drug is being recalled due to dissolution test failure detected during routine stability testing, which could result in it taking longer for the drug to dissolve once taken, and may result in the drug being less effective or ineffective.
Pfizer is voluntarily recalling five (5) lots of Accupril (Quinapril HCl) tablets, 10 mg, 20 mg, 40 mg due to the presence of a nitrosamine, Nnitroso-quinapril, observed in recent testing above the Acceptable Daily Intake (ADI) level.
Mylan Pharmaceuticals Inc. voluntarily recalled one (1) lot of its Insulin Glargine Injection, 100 units/ml (U-100) due to the potential for the label to be missing on some vials, which may lead to administration of the wrong strength or wrong product.
Princeton, NJ, Sandoz Inc. voluntarily recalled 13 lots of oral Orphenadrine Citrate 100 mg Extended Release (ER) tablets due to the presence of a nitrosamine impurity, which may cause cancer in amounts above acceptable levels that was detected in the lots during testing.
Pfizer is voluntarily recalling six (6) lots of Accuretic tablets, as well as two authorized generics distributed by Greenstone, one(1) lot of quinapril and hydrochlorothiazide tablets, and four (4) lots of quinapril HCl/hydrochlorothiazide tablets. These drugs are being recalled due to the presence of nitrosamine, N-nitroso-quinapril, a substance that may cause cancer if detected in amounts above acceptable levels, depending on the amount of exposure.
Adamis Pharmaceuticals Corporation voluntarily recalled certain lots of Symjepi (epinephrine) Injection 0.15mg (0.15mg/0.3mL) and 0.3mg (0.3mg/0.3mL) Pre-Filled Single-Dose Syringes. This drug has certain batches being recalled due to the potential clogging of the needle preventing the dispensing of epinephrine.
Mylan Pharmaceuticals Inc. is voluntarily recalling one lot (lot #BF20003118; exp. 08/2022) of Semglee® (insulin glargine injection), 100 units/ml (U-100), 3mL prefilled pens due to possible missing labels on some pre-filled pens.
Viona Pharmaceuticals Inc. is voluntarily recalling 23 lots of Metformin Hydrochloride Extended–Release tablets, USP 750 mg, due to the detection of Nnitrosodimethylamine, a substance that could cause cancer, during testing in one lot of the product.
Taro Pharmaceuticals U.S.A., Inc. is voluntarily recalling one lot (lot # AC13786, Exp 12/2022) of Clobetasol Propionate 0.05% Ointment 60 GM because routine testing found the presence of a bacteria called R. pickettii.
Padagis US Pharmaceuticals Ltd. is voluntarily recalling three lots of Nitroglycerin Lingual Spray, 12g due to the remote risk that the product may not properly dispense medication.
Sandoz, Inc. is voluntarily recalling one lot (lot # SAB06761A, Exp 04/2023) of Enoxaparin Sodium Injection, USP 40 mg/0.4 mL Single-Dose Syringes. This drug is being recalled due to exposure to higher temperatures than recommended during shipment, which may have significantly impacted the recalled product’s effectiveness.
CSL Behring Biotherapies for Life is voluntarily recalling four lots (P10034060, P100343632, P100369102, P100369103) of Hizentra 20% (10g/50mL) due to increased reports of local hypersensitivity and other injection-site reactions after taking it.
Lupin Pharmaceuticals, Inc. is voluntarily recalling all batches of Irbesartan (75mg, 150mg and 300mg) Tablets USP and Irbesartan and Hydrochlorothiazide (150mg/12.5mg and 300mg/12.5mg) Tablets USP due to certain test batches containing above acceptable limits of an impurity.
Eli Lilly and Company is voluntarily recalling one (1) lot (lot #D239382D; expires April 2022) of Glucagon Emergency Kit for Low Blood Sugar (Glucagon for Injection, 1 mg per vial; Diluent for Glucagon, 1 mL syringe due to the vial of the Glucagon diluent being a liquid instead of a powder.
Coppertone, owned by Beiersdorf, is voluntarily recalling specific lots of five Coppertone aerosol sunscreen spray products: Pure & Simple Baby SPF 50 spray, Pure & Simple Kids SPF 50 spray, Pure & Simple SPF 50 spray, Sport Mineral SPF 50 spray, and Travel-Size Sport Spray SPF 50. Coppertone decided to recall these drugs due to the presence of Benzene in these products.
Bayer U.S. LLC is voluntarily recalling all lots of Lotrimin® AF and Tinactin® spray products, which are anti-fungal medications used to treat athlete’s food, jock itch, ringworm and other fungal skin infections. Bayer decided to recall these drugs due to the presence of Benzene in some samples of the products.
Pfizer is voluntarily recalling all lots Chantix 0.5 mg and 1 mg tablets, a drug used to help quit smoking. Pfizer made this decision because the affected medicines were found to contain impurities in amounts above the accepted level.
Jacobus Pharmaceutical Company Inc. is voluntarily recalling three (3) lots of f Ruzurgi (amifampridine) 10 mg tablets due to contamination.
Azurity Pharmaceuticals, Inc. is voluntarily recalling one lot of Firvanq® (Vancomycin Hydrochloride for oral solution), Vancomycin 50 mg/mL Kits, which treats diarrhea and Enterocolitis. The drug is being recalled due to the kit containing a different diluent bottle than Firvanq, which may cause you to take the wrong dosage.”
Teligent Pharma, Inc. is recalling five lots of Lidocaine HCl Topical Solution 4%, 50 mL, a topical anesthetic. Teligent Pharma discovered that the affected lot was super potent, which may lead to higher doses than recommended.
Atovaquone Oral Suspension is prescribed to treat pneumocystis jiroveci (pneumocystis carinii) pneumonia. KVK Tech, In., a company that makes Atovaquone Oral Suspension, USP 750mg/5ml, is voluntarily recalling 2 lots of this drug.
April 30, 2021
The U.S. Food and Drug Administration (FDA) announced that Acella Pharmaceuticals, LLC is voluntarily recalling thirty-eight (38) lots of NP Thyroid®, Thyroid Tablets, USP. The products are being recalled because testing has found these lots to be sub potent, meaning they don’t provide the amount of relief per dose as expected. If you take NP Thyroid tablets, speak with your health care professional as soon as possible to see if there are other available medicines for you.
April 20, 2021
Apotex Corp is voluntarily recalling one (3) lots of Guanfacine ER Tablets, 2 mg to the consumer level due to trace amounts of Quetiapine Fumarate.
April 6, 2021
Alembic Pharmaceuticals Inc is voluntarily recalling one (1) lot of Telmisartan Tablets, 20 mg to the consumer level due to a label mix-up.