Drug news and alerts

On June 2, 2025, Amneal Pharmaceutical LLC issued a recall of Sulfamethoxazole/Trimethoprim 400 mg/80 mg Tablets, due to microbial contamination. The company said in a U.S. Food and Drug Administration (FDA) recall notice that the contaminated products could display black dots on the surface of the tablets.

Drug recall for Sulfamethoxazole/Trimethoprim

On June 25, 2024, the U.S. Food and Drug Administration (FDA) announced that American Health Packaging on behalf of BluePoint Laboratories is voluntarily recalling 21 batches of Potassium Chloride Extended-Release Capsules, USP (750 mg) 10 mEq K, at the consumer level. The company is initiating this recall due to failed dissolution that may impact the effectiveness and cause high potassium levels. 

Drug recall for Blue Point Potassium Chloride

On January 31, 2025, Alvogen, Inc. announced that it is voluntarily recalling one (1) lot of Fentanyl Transdermal System 25 mcg/h transdermal patches to the consumer level. These products are being recalled because it is possible that the patches could be multi-stacked, adhered one on top of the other, in a single product pouch. Application of multi-stacked patches could cause serious or fatal respiratory depression, especially in first-time users, children, and the elderly.

Drug recall for Alvogen Fentanyl

On November 18, 2024, Endo USA Inc. announced it is expanding its previously announced voluntary recall of Clonazepam Orally Disintegrating Tablets, USP, at the consumer level. The company is initiating this recall due to a potential mislabeling of the carton strength.

Drug recall for Clonazepam

On December 23, 2024, Astellas Pharma US, Inc. announced that it is voluntarily recalling one (1) lot of PROGRAF® 0.5mg (tacrolimus) and one (1) lot of ASTAGRAF XL® 0.5mg (tacrolimus extended-release) capsules at the consumer level. These products are being recalled because bottles may contain empty capsules which may be fatal for some patients.

Drug recall for PROGRAF® 0.5mg (tacrolimus) and ASTAGRAF XL® 0.5mg (tacrolimus extended-release) capsules

The company that makes RELYVRIO® announced on April 4th, 2024, the decision to voluntarily withdraw the product from the market in the U.S. RELYVRIO® will no longer be available for new patients. RELYVRIO® was used for the treatment of amyotrophic lateral sclerosis (ALS) in adults. The company made this decision after it failed to prove to be effective in a large clinical trial.

On March 27, 2024, the U.S. Food and Drug Administration (FDA) announced that Amneal Pharmaceuticals, LLC. is voluntarily recalling four (4) lots of Vancomycin Hydrochloride for Oral Solution USP, 250mg/5mL, at the consumer level. The company is initiating this recall due to the potential for some bottles to have dosing above the maximum daily dose allowance, which may be harmful.

Drug recall for Vancomycin Hydrochloride for Oral Solution USP, 250mg/5mL

On September 29, 2023, the U.S. Food and Drug Administration (FDA) announced that KVK-Tech, Inc. is voluntarily recalling one (1) lot of its Betaxolol Tablets, USP 10 mg. The company is initiating this recall due to a single Oxycodone HCl  5 mg tablet found on the packaging line for Betaxolol.

Drug recall for Betaxolol Tablets, USP 10 mg

On September 22, 2023, the U.S. Food and Drug Administration (FDA) announced that VistaPharm LLC is voluntarily recalling one (1) lot of Sucralfate Oral Suspension, 1g/10mL due to Bacterial contamination in the product.

Drug recall for Sucralfate Oral Suspension, 1g/10mL

On September 11, 2023, the U.S. Food and Drug Administration (FDA) announced that Novartis is voluntarily recalling one (1) lot of its Sandimmune Oral Solution (cyclosporine oral solution, USP), 100 mg/ml. The company is initiating this recall due to crystal formation in some bottles, which could possibly result in incorrect dosing.

Drug recall for Sandimmune® Oral Solution (Cyclosporine Oral Solution, USP), 100 mg/mL

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.

Drug recall for Dronabinol Capsules and Ziprasidone Hydrochloride Capsules

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.

Drug recall for Tydemy

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.

Drug recall for Albuterol Sulfate Inhalation Aerosol, 90 mcg (200 Metered Inhalation)

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.

Drug recall notice for Atovaquone Oral Suspension

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.

Drug market withdrawal for Makena (hydroxyprogesterone caproate injection)

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.

Drug recall for all drug products from Akorn

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.

Drug recall notice for Dabigatran Etcxilate Capsules, USP 75 mg and 150 mg

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.

Drug recall notice for Tirosint-Sol (levothyroxine sodium)

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.

Drug recall notice for Brimonidine Tartrate Ophthalmic Solution, 0.15%

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.

Drug recall notice for Octreotide

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.

Drug recall notice for Quinapril and Hydrochlorothiazide

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.

Drug recall notice for Insulin Glargine Injection

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.

Drug recall notice for Ukoniq Tablets

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.

Drug recall notice for Anagrelide 0.5 MG Capsules

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.

Drug recall notice for Accupril (Quinapril HCl) tablets

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.

Drug recall notice for Insulin Glargine Injection

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.

Drug recall notice for Orphenadrine Citrate 100 mg (ER) tablets

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.

Drug recall notice for Accuretic (Quinapril) tablets

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.

Drug recall notice for Symjepi

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.

Drug recall notice for Semglee (insulin glargine injection) 3mL prefilled 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.

Drug recall notice for Metformin hydrochloride extended-release tablets