Drug news and alerts

On September 30, 2025, Grifols Therapeutics LLC. announced its decision to voluntarily withdraw two (2) lots of Gamunex-C. This voluntary withdrawal is being conducted as a precautionary measure due to an increased rate of allergic/hypersensitivity type reactions associated with these specific lots.

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On September 11, 2025, Intercept Pharmaceuticals, Inc. announced its decision to voluntarily withdraw OCALIVA^® (obeticholic acid) from the US market because Ocaliva may increase the risk of serious liver injury in people taking Ocaliva to treat primary biliary cholangitis (PBC). 

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On August 27, 2025, Unichem Pharmaceuticals (USA), Inc. is voluntarily recalling one (1) lot of Cyclobenzaprine Hydrochloride Tablets USP 10 mg, to the consumer level. The Cyclobenzaprine 10mg (90ct) label was mistakenly placed on a bottle containing Meloxicam 7.5 mg tablets.

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On August 13, 2025, Celltrion USA, initiated a voluntary recall of one (1) lot of Steqeyma® (Ustekinumab-stba) 90 mg/mL injection to the consumer level, due to incorrect assembly.

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On July 11, 2025, Nostrum Laboratories, Inc., voluntarily recalled Sucralfate tablets USP 1 gram due to the company filing for bankruptcy on Sept. 30, 2024. The company has ceased all operations. As a result of discontinuation of its Quality activities, Nostrum Laboratories cannot guarantee that any lots of this product still within expiry can meet all intended specifications through the product’s labeled shelf life.

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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.

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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. 

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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.

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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.

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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.

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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.

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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.

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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.

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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.

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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.

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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.

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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.

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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.

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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.

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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.

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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.

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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.

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