The U.S. Food and Drug Administration (FDA) has announced three separate nationwide drug recalls involving thyroid medication, an injectable antibiotic, and an injectable blood vessel medication because of manufacturing issues that could pose health risks to patients.
The recalls involve certain lots of levothyroxine sodium tablets distributed by Major Pharmaceuticals, Cefazolin in Dextrose Injection manufactured by Baxter International, and Papaverine Hydrochloride Injection produced by American Regent Inc.
Here’s what patients and healthcare providers should know about each recall.
Levothyroxine Tablets Recalled for Reduced Potency
Major Pharmaceuticals voluntarily recalled multiple lots of Levothyroxine Sodium Tablets, a prescription medication used to treat hypothyroidism, after testing found the products were subpotent, meaning they may not contain the labeled amount of active ingredient.
The FDA classified the recall as a Class II recall, indicating use of the product could cause temporary or medically reversible adverse health consequences.
The affected tablets were distributed nationwide after January 22, 2025, and include several strengths ranging from 25 micrograms to 150 micrograms. Both Major Pharmaceuticals packaging and Cardinal Health unit-dose blister packages are included in the recall.
According to the company, taking the recalled medication is not expected to cause serious adverse health effects, but patients using affected lots should contact their pharmacy or healthcare provider and arrange to return the recalled medication.
Baxter Recalls Injectable Antibiotic
Baxter International is recalling one nationwide lot of Cefazolin in Dextrose Injection, USP, 2 grams/100 milliliters, after particulate matter identified as cardboard was found in the solution.
The antibiotic is commonly administered intravenously to treat bacterial infections or help prevent infections during surgery.
The recalled product includes:
- Product: Cefazolin in Dextrose Injection, USP, 2 g/100 mL
- Lot Number: LD175708
- Expiration Date: February 14, 2027
- NDC: 0338-3508-41
The product was distributed across the United States between March 25 and June 30, 2025.
The FDA said intravenous administration of contaminated medication could cause pulmonary embolism, blocked blood vessels, inflammation of veins, organ damage, or immune system complications. Baxter said it has not received any reports of injuries related to the recalled lot.
Healthcare facilities are instructed to stop using the affected product immediately and return it according to their facility’s procedures.
American Regent Recalls Papaverine Injection
American Regent Inc. has also issued a voluntary nationwide recall of one lot of Papaverine Hydrochloride Injection, USP, 60 mg/2 mL after discovering visible particulate matter consisting of glass and/or paraformaldehyde.
Papaverine is a prescription medication used to relax smooth muscles and widen blood vessels. It is prescribed to treat certain circulation disorders, visceral spasms, and erectile dysfunction.
The recalled product includes:
- Product: Papaverine Hydrochloride Injection, USP, 60 mg/2 mL
- Lot Number: 25202
- Expiration Date: November 30, 2026
- NDC: 0517-4002-25
The medication was distributed nationwide beginning September 30, 2025.
According to the FDA, injectable particulate matter may cause swelling or irritation at the injection site. In more serious cases, particles can block blood vessels in the heart, lungs or brain, potentially causing stroke or death, particularly in patients with cardiovascular or pulmonary disease.
American Regent said it has not received any reports of adverse events associated with the recalled lot.
Healthcare providers and distributors should stop using the product immediately and either return it to the place of purchase or dispose of it as instructed.
What Patients Should Do
Patients should not stop taking prescribed medications without first consulting their healthcare provider.
Anyone who believes they have received one of the recalled medications should:
- Check the lot number on their prescription or medication packaging.
- Contact their pharmacy, healthcare provider, or prescribing physician.
- Follow the recall instructions provided by the manufacturer.
- Report any adverse reactions to the FDA’s MedWatch Safety Information and Adverse Event Reporting Program.
All three recalls remain ongoing, and the FDA said no injuries or adverse events had been reported at the time the recall notices were issued.
Provided by Dallas Express
