The FDA has issued a recall for various medications. About 22 million Americans could be affected each year.
Major Rugby, also known as Major Pharmaceuticals, a leading generic drug manufacturer in the U.S., is recalling a significant number of levothyroxine sodium tablets, with expiration dates ranging from this month to early next year.
The recall stems from issues of “low potency” of the drug, meaning it might not have enough effectiveness. The FDA categorized this as Class II, indicating it could lead to temporary health issues.
List of Recalled Medicines
Levothyroxine is available in multiple forms, including capsules, solutions, and tablets. The tablets from Major and Cardinal brands are being recalled.
Major brand:
- 25 mcg, 100 tablets, lot number N02212, expiration date July 2026
- 50 mcg, 100 tablets, lot number N02200, expiration date October 2026
- 75 mcg, 100 tablets, lot numbers N02172, N02296, N02288, expiration dates July 2026 and December 2026
- 88 mcg, 100 tablets, lot number N02310, expiration date January 2027
- 112 mcg, 100 tablets, lot number N02203, expiration date September 2026
- 125 mcg, 100 tablets, lot number N02266, expiration date November 2026
- 150 mcg, 100 tablets, lot number N02167, expiration date July 2026
Cardinal brand:
- 25 mcg, 10 tablets, lot numbers N02212A, N02212B (bag), N02212 (blister), expiration date July 2026
- 50 mcg, 10 tablets, lot numbers N02200A, N02200B (bag), N02200 (blister), expiration date October 2026
- 75 mcg, 10 tablets, lot numbers N02172A, N02172B, N02288A, N02288B (bags), N02172, N02288 (blister), expiration dates July 2026 and December 2026
- 125 mcg, 10 tablets, lot numbers N02266A, N02266B (bags), N02266 (blister), expiration date November 2026
- 150 mcg, 10 tablets, lot number N02167A (bag), N02167 (blister), expiration date July 2026
If you think your medication might be included, it’s a good idea to check the lot numbers.
The company has asked retailers to inform customers about returning the products.
If you’re affected by this recall, it’s wise to speak with your doctor. They can provide guidance and help you find a replacement instead of abruptly stopping your medication or adjusting your dosage alone.
About the Medication
Levothyroxine is prescribed for hypothyroidism, a condition where the thyroid gland isn’t producing enough hormones.
Roughly 12% of Americans, which is about 40 million people, experience hypothyroidism. It can result in weight gain and fatigue, among other symptoms. Some other signs include constipation, rough skin and hair, muscle weakness, depression, and issues with memory. People with this condition might feel more sensitive to cold temperatures as well.
Often, hypothyroidism is misdiagnosed as other health problems, such as depression or aging. But if not treated, it can lead to more serious issues like heart disease.
Levothyroxine helps by replacing hormones that the body is struggling to produce on its own. Additionally, it’s used to reduce the size of an enlarged thyroid, known as goiter, that can develop from untreated hypothyroidism.
Interestingly, this isn’t the first recall linked to levothyroxine. Just last year, 160,000 bottles were recalled by another manufacturer. And earlier in 2023, there was a recall concerning an oral solution of levothyroxine.
Both recalls were for similar reasons.
