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Thyroid Medication Recalled Due to Potency Issue
Some levothyroxine tablets may contain less active ingredient than the label states
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Key takeaways
- Multiple lots of levothyroxine tablets were recalled because some may contain less active ingredient than listed on the label.
- The Class II recall covers prescription tablets in strengths from 25 mcg to 150 mcg with expiration dates through January 2027.
- Consumers can compare lot numbers on their medication with the recall notice or ask a pharmacist for help identifying affected products.
Major Pharmaceuticals has issued a nationwide recall of multiple lots of levothyroxine sodium tablets, a prescription thyroid medication, after finding some tablets may contain less active ingredient than the label states, according to a recall notice from the Food and Drug Administration.The recall covers several strengths of levothyroxine, packaged in 100-tablet cartons and 10-tablet unit-dose blister packs.
The FDA classified the recall as Class II, meaning use of the affected tablets may cause temporary or medically reversible health consequences, though the probability of a serious health issue is remote. For Class II recalls, the FDA says patients and consumers can generally continue using the medicine unless otherwise directed by the recalling company or the FDA.
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Levothyroxine treats hypothyroidism, or underactive thyroid, a condition in which the thyroid gland doesn’t produce enough hormone to meet the body’s needs. Those hormones affect a range of body functions, including heart rate, weight, digestion and mood, according to Medline Plus.
Which thyroid medication is recalled?
The recall affects certain lots of levothyroxine sodium tablets, packaged and distributed by Major Pharmaceuticals. Some of the recalled products were also distributed by Cardinal Health, according to the FDA notice.The recalled prescription-only tablets include multiple strengths ranging from 25 mcg to 150 mcg. The affected expiration dates range from July 2026 to January 2027.
Major-distributed levothyroxine tablets
These recalled products were packaged in 100-tablet cartons containing 10-by-10 unit-dose blister packs. The recall includes these strengths:
25 mcg
- Lot: N02212
- Expiration: July 2026
- NDC: 0904-6949-61
50 mcg
- Lot: N02200
- Expiration: October 2026
- NDC: 0904-6950-61
75 mcg
- Lots: N02172, N02296, N02288
- Expiration range: July 2026 to December 2026
- NDC: 0904-6951-61
88 mcg
- Lot: N02310
- Expiration: January 2027
- NDC: 0904-6952-61
112 mcg
- Lot: N02203
- Expiration: September 2026
- NDC: 0904-6954-61
125 mcg
- Lot: N02266
- Expiration: November 2026
- NDC: 0904-6955-61
150 mcg
- Lot: N02167
- Expiration: July 2026
- NDC: 0904-6956-61
Cardinal-distributed levothyroxine tablets
These recalled products were packaged in 10-tablet cartons containing 10-by-1 unit-dose blister packs and distributed by Cardinal Health. The recall includes these strengths:
25 mcg
- Lot: N02212
- Expiration: July 2026
- NDC blister: 0904-6949-61
50 mcg
- Lot: N02200
- Expiration: October 2026
- NDC blister: 0904-6950-61
75 mcg
- Lots: N02172, N02288
- Expiration range: July 2026 to December 2026
- NDC blister: 0904-6951-61
125 mcg
- Lot: N02266
- Expiration: November 2026
- NDC blister: 0904-6951-61
150 mcg
- Lot: N02167
- Expiration: July 2026
- NDC blister: 0904-6956-61
(For the full product table, lot numbers and NDC information, see the FDA’s recall notice.)
How to check your medication
Check the label or packaging for the medication name, strength, NDC, lot number and expiration date. The FDA says consumers can check whether their medicine is recalled by comparing the lot number on the medication label with the lot number listed in the recall notice.
If your medication is packaged in a pharmacy-labeled container and the original lot information is not visible, contact your pharmacist or health care provider to help confirm whether your medication came from an affected lot.
What should patients do?
The FDA says Class II recalls are generally conducted at the retail level, and patients and consumers can generally continue using the medicine unless otherwise directed by the recalling company or the FDA.
Additionally, the Major Pharmaceutical’s recall response form asks wholesale and retail distributors to quarantine and return any recalled product on hand and to notify customers who received, or may have received, the recalled product.
If you believe your levothyroxine is part of the recall, contact your pharmacist or health care provider.
This article used AI tools to compile recall data. An AARP editor reviewed and refined the content for accuracy and clarity.
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