Levothyroxine Sodium Tablets Recalled for Subpotency
Major Pharmaceuticals is recalling Levothyroxine Sodium Tablets, 25 mcg, due to subpotency. The recall affects nationwide U.S. distribution of specific lot numbers.
The agency’s classification
FDA (Drugs): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: This is an FDA Class II recall of a prescription drug where subpotency could lead to inadequate treatment of a serious medical condition. The rubric assigns Severe (score 4) to FDA Class II recalls with potential for significant health impact, and this recall involves a critical medication for thyroid function.
Plain-English summary
Major Pharmaceuticals is voluntarily recalling Levothyroxine Sodium Tablets, USP, 25 mcg (0.025 mg), packaged in 10-tablet unit dose blisters per carton. The product is being recalled because it was found to be subpotent, meaning it may contain less of the active ingredient than labeled.
The recalled product was distributed nationwide in the United States. The affected lots are identified by bag lot numbers N02212A and N02212B, and blister lot number N02212, all with an expiration date of July 2026. The NDC carton number is 55154-3558-0 and the NDC blister number is 0904-6949-61.
Levothyroxine is a prescription medication used to treat thyroid hormone deficiency. Subpotent tablets may result in inadequate treatment of hypothyroidism, potentially leading to symptoms such as fatigue, weight gain, and other complications associated with insufficient thyroid hormone levels.
Consumers and healthcare providers should check the lot numbers and expiration dates of any Levothyroxine Sodium Tablets they have on hand. Anyone with affected product should contact their pharmacy or healthcare provider for a replacement. The recall was initiated on July 13, 2026, and the FDA was notified on July 17, 2026.
The recalled product
- Product
- LEVOTHYROXINE SODIUM (LEVOTHYROXINE SODIUM)
- Brand
- LEVOTHYROXINE SODIUM
- Manufacturer
- Major Pharmaceuticals
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (4)
- Bag lot #: N02212A
- N02212B
- Exp. Date 07/2026
- Blister lot #: N02212
UPCs (1)
- 0055154356305
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 12 recalled by Major Pharmaceuticals under a single FDA (Drugs) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
See all 12 products in this recall →Related recalls
Same brand · LEVOTHYROXINE SODIUM
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