Levothyroxine Sodium Tablets Recalled for Subpotency
Major Pharmaceuticals is recalling Levothyroxine Sodium Tablets, 25 mcg, lot N02212, due to subpotency. The recall is nationwide and voluntary.
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 with a subpotency defect that could compromise therapeutic effectiveness. Per the rubric, FDA Class II recalls are scored as Severe (4).
Plain-English summary
Major Pharmaceuticals is voluntarily recalling Levothyroxine Sodium Tablets, USP, 25 mcg (0.025 mg), packaged in 100-tablet cartons (10 x 10 unit dose blisters), NDC 0904-6949-61. The recalled product is identified by Lot Number N02212 and an expiration date of July 2026.
The reason for the recall is subpotent drug, meaning the tablets may not contain the full labeled amount of levothyroxine sodium. Levothyroxine is a prescription thyroid hormone replacement; reduced potency could lead to inadequate treatment of hypothyroidism.
The recall affects products distributed nationwide in the United States. The recall was initiated on July 13, 2026, with Major Pharmaceuticals notifying its customers by letter. The FDA classified this recall as Class II.
Consumers and patients taking this medication should check their tablets against the recalled lot number. Anyone with questions should contact their pharmacist or healthcare provider. The recalling firm is continuing the recall and working with the FDA.
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 (2)
- Lot#: N02212
- Exp. Date 07/2026
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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