Levothyroxine Sodium Tablets Recalled for Subpotency
Major Pharmaceuticals is voluntarily recalling Levothyroxine Sodium 125 mcg tablets (Lot N02266, Exp. 11/2026) nationwide due to subpotency, meaning the tablets may contain less active ingredient than labeled.
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 subpotent prescription drug. Per the rubric, FDA Class II recalls are scored at 4 (Severe) when they involve risk-of-harm products where injury has not yet been reported, as is the case here with no reported illnesses.
Plain-English summary
Major Pharmaceuticals is voluntarily recalling Levothyroxine Sodium Tablets, USP, 125 mcg (0.0125 mg), distributed in 100-tablet cartons (10 x 10 unit dose blisters). The product is identified by NDC 0904-6955-61, Lot Number N02266, and an expiration date of November 2026.
The recall is classified as Class II by the FDA and was initiated due to a subpotent drug condition, meaning the tablets may contain less of the active ingredient than stated on the label. Levothyroxine is a thyroid hormone replacement; reduced potency could lead to inadequate treatment of hypothyroidism.
The recall affects products distributed nationwide in the United States. The recall initiation date was July 13, 2026, and the FDA was notified by letter. The status of the recall is currently ongoing.
Consumers and healthcare providers should check for the recalled lot number and expiration date. Patients taking this medication should contact their healthcare provider to discuss replacement options and should not continue taking medication from the recalled lot. Any adverse reactions should be reported to the FDA.
The recalled product
- Product
- LEVOTHYROXINE SODIUM (LEVOTHYROXINE SODIUM)
- Brand
- LEVOTHYROXINE SODIUM
- Manufacturer
- Major Pharmaceuticals
- Category
- Drug — Prescription Oral Tablet
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 #: N02266
- Exp. Date 11/2026
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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