Levothyroxine Sodium Tablets Recalled for Subpotency by Major Pharmaceuticals
Major Pharmaceuticals is voluntarily recalling Levothyroxine Sodium Tablets (50 mcg) from lot N02200 due to subpotency, meaning the tablets may contain less active ingredient than labeled. Products were distributed nationwide in the USA.
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 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: FDA Class II recall for a subpotent drug, which falls under the 'risk-of-harm products where injury has not yet been reported' criterion for High severity. No hospitalization or illness reports are mentioned in the source text.
Plain-English summary
Major Pharmaceuticals is voluntarily recalling Levothyroxine Sodium Tablets, USP, 50 mcg (0.050 mg), from lot number N02200 with an expiration date of October 2026. The product is packaged as 100 tablets (10 x 10 unit dose blisters) per carton with NDC 0904-6950-61.
The recall is due to the drug being subpotent, meaning the tablets may contain less of the active ingredient (levothyroxine sodium) than indicated on the label. Levothyroxine is used to treat hypothyroidism (an underactive thyroid), and subpotency could result in inadequate treatment.
The recall affects products distributed nationwide in the United States. The recall was initiated on July 13, 2026, and is classified as FDA Class II. The status is currently ongoing.
Consumers should check their medication against lot number N02200 and expiration date 10/2026. Anyone with recalled tablets should contact their healthcare provider or pharmacist before stopping or changing their medication. Major Pharmaceuticals is notifying distributors and retailers.
The recalled product
- Product
- LEVOTHYROXINE SODIUM (LEVOTHYROXINE SODIUM)
- Brand
- LEVOTHYROXINE SODIUM
- Manufacturer
- Major Pharmaceuticals
- Hazard
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 #: N02200
- Exp. Date 10/2026
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
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