Levothyroxine Sodium Tablets Recalled for Subpotency
Major Pharmaceuticals is recalling Levothyroxine Sodium Tablets, 88 mcg, lot N02310, due to subpotency. The recall is voluntary and affects nationwide distribution in the USA.
What this means for you
Illness, injury, or structural failure has been reported. 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 (levothyroxine) due to subpotency. Per the rubric, FDA Class II recalls are scored as Severe (4), particularly given the critical nature of thyroid hormone replacement therapy where incorrect dosing can lead to serious health consequences.
Plain-English summary
Major Pharmaceuticals is voluntarily recalling Levothyroxine Sodium Tablets, USP, 88 mcg (0.088 mg), packaged in 100-tablet cartons (10 x 10 unit dose blisters), NDC 0904-6952-61. The affected product is lot number N02310 with an expiration date of January 2027.
The reason for the recall is subpotency, meaning the tablets may contain less of the active ingredient than indicated on the label. Levothyroxine is a prescription medication used to treat thyroid hormone deficiency, and subpotent doses could reduce its effectiveness.
The recall affects nationwide distribution in the United States. The product was distributed to pharmacies, hospitals, and other healthcare facilities. No illnesses or injuries have been reported in connection with this recall.
Consumers and healthcare providers who have questions or who have distributed or used the recalled product should contact Major Pharmaceuticals. Patients currently taking this medication should talk to their healthcare provider before stopping or changing their dose.
The recalled product
- Product
- LEVOTHYROXINE SODIUM (LEVOTHYROXINE SODIUM)
- Brand
- LEVOTHYROXINE SODIUM
- Manufacturer
- Major Pharmaceuticals
- Category
- Drug — Prescription Tablet
- Hazard
- subpotent-drug
- dosing-error
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 #: N02310
- Exp. Date 01/2027
Distribution
Distributed nationwide across the United States.
Related recalls
Same brand · LEVOTHYROXINE SODIUM
- HighLEVOTHYROXINE SODIUM Tablets Recalled Due to Subpotent Drug Content
FDA (Drugs) · 2026-07-29
- HighLevothyroxine Sodium Tablets Recalled for Subpotency by Major Pharmaceuticals
FDA (Drugs) · 2026-07-29
- SevereLevothyroxine Sodium Tablets Recalled for Subpotency
FDA (Drugs) · 2026-07-29
- HighLevothyroxine Sodium Tablets Recalled Due to Subpotent Drug Concerns
FDA (Drugs) · 2026-07-29
- SevereMajor Pharmaceuticals Recalls Levothyroxine Sodium Tablets Over Subpotency
FDA (Drugs) · 2026-07-29
Same category
- HighRohto Cooling Eye Drops Max Strength Recalled Due to Sterility Concerns
FDA (Drugs) · 2026-07-29
- HighNaropin Injection Recall Over Particulate Matter Contamination
FDA (Drugs) · 2026-07-29
- ModerateFDA Recalls Xylocaine Injections Due to Hair Contamination
FDA (Drugs) · 2026-07-29
- ModerateCyproheptadine Hydrochloride Syrup Recall Due to Precipitate
FDA (Drugs) · 2026-07-29
- HighLidocaine Injection Recall Due to Hair Contamination
FDA (Drugs) · 2026-07-29