The Recall Desk
SevereFDA (Drugs)·D-0702-2026·Announced 2026-07-29

Major Pharmaceuticals Recalls Levothyroxine Sodium Tablets Over Subpotency

Major Pharmaceuticals is voluntarily recalling Levothyroxine Sodium Tablets, 75 mcg, NDC 0904-6951-61, due to subpotency. The recall affects lots N02172, N02296, and N02288 with expiration dates in July and December 2026, distributed nationwide.

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 subpotent prescription drug. Per the rubric, FDA Class II recalls are scored as Severe (4), particularly given the potential for medically reversible adverse health consequences from subpotency in a critical hormone replacement therapy.

Plain-English summary

Major Pharmaceuticals has issued a voluntary recall of Levothyroxine Sodium Tablets, USP, 75 mcg (0.075 mg), packaged in 100-tablet cartons (10 x 10 unit dose blisters), NDC 0904-6951-61. The product is a human prescription drug used to treat thyroid hormone deficiency.

The recall was initiated due to a subpotent drug condition, meaning the tablets may not contain the full labeled amount of active ingredient. The affected lots are N02172 with an expiration date of July 2026, and N02296 and N02288 with an expiration date of December 2026. The recall was classified as Class II by the FDA, indicating that use of or exposure to the product may cause temporary or medically reversible adverse health consequences.

The recalled product was distributed nationwide in the United States. Healthcare professionals and consumers who have Levothyroxine Sodium Tablets from the affected lots should stop using the product and return it to the place of purchase. Patients currently taking this medication should contact their healthcare provider to discuss alternative treatment options, as interruption or reduction in dosage may affect thyroid hormone levels.

The recall was initiated on July 13, 2026, with the firm notifying distributors via letter. The FDA was notified and classified the recall on July 17, 2026. Consumers with questions may contact Major Pharmaceuticals for more information.

The recalled product

Product
LEVOTHYROXINE SODIUM (LEVOTHYROXINE SODIUM)
Brand
LEVOTHYROXINE SODIUM
Manufacturer
Major Pharmaceuticals
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 (5)

  • Lot# N02172
  • exp 07/2026
  • N02296
  • N02288
  • Exp. Date 12/2026

Distribution

Distributed nationwide across the United States.