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FDA recalls thyroid medication over potency issues

The affected Levothyroxine tablets were distributed across the United States beginning in January 2025

FDA recalls thyroid medication over potency issues
FDA recalls thyroid medication over potency issues

Major Rugby, a drug which is frequently prescribed to treat hypothyroidism, a nationwide recall has been issued for some Levothyroxine Sodium tablets made by enlarged thyroid glands and certain types of thyroid cancer.

According to the company's recall notice, the affected tablets were distributed across the United States beginning in January 2025 under the Major and Cardinal brand names.

Why the medication was recalled?

The reason behind recall is the presence of less active drug as compared to the indicated one on the label, making it subpotent.

Although the manufacturer stated that consuming the affected tablets is “not likely to cause adverse health effects," patients are advised to stop using the recalled products and return them to the place of purchase.

Due to levothyroxine assist regulating thyroid hormone levels, getting a lower-than-prescribed dose could affect treatment in several patients.

Consumers are urged to consult their doctors if they have been using the recalled drugs.


Products included in the recall

25 mcg (0.025 mg), 100 tablets (10 x 10 unit dose blisters)

Lot # N02212, Exp. Date 07/2026

50 mcg (0.050 mg), 100 tablets (10 x 10 unit dose blisters)

Lot # N02200, Exp. Date 10/2026

75 mcg (0.075 mg), 100 tablets (10 x 10 unit dose blisters)

Lot # N02172, Exp. Date 07/2026

Lot # N02296, N02288, Exp. Date 12/2026

88 mcg (0.088 mg), 100 tablets (10 x 10 unit dose blisters)

Lot # N02310, Exp. Date 01/2027

112 mcg (0.0112 mg), 100 tablets (10 x 10 unit dose blisters)

Lot # N02203, Exp. Date 09/2026

125 mcg (0.0125 mg), 100 tablets (10 x 10 unit dose blisters)

Lot # N02266, Exp. Date 11/2026

150 mcg (0.0150 mg), 100 tablets (10 x 10 unit dose blisters)

Lot # N02167, Exp. Date 07/2026

25 mcg (0.025 mg), 10 tablets (10 x 1 unit dose blisters)

Bag lot # N02212A, N02212B, Exp. Date 07/2026

Blister lot # N02212, Exp. Date 07/2026

50 mcg (0.050 mg), 10 Tablets (10 x 1 unit dose blisters)

Bag lot # N02200A, N02200B, Exp. Date 10/2026

Blister lot # N02200, Exp. Date 10/2026

125 mcg (0.0125 mg), 10 tablets (10 x 1) unit dose blisters per carton

Bag lot # N02266A, N02266B, Exp. Date 11/2026

Blister lot # N02266, Exp. Date 11/2026

150 mcg (0.0150 mg), 10 tablets (10 x 1) unit dose blisters per carton

Bag lot # N02167A, Exp. Date 07/2026

Blister lot # N02167, Exp. Date 07/2026