Macleods Recalls Levothyroxine Sodium Tablets Due to Subpotency

Macleods Pharma USA, Inc has initiated a voluntary nationwide recall of levothyroxine sodium tablets USP, 150 mcg, supplied in 1000-count bottles (NDC 33342-401-44). The product is manufactured by Macleods Pharmaceuticals Ltd., Gujarat, India, for Macleods Pharma USA, Inc, Princeton, New Jersey. The recall is being conducted at the bottle level. A total of 1315 bottles are affected. The recall applies to lot number 16240062A, with an expiration date of March 2026. The firm notified consignees via letter. The recall was initiated on February 26, 2026, and remains ongoing. Distribution occurred nationwide within the United States.

The reason for the recall is subpotency, a quality issue in which the product contains less active ingredient than labeled, potentially resulting in reduced therapeutic effect. Inadequate dosing of levothyroxine may lead to insufficient treatment of hypothyroidism and could result in persistent symptoms or complications in affected patients. The recall has been classified by the US Food and Drug Administration (FDA) as Class II (recall number D-0403-2026; event ID 98510), indicating that use of or exposure to the product may cause temporary or medically reversible adverse health consequences, with a remote probability of serious outcomes. No press release has been issued. The action was voluntary and firm-initiated, and there is no termination date currently listed.

The recalling firm, Macleods Pharma USA, Inc, Princeton, New Jersey, is responsible for the action. Pharmacists and health care providers should review inventory for the affected lot number and follow recall instructions provided in the notification letter. Levothyroxine is a synthetic thyroid hormone indicated for the treatment of hypothyroidism and for suppression of thyroid-stimulating hormone (TSH) in certain clinical settings.

Reference

FDA. Enforcement Report. April 1, 2026. Accessed April 2, 2026. https://www.accessdata.fda.gov/scripts/ires/index.cfm