Iodine Solution Recalled

Safecor Health is recalling 166,022 bottles of strong iodine solution because of Current Good Manufacturing Practice deviations. The November 8, 2023, US Food and Drug Administration (FDA) Enforcement Report cites the absence of compendial requirements as the reason for the recall.

The recall affects strong iodine solution (Lugol’s solution, iodine 5%) in 14-mL glass dropper bottles (NDC 48433-230-15) from lots 21A0073 (Exp. 11/30/23), 21A0091 (Exp. 12/31/23), 21A0103 (Exp. 1/31/24), 21A0135 (Exp. 3/31/24), 22A0011 (Exp. 6/30/24), 22A0019 (Exp. 7/31/24), 22A0057 (Exp. 9/30/24), 22A0083 (Exp. 11/30/24), 22A0104 (Exp. 12/31/24), 22A0110 (Exp. 1/31/25), 22A0150 (Exp. 3/31/25), 23A0007 (Exp. 6/30/25), 23A0041 (Exp. 9/30/25), 23A0045 (Exp. 11/30/25), 23A0058 (Exp. 11/30/25), 23A0067 (Exp. 11/30/25), 23A0080 (Exp. 12/31/25), and 23A0090 (Exp. 1/31/26).

The recalled products were distributed throughout the US.

Safecor Health voluntarily initiated the recall October 19, 2023. The FDA designated the recall Class II on November 1, 2023. Drugs affected by Class II recalls may cause temporary or medically reversible adverse health consequences if used. While remote, a possibility of serious harm also exists.

Strong iodine solution is a prescription medication used in the prophylaxis of simple and colloid goiters and in the treatment of exophthalmic goiter.