The Food and Drug Administration has classified a nationwide recall of the thyroid medication Levothyroxine as a Class II recall.
The agency said in an enforcement report that the drug was recalled because it is “subpotent.”
Major Pharmaceuticals, based in Dublin, Ohio, issued the recall on July 13. It was marked a Class II on July 17.
The enforcement report did not indicate how many pills are part of the recall but did provide the following list of affected lots:
- Levothyroxine Sodium Tablets, USP, 25 mcg, lot number N02212, and expiration date 07/2026
- Levothyroxine Sodium Tablets, USP, 50, lot number N02200, and expiration date 10/2026
- Levothyroxine Sodium Tablets, USP, 75 mcg, lot number N02172, expiration date 07/2026
- Levothyroxine Sodium Tablets, USP, 75 mcg, lot numbers N02296, N02288, expiration date 12/2026
- Levothyroxine Sodium Tablets, USP, 88 mcg, lot number N02203, expiration date 09/2026
- Levothyroxine Sodium Tablets, USP, 125 mcg, lot number N02266, expiration date 11/2026
- Levothyroxine Sodium Tablets, USP, 150 mcg, lot number N02167, expiration date 07/2026
- Levothyroxine Sodium Tablets, USP, 25 mcg, bag lot number N02212A, N02212B, expiration date 07/2026
- Levothyroxine Sodium Tablets, USP, 25 mcg, blister lot number N02212, expiration date 07/2026
- Levothyroxine Sodium Tablets, USP, 50 mcg, bag lot number N02200A, N02200B, expiration date 10/2026
- Levothyroxine Sodium Tablets, USP, 50 mcg, blister lot number N02200, expiration date 10/2026
- Levothyroxine Sodium Tablets, USP, 75 mcg, bag lot number N02172A, N02172B, expiration date 07/2026
- Levothyroxine Sodium Tablets, USP, 75 mcg, bag lot number N02288A, N02288B, expiration date 12/2026
- Levothyroxine Sodium Tablets, USP, 75 mcg, blister lot number N02172, expiration date 07/2026
- Levothyroxine Sodium Tablets, USP, 75 mcg, blister lot number N02288, expiration date 12/2026
- Levothyroxine Sodium Tablets, USP, 125 mcg, bag lot number N02266A, N02266B, expiration date 11/2026
- Levothyroxine Sodium Tablets, USP, 125 mcg, blister lot number N02266, expiration date 11/2026
- Levothyroxine Sodium Tablets, USP, 150 mcg, bag lot number N02167A, expiration date 07/2026
- Levothyroxine Sodium Tablets, USP, 150 mcg, blister lot number N02167, expiration date 07/2026
A Class II recall is one where “a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote,” the FDA said.
The company said it is a voluntary recall, but added it is “not likely to cause adverse health effects.”
If people have the recalled medications, they are told to return them to the place of purchase.
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