FDA·Medicines·October 28, 2026

Pfizer recalls Levoxyl 175 mcg levothyroxine sodium tablets over weaker-than-labeled strength

The tablets are subpotent, meaning they are weaker than labeled, after a stability test confirmed an out-of-specification assay result.

What to do

The notice does not give instructions. Read the official notice for details.

Note from Recalled Today: Don't stop taking a prescribed medicine before you talk to your pharmacist or doctor.

Recall details

Product
Levoxyl (levothyroxine sodium tablets, USP), tablets, 175 mcg, 100 tablet bottle, Rx only, Distributed by Pfizer Inc., New York, NY 10017, Made in Austria. NDC 60793-859-01.; Levoxyl (levothyroxine sodium tablets, USP), tablets, 175 mcg, 1000-count bottle, Rx only, Distributed by Pfizer Inc., New York, NY 10017, Made in Austria. NDC 60793-859-10
Company
Pfizer
Hazard
Subpotent Drug: confirmed out-of-specification (OOS) assay during stability testing.
Units
15,815 100-count bottles; 134 1000-count bottles
Where sold
US Nationwide and Puerto Rico
FDA classification
Class II · Ongoing
Classified by FDA
October 16, 2026
Recall started
September 29, 2026
FDA enforcement report
October 28, 2026
Identifiers
  • Codes: Lot # 24W06, Exp: 11/30/2026
  • FDA recall number: D-0052-2027
  • Codes: Lot # 24W07, Exp: 11/30/2026
  • FDA recall number: D-0051-2027

The headline, summary and steps above are written in plain English from the official notice below. Identifiers are copied exactly as the agency published them. Always check the official notice before you act.

Official notice

The notice's own wording from FDA.

Product
Levoxyl (levothyroxine sodium tablets, USP), tablets, 175 mcg, 100 tablet bottle, Rx only, Distributed by Pfizer Inc., New York, NY 10017, Made in Austria. NDC 60793-859-01. | Levoxyl (levothyroxine sodium tablets, USP), tablets, 175 mcg, 1000-count bottle, Rx only, Distributed by Pfizer Inc., New York, NY 10017, Made in Austria. NDC 60793-859-10
Reason for recall
Subpotent Drug: confirmed out-of-specification (OOS) assay during stability testing.
Classification
Class II (Ongoing)
Distribution
US Nationwide and Puerto Rico
Quantity
15,815 100-count bottles; 134 1000-count bottles

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