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Drug FDA Class II Ongoing Sub/super-potent

Levothyroxine Sodium Tablets USP 150 mcg, 1000 Tablets bottle, Rx Only, Manufactured for: Macleods Pharma USA, Inc., Princeton, NJ, Manufactured by: Macleods Pharmaceuticals Ltd., Sarigam, Valsad, Guajarat, INDIA NDC 33342-401-44

MACLEODS PHARMA USA, INC Published Apr 1, 2026

Risk level

Class II

May cause a temporary or reversible health problem; slight chance of serious harm.

Severity score 60/100

What should you do?

  • Check whether you have this product, using the lot codes, UPCs, and dates listed below.
  • Do not eat, serve, or sell the affected product.
  • Return it to the place of purchase for a refund, or throw it away in a sealed bag so people and animals can’t get to it.
  • Contact MACLEODS PHARMA USA, INC or your place of purchase with questions, and see the source record below for full details.
Reason for recall

Subpotent Drug

Hazards

Subpotency · primary

Affected products (1)

Levothyroxine Sodium Tablets USP 150 mcg, 1000 Tablets bottle, Rx Only, Manufactured for: Macleods Pharma USA, Inc., Princeton, NJ, Manufactured by: Macleods Pharmaceuticals Ltd., Sarigam, Valsad, Guajarat, INDIA NDC 33342-401-44

LEVOTHYROXINE SODIUM · 1315 bottles

NDC: 33342-393, 33342-394, 33342-395, 33342-396, 33342-397, 33342-398, 33342-399, 33342-400, 33342-401, 33342-402, 33342-403, 33342-404, 33342-393-10, 33342-393-11, 33342-393-44, 33342-394-10, 33342-394-11, 33342-394-44, 33342-395-10, 33342-395-11, 33342-395-44, 33342-396-10, 33342-396-11, 33342-396-44, 33342-397-10, 33342-397-11, 33342-397-44, 33342-398-10, 33342-398-11, 33342-398-44, 33342-399-10, 33342-399-11, 33342-399-44, 33342-400-10, 33342-400-11, 33342-400-44, 33342-401-10, 33342-401-11, 33342-401-44, 33342-402-10, 33342-402-11, 33342-402-44, 33342-403-10, 33342-403-11, 33342-403-44, 33342-404-10, 33342-404-11, 33342-404-44
Lot codes: 16240062A
Code info: Lot 16240062A, exp date 3/2026

Affected areas

Nationwide

Timeline

  1. Initiated
    Feb 26, 2026
  2. Published
    Apr 1, 2026
Recall number
D-0403-2026
Agency
U.S. Food and Drug Administration
Country
US
Source data (openFDA JSON) About FDA enforcement reports

FDA records come from the openFDA drug enforcement-report dataset — the agency's full weekly enforcement list. Most entries are not issued as consumer press releases, so they won't appear on fda.gov/recalls or in a web search. The source record link above resolves this exact recall by its number.