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Drug FDA Class III Ongoing Foreign material

Levothyroxine Sodium Tablets, USP 112 mcg (0.112mg), 1000 tablets, Rx Only, Manufactured for: Macleods Pharma USA, Inc. Princeton, NJ 08540. Manufactured by: Macleods Pharmaceuticals Ltd. Sarigam, Valsad, Gujarat, India, NDC 33342-398-44.

Macleods Pharmaceuticals Ltd Published Jun 18, 2025

Risk level

Class III

Unlikely to cause harm, but violates labeling or manufacturing rules.

Severity score 40/100

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 Pharmaceuticals Ltd or your place of purchase with questions, and see the source record below for full details.
Reason for recall

Presence of a foreign substance: black hair found embedded in tablet.

Hazards

Hair · primary

Affected products (1)

Levothyroxine Sodium Tablets, USP 112 mcg (0.112mg), 1000 tablets, Rx Only, Manufactured for: Macleods Pharma USA, Inc. Princeton, NJ 08540. Manufactured by: Macleods Pharmaceuticals Ltd. Sarigam, Valsad, Gujarat, India, NDC 33342-398-44.

LEVOTHYROXINE SODIUM · 1,344- 1000 count 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
Code info: Lot #: MLF2401A, Exp 01/31/2026

Affected areas

Nationwide

Timeline

  1. Initiated
    May 29, 2025
  2. Published
    Jun 18, 2025
Recall number
D-0470-2025
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.