Changeflow GovPing Pharma & Drug Safety Levothyroxine 150 mcg, Class II recall
Priority review Enforcement Removed Final

Levothyroxine 150 mcg, Class II recall

Favicon for changeflow.com FDA: Drug Recalls Class II
Filed April 1st, 2026
Detected April 7th, 2026
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Summary

FDA announced a Class II recall of Levothyroxine Sodium Tablets USP 150 mcg (1000 tablet bottles) manufactured by Macleods Pharmaceuticals Ltd. for Macleods Pharma USA, Inc. The recall was initiated due to subpotent drug concerns. The recall is ongoing with nationwide distribution.

What changed

Macleods Pharma USA, Inc. initiated a Class II drug recall for Levothyroxine Sodium Tablets USP 150 mcg, 1000 tablet bottles, distributed nationwide. The reason for recall is subpotent drug - the medication may contain less than the required active pharmaceutical ingredient. This Class II classification indicates the subpotent product may cause temporary or medically reversible adverse health consequences, or remote possibility of serious adverse effects if the medication does not provide adequate thyroid hormone replacement.

Pharmaceutical distributors and healthcare providers should immediately identify and quarantine any remaining stock of the affected Levothyroxine 150 mcg product. Pharmacies should check their inventory against recall notices and notify patients who may have received this medication. Patients currently taking this product should contact their healthcare provider to discuss alternative thyroid hormone replacement therapy and report any adverse effects. The recall is ongoing and additional lot-specific information should be monitored through FDA communications.

What to do next

  1. Quarantine and cease distribution of affected Levothyroxine 150 mcg product pending further FDA guidance
  2. Notify healthcare providers and patients who received the recalled product about the subpotency issue
  3. Report any adverse events or lack of therapeutic effect potentially related to this recall to FDA MedWatch

Source document (simplified)

MACLEODS PHARMA USA, INC

Drug Recalls (Class II)

← All Drug Recalls (Class II) Class II D-0403-2026 · 20260401 · Ongoing

Product

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, ...

Reason for Recall

Subpotent Drug

Distribution

Nationwide

Source: openFDA Enforcement API

Named provisions

Drug Recalls (Class II) Subpotent Drug

Source

Analysis generated by AI. Source diff and links are from the original.

Classification

Agency
FDA
Filed
April 1st, 2026
Instrument
Enforcement
Legal weight
Binding
Stage
Final
Change scope
Substantive
Document ID
D-0403-2026

Who this affects

Applies to
Pharmaceutical companies Healthcare providers Patients
Industry sector
3254 Pharmaceutical Manufacturing 4231 Wholesale Trade 6211 Healthcare Providers
Activity scope
Drug Distribution Drug Manufacturing
Geographic scope
United States US

Taxonomy

Primary area
Pharmaceuticals
Operational domain
Compliance
Topics
Product Safety Healthcare

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