Levothyroxine 150 mcg, Class II recall
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
- Quarantine and cease distribution of affected Levothyroxine 150 mcg product pending further FDA guidance
- Notify healthcare providers and patients who received the recalled product about the subpotency issue
- 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
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