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Life sciences · Safety recall
U.S. Food and Drug Administration · September 2, 2026
An action by a regulator. Authoritative on labelling and availability.
The FDA has initiated a Class II recall of levothyroxine sodium 50 mcg tablets distributed by Accord Healthcare due to subpotency. This is an ongoing voluntary recall affecting the entire United States market for the affected lot or batch.
Safety recall. Patients prescribed levothyroxine sodium 50 mcg tablets from affected Accord Healthcare product; nationwide U.S. population.. Accord Healthcare, Inc., Raleigh, NC 27617 (U.S. distributor); Intas Pharmaceuticals Limited, Dehradun, India (manufacturer); distribution: nationwide United States.
Levothyroxine Sodium Tablets, USP, 50 mcg (0.05 mg), 1000-count bottles subject to recall Reason for recall: subpotent drug—product contains less active ingredient than labeled Nationwide distribution within the United States affected
No clinical trial data or patient harm reports included in this regulatory record. Recall initiated voluntarily by manufacturer; Class II classification indicates potential for adverse health consequences
Patients receiving affected tablets may experience subtherapeutic hormone replacement, leading to inadequate thyroid hormone supplementation. Clinicians should verify patient inventory and consider dose verification or product switching if patients report symptoms of hypothyroidism or receive affected lot numbers.
FDA Class II recall of levothyroxine sodium tablets for subpotency; a safety action affecting drug quality and patient safety nationwide.
As stated by the source record.
Quoted from the source exactly as published.
Patients receiving affected tablets may experience subtherapeutic hormone replacement, leading to inadequate thyroid hormone supplementation. Clinicians should verify patient inventory and consider dose verification or product switching if patients report symptoms of hypothyroidism or receive affected lot numbers.
Graded across the dimensions that decide whether you should act, each from what the source actually supports. There is no single score, and where a dimension was not assessed it says so.
FDA enforcement report D-0776-2026. This is a regulatory safety action, not a clinical study. Classification: Class II. Status: Ongoing. Recalling firm: ACCORD HEALTHCARE, INC.. Initiated as: Voluntary: Firm initiated. Product: Levothyroxine Sodium Tablets, USP, 50 mcg (0.05 mg), 1000-count bottles, Rx Only, Manufactured for: Accord Healthcare, Inc., Raleigh, NC 27617, Manufactured by: Intas Pharmaceuticals Limited, Camp Road, Selaqui, Dehradun-248 197, India, NDC 16729-448-17. Reason for recall: Subpotent Drug Distribution: Nationwide within the United States
Taken from the source record, never inferred. Follow any of these and new work involving them reaches your briefing.