Levothyroxine Sodium Tablets Recall for Subpotent Drug
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Major Pharmaceuticals is recalling Levothyroxine Sodium Tablets, USP, 50 mcg due to subpotency. The recall affects specific lots distributed nationwide.
What this FDA recall tells you, and what most readers miss
This notice was issued by FDA on August 11, 2026 and geographically references United States. Its severity classification of "medium" signals how the issuing agency weighs the risk of harm if no action is taken - "critical" and "high" tier alerts typically carry direct consumer actions, while "medium" and "low" tend toward informational guidance or monitoring advisories. The category it belongs to - FDA Recalls - determines the consumer-protection framework behind it, which shapes what remedies (refunds, replacements, repairs, or the recall itself) are available to affected consumers and which agency holds statutory responsibility for enforcement.
Most readers skim a notice like this, check whether they are personally affected, and move on. The more useful lens is to verify its scope, source, and timestamp, then compare related notices without assuming that one record proves a broader trend.
Areazine pairs this record with the original agency URL so you can check the primary source before acting. Its related labels are recall, product-safety, fda, drugs.
What Happened
Major Pharmaceuticals initiated a voluntary recall of Levothyroxine Sodium Tablets, USP, 50 mcg (0.050 mg) because the product is subpotent.
Which Products Are Affected
The recall covers Levothyroxine Sodium Tablets, USP, 50 mcg (0.050 mg), 10 Tablets (10 x 1) unit dose blisters per carton. NDC Bag: 55154-3559-0; NDC Blister: 0904-6950-61. Affected lots are Bag lot #: N02200A, N02200B (Exp. Date 10/2026) and Blister lot #: N02200 (Exp. Date 10/2026). The product is packaged and distributed by Major Pharmaceuticals, Indianapolis, IN, and distributed by Cardinal Health, Dublin, OH. Distribution was nationwide in the USA. Recall number D-0708-2026.
What You Should Do
Consumers should contact their physician or healthcare provider if they have the affected product. The recalling firm is Major Pharmaceuticals at 7000 Cardinal Pl, Dublin, OH 43017.
Why This Matters
Subpotent levothyroxine may result in reduced therapeutic effect for patients requiring thyroid hormone replacement.
Source
FDA recall D-0708-2026 (https://www.fda.gov)
Original source: FDA Official Notice ↗
Related FDA Recalls
All FDA Recalls →Nationwide notices with similar length or severity timing 8
Two Areazine-derived peer sets for this FDA recall: nearest notices by body length and by same severity near the same agency date. Peers come from other categories so they are not the same-feed Related list above.
Similar body length
Nearest notices by article body length (1,073 characters here).
Similar severity timing
Same severity (medium) notices issued closest in time to August 11, 2026.
Frequently Asked Questions
Common questions about this FDA recall.