Mylan recalls 125 mcg levothyroxine tablets due to potential super-potent drug levels. Affected units may cause unsafe thyroid hormone levels if taken.
Super-Potent Drug: Out of specification potency results were obtained.
Mylan is recalling 125 mcg levothyroxine tablets that may have higher-than-stated potency. This could cause unsafe thyroid hormone levels if taken as directed.
The tablets may contain more active drug than labeled, leading to potentially unsafe thyroid hormone levels. This could cause symptoms like rapid heartbeat, anxiety, or weight loss if taken without medical supervision.
People with prescriptions for these levothyroxine tablets are affected. Those with thyroid conditions are at higher risk.
Check for Mylan's 125 mcg levothyroxine tablets in 100-unit blister packs. The lot number 3115773 was made in India and expires March 31, 2025.
Verify the product label shows Mylan, 125 mcg levothyroxine, 100-unit blister packs, lot 3115773, expiring March 31, 2025.
The recall states the tablets may have higher-than-stated potency, but the official notice does not specify if they are safe to use.
Check for Mylan's 125 mcg levothyroxine tablets in 100-unit blister packs with lot number 3115773, expiring March 31, 2025.
The recall record does not specify any remedy or action steps for affected products.
We’ve drafted a message you can send Mylan to request your refund or repair — edit it as you like.
Subject: Recall D-0291-2025 — Mylan Mylan Hello, I own a Mylan that is covered by recall D-0291-2025 from Mylan. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.