Lupin recalls 75 mcg levothyroxine tablets due to impurity issues detected in drug substance during stability testing. Affected units may pose safety risks if not properly handled.
Failed Impurities/Degradation Specifications: Out of specifications result observed in the drug substance for impurity test during 3-month long term stability study.
Lupin is recalling 1000-count levothyroxine tablets (75 mcg) because impurities were found in the drug substance during stability testing. This could affect medication safety if the tablets are used without proper quality control.
The drug substance showed impurities outside acceptable limits during a 3-month stability test. This could mean the medication might not work properly or cause safety issues if the tablets are taken without proper quality control.
Prescription patients using Lupin's 75 mcg levothyroxine tablets may be affected. Those with thyroid conditions requiring this medication are most at risk.
Check for Lupin brand levothyroxine tablets labeled 75 mcg (0.075mg) with 1000 tablets. The product was manufactured by Lupin Limited in India and sold in the US with NDC# 68180-967-03.
Look for the NDC code 68180-967-03 on the tablet packaging to confirm if it's affected.
The drug substance showed impurities outside acceptable limits during a 3-month stability test.
The official notice doesn't specify if this impurity risk causes harm, so the danger level is unknown.
Check for the NDC code 68180-967-03 on the packaging. The product was manufactured by Lupin Limited in India and sold in the US.
We’ve drafted a message you can send Lupin to request your refund or repair — edit it as you like.
Subject: Recall D-0167-2025 — Lupin Lupin Hello, I own a Lupin that is covered by recall D-0167-2025 from Lupin. 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.
