UnratedDrug recall · FDA · Published December 20, 2024
Lupin Levothyroxine Tablets Recall: Impurity Risk in Drug Substance
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.
Take action
Contact the company
📍Recalling firmLupin Pharmaceuticals Inc.Harborplace Tower, 111 S Calvert St Fl 21st · Baltimore, MD 21202-6174
“Lupin Levothyroxine Tablets Recall: Impurity Risk in Drug Substance.” GovInfoNow, updated August 17, 2026. https://govinfonow.com/recall/32348-lupin-levothyroxine-tablets-recall-impurity-risk-in-drug-substance. Based on FDA recall #D-0167-2025 (https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0167-2025%22&limit=1).
Lupin Pharmaceuticals Inc. recalled Levothyroxine Sodium Tablets, Lupin, 75 mcg due to failed impurity specifications, the FDA said on Dec. 20, 2024. The Class II recall affects 480 bottles distributed by one Ohio distributor.
How to tell if you have it
Brand: Lupin
Product: Levothyroxine Sodium Tablets, Lupin, 75 mcg (0.075mg), 1000 Tablets
NDC#: 68180-967-03
Lot#: LA01276
Exp Date: 07/2026
The hazard
The recall was initiated because an out-of-specification result was observed in the drug substance for the impurity test during a three-month long-term stability study.
Context
GovInfoNow's records show Lupin Pharmaceuticals Inc. has had 90 other recalls since Jan. 31, 2013. Other recent recalls of similar products include Lupin Clobetasol Cream Recall (Aug. 3, 2026), Lupin Glucagon Emergency Kit Recall (June 23, 2026), and Lupin prednisolone acetate ophthalmic suspension recall (June 4, 2026). Other recent recalls of similar products include Major Pharmaceuticals Levothyroxine Tablets Recall (July 13, 2026) and Accord Healthcare Levothyroxine Tablets Recall (Aug. 6, 2026).
How to tell if you have this one
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.
Brand
Lupin
Category
Drug
Based on the official FDA remedy
What to do — step by step
Check Product Details
Look for the NDC code 68180-967-03 on the tablet packaging to confirm if it's affected.
Where it went and when
Where it was distributed
Distributed in Ohio.
Listed by the agency
Not listed
FDA distribution: “One US distributor in Ohio.” States read from FDA’s own wording; “not listed” means the notice does not name it.
States: Ohio.
Recall timeline
FDA terminated this recall 14 months after the firm started it.
1Firm started the recall
2FDA classified it Class II
3Published in FDA’s Enforcement Report
4FDA terminated the recall
Dates from the agency record only; steps without a date are left out.
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.
Official source: FDA Recall #D-0167-2025 (December 20, 2024) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for D-0167-2025 to see it in context.
Plain-language summary written by qwen3:4b on August 17, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.