Levothyroxine Sodium Tablets — Class II drug recall D-0167-2025

Terminated recall by Lupin Pharmaceuticals Inc., reported 2025-01-08, distributed in OH. Failed Impurities/Degradation Specifications: Out of specifications result observed in the drug substance for

Recall number	`D-0167-2025`
Product type	Drug
Classification	Class II
Status	Terminated
Voluntary or mandated	Voluntary
Recalling firm	Lupin Pharmaceuticals Inc., Baltimore, MD, United States
Recall initiated	2024-12-20
Classified	2024-12-30
Reported by FDA	2025-01-08
Terminated	2026-02-17
Distributed	OH
Reason classes	specification failure
NDC	`68180-0965`, `68180-0965-01`, `68180-0965-02`, `68180-0965-03`, `68180-0965-09`, `68180-0966`, `68180-0966-01`, `68180-0966-02`, `68180-0966-03`, `68180-0966-09`, `68180-0967`, `68180-0967-01`, `68180-0967-02`, `68180-0967-03`, `68180-0967-09`, `68180-0968`, `68180-0968-01`, `68180-0968-02`, `68180-0968-03`, `68180-0968-09`, `68180-0969`, `68180-0969-01`, `68180-0969-02`, `68180-0969-03`, `68180-0969-09` and 35 more
Lot numbers	`LA01276`
Expiration dates	`2026-07`

Product

Levothyroxine Sodium Tablets, Lupin, 75 mcg (0.075mg), 1000 Tablets, Rx Only, Manufactured for: Lupin Pharmaceuticals, Inc. Baltimore, Maryland 21202 United States, Manufactured by: Lupin Limited, Pithampur (M.P)- 454 775 INDIA, NDC# 68180-967-03

Reason for recall

Failed Impurities/Degradation Specifications: Out of specifications result observed in the drug substance for impurity test during 3-month long term stability study.

Machine access

This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/D-0167-2025. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.

Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.