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Class II

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

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

Recall number
D-0167-2025
Report date
January 8, 2025
Classification
Class II
Status in dataset
Terminated
Recalling firm
Lupin Pharmaceuticals Inc.
Generic names
LEVOTHYROXINE SODIUM
Brand names
LEVOTHYROXINE SODIUM
Product NDCs
68180-965, 68180-966, 68180-967, 68180-968, 68180-969, 68180-970, 68180-971, 68180-972, 68180-973, 68180-974, 68180-975, 68180-976

Code and lot information

Lot# LA01276, Exp Date: 07/2026

Distribution

One US distributor in Ohio.

Do not stop or change a prescribed medication based only on this page.Contact your pharmacist or prescriber and compare the exact product, manufacturer, NDC, and lot information.

Source and limitations

This page reflects a public openFDA Drug Enforcement record. The dataset was last checked on September 23, 2026. openFDA states that enforcement data should not be used alone to issue public alerts or track the full lifecycle of a recall.

Review the official FDA Drug Recalls page and the underlying openFDA query.