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Drug FDA Class II Terminated Failed specifications

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

Lupin Pharmaceuticals Inc. Published Jan 8, 2025

Risk level

Class II

May cause a temporary or reversible health problem; slight chance of serious harm.

Severity score 45/100

What should you do?

  • Check whether you have this product, using the lot codes, UPCs, and dates listed below.
  • Do not eat, serve, or sell the affected product.
  • Return it to the place of purchase for a refund, or throw it away in a sealed bag so people and animals can’t get to it.
  • Contact Lupin Pharmaceuticals Inc. or your place of purchase with questions, and see the source record below for full details.
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.

Hazards

Failed Impurities/Degradation Specifications · primary

Affected products (1)

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

LEVOTHYROXINE SODIUM · 480 1000-count bottles

NDC: 68180-965, 68180-966, 68180-967, 68180-968, 68180-969, 68180-970, 68180-971, 68180-972, 68180-973, 68180-974, 68180-975, 68180-976, 68180-965-03, 68180-965-02, 68180-965-09, 68180-965-01, 68180-966-03, 68180-966-02, 68180-966-09, 68180-966-01, 68180-967-03, 68180-967-02, 68180-967-09, 68180-967-01, 68180-968-09, 68180-968-02, 68180-968-01, 68180-968-03, 68180-969-01, 68180-969-02, 68180-969-03, 68180-969-09, 68180-970-01, 68180-970-02, 68180-970-03, 68180-970-09, 68180-971-01, 68180-971-02, 68180-971-03, 68180-971-09, 68180-972-01, 68180-972-02, 68180-972-03, 68180-972-09, 68180-973-01, 68180-973-02, 68180-973-03, 68180-973-09, 68180-974-01, 68180-974-02, 68180-974-03, 68180-974-09, 68180-975-03, 68180-975-02, 68180-975-01, 68180-975-09, 68180-976-01, 68180-976-02, 68180-976-03, 68180-976-09
Lot codes: LA01276
Code info: Lot# LA01276, Exp Date: 07/2026

Affected areas

Ohio

Timeline

  1. Initiated
    Dec 20, 2024
  2. Published
    Jan 8, 2025
  3. Terminated
    Feb 17, 2026
Recall number
D-0167-2025
Agency
U.S. Food and Drug Administration
Country
US
Source data (openFDA JSON) About FDA enforcement reports

FDA records come from the openFDA drug enforcement-report dataset — the agency's full weekly enforcement list. Most entries are not issued as consumer press releases, so they won't appear on fda.gov/recalls or in a web search. The source record link above resolves this exact recall by its number.