Recalls / Class II
Class IID-0167-2025
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
- Brand name
- Levothyroxine Sodium
- Generic name
- Levothyroxine Sodium
- Active ingredient
- Levothyroxine Sodium
- Route
- Oral
- NDCs
- 68180-965, 68180-966, 68180-967, 68180-968, 68180-969, 68180-970, 68180-971, 68180-972, 68180-973, 68180-974 +2 more
- FDA application
- ANDA209713
- Affected lot / code info
- Lot# LA01276, Exp Date: 07/2026
Why it was recalled
Failed Impurities/Degradation Specifications: Out of specifications result observed in the drug substance for impurity test during 3-month long term stability study.
Recalling firm
- Firm
- Lupin Pharmaceuticals Inc.
- Manufacturer
- Lupin Pharmaceuticals, Inc.
- Notification channel
- Type
- Voluntary: Firm initiated
- Address
- Harborplace Tower, 111 S Calvert St Fl 21st, Baltimore, Maryland 21202-6174
Distribution
- Quantity
- 480 1000-count bottles
- Distribution pattern
- One US distributor in Ohio.
Timeline
- Recall initiated
- 2024-12-20
- FDA classified
- 2024-12-30
- Posted by FDA
- 2025-01-08
- Terminated
- 2026-02-17
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-0167-2025. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.