FDA Drug recall D-0167-2025
Levothyroxine Sodium Tablets, Lupin, 75 mcg (0.075mg), 1000 Tablets, Rx Only, Manufactured for: Lupin Pharmaceuticals, Inc
- FDA Drug
- Class II
- terminated
- Published 2025-01-08
On 2025-01-08 the FDA classified a Class II recall of Levothyroxine Sodium Tablets, Lupin, 75 mcg (0.075mg), 1000 Tablets, Rx Only, Manufactured for: Lupin Pharmaceuticals, Inc by Lupin Pharmaceuticals, citing failed Impurities/Degradation Specifications: Out of specifications result observed in the drug substance for impurity test during 3-month long term stability study.
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-0167-2025 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2024-12-20 |
| Published | 2025-01-08 |
| Last updated | 2026-09-13 11:52 UTC |
| Company | Lupin Pharmaceuticals |
| Distribution | OH |
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
Failed Impurities/Degradation Specifications: Out of specifications result observed in the drug substance for impurity test during 3-month long term stability study.
Identifiers
| ndc | 68180-965-03 |
|---|---|
| ndc | 68180-965-02 |
| ndc | 68180-965-09 |
| ndc | 68180-965-01 |
| ndc | 68180-966-03 |
| ndc | 68180-966-02 |
| ndc | 68180-966-09 |
| ndc | 68180-966-01 |
| ndc | 68180-967-03 |
| ndc | 68180-967-02 |
| ndc | 68180-967-09 |
| ndc | 68180-967-01 |
| ndc | 68180-968-09 |
| ndc | 68180-968-02 |
| ndc | 68180-968-01 |
| ndc | 68180-968-03 |
| ndc | 68180-969-01 |
| ndc | 68180-969-02 |
| ndc | 68180-969-03 |
| ndc | 68180-969-09 |
| ndc | 68180-970-01 |
| ndc | 68180-970-02 |
| ndc | 68180-970-03 |
| ndc | 68180-970-09 |
| ndc | 68180-971-01 |
| ndc | 68180-971-02 |
| ndc | 68180-971-03 |
| ndc | 68180-971-09 |
| ndc | 68180-972-01 |
| ndc | 68180-972-02 |
| ndc | 68180-972-03 |
| ndc | 68180-972-09 |
| ndc | 68180-973-01 |
| ndc | 68180-973-02 |
| ndc | 68180-973-03 |
| ndc | 68180-973-09 |
| ndc | 68180-974-01 |
| ndc | 68180-974-02 |
| ndc | 68180-974-03 |
| ndc | 68180-974-09 |
| ndc | 68180-975-03 |
| ndc | 68180-975-02 |
| ndc | 68180-975-01 |
| ndc | 68180-975-09 |
| ndc | 68180-976-01 |
| ndc | 68180-976-02 |
| ndc | 68180-976-03 |
| ndc | 68180-976-09 |
| code_info | Lot# LA01276, Exp Date: 07/2026 |
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:52 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0167-2025%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.