FDA Drug recall D-0541-2026
Liraglutide Injection, 18 mg/3 mL (6 mg/mL), Rx only, Manufactured for: Lupin Pharmaceuticals, Inc., Naples, FL 34108, Manufactured by: Lup…
- FDA Drug
- Class II
- ongoing
- Published 2026-05-27
On 2026-05-27 the FDA classified a Class II recall of Liraglutide Injection, 18 mg/3 mL (6 mg/mL), Rx only, Manufactured for: Lupin Pharmaceuticals, Inc., Naples, FL 34108, Manufactured by: Lup… by Lupin Pharmaceuticals, citing presence of particulate matter: a white thread-like structure in the cartridge.
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-0541-2026 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2026-04-24 |
| Published | 2026-05-27 |
| Last updated | 2026-09-13 11:52 UTC |
| Company | Lupin Pharmaceuticals |
| Distribution | US |
Product
Liraglutide Injection, 18 mg/3 mL (6 mg/mL), Rx only, Manufactured for: Lupin Pharmaceuticals, Inc., Naples, FL 34108, Manufactured by: Lupin Limited, Nagpur 441108, INDIA, a) 2 Pens- NDC 70748-346-02; b) 3 Pens - NDC 70748-346-03.
Reason
Presence of particulate matter: a white thread-like structure in the cartridge
Identifiers
| ndc | 70748-346-02 |
|---|---|
| ndc | 70748-346-03 |
| code_info | Lots: a) WB00097, WB00094, WB00088, Expires: Jul. 2027; WB00103, Expires: Oct. 2027; WC00016, Expires: Dec. 2027; b) WB…Lots: a) WB00097, WB00094, WB00088, Expires: Jul. 2027; WB00103, Expires: Oct. 2027; WC00016, Expires: Dec. 2027; b) WB00098, WB00092, WB00093, Expires: Jul. 2027; WB00104, WB00106, WB00105, Expires: Oct. 2027. |
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:52 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0541-2026%22
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