FDA DrugsClass II
Liraglutide Injection, 18 mg/3 mL (6 mg/mL), Rx only, Manufactured for: Lupin Ph...
Published: May 27, 2026Recall ID: D-0541-2026Category: drugsCountry: US
Reason for Recall / Hazard
Presence of particulate matter: a white thread-like structure in the cartridge
Product Description & Identification
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.
Additional Source Details
| Field | Value |
|---|---|
| City | Naples |
| State | FL |
| Openfda › Nui › 1 | N0000178480 |
| Openfda › Nui › 2 | M0160181 |
| Openfda › Nui › 3 | N0000020058 |
| Openfda › Unii | 839I73S42A |
| Openfda › Route | SUBCUTANEOUS |
| Openfda › Rxcui | 897122 |
| Openfda › Spl id | e829ecbe-8005-412e-a0a1-65b44265050f |
| Openfda › Brand name | LIRAGLUTIDE |
| Openfda › Spl set id | 0450d8a2-a88e-4849-9788-ed4f5246f223 |
| Openfda › Package ndc › 1 | 70748-346-02 |
| Openfda › Package ndc › 2 | 70748-346-03 |
| Openfda › Product ndc | 70748-346 |
| Openfda › Generic name | LIRAGLUTIDE |
| Openfda › Product type | HUMAN PRESCRIPTION DRUG |
| Openfda › Pharm class cs | Glucagon-Like Peptide 1 [CS] |
| Openfda › Substance name | LIRAGLUTIDE |
| Openfda › Pharm class epc | GLP-1 Receptor Agonist [EPC] |
| Openfda › Pharm class moa | Glucagon-like Peptide-1 (GLP-1) Agonists [MoA] |
| Openfda › Manufacturer name | Lupin Pharmaceuticals, Inc. |
| Openfda › Application number | ANDA215421 |
| Openfda › Is original packager | true |
| Event id | 98809 |
| Address 1 | 5801 Pelican Bay Blvd Ste 500 |
| Code info | 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. |
| Postal code | 34108-2734 |
| Report date | 20260527 |
| Product type | Drugs |
| Product quantity | 217,621 pen injectors |
| Reason for recall | Presence of particulate matter: a white thread-like structure in the cartridge |
| Voluntary mandated | Voluntary: Firm initiated |
| Recall initiation date | 20260424 |
| Initial firm notification | Letter |
| Center classification date | 20260519 |
Overview
- Recalling FirmLupin Pharmaceuticals Inc.
- StatusOngoing
- Risk LevelClass II
- DistributionNationwide within U.S