Liraglutide Injection Recalled Due to Particulate Matter in Cartridges
Lupin Pharmaceuticals is recalling Liraglutide Injection due to the presence of white thread-like structures (particulate matter) found in cartridges. The recall affects 217,621 pen injectors distributed nationwide.
The agency’s classification
FDA (Drugs): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: This is an FDA Class II recall with a significant potential for patient harm: particulate matter in an injectable drug product poses a direct risk of injection injury or adverse effects if administered. The source text does not report any illnesses or injuries to date, but the hazard is concrete and non-theoretical, placing this in the High category.
Plain-English summary
Lupin Pharmaceuticals Inc. is recalling Liraglutide Injection, 18 mg/3 mL (6 mg/mL), due to the presence of particulate matter—specifically white thread-like structures—found in the cartridge. The affected product is available in 2-pen and 3-pen packages under NDC 70748-346-02 and 70748-346-03, manufactured by Lupin Limited in Nagpur, India.
The recall involves specific lot numbers with expiration dates ranging from July 2027 through December 2027: Lot numbers WB00097, WB00094, WB00088, WB00103, WC00016, WB00098, WB00092, WB00093, WB00104, WB00106, and WB00105. A total of 217,621 pen injectors have been distributed nationwide in the United States.
Patients and healthcare providers should stop using affected pens immediately. Patients should contact their healthcare provider or pharmacist for replacement medication and should not attempt to use any affected pens. Healthcare providers and pharmacists should quarantine remaining stock and contact their suppliers for return authorization.
The recalled product
- Product
- LIRAGLUTIDE (LIRAGLUTIDE)
- Brand
- LIRAGLUTIDE
- Manufacturer
- Lupin Pharmaceuticals Inc.
- Affected units
- 217,621
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (15)
- Lots: a) WB00097
- WB00094
- WB00088
- Expires: Jul. 2027
- WB00103
- Expires: Oct. 2027
- WC00016
- Expires: Dec. 2027
- b) WB00098
- WB00092
- WB00093
- WB00104
- WB00106
- WB00105
- Expires: Oct. 2027.
Distribution
Distributed nationwide across the United States.
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