Lupin Liraglutide Injection Recall Issued for Particulate Matter
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Lupin Pharmaceuticals Inc. is voluntarily recalling 217,621 Liraglutide Injection pens nationwide due to the presence of particulate matter in the cartridge.
What this FDA recall tells you, and what most readers miss
This notice was issued by FDA on June 10, 2026 and geographically references United States. Its severity classification of "medium" signals how the issuing agency weighs the risk of harm if no action is taken - "critical" and "high" tier alerts typically carry direct consumer actions, while "medium" and "low" tend toward informational guidance or monitoring advisories. The category it belongs to - FDA Recalls - determines the consumer-protection framework behind it, which shapes what remedies (refunds, replacements, repairs, or the recall itself) are available to affected consumers and which agency holds statutory responsibility for enforcement.
Most readers skim a notice like this, check whether they are personally affected, and move on. The more useful lens is to read it as a data point about the issuing system: how quickly FDA detected the hazard, how precise the geographic or product-identifier scope is, and whether similar notices have clustered in the same category or region in the last 90 days. Cluster patterns frequently precede a broader regulatory action, a single localized FDA recall is isolated; three of them within a quarter often indicate a supply-chain, infrastructure, or seasonal driver that will keep producing notices until something structural changes.
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What Happened
Lupin Pharmaceuticals Inc. initiated a voluntary recall of Liraglutide Injection after discovering the presence of particulate matter described as a white thread-like structure in the cartridge.
Which Products Are Affected
The recall covers Liraglutide Injection, 18 mg/3 mL (6 mg/mL), Rx only, in two configurations: a) 2 Pens (NDC 70748-346-02) and b) 3 Pens (NDC 70748-346-03). Affected lots include a) WB00097, WB00094, WB00088 (Exp. Jul. 2027), WB00103 (Exp. Oct. 2027), WC00016 (Exp. Dec. 2027); b) WB00098, WB00092, WB00093 (Exp. Jul. 2027), WB00104, WB00106, WB00105 (Exp. Oct. 2027). A total of 217,621 pen injectors are involved, distributed nationwide within the U.S. The recall number is D-0541-2026.
What You Should Do
Consumers should consult their healthcare provider regarding the recalled product.
Why This Matters
The Class II recall addresses a defect that could cause temporary or reversible adverse health consequences.
Source
FDA Enforcement Report - Recall D-0541-2026, Lupin Pharmaceuticals Inc.
Original source: FDA Official Notice ↗
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