CLASS II ONGOING Drug recall · Reported 27 May 2026 · FDA Enforcement Report
Liraglutide Injection, 18 mg/ (6 mg/mL) recalled
Lupin Pharmaceuticals is recalling Liraglutide Injection, 18 mg/ (6 mg/mL), distributed nationwide in the US. The recall was initiated on 24 Apr 2026 and the FDA has classified it as Class II.
Check your package
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
Recall details
- Recall number
- D-0541-2026
- FDA event ID
- 98809
- Recalling firm
- Lupin Pharmaceuticals, Naples, FL
- Brand
- Liraglutide
- Manufacturer
- Lupin Pharmaceuticals, Inc.
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 24 Apr 2026
- FDA classified
- 19 May 2026
- Reported
- 27 May 2026
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Particulate Matter
- Drug class
- Diabetes Medication
Timeline
| 24 Apr 2026 | Recall initiated by company | |
| 19 May 2026 | Classified by FDA | +25 days |
| 27 May 2026 | Published in enforcement report | +8 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Presence of particulate matter: a white thread-like structure in the cartridge
Product as listed by the FDA
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.
Where it was distributed
Nationwide within U.S
Questions about this recall
Why was it recalled?
Presence of particulate matter: a white thread-like structure in the cartridge
Which lots are affected?
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.
Where was it sold?
Nationwide within U.S
What should I do if I have it?
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
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Other Liraglutide recalls
All 3| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | ViCTOZA (liraglutide) injection, 18 mg/ (6 mg/mL), contains recalledVictoza | Novo Nordisk | Temperature Abuse | Nationwide |
| Drug | CLASS II | Saxenda (liraglutide) Injection, 18 mg/ (6 mg/mL) recalledSaxenda | Novo Nordisk | Temperature Abuse | Nationwide |