Why it was recalled
Presence of particulate matter: a white thread-like structure in the cartridge
Product description
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.
Lot numbers, UPCs & expiration codes
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 it was sold
Nationwide within U.S
What to do if you have this product
- Compare the lot number and expiration date on your package with the codes above.
- Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
- If you have symptoms you think are related, contact your doctor. In an emergency call 911.
- Report side effects to FDA MedWatch at 1-800-FDA-1088.
Recall details
- Recall number
- D-0541-2026
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- Apr 24, 2026
- FDA report date
- May 27, 2026
- Quantity
- 217,621 pen injectors
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Lupin Pharmaceuticals Inc.
Original FDA data
Every field from FDA enforcement report D-0541-2026, exactly as published.
Show all FDA fields
- City
- Naples
- State
- FL
- Status
- Ongoing
- Country
- United States
- Event ID
- 98809
- Address
- 5801 Pelican Bay Blvd Ste 500
- Code information
- 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
- May 27, 2026
- Product type
- Drugs
- Recall number
- D-0541-2026
- Classification
- Class II
- Recalling firm
- Lupin Pharmaceuticals Inc.
- 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
- Product description
- 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.
- Distribution pattern
- Nationwide within U.S
- Recall initiation date
- Apr 24, 2026
- Initial firm notification
- Letter
- Center classification date
- May 19, 2026