Liraglutide Injection recall
FDA recall D-0541-2026 · initiated Apr 24, 2026
Lupin Pharmaceuticals Inc. recalled Liraglutide Injection in Apr 2026 — an FDA Class II recall (D-0541-2026) because Presence of particulate matter: a white thread-like structure in the cartridge.
May cause temporary or medically reversible harm; low probability of serious harm.
Why it was recalled
Presence of particulate matter: a white thread-like structure in the cartridge
Something got into the product
A physical or chemical contaminant was found — glass or metal fragments, or a solvent that should not be there.
This is a manufacturing or quality failure, not a finding that the medicine is unsafe to take — across every recall we hold, none was issued for that reason. It does not mean the batch was harmless.
Is your product affected? Check the lot number
A recall covers only specific lots. Find the lot number and expiration date on your package and compare them to the affected codes below — if yours is not listed, it was not part of this recall.
Quantity recalled: 217,621 pen injectors
Details
- Product
- 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.
- Recalling company
- Lupin Limited
- Classification
- Class II
- Status
- Ongoing
- Type
- Voluntary: Firm initiated
- Distribution
- Nationwide within U.S
- Initiated
- Apr 24, 2026
- FDA report date
- May 27, 2026
Frequently asked
- Was Liraglutide Injection recalled?
- Lupin Pharmaceuticals Inc. recalled Liraglutide Injection in Apr 2026 — an FDA Class II recall (D-0541-2026) because Presence of particulate matter: a white thread-like structure in the cartridge. May cause temporary or medically reversible harm; low probability of serious harm.
- Why was Liraglutide Injection recalled?
- Per the FDA enforcement record, the reason for recall D-0541-2026 was: Presence of particulate matter: a white thread-like structure in the cartridge
- Is a recalled Liraglutide Injection dangerous to take?
- An FDA recall removes specific lots from the market for a defined reason and does not by itself mean the medicine is unsafe for everyone — your specific lot may never have been affected. May cause temporary or medically reversible harm; low probability of serious harm. Check the FDA notice for the affected lot numbers and expiration dates, and ask your pharmacist or doctor before stopping a prescribed medicine. This reproduces public FDA data and is not medical advice.
- Which lots of Liraglutide Injection are affected?
- Distributed: Nationwide within U.S. The recall covers these lots — 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.. Check the lot number and expiration date on your package against this list; if yours is not listed, it was not part of recall D-0541-2026.