Lanreotide Injection recall (Cipla USA, Inc.)
DrugClass IIOngoing
Summary: Cipla USA, Inc. is recalling Lanreotide Injection, 120 mg/0.5 mL, 0.5 mL per pre-filled syringe, For deep subcutaneous injection, Rx Only, Manufactured for: Cipla USA, Inc., 10 Independence Boulevard, Suite 300, Warren, NJ 07059. NDC: 69097-870-67. Reason: Presence of Particulate Matter.
What is being recalled
Lanreotide Injection, 120 mg/0.5 mL, 0.5 mL per pre-filled syringe, For deep subcutaneous injection, Rx Only, Manufactured for: Cipla USA, Inc., 10 Independence Boulevard, Suite 300, Warren, NJ 07059. NDC: 69097-870-67
Why
Presence of Particulate Matter.
How serious is it
Class II is the middle level: using or being exposed to this product may cause temporary or medically reversible health problems, and the chance of serious harm is remote.
Where it was sold
Nationwide in the USA
How to tell if yours is affected
Lot, expiry: 4301954IR1 , exp 31/10/2026 ; 4301994IR1 , exp 31/10/2026 ; 4301995IR1 , exp 31/10/2026 ; 4301996IR1 , exp 31/10/2026 ; 4400005IR1 , exp 30/11/2026 ; 4400006IR1 , exp 30/11/2026 ; 4400007IR1 , exp 30/11/2026 ; 4400124IR1 , exp 30/11/2026 ; 4400154IR1 , exp 30/11/2026 ; 4400155IR1 , exp 30/11/2026 ; 4400156IR1 , exp 30/11/2026 ; 4400373IR1 , exp 31/12/2026 ; 4400374IR1 , exp 31/12/2026 ; 4400375IR1 , exp 31/12/2026 ; 4400455IR1 , exp 31/1/2027 ; 4400456IR1 , exp 31/1/2027 ; 4400457IR1 , exp 31/1/2027 ; 4400544IR1 , exp 28/2/2027 ; 4400606IR1 , exp 28/2/2027 ; 4400607IR1 , exp 28/2/2027 ; 4400696IR1 , exp 28/2/2027 ; 4400697IR1 , exp 28/2/2027 ; 4400779IR1 , exp 28/2/2027 ; 4400780IR1 , exp 28/2/2027 ; 4400781IR1 , exp 28/2/2027 ; 4400844IR1 , exp 31/3/2027 ; 4400845IR1 , exp 31/3/2027 ; 4400849IR1 , exp 31/3/2027 ; 4400984IR1 , exp 31/3/2027 ; 4400985RIR , exp 31/3/2027 ; 4400986IR1 , exp 31/3/2027 ; 4401023IR1 , exp 31/3/2027 ;
What to do
Check the product name, lot number and expiration date on your package against the codes above. If they match, do not stop taking a prescription medicine without talking to your doctor or pharmacist first; ask them about a replacement. Return or dispose of the product as your pharmacy advises.
Recall facts
| Recall number | D-0290-2026 |
| Category | Drug |
| Agency | U.S. Food and Drug Administration (FDA) |
| Severity | Class II |
| Status | Ongoing |
| Recall started | January 2, 2026 |
| Reported | January 21, 2026 |
| Company | Cipla USA, Inc. |
| Company location | Warren, NJ, United States |
| Initiated by | Voluntary: Firm initiated |
| Quantity | 15,221 syringes |
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