FDA DrugsClass II
Lanreotide Injection, 120 mg/0.5 mL, 0.5 mL per pre-filled syringe, For deep sub...
Published: January 21, 2026Recall ID: D-0290-2026Category: drugsCountry: US
Reason for Recall / Hazard
Presence of Particulate Matter.
Product Description & Identification
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
Affected Products
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
Additional Source Details
| Field | Value |
|---|---|
| City | Warren |
| State | NJ |
| Openfda › Unii | IEU56G3J9C |
| Openfda › Route | SUBCUTANEOUS |
| Openfda › Rxcui › 1 | 749811 |
| Openfda › Rxcui › 2 | 749814 |
| Openfda › Rxcui › 3 | 749817 |
| Openfda › Spl id | fd205110-15eb-4707-82b2-185e5bbf616b |
| Openfda › Brand name | LANREOTIDE ACETATE |
| Openfda › Spl set id | 11da176a-99bc-4ada-8b3f-6bd2b37a6313 |
| Openfda › Package ndc › 1 | 69097-880-67 |
| Openfda › Package ndc › 2 | 69097-890-67 |
| Openfda › Package ndc › 3 | 69097-870-67 |
| Openfda › Product ndc › 1 | 69097-870 |
| Openfda › Product ndc › 2 | 69097-880 |
| Openfda › Product ndc › 3 | 69097-890 |
| Openfda › Generic name | LANREOTIDE ACETATE |
| Openfda › Product type | HUMAN PRESCRIPTION DRUG |
| Openfda › Substance name | LANREOTIDE ACETATE |
| Openfda › Manufacturer name | Cipla USA Inc. |
| Openfda › Application number | NDA215395 |
| Openfda › Is original packager | true |
| Event id | 98247 |
| Address 1 | 10 Independence Blvd |
| Code info | 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... [TRUNCATED] |
| Postal code | 07059-2730 |
| Report date | 20260121 |
| Product type | Drugs |
| Product quantity | 15,221 syringes |
| Reason for recall | Presence of Particulate Matter. |
| Voluntary mandated | Voluntary: Firm initiated |
| Recall initiation date | 20260102 |
| Center classification date | 20260115 |
Overview
- Recalling FirmCipla USA, Inc.
- StatusOngoing
- Risk LevelClass II
- DistributionNationwide in the USA