Lanreotide Injection — Class II drug recall D-0423-2026
Ongoing recall by Cipla USA, Inc., reported 2026-04-15, distributed nationwide. Lack of Assurance of Sterility: Due to an FDA observation at the contract manufacturing site for deficiencies
| Recall number | D-0423-2026 |
|---|---|
| Product type | Drug |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Cipla USA, Inc., Warren, NJ, United States |
| Recall initiated | 2026-03-13 |
| Classified | 2026-04-03 |
| Reported by FDA | 2026-04-15 |
| Distributed | Nationwide (US) |
| Reason classes | sterility |
| NDC | 69097-0906, 69097-0906-67, 69097-0907, 69097-0907-67, 69097-0908, 69097-0908-67 |
| Lot numbers | 4401699IR1, 4401699IR2, 4401700IR1, 4401701IR1, 4401702IR1, 4401722IR1, 4401723IR1, 4401724IR1, 4401725IR1, 4401732IR1, 4401768IR1, 4401769IR1, 4401787IR1, 4401815IR1, 4401816IR1, 4401834IR1, 4401835IR1, 4401846IR1, 4401851IR1, 4500017IR1, 4500031IR1, 4500032IR1, 4500033IR1, 4500076IR1, 4500117IR1, 4500118IR1, 4500173IR1, 4500270IR1, 4500271IR1, 4500273IR1, 4500312IR1, 4500313IR1, 4500350IR1, 4500351IR1, 4500383IR1, 4500404IR1, 4500436RI1, 4500482IR1, 4500543IR1, 4500544IR1 and 35 more |
| Expiration dates | 2026-05-31, 2026-06-30, 2026-11-30, 2026-12-31, 2027-01-31, 2027-02-28, 2027-03-31, 2027-04-30, 2027-05-31, 2027-06-30, 2027-07-31, 2027-08-31, 2027-09-30 |
Product
Lanreotide Injection, 120 mg/0.5 mL, Box contains 1 Pre-filled syringe, Single dose only, Rx Only, Manufactured by: Pharmathen International, S.A., Rodopi, Greece. Manufactured for: Cipla USA, Inc., 10 Independence Boulevard, Suite 300, Warren, NJ 07059. NDC 69097-906-67
Reason for recall
Lack of Assurance of Sterility: Due to an FDA observation at the contract manufacturing site for deficiencies in their visual inspection procedure.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/D-0423-2026. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.