Reported Apr 15, 2026 · Ongoing
Lanreotide Injection, 120 mg*/0.5 mL, Box contains 1 Pre-filled syringe and 1 safety needle, Single dose only, Rx Only,…
Cipla USA, Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Cipla USA, Inc. · 10 Independence Blvd · Warren, NJ · 07059-2730
Is this the product you have?
- Lanreotide Injection, 120 mg*/0.5 mL, Box contains 1 Pre-filled syringe and 1 safety needle, Single dose only, Rx Only
- Manufactured byPharmathen International, S.A., Rodopi, Greece
- Manufactured forCipla USA, Inc., 10 Independence Boulevard, Suite 300, Warren, NJ 07059
- NDC69097-870-67
- Lot codes and dates
- Lot
- expiry
128 of 128 codes
4401666IR1Exp 8/31/20274401703IR1Exp 9/30/20274401703IR2EXP 9/30/20274401704IR1Exp 9/30/20274401705IR1Exp 9/30/20274401706IR1Exp 9/30/20274401720IR1Exp 9/30/20274401721IR1Exp 9/30/20274401733IR1Exp 9/30/20274401770IR1Exp 9/30/20274401777IR1Exp 9/30/20274401788IR1Exp 10/31/20274401804IR1Exp 10/31/20274401805IR1Exp 10/31/20274401824IR1Exp 10/31/20274401860IR1Exp 10/31/20274500019IR1Exp 11/30/20274500035IR1Exp 11/30/20274500036IR1Exp 11/30/20274500078IR1Exp 11/30/20274500079IR1Exp 11/30/20274500102IR1Exp 12/31/20274500119IR1Exp 12/31/20274500120IR1Exp 12/31/20274500121IR1Exp 12/31/20274500268IR1Exp 1/31/20284500269IR1Exp 1/31/20284500272IR1Exp 1/31/20284500314IR2EXP 1/31/20284500314RIREXP 1/31/2028
- Amount recalled
- 54,583 syringes
This recall covers 2 products
The agency filed one notice per product. You are reading one of them; the other one is below.
Where it was sold
- Nationwide
Why it was recalled
Lack of Assurance of Sterility: Due to an FDA observation at the contract manufacturing site for deficiencies in their visual inspection procedure.
This product could cause temporary or reversible health problems — stop using it.
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The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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