FDA recall, , Moderate risk
Cipla Lanreotide Injection
Lanreotide Injection lacks assurance of sterility due to deficiencies in visual inspection.
Summary by Recall Canary from the FDA notice
What happened
Cipla USA, Inc., of Warren, New Jersey, is recalling Lanreotide Injection, 120 mg/0.5 mL, Box contains 1 Pre-filled syringe, Single dose only, Rx Only, and Lanreotide Injection, 120 mg*/0.5 mL, Box contains 1 Pre-filled syringe and 1 safety needle, Single dose only, Rx Only, because of a lack of assurance of sterility due to an FDA observation at the contract manufacturing site for deficiencies in their visual inspection procedure.
The recall began March 13, 2026, and was added to the FDA's Enforcement Report on April 3, 2026, with nationwide distribution in the USA.
What to do
We don't have product-specific instructions for this recall. FDA's general advice for medicine recalls:
- Check the FDA or company notice for instructions specific to this product.
- Ask your pharmacist or doctor whether your lot is affected and what to do.
Is yours affected?
Match your product and all the details in one listed combination.
An NDC (National Drug Code) is usually printed on the drug's label.
Lanreotide Injection
- Strength
- 120 mg
- NDC
- 69097-906-67
- Lot code
- 4401699IR2
- 4401700IR1
- 4401701IR1
- 4401702IR1
- 4401722IR1
- 4401723IR1
- 4401724IR1
- 4401725IR1
- 4401732IR1
- 4401768IR1
- 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
- 4500586IR1
- 4500587IR1
- 4500633IR1
- 4500634IR1
- 4500686IR1
- 4500695IR1
- 4500696IR1
- 4500756IR1
- 4500757IR1
- 4500790IR1
- 4500820IR1
- 4500843IR1
- 4500845IR1
- 4500854IR1
- 4500898IR1
- 4500899IR1
- 4500900IR1
- 4500941IR1
- 4500942IR1
- 4500954IR1
- 4500955IR1
- 4500956IR1
- 4500960IR1
- 4501104IR1
- 4501105IR1
- 4501107IR1
- 4501163IR1
- 4501168IR1
- 4501169IR1
- 4501216IR1
- 4501280IR1
- 4501493IR1
- 4501381IR1
- 4501279IR1
- 4501380IR1
- NDC
- 69097-870-67
- Lot code
- 4401703IR1
- 4401703IR2
- 4401704IR1
- 4401705IR1
- 4401706IR1
- 4401720IR1
- 4401721IR1
- 4401733IR1
- 4401770IR1
- 4401777IR1
- 4401788IR1
- 4401804IR1
- 4401805IR1
- 4401824IR1
- 4401860IR1
- 4500019IR1
- 4500035IR1
- 4500036IR1
- 4500078IR1
- 4500079IR1
- 4500102IR1
- 4500119IR1
- 4500120IR1
- 4500121IR1
- 4500268IR1
- 4500269IR1
- 4500272IR1
- 4500314IR2
- 4500314RIR
- 4500315IR1
- 4500352IR1
- 4500353IR1
- 4500354IR1
- 4500355IR1
- 4500408IR1
- 4500409IR1
- 4500410IR1
- 4500480IR1
- 4500481IR1
- 4500545IR1
- 4500546IR1
- 4500588IR1
- 4500589IR1
- 4500635IR1
- 4500636IR1
- 4500687IR1
- 4500688IR1
- 4500758IR1
- 4500759IR1
- 4500788IR1
- 4500789IR1
- 4500819IR1
- 4500846IR1
- 4500849IR1
- 4500850IR1
- 4500907IR1
- 4501108IR1
- 4501109IR1
- 4501110IR1
- 4501111IR1
- 4501166IR1
- 4501386IR1
- 4501387IR1
Recall details
- Company began the recall
- Sold in
Nationwide in the USA
- Company
- Cipla USA, Inc.Warren, New Jersey
- Hazard
- Sterility problem
- Risk
Moderate risk
Taking it may cause short-term health problems, or ones that treatment can reverse. Serious harm is unlikely.
FDA Class II recall · How risk is rated
- Event ID
- 98575
- Recall numbers
- D-0422-2026 to D-0423-2026
All recalls from Cipla USA, Inc.
Timeline
FDA's Enforcement Report is its public list of recalls; FDA adds a recall when it posts it and publishes the list weekly.
Company began the recall
Added to FDA's Enforcement Report · Classified by FDA
In FDA's weekly enforcement report
Listed on Recall Canary
Summary updated
