FDA drug recalls · openFDA
Is LANREOTIDE ACETATE recalled?
The FDA has recorded 3 recalls of LANREOTIDE ACETATE (2026) , recalled under brand like LANREOTIDE ACETATE. 3 still ongoing.
0
Class I (most serious)
3
Class II
0
Class III
3
ongoing
A recall doesn't mean your pills are affected
Drug recalls are issued by lot (specific batches, identified by lot numbers / NDC) — not for every bottle of LANREOTIDE ACETATE ever made. To know if yours is involved, match the lot codes on the recall below against your bottle, or ask your pharmacist. Do not stop a prescribed medication because of a recall without talking to your pharmacist or prescriber — stopping can be more dangerous than the recall. The Class is the FDA's risk judgment (Class I = reasonable probability of serious harm or death), not a measurement that harm occurred; most recalls are voluntary and Class II/III.
Why it was recalled
Lack of Assurance of Sterility: Due to an FDA observation at the contract manufacturing site for deficiencies in their v 2
Presence of Particulate Matter. 1
The recalls
Class I and ongoing recalls first. Tap a recall for its full record and lot detail.
Lanreotide Injection, 120 mg/0.5 mL, Box contains 1 Pre-filled syringe, Single dose only, Rx Only, Manufactured by: Phar Class II ongoing
Cipla USA, Inc. 2026-03-13 lots: Lot, expiry: 4401699IR1, Exp. 5/31/2026; 4401699IR2, Exp. 5/31/2026; 4401700IR1, Exp. 5/31/2026; 4401701IR1, Exp. 5/31/2026; 4401702IR1, Exp. 5/31/2026; 4401722IR1, Exp. 5/31/2026; 4401723IR1, Exp. 5/31/2026; 4401724IR1, Exp. 5/31/2026; 4401725IR1, Exp. 5/31/2026; 4401732IR1, Exp. 5/31/2026; 4401768IR1, Exp. 6/30/2026 4401769IR1, Exp. 11/30/2026; 4401787IR1, Exp. 11/30/2026; 4401815IR1, Exp. 11/30/2026; 4401816IR1, Exp. 11/30/2026; 4401834IR1, Exp. 11/30/2026; 4401835IR1, Exp. 11/30/2026; 4401846IR1, Exp. 11/30/2026; 4401851IR1, Exp. 11/30/2026; 4500017IR1, Exp. 12/31/2026; 4500031IR1, Exp. 12/31/2026; 4500032IR1, Exp. 12/31/2026; 4500033IR1, Exp. 12/31/2026; 4500076IR1, Exp. 1/31/2027; 4500117IR1, Exp. 2/28/2027; 4500118IR1, Exp. 2/28/2027; 4500173IR1, Exp. 4/31/2027; 4500270IR1, Exp. 2/28/2027; 4500271IR1, Exp. 2/28/2027; 4500273IR1, Exp. 2/28/2027; 4500312IR1, Exp. 2/28/2027; 4500313IR1, Exp. 3/31/2027; 4500350IR1, Exp. 3/31/2027; 4500351IR1, Exp. 3/31/2027; 4500383IR1, Exp. 3/31/2027; 4500404IR1, Exp. 3/31/2027; 4500436RI1, Exp. 3/31/2027; 4500482IR1, Exp. 4/30/2027; 4500543IR1, Exp. 4/30/2027; 4500544IR1, Exp. 4/30/2027; 4500586IR1, Exp. 5/31/2027; 4500587IR1, Exp. 5/31/2027; 4500633IR1, Exp. 5/31/2027; 4500634IR1, Exp. 5/31/2027; 4500686IR1, Exp. 5/31/2027; 4500695IR1, Exp. 5/31/2027; 4500696IR1, Exp. 5/31/2027; 4500756IR1, Exp. 6/30/2027; 4500757IR1, Exp. 6/30/2027; 4500790IR1, Exp. 6/30/2027; 4500820IR1, Exp. 6/30/2027; 4500843IR1, Exp. 6/30/2027; 4500845IR1, Exp. 6/30/2027; 4500854IR1, Exp. 6/30/2027; 4500898IR1, Exp. 6/30/2027; 4500899IR1, Exp. 6/30/2027; 4500900IR1, Exp. 7/31/2027; 4500941IR1, Exp. 6/30/2027; 4500942IR1, Exp. 6/30/2027; 4500954IR1, Exp. 6/30/2027; 4500955IR1, Exp. 8/31/2027; 4500956IR1, Exp. 8/31/2027; 4500960IR1, Exp. 7/31/2027; 4501104IR1, Exp. 8/31/2027; 4501105IR1, Exp. 8/31/2027; 4501107IR1, Exp. 8/31/2027; 4501163IR1, Exp. 8/31/2027; 4501168IR1, Exp. 8/31/2027; 4501169IR1, Exp. 8/31/2027; 4501216IR1, Exp. 8/31/2027; 4501280IR1, Exp. 9/30/2027; 4501493IR1, Exp. 9/30/2027; 4501381IR1, Exp. 9/30/2027; 4501279IR1, Exp. 9/30/2027; 4501380IR1, Exp. 9/30/2027;
Lanreotide Injection, 120 mg/0.5 mL, 0.5 mL per pre-filled syringe, For deep subcutaneous injection, Rx Only, Manufactur Class II ongoing
Cipla USA, Inc. 2026-01-02 lots: 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 ;
Lanreotide Injection, 120 mg*/0.5 mL, Box contains 1 Pre-filled syringe and 1 safety needle, Single dose only, Rx Only, Class II ongoing
Cipla USA, Inc. 2026-03-13 lots: Lot, expiry: 4401666IR1, Exp 8/31/2027; 4401703IR1, Exp 9/30/2027; 4401703IR2, EXP 9/30/2027; 4401704IR1, Exp 9/30/2027; 4401705IR1, Exp 9/30/2027; 4401706IR1, Exp 9/30/2027; 4401720IR1, Exp 9/30/2027; 4401721IR1, Exp 9/30/2027; 4401733IR1, Exp 9/30/2027; 4401770IR1, Exp 9/30/2027; 4401777IR1, Exp 9/30/2027; 4401788IR1, Exp 10/31/2027; 4401804IR1, Exp 10/31/2027; 4401805IR1, Exp 10/31/2027; 4401824IR1, Exp 10/31/2027; 4401860IR1, Exp 10/31/2027; 4500019IR1, Exp 11/30/2027; 4500035IR1, Exp 11/30/2027; 4500036IR1, Exp 11/30/2027; 4500078IR1, Exp 11/30/2027; 4500079IR1, Exp 11/30/2027; 4500102IR1, Exp 12/31/2027; 4500119IR1, Exp 12/31/2027; 4500120IR1, Exp 12/31/2027; 4500121IR1, Exp 12/31/2027; 4500268IR1, Exp 1/31/2028; 4500269IR1, Exp 1/31/2028; 4500272IR1, Exp 1/31/2028; 4500314IR2, EXP 1/31/2028; 4500314RIR, EXP 1/31/2028; 4500315IR1, Exp 2/28/2028; 4500352IR1, Exp 2/28/2028; 4500353IR1, Exp 2/28/2028; 4500354IR1, Exp 2/28/2028; 4500355IR1, Exp 2/28/2028; 4500408IR1, Exp 2/28/2028; 4500409IR1, Exp 3/31/2028; 4500410IR1, Exp 3/31/2028; 4500480IR1, Exp 3/31/2028; 4500481IR1, Exp 3/31/2028; 4500545IR1, Exp 3/31/2028; 4500546IR1, Exp 3/31/2028; 4500588IR1, Exp 4/30/2028; 4500589IR1, Exp 4/30/2028; 4500635IR1, Exp 4/30/2028; 4500636IR1, Exp 4/30/2028; 4500687IR1, Exp 4/30/2028; 4500688IR1, Exp 4/30/2028; 4500758IR1, Exp 4/30/2028; 4500759IR1, Exp 5/31/2028; 4500788IR1, Exp 5/31/2028; 4500789IR1, Exp 5/31/2028; 4500819IR1, Exp 5/31/2028; 4500846IR1, Exp 5/31/2028; 4500849IR1, Exp 6/30/2028; 4500850IR1, Exp 7/31/2028; 4500907IR1, Exp 7/31/2028; 4501108IR1, Exp 7/31/2028; 4501109IR1, Exp 7/31/2028; 4501110IR1, Exp 7/31/2028; 4501111IR1, Exp 7/31/2028; 4501166IR1, Exp 7/31/2028; 4501386IR1, Exp 8/31/2028; 4501387IR1, Exp 8/31/2028;
RECORDED — these are the FDA's published recall enforcement records (openFDA), grouped by the generic drug name. Scope: drug recalls the FDA recorded with a generic name; device recalls and recalls without a generic name are in the full recall browse. "Ongoing" reflects openFDA's last-published status — confirm current status and your lot at the FDA recall database. This page informs and routes; it is not medical advice.