Cipla lanreotide prefilled syringes recalled over visual inspection deficiencies
Cipla is recalling Lanreotide Injection 120 mg/0.5 mL prefilled syringes for lack of assurance of sterility, following an FDA observation of deficiencies in visual inspection at the contract manufacturing site.
The agency’s classification
FDA (Drugs): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: FDA Class II recall of a sterile injectable where sterility cannot be assured, a risk of harm with no injuries reported in the source.
Plain-English summary
Cipla USA, Inc. is recalling Lanreotide Injection, 120 mg/0.5 mL, supplied as a box containing one single dose prefilled syringe, NDC 69097-906-67. The product is manufactured by Pharmathen International, S.A. in Rodopi, Greece.
The stated reason is lack of assurance of sterility, arising from an FDA observation at the contract manufacturing site of deficiencies in its visual inspection procedure. Sterility is a defining requirement of an injectable product. The FDA classified the action as Class II.
Multiple lots are affected, listed in the recall notice, with expiry dates including 5/31/2026. Distribution was nationwide in the USA.
This is a prescription product supplied to healthcare providers. Patients should not stop a prescribed treatment without medical advice; providers and pharmacies should check stock against the lot numbers in the recall notice and follow the instructions issued by Cipla.
The recalled product
- Product
- LANREOTIDE ACETATE (LANREOTIDE ACETATE)
- Brand
- LANREOTIDE ACETATE
- Manufacturer
- Cipla USA, Inc.
- Category
- Drug — Injectable solution
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (20)
- Lot
- expiry: 4401699IR1
- Exp. 5/31/2026
- 4401699IR2
- 4401700IR1
- 4401701IR1
- 4401702IR1
- 4401722IR1
- 4401723IR1
- 4401724IR1
- 4401725IR1
- 4401732IR1
- 4401768IR1
- Exp. 6/30/2026 4401769IR1
- Exp. 11/30/2026
- 4401787IR1
- 4401815IR1
- 4401816IR1
- 4401834IR1
- 4401835IR1
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 2 recalled by Cipla USA, Inc. under a single FDA (Drugs) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
See all 2 products in this recall →Related recalls
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