Lanreotide prefilled syringes recalled over the presence of particulate matter
Cipla USA is recalling 15,221 prefilled syringes of Lanreotide Injection, 120 mg/0.5 mL, over the presence of particulate matter.
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: Scored 3 under the risk-of-harm criterion: particulate matter in an injectable product is a stated contaminant, and no injuries are reported.
Plain-English summary
Lanreotide Injection, 120 mg/0.5 mL, 0.5 mL per pre-filled syringe for deep subcutaneous injection, manufactured for Cipla USA, Inc. of Warren, New Jersey, under NDC 69097-870-67, is being recalled.
The reason given in the enforcement record is the presence of particulate matter.
The recall covers 15,221 syringes from lots including 4301954IR1, 4301994IR1 and 4301995IR1, all expiring 31/10/2026. Distribution was nationwide in the USA. The FDA has classified the action as Class II.
Patients should not stop using a prescribed medicine without speaking to their prescriber or pharmacist, who can confirm whether a specific syringe is affected and arrange a replacement.
The recalled product
- Product
- LANREOTIDE ACETATE (LANREOTIDE ACETATE)
- Brand
- LANREOTIDE ACETATE
- Manufacturer
- Cipla USA, Inc.
- Category
- Drug — Injectable
- Affected units
- 15,221
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: 4301954IR1
- exp 31/10/2026
- 4301994IR1
- 4301995IR1
- 4301996IR1
- 4400005IR1
- exp 30/11/2026
- 4400006IR1
- 4400007IR1
- 4400124IR1
- 4400154IR1
- 4400155IR1
- 4400156IR1
- 4400373IR1
- exp 31/12/2026
- 4400374IR1
- 4400375IR1
- 4400455IR1
- exp 31/1/2027
Distribution
Distributed nationwide across the United States.
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