Lanreotide Acetate Injectable Drug Recalled Nationwide for Particulate Matter Contamination
Cipla USA is recalling 15,221 pre-filled syringes of Lanreotide Acetate 120 mg/0.5 mL due to the presence of particulate matter. The prescription injectable was distributed nationwide and patients should contact their healthcare provider.
What this means for you
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 drug recall involving contamination (particulate matter) in an injectable product. No adverse events or injuries are reported in the source text, but the presence of foreign particles in a prescription injectable poses a potential risk to patient safety.
Plain-English summary
Cipla USA, Inc. is recalling 15,221 pre-filled syringes of Lanreotide Acetate 120 mg/0.5 mL due to the presence of particulate matter in the recalled lots. The product is a prescription injectable indicated for deep subcutaneous injection.
The affected product was distributed nationwide in the United States. Multiple lots are included in the recall, with expiration dates ranging from October 2026 through March 2027.
Patients who have received any of the affected lots should contact their healthcare provider or pharmacist to discuss whether their specific lot is involved and whether treatment continuation is appropriate. Healthcare providers and patients should not use the recalled product and should return it to the pharmacy.
The recalled product
- Product
- LANREOTIDE ACETATE (LANREOTIDE ACETATE)
- Brand
- LANREOTIDE ACETATE
- Manufacturer
- Cipla USA, Inc.
- Category
- Drug — Prescription Injectable
- Hazard
- particulate-matter
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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