FDA recall, , Moderate risk
Cipla USA Lanreotide Injection
Lanreotide Injection contains particulate matter.
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, 0.5 mL per pre-filled syringe, for deep subcutaneous injection, due to the presence of particulate matter. The recall began on January 2, 2026, and was added to the FDA's Enforcement Report on January 15, 2026. The product was distributed nationwide in the USA.
The recalled product is manufactured for Cipla USA, Inc., and the recall involves 15,221 syringes. The FDA classified the recall on January 15, 2026, and it was included in the FDA's weekly enforcement report on January 21, 2026.
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 the NDC and lot code listed under your product.
An NDC (National Drug Code) is usually printed on the drug's label.
Lanreotide Injection
- NDC
- 69097-870-67
- Lot code
- 4301994IR1
- 4301995IR1
- 4301996IR1
- 4400005IR1
- 4400006IR1
- 4400007IR1
- 4400124IR1
- 4400154IR1
- 4400155IR1
- 4400156IR1
- 4400373IR1
- 4400374IR1
- 4400375IR1
- 4400455IR1
- 4400456IR1
- 4400457IR1
- 4400544IR1
- 4400606IR1
- 4400607IR1
- 4400696IR1
- 4400697IR1
- 4400779IR1
- 4400780IR1
- 4400781IR1
- 4400844IR1
- 4400845IR1
- 4400849IR1
- 4400984IR1
- 4400985RIR
- 4400986IR1
- 4401023IR1
Recall details
- Company began the recall
- Sold in
Nationwide in the USA
- Company
- Cipla USA, Inc.Warren, New Jersey
- Hazard
- Foreign object
- 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
- 98247
- Recall number
- D-0290-2026
- Quantity recalled
- 15,221 syringes
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
