Recalls / Class II
Class IID-0218-2026
Product
Lanthanum Carbonate chewable tablets, 1000mg*, 10x9 bottles per patient pack carton, Rx Only, Manufactured by: Invagen Pharmaceuticals, Inc., (a subsidary of Cipla Ltd) Hauppauge, NY 11786, Manufactured for: Exelan Pharmaceuticals, Inc., Boca Raton, FL 33422, Carton NDC 76282-478-90; Bottle NDC 76282-478-13.
- Brand name
- Lanthanum Carbonate
- Generic name
- Lanthanum Carbonate
- Active ingredient
- Lanthanum Carbonate
- Route
- Oral
- NDCs
- 76282-476, 76282-477, 76282-478
- FDA application
- ANDA206868
- Affected lot / code info
- Lot# NB240314, exp 12/31/2025
Why it was recalled
Failed stability specifications: Out of specification for hardness test
Recalling firm
- Firm
- Cipla USA, Inc.
- Manufacturer
- Exelan Pharmaceuticals, Inc.
- Notification channel
- N/A
- Type
- Voluntary: Firm initiated
- Address
- 10 Independence Blvd, N/A, Warren, New Jersey 07059-2730
Distribution
- Quantity
- N/A
- Distribution pattern
- Nationwide in the USA
Timeline
- Recall initiated
- 2025-10-24
- FDA classified
- 2025-12-05
- Posted by FDA
- 2025-12-17
- Status
- Ongoing
Source: openFDA Drug Enforcement endpoint. Recall record D-0218-2026. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.