Why it was recalled
Failed stability specifications: Out of specification for hardness test
Product description
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.
Lot numbers, UPCs & expiration codes
Lot# NB240314, exp 12/31/2025
Where it was sold
Nationwide in the USA
What to do if you have this product
- Compare the lot number and expiration date on your package with the codes above.
- Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
- If you have symptoms you think are related, contact your doctor. In an emergency call 911.
- Report side effects to FDA MedWatch at 1-800-FDA-1088.
Recall details
- Recall number
- D-0218-2026
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- Oct 24, 2025
- FDA report date
- Dec 17, 2025
- Quantity
- N/A
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Cipla USA, Inc.
Original FDA data
Every field from FDA enforcement report D-0218-2026, exactly as published.
Show all FDA fields
- City
- Warren
- State
- NJ
- Status
- Ongoing
- Country
- United States
- Event ID
- 97855
- Address
- 10 Independence Blvd
- Code information
- Lot# NB240314, exp 12/31/2025
- Postal code
- 07059-2730
- Report date
- Dec 17, 2025
- Product type
- Drugs
- Recall number
- D-0218-2026
- Classification
- Class II
- Recalling firm
- Cipla USA, Inc.
- Reason for recall
- Failed stability specifications: Out of specification for hardness test
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- 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.
- Distribution pattern
- Nationwide in the USA
- Recall initiation date
- Oct 24, 2025
- Center classification date
- Dec 5, 2025