Cipla recalls Lanthanum Carbonate 1000mg chewable tablets because tablets failed a hardness test
The tablets failed a stability check because their hardness was out of specification, meaning they did not meet the required standard for how firm the tablets should be.
What to do
The notice does not give instructions. Read the official notice for details.
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Recall details
- Product
- Lanthanum Carbonate chewable tablets, 1000mg*, 10x9 bottles per patient pack carton, Rx Only, Manufactured by: Invagen Pharmaceuticals, Inc., Hauppauge, NY 11786, Manufactured for : Cipla USA, Inc., 10 Independence Boulevard, Suite 300, Warren, NJ 07059, NDC 69097-936-98.; Lanthanum Carbonate chewable tablets, 1000mg*, 10x9 bottles per patient pack carton, Rx Only, Manufactured by: Invagen…
- Company
- Cipla USA, Inc.
- Hazard
- Failed stability specifications: Out of specification for hardness test
- Units
- 1180 boxes; N/A
- Where sold
- Nationwide in the USA
- FDA classification
- Class II · Ongoing
- Classified by FDA
- December 5, 2025
- Recall started
- October 24, 2025
- FDA enforcement report
- December 17, 2025
- Identifiers
- Codes: lot# NB240315, exp 12/31/2025
- FDA recall number: D-0217-2026
- Codes: Lot# NB240314, exp 12/31/2025
- FDA recall number: D-0218-2026
The headline, summary and steps above are written in plain English from the official notice below. Identifiers are copied exactly as the agency published them. Always check the official notice before you act.
Official notice
The notice's own wording from FDA.
- Product
- Lanthanum Carbonate chewable tablets, 1000mg*, 10x9 bottles per patient pack carton, Rx Only, Manufactured by: Invagen Pharmaceuticals, Inc., Hauppauge, NY 11786, Manufactured for : Cipla USA, Inc., 10 Independence Boulevard, Suite 300, Warren, NJ 07059, NDC 69097-936-98. | 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.
- Reason for recall
- Failed stability specifications: Out of specification for hardness test
- Classification
- Class II (Ongoing)
- Distribution
- Nationwide in the USA
- Quantity
- 1180 boxes; N/A
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