Cipla Recalls Lanthanum Carbonate Chewable Tablets Over Stability Failures
Key Takeaways
- Two Lanthanum Carbonate 1000 mg chewable tablet lots have been recalled nationwide due to failed stability specifications related to tablet hardness.
- The recalls are Class II, indicating the potential for reversible or temporary health consequences but not severe harm.
- Products were manufactured by Invagen Pharmaceuticals (a Cipla subsidiary) and recalled by Cipla USA, Inc., with distribution across the United States.
Cipla USA, Inc. has initiated a voluntary Class II recall involving two lots of Lanthanum Carbonate 1000 mg chewable tablets, following US Food and Drug Administration (FDA) identification of out-of-specification hardness results during stability testing. The affected products include:
- Lot NB240315 (NDC 69097-936-98) manufactured for Cipla USA
- Lot NB240314 (Carton NDC 76282-478-90; Bottle NDC 76282-478-13) manufactured for Exelan Pharmaceuticals
Both lots carry an expiration date of December 31, 2025, and were produced by Invagen Pharmaceuticals, Inc. in Hauppauge, NY.
The recall stems from tablets failing stability specifications related to hardness, which could potentially affect dose integrity, disintegration, or patient adherence—critical considerations for pharmacists dispensing lanthanum carbonate. While no injuries or adverse events have been reported, compromised tablet hardness may interfere with appropriate phosphate binding, especially in patients with chronic kidney disease (CKD) who rely on consistent dosing.
The recall, classified as Class II, indicates that use of the product may cause reversible or medically manageable adverse effects. Both recalls fall under the same FDA Event ID (97855) and were initiated on October 24, 2025, with classification finalized on December 5, 2025. The products were distributed nationwide in the US, and no public press release has been issued. The recall remains ongoing.
Lanthanum carbonate is a phosphate binder indicated to reduce serum phosphate levels in patients with end-stage renal disease (ESRD). It is used to help manage hyperphosphatemia when dietary phosphate restriction alone is insufficient.
Reference
FDA. Enforcement Report. December 17, 2025. Accessed December 18, 2025. https://www.accessdata.fda.gov/scripts/ires/index.cfm
