Drug FDA Class II Ongoing Failed specifications
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.
Cipla USA, Inc. Published Dec 17, 2025
Risk level
Class IIMay cause a temporary or reversible health problem; slight chance of serious harm.
Severity score 60/100
What should you do?
- Check whether you have this product, using the lot codes, UPCs, and dates listed below.
- Do not eat, serve, or sell the affected product.
- Return it to the place of purchase for a refund, or throw it away in a sealed bag so people and animals can’t get to it.
- Contact Cipla USA, Inc. or your place of purchase with questions, and see the source record below for full details.
Reason for recall
Failed stability specifications: Out of specification for hardness test
Hazards
Failed Hardness Test · primary
Affected products (1)
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 · 1180 boxes
NDC: 69097-934, 69097-935, 69097-936, 69097-934-57, 69097-934-98, 69097-935-89, 69097-935-98, 69097-936-65, 69097-936-98
Lot codes: NB240315
Code info: lot# NB240315, exp 12/31/2025
Affected areas
Nationwide
Timeline
- InitiatedOct 24, 2025
- PublishedDec 17, 2025
- Recall number
- D-0217-2026
- Agency
- U.S. Food and Drug Administration
- Country
- US
FDA records come from the openFDA drug enforcement-report dataset — the agency's full weekly enforcement list. Most entries are not issued as consumer press releases, so they won't appear on fda.gov/recalls or in a web search. The source record link above resolves this exact recall by its number.