CLASS II ONGOING Drug recall · Reported 17 Dec 2025 · FDA Enforcement Report
Lanthanum Carbonate chewable tablets, 1000mg* recalled by Cipla USA
Cipla USA is recalling Lanthanum Carbonate chewable tablets, 1000mg*, bottles per patient pack, distributed nationwide in the US. The recall was initiated on 24 Oct 2025 and the FDA has classified it as Class II.
Check your package
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
Recall details
- Recall number
- D-0217-2026
- FDA event ID
- 97855
- Recalling firm
- Cipla USA, Warren, NJ
- Brand
- Lanthanum Carbonate
- Manufacturer
- Cipla USA Inc.
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 24 Oct 2025
- FDA classified
- 5 Dec 2025
- Reported
- 17 Dec 2025
- Type
- Voluntary: Firm initiated
- Customers notified by
- N/A
- Reason category
- Potency & Assay
Timeline
| 24 Oct 2025 | Recall initiated by company | |
| 5 Dec 2025 | Classified by FDA | +42 days |
| 17 Dec 2025 | Published in enforcement report | +12 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Failed stability specifications: Out of specification for hardness test
Potency and specification recalls happen when a batch tests outside its approved limits for strength, purity or dissolution, which can mean the dose delivered is higher or lower than labelled.
Product as listed by the FDA
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.
Where it was distributed
Nationwide in the USA
Questions about this recall
Why was it recalled?
Failed stability specifications: Out of specification for hardness test
Which lots are affected?
lot# NB240315, exp 12/31/2025
Where was it sold?
Nationwide in the USA
What should I do if I have it?
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
Other products in this recall event
1 other product · FDA event 97855| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| CLASS II | Lanthanum Carbonate chewable tablets, 1000mg* recalled by Cipla USALanthanum Carbonate | Cipla USA | Potency & Assay | Nationwide |
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| Drug | CLASS II | Fosfomycin Tromethamine Granules for Oral Solution recalled by Cipla USAFosfomycin Tromethamine | Cipla USA | Potency & Assay | Nationwide |
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Other Lanthanum Carbonate recalls
All 4| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Lanthanum Carbonate chewable tablets, 1000mg* recalled by Cipla USALanthanum Carbonate | Cipla USA | Potency & Assay | Nationwide |
| Drug | CLASS II | Lanthanum Carbonate Chewable Tablets, 1000mg recalled by Cipla USA | Cipla USA | Other | Nationwide |
| Drug | CLASS II | Lanthanum Carbonate Chewable Tablets, 1000mg recalled by Cipla USA | Cipla USA | Other | Nationwide |