CLASS II ONGOING Drug recall · Reported 20 Nov 2024 · FDA Enforcement Report
Lanthanum Carbonate Chewable Tablets, 1000mg recalled by Cipla USA
Cipla USA is recalling Lanthanum Carbonate Chewable Tablets, 1000mg, distributed nationwide in the US. The recall was initiated on 23 Oct 2024 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-0044-2025
- FDA event ID
- 95611
- Recalling firm
- Cipla USA, Warren, NJ
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 23 Oct 2024
- FDA classified
- 12 Nov 2024
- Reported
- 20 Nov 2024
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Other Reasons
Timeline
| 23 Oct 2024 | Recall initiated by company | |
| 12 Nov 2024 | Classified by FDA | +20 days |
| 20 Nov 2024 | Published in enforcement report | +8 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Failed Tablet/Capsule Specifications: Complaints received of crushed and broken tablets.
Product as listed by the FDA
Lanthanum Carbonate Chewable Tablets, 1000mg, 10-count bottle, Rx only, Manufactured for Exelan Pharmaceuticals, NDC 76282-0478-90
Where it was distributed
USA nationwide.
Questions about this recall
Is Lanthanum Carbonate Chewable Tablets, 1000mg recalled?
Yes. Cipla USA recalled Lanthanum Carbonate Chewable Tablets, 1000mg on 23 Oct 2024. The recall is Class II and its status is Ongoing. Recall number D-0044-2025.
Why was it recalled?
Failed Tablet/Capsule Specifications: Complaints received of crushed and broken tablets.
Which lots are affected?
Lot# NB240873, Exp 03/31/2026
Where was it sold?
USA nationwide.
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 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
More recalls from Cipla USA
All 23| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Cinacalcet Hydrochloride Tablets, 60 mg recalled by Cipla USACinacalcet | Cipla USA | Nitrosamine Impurity | Nationwide |
| Drug | CLASS II | Cinacalcet Hydrochloride Tablets, 90 mg recalled by Cipla USACinacalcet | Cipla USA | Nitrosamine Impurity | Nationwide |
| Drug | CLASS II | Cinacalcet Hydrochloride Tablets, 30 mg recalled by Cipla USACinacalcet | Cipla USA | Nitrosamine Impurity | Nationwide |
| Drug | CLASS II | Cinacalcet Hydrochloride Tablets, 60 mg recalled by Cipla USACinacalcet | Cipla USA | Nitrosamine Impurity | Nationwide |
| Drug | CLASS II | Cinacalcet Hydrochloride Tablets, 90 mg recalled by Cipla USACinacalcet | Cipla USA | Nitrosamine Impurity | Nationwide |
Other Lanthanum carbonate chewable recalls
All 2| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Lanthanum Carbonate Chewable Tablets, 1000mg recalled by Cipla USA | Cipla USA | Other | Nationwide |