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Drug FDA Class II Ongoing Quality

Lanthanum Carbonate Chewable Tablets, 1000mg, 10-count bottle, Rx only, Manufactured for Cipla USA, NDC 69097-0936-98

Cipla USA, Inc. Published Nov 20, 2024

Risk level

Class II

May 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 Tablet/Capsule Specifications: Complaints received of crushed and broken tablets.

Affected products (1)

Lanthanum Carbonate Chewable Tablets, 1000mg, 10-count bottle, Rx only, Manufactured for Cipla USA, NDC 69097-0936-98

1,875 boxes (cipla and exlan)

Lot codes: NB240316
Code info: Lot # NB240316, Exp 12/31/25

Affected areas

Nationwide

Timeline

  1. Initiated
    Oct 23, 2024
  2. Published
    Nov 20, 2024
Recall number
D-0043-2025
Agency
U.S. Food and Drug Administration
Country
US
Source data (openFDA JSON) About FDA enforcement reports

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.