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Drug FDA Class III Ongoing Mislabeling

Sevelamer Carbonate for Oral Suspension 0.8g packets, packaged in 90 packets per container, Distributor: Dr. Reddy's Laboratories Inc., Princeton, NJ 08540, Made in India NDC 43598-478-90

Dr. Reddy's Laboratories, Inc. Published Aug 14, 2024

Risk level

Class III

Unlikely to cause harm, but violates labeling or manufacturing rules.

Severity score 40/100

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 Dr. Reddy's Laboratories, Inc. or your place of purchase with questions, and see the source record below for full details.
Reason for recall

Labeling: Incorrect or Missing Lot and/or Exp Date. Missing lot number and expiration dates on packets

Affected products (1)

Sevelamer Carbonate for Oral Suspension 0.8g packets, packaged in 90 packets per container, Distributor: Dr. Reddy's Laboratories Inc., Princeton, NJ 08540, Made in India NDC 43598-478-90

SEVELAMER CARBONATE FOR ORAL SUSPENSION · 5,136 cartons

NDC: 43598-478, 43598-479, 43598-478-01, 43598-478-90, 43598-479-01, 43598-479-90
Code info: Lot #: T2305999, Exp. Date 11/2025

Affected areas

Nationwide

Timeline

  1. Initiated
    Jun 26, 2024
  2. Published
    Aug 14, 2024
Recall number
D-0625-2024
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.