Sevelamer Carbonate for Oral Suspension 0.8g packets recall
FDA recall D-0625-2024 · initiated Jun 26, 2024
Dr. Reddy's Laboratories, Inc. recalled Sevelamer Carbonate for Oral Suspension 0.8g packets in Jun 2024 — an FDA Class III recall (D-0625-2024) because Labeling: Incorrect or Missing Lot and/or Exp Date. Missing lot number and expiration dates on packets.
Unlikely to cause harm but violates FDA labeling or manufacturing regulations.
Why it was recalled
Labeling: Incorrect or Missing Lot and/or Exp Date. Missing lot number and expiration dates on packets
Labelling, packaging or a product mix-up
The wrong information — or the wrong medicine — ended up in the pack. A mix-up is a manufacturing failure that can still be dangerous to swallow.
This is a manufacturing or quality failure, not a finding that the medicine is unsafe to take — across every recall we hold, none was issued for that reason. It does not mean the batch was harmless.
Is your product affected? Check the lot number
A recall covers only specific lots. Find the lot number and expiration date on your package and compare them to the affected codes below — if yours is not listed, it was not part of this recall.
Quantity recalled: 5,136 cartons
Details
- Product
- 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
- Recalling company
- Dr. Reddy's Laboratories Limited
- Classification
- Class III
- Status
- Ongoing
- Type
- Voluntary: Firm initiated
- Distribution
- Nationwide within the United States
- Initiated
- Jun 26, 2024
- FDA report date
- Aug 14, 2024
Frequently asked
- Was Sevelamer Carbonate for Oral Suspension 0.8g packets recalled?
- Dr. Reddy's Laboratories, Inc. recalled Sevelamer Carbonate for Oral Suspension 0.8g packets in Jun 2024 — an FDA Class III recall (D-0625-2024) because Labeling: Incorrect or Missing Lot and/or Exp Date. Missing lot number and expiration dates on packets. Unlikely to cause harm but violates FDA labeling or manufacturing regulations.
- Why was Sevelamer Carbonate for Oral Suspension 0.8g packets recalled?
- Per the FDA enforcement record, the reason for recall D-0625-2024 was: Labeling: Incorrect or Missing Lot and/or Exp Date. Missing lot number and expiration dates on packets
- Is a recalled Sevelamer Carbonate for Oral Suspension 0.8g packets dangerous to take?
- An FDA recall removes specific lots from the market for a defined reason and does not by itself mean the medicine is unsafe for everyone — your specific lot may never have been affected. Unlikely to cause harm but violates FDA labeling or manufacturing regulations. Check the FDA notice for the affected lot numbers and expiration dates, and ask your pharmacist or doctor before stopping a prescribed medicine. This reproduces public FDA data and is not medical advice.
- Which lots of Sevelamer Carbonate for Oral Suspension 0.8g packets are affected?
- Distributed: Nationwide within the United States. The recall covers these lots — Lot #: T2305999, Exp. Date 11/2025. Check the lot number and expiration date on your package against this list; if yours is not listed, it was not part of recall D-0625-2024.