CLASS III ONGOING Drug recall · Reported 14 Aug 2024 · FDA Enforcement Report
Sevelamer Carbonate for Oral Suspension packets recalled
Dr. Reddy's Laboratories is recalling Sevelamer Carbonate for Oral Suspension packets, distributed nationwide in the US. The recall was initiated on 26 Jun 2024 and the FDA has classified it as Class III.
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-0625-2024
- FDA event ID
- 94884
- Recalling firm
- Dr. Reddy's Laboratories, Princeton, NJ
- Manufacturer
- Dr. Reddys Laboratories Inc
- Classification
- Class III
- Status
- Ongoing
- Recall initiated
- 26 Jun 2024
- FDA classified
- 2 Aug 2024
- Reported
- 14 Aug 2024
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Packaging Defects
Timeline
| 26 Jun 2024 | Recall initiated by company | |
| 2 Aug 2024 | Classified by FDA | +37 days |
| 14 Aug 2024 | 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
Labeling: Incorrect or Missing Lot and/or Exp Date. Missing lot number and expiration dates on packets
Packaging recalls include wrong labels, wrong products in the wrong bottle, missing leaflets, short-filled or empty capsules and seals that fail.
Product as listed by the FDA
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
Where it was distributed
Nationwide within the United States
Questions about this recall
Why was it recalled?
Labeling: Incorrect or Missing Lot and/or Exp Date. Missing lot number and expiration dates on packets
Which lots are affected?
Lot #: T2305999, Exp. Date 11/2025
Where was it sold?
Nationwide within the United States
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 III mean?
Class III recalls are for products unlikely to cause any adverse health consequence, usually labelling or quality issues.
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.
More recalls from Dr. Reddy's Laboratories
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|---|---|---|---|---|---|
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| Drug | CLASS II | Omeprazole Delayed-release Capsules, USP, 20mg recalledOmeprazole | Dr. Reddy's Laboratories | Other | Nationwide |
| Drug | CLASS I | Levetiracetam 0.75% in Sodium Chloride Injection 1,000 mg recalledLevetiracetam | Dr. Reddy's Laboratories | Labeling Errors | Nationwide |
| Drug | CLASS III | Javygtor (sapropterin dihydrochloride) Tablets 100mg recalledJavygtor | Dr. Reddy's Laboratories | Potency & Assay | Nationwide |