Dr. Reddy's Cinacalcet Tablets Recall: N-Nitroso Impurity Risk
Dr. Reddy's recalls 90mg Cinacalcet tablets with potential N-nitroso impurity above FDA limits. Rx-only medication may pose health risks. Check NDC 43598-369-30 and lot numbers for affected batches.
Lower-risk recall
CGMP Deviations: Presence of N-nitroso Cinacalcet impurity above FDA recommended interim limit
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What happened, in plain English
Dr. Reddy's is recalling 90mg Cinacalcet tablets due to a chemical impurity that may exceed FDA safety limits. This could pose health risks to people using the medication as prescribed. Read more at govinfonow.com/recall/32513-dr-reddy-s-cinacalcet-tablets-recall-n-nitroso-impurity-risk.
Source Summary by GovInfoNow · govinfonow.com/recall/32513-dr-reddy-s-cinacalcet-tablets-recall-n-nitroso-impurity-risk · Updated August 17, 2026 · FDA enforcement record: FDA #D-0028-2025
Cite this page
“Dr. Reddy's Cinacalcet Tablets Recall: N-Nitroso Impurity Risk.” GovInfoNow, updated August 17, 2026. https://govinfonow.com/recall/32513-dr-reddy-s-cinacalcet-tablets-recall-n-nitroso-impurity-risk. Based on FDA recall #D-0028-2025 (https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0028-2025%22&limit=1).
Why it’s dangerous
The tablets contain N-nitroso impurities above the FDA's interim safety limit. This impurity could potentially cause health issues, though the exact risk level isn't specified in the recall notice.
Who’s affected
People prescribed Cinacalcet tablets by a doctor who received the recalled product. Those with kidney disease or on dialysis are most at risk due to the medication's use.
How to tell if you have this one
Check for the product name 'Cinacalcet Tablets, 90 mg, 30-count bottle' with NDC 43598-369-30. Look for lot numbers T2201443 (expiring 03/2025) or T2300664 (expiring 12/2025).
- Brand
Dr. Reddy's- Category
Drug
All 3 products in this recall
FDA lists each product line separately under one recall event. Check your product description, lot or code numbers against each row. Every row shares the hazard and remedy on this page.
- Classification
Class II- Status
Ongoing- Distribution
USA Nationwide.- NDC
43598-367-30, 43598-367-05, 43598-368-30, 43598-368-05, 43598-369-30, 43598-369-05
| Recall number | Product, codes & lots | Quantity |
|---|---|---|
| D-0026-2025 | Cinacalcet Tablets, 30 mg, 30-count bottle, Rx Only, Dr. Reddy's Laboratories Inc, Princeton, NJ 08540, Made in India, NDC 43598-367-30.; Lot# T2200120, T2200121, T2200119, T2200116, T2200118, T2200117, Exp 11/2024; T2200695, T2200694, T2200696, T2200697, Exp 01/2025; T2201426, T2201428, T2201432, T2201427, T2201430, T2201429, T2201431, Exp 03/2025; T2202743, T2202742, T2202741, & T2202740, Exp 06/2025; T2203081, T2203079, T2203080, T2203082, T2203083 & T2203084, Exp 07/2025; T2300770, T2300771, T2300769, T2300766, T2300767 & T2300768, Exp 12/2025 Lots T2301663, T2301665, T2301662, T2301664, T2301667, T2301661, T2301666, T2301660, T2301658 & T2301659, Exp Date 02/2026 Lots T2304704, T2304703, T2304705, T2304706, Exp Date 08/2026 Lots T2400468, T2400469, T2400473 & T2400474 Exp Date 11/2026 | 285126 bottles |
| D-0027-2025 | Cinacalcet Tablets, 60 mg, 30-count bottles, Rx Only, Dr. Reddy's Laboratories Inc, Princeton, NJ 08540, Made in India, NDC 43598-368-30.; Lot# T2200698, Exp 01/2025; T2201444, Exp 03/2025; T2202827, Exp 06/2025; T2300531, Exp 12/2025; T2301696, Exp 02/2026; T2304726, Exp 08/2026; T2400480, Exp 11/2026. | 35880 bottles |
| D-0028-2025 | Cinacalcet Tablets, 90 mg, 30-count bottle, Rx Only, Dr. Reddy's Laboratories Inc, Princeton, NJ 08540, Made in India., NDC 43598-369-30.; Lot# T2201443, Exp 03/2025; T2300664, Exp 12/2025. | 10584 bottles |
What to do — step by step
Check Product Details
Verify the NDC code 43598-369-30 and lot numbers T2201443 or T2300664 on the packaging.
Where it went and when
Where it was distributed
Distributed nationwide.
FDA distribution: “USA Nationwide.” States read from FDA’s own wording; “not listed” means the notice does not name it.
Distributed nationwide.
Recall timeline
FDA published this recall 28 days after the firm started it.
- Firm started the recall
- FDA classified it Class II
- Published in FDA’s Enforcement Report
Dates from the agency record only; steps without a date are left out.
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Where this comes from
The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
- Official source: FDA Recall #D-0028-2025 (October 9, 2024) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for D-0028-2025 to see it in context.
- Plain-language summary written by qwen3:4b on August 17, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
- GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.