Reported Apr 22, 2026 · Ongoing
Cinacalcet Hydrochloride Tablets, 30 mg, 30 Tablets per bottle, Rx Only, Manufactured by: Cipla Ltd., MIDC, Patalganga,…
Cipla USA, Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Cipla USA, Inc. · 10 Independence Blvd · Warren, NJ · 07059-2730
Is this the product you have?
- Cinacalcet Hydrochloride Tablets, 30 mg, 30 Tablets per bottle, Rx Only
- Manufactured byCipla Ltd., MIDC, Patalganga, India
- Manufactured forCipla USA, Inc., 10 Independence Boulevard, Suite 300, Warren, NJ 07059
- NDC69097-410-02
- Lot codes and dates
- Lot
- expiry
Lot 4PB05264PB05274PB0528exp September-2026Lot 5PB0173exp January-2027
- Amount recalled
- 113,336 bottles
This recall covers 3 products
The agency filed one notice per product. You are reading one of them; the other 2 are below.
Where it was sold
- Nationwide
Why it was recalled
CGMP Deviations; presence N-Nitroso Cinacalcet above the acceptable daily intake limit
This product could cause temporary or reversible health problems — stop using it.
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The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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