Quick Facts at a Glance
- Recall Date
- March 16, 2026
- Hazard Level
- HIGH
- Brands
- CINACALCET, Cipla USA Inc.
- Geographic Scope
- 1 states
What to Do Now
Use this page like a recall checklist: verify the product first, then act on the official remedy.
Immediate steps
- 1Stop using the product until you confirm whether it is included in the recall.
- 2Compare the product label, model number, UPC, color, size, and purchase location against the identifiers below.
- 3Follow the official remedy from FDA - Drug Safety; save photos, receipts, labels, and correspondence before contacting the company.
- 4If the product could harm a child, older adult, pet, or patient, move it out of reach immediately.
Check these identifiers
- Brand
- CINACALCET, Cipla USA Inc.
- Model numbers
- Lot, expiry: Lot 4PB0526, 4PB0527, 4PB0528, exp September-2026, Lot 5PB0173, exp January-2027
- UPC codes
- 69097-410, 69097-411, 69097-412, 69097-410-02, 69097-411-02, 69097-412-02
- Where affected
- ALL
Recall Timeline
Key dates and source checks for this recall record.
Recall announced
March 16, 2026
Reported by FDA DRUG
April 22, 2026
RecallRadar source check
April 29, 2026
Consumer action
Use the official remedy and keep documentation.
Hazard Information
CGMP Deviations; presence N-Nitroso Cinacalcet above the acceptable daily intake limit
What You Should Do
Consumers and healthcare providers should stop using this product immediately. Contact Cipla USA, Inc. or your healthcare provider for guidance. Notification method: Letter
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Full Description
Cinacalcet Hydrochloride Tablets, 30 mg, 30 Tablets per bottle, Rx Only, Manufactured by: Cipla Ltd., MIDC, Patalganga, India; Manufactured for: Cipla USA, Inc., 10 Independence Boulevard, Suite 300, Warren, NJ 07059. NDC: 69097-410-02. Generic: CINACALCET; Brand: CINACALCET. Reason: CGMP Deviations; presence N-Nitroso Cinacalcet above the acceptable daily intake limit. Classification: Class II. Quantity: 113,336 bottles. Distribution: Nationwide in the USA
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Safety Guide
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