Quick Facts at a Glance
- Recall Date
- June 29, 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 #: 5PB0465, 5PB0466, 5PB0557, Exp 4/30/2027, 5PB0629, 5PB0630, 5PB0633, 5PB0637 +2 more
- 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
June 29, 2026
Reported by FDA DRUG
July 8, 2026
RecallRadar source check
July 14, 2026
Consumer action
Use the official remedy and keep documentation.
Hazard Information
cGMP Deviations: presence of N-nitroso-cinacalcet, above the acceptable daily intake (ADI).
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-count 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 of N-nitroso-cinacalcet, above the acceptable daily intake (ADI).. Classification: Class II. Quantity: 31,824 bottles. Distribution: USA Nationwide
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Safety Guide
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