Cinacalcet Hydrochloride Tablets recall: CGMP Deviations
Cinacalcet Hydrochloride Tablets, 30 mg, 30-count bottle, Rx Only, Manufactured by: Cipla Ltd., MIDC, Patalganga, India; Manufactured for: Cipla USA…
Why was Cinacalcet Hydrochloride Tablets recalled?
cGMP Deviations: presence of N-nitroso-cinacalcet, above the acceptable daily intake (ADI).
What should I do if I have this product?
The recall is ongoing. Follow the firm and FDA instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
Lot #: 5PB0465, 5PB0466, 5PB0557, Exp 4/30/2027; 5PB0629, 5PB0630, 5PB0633, 5PB0637, 5PB0638, Exp 6/30/2027
- Product
- Cinacalcet Hydrochloride Tablets, 30 mg, 30-count bottle, Rx Only, Manufactured by: Cipla Ltd., MIDC, Patalganga, India; Manufactured for: Cipla USA…
- Recalling firm
- Cipla USA, Inc.
- Quantity
- 31,824 bottles
- Distribution
- USA Nationwide
- Recall date
- July 8, 2026
- Classification
- Class II
- Status
- Ongoing
- Agency
- FDA (drug)