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Cinacalcet Hydrochloride Tablets, 60 mg, 30-count bottle, Rx Only Recall 2026

CINACALCETIssued June 29, 2026Updated Reviewed by the Recall Watch editorial team

CINACALCET Cinacalcet Hydrochloride Tablets, 60 mg, 30-count bottle, Rx Only, Manufactured by: Cipla Ltd., MIDC, Patalganga, India; Manufactured for: Cipla USA, Inc., 10 Independence Boulevard, Suite 300, Warren — recalled per FDA on 6/29/2026. Reason: cGMP Deviations: presence of N-nitroso-cinacalcet, above the acceptable daily intake (ADI)..

Agency
FDA
Issued
Jun 29, 2026
Brand
CINACALCET
Distribution
1 states
Lots affected
9
What to do right now

Steps to take for this recall

  1. Stop using it

    Take it out of rotation. Don't consume, wear, or operate.

  2. Verify the match

    Compare lot numbers, UPCs, and dates against your product.

  3. Return or dispose

    Follow the manufacturer's instructions to refund or safely dispose.

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Verified summary of the official U.S. Food and Drug Administration notice · Issued June 29, 2026 · Last synced Nov 1, 2026

What's recalled

Cinacalcet Hydrochloride Tablets, 60 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 69097-411-02

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Why it was recalled

cGMP Deviations: presence of N-nitroso-cinacalcet, above the acceptable daily intake (ADI).

Affected products & lot numbers
9 lots called out

Affected Lot Numbers

Check your product label — do not use if your lot number appears below.

Lot Number
Lot #: 5PB0165
5PB0166
Exp 1/31/2027
5PB0552
Exp 4/30/2027
5PB0642
5PB0643
5PB0644
Exp 6/30/2027
Where was it sold
1 state

USA Nationwide

nationwide
Official noticefda.gov
More recalls like this
8 related — by brand, contaminant, and category

Frequently asked questions

Is the CINACALCET recall still active?

Yes, this recall is currently active as of June 29, 2026. Do not use or consume the affected product.

What lot numbers are affected?

Affected lot numbers: Lot #: 5PB0165, 5PB0166, Exp 1/31/2027, 5PB0552, Exp 4/30/2027, 5PB0642, 5PB0643, 5PB0644, Exp 6/30/2027. Check the label on your product.

What should I do if I have the recalled CINACALCET?

Do not consume or use this product. Return it to the store for a full refund, or dispose of it safely.