Class II U.S. Food and Drug Administration

Cipla USA, Inc. Cinacalcet Hydrochloride Tablets, 90 mg, 30 Tablets per bottle recall: CGMP Deviations; presence N-Nitroso Cinacalcet above the acceptable daily

Recall published 6 months ago

CGMP Deviations; presence N-Nitroso Cinacalcet above the acceptable daily intake limit

The hazard: Labelling or manufacturing-practice failure

The defect here is documentary: wrong strength on the label, a mismatched barcode, or records that do not demonstrate the product was made correctly.

What the notice says: CGMP Deviations; presence N-Nitroso Cinacalcet above the acceptable daily intake limit

Why it matters: The label, the strength printed on it, the barcode or the manufacturing records do not meet federal requirements. The practical danger is someone taking the wrong drug or the wrong dose while believing they have the right one.

Symptoms and when to call a doctor

If you may have taken a product that turned out to be a different drug or strength from the one on the label, call your prescriber, and call Poison Control on 1-800-222-1222 if you feel unwell. Describe what the pack said and what you actually took.

This page is general information, not medical advice. If you feel unwell, a clinician who can see you is the only person able to judge your case.

Recall details

Recall number
D-0451-2026
Published
April 22, 2026
Risk level
Class II
Status
Ongoing
Issued by
U.S. Food and Drug Administration
Brand
Cipla USA, Inc.
Product type
Prescription & OTC drugs
Units affected
63,192 bottles
Distribution
Nationwide
Made in
United States
Lot / code info
Lot, expiry: 4PB0224, exp March-2026; 4PB0505, 4PB0506, 4PB0507, exp September-2026; 5PB0564, exp April-2027

Products covered by this recall

Cinacalcet Hydrochloride Tablets, 90 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: 69097-412-02

Check your product

The notice names 7 codes you can read straight off the package. Type the one printed on yours and the list below narrows to it.

Best-by / use-by date

Printed beside the lot code, not on the price sticker.

  • 4PB0224
  • exp March-2026
  • September-2026
  • April-2027 — 63
  • 192 bottles

NDC number

On the carton and again on the bottle or blister label.

  • 69097-412-02

Package size

Match the net weight or the piece count on the front of the pack.

  • 90 mg

Codes are lifted verbatim from the FDA — Drug enforcement notice. A code that is missing here may still be covered — the official notice is the complete list.

What to do about Labelling

Cipla USA, Inc. — The defect here is documentary: wrong strength on the label, a mismatched barcode, or records that do not demonstrate the product was made correctly.

  1. Compare the lot number and strength on your pack with the codes above and with what your prescription actually says.
  2. Keep taking the medicine as prescribed unless the notice or your prescriber says otherwise.
  3. Return the affected pack to the pharmacy for a replacement from a good lot.
  4. Report a mismatch to FDA MedWatch, especially if it reached you rather than being caught at the counter.

What the company owes you

A recalled medicine is the manufacturer’s cost to carry, not yours or your pharmacist’s.

  • The purchase price or co-pay is refundable, and so is the cost of returning the product if they ask you to ship it.
  • Ask the pharmacy to handle the claim where they can — they process recall returns in bulk and it saves you the correspondence.
  • Keep the carton, the leaflet and the pharmacy label together until the claim is closed.
  • Costs beyond the price of the medicine need to go to the company directly, in writing, with the recall number quoted.

Company contact: Cipla USA, Inc. — 10 Independence Blvd, Warren, NJ, 07059-2730

The official notice

This page summarises a notice published by U.S. Food and Drug Administration. The agency notice is the authoritative version — read it before you act, and treat it as the final word if anything here looks different.

Open the FDA — Drug enforcement record U.S. Food and Drug Administration recalls

Questions people ask about this recall

Why was Cipla USA, Inc. prescription & otc drugs recalled?

CGMP Deviations; presence N-Nitroso Cinacalcet above the acceptable daily intake limit CGMP Deviations; presence N-Nitroso Cinacalcet above the acceptable daily intake limit

How do I know if I have the recalled product?

Match the codes printed on your package against the notice: best-by date 4PB0224 or exp March-2026. If the code on your package is not on that list, your unit is outside the recall.

What should I do with it right now?

Compare the lot number and strength on your pack with the codes above and with what your prescription actually says.

Can I get my money back?

The purchase price or co-pay is refundable, and so is the cost of returning the product if they ask you to ship it.

Where was the recalled product sold?

It was distributed nationwide.

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