Class II U.S. Food and Drug Administration

Cipla USA, Inc. Cinacalcet Hydrochloride Tablets, 30 mg, 30-count bottle recall: cGMP Deviations: presence of N-nitroso-cinacalcet

Recall published 4 months ago

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

The hazard: Labelling or manufacturing-practice failure

This recall is about what the packaging says rather than what is in it — which still matters, because the label is how a dose gets chosen.

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

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-0661-2026
Published
July 8, 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
31,824 bottles
Distribution
Nationwide
Made in
United States
Lot / code info
Lot #: 5PB0465, 5PB0466, 5PB0557, Exp 4/30/2027; 5PB0629, 5PB0630, 5PB0633, 5PB0637, 5PB0638, Exp 6/30/2027

Products covered by this recall

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

Check your product

The notice names 13 codes you can read straight off the package. Type the one printed on yours and the list below narrows to it.

Lot or batch code

Usually ink-stamped near the seam, the cap or the bottom of the pack.

  • 5PB0465
  • 5PB0466
  • 5PB0557
  • Exp 4
  • 30
  • 2027

Best-by / use-by date

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

  • 30
  • 2027
  • 2027 — 31
  • 824 bottles

NDC number

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

  • 69097-410-02

Package size

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

  • 30 mg
  • 30 count

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. — This recall is about what the packaging says rather than what is in it — which still matters, because the label is how a dose gets chosen.

  1. Compare the lot number and strength on your pack with the codes above and with what your prescription actually says.
  2. If what you were dispensed does not match your prescription, call the pharmacy before taking another dose.
  3. Keep taking the medicine as prescribed unless the notice or your prescriber says otherwise.
  4. Return the affected pack to the pharmacy for a replacement from a good lot.

Refunds and replacements

With medicines, a replacement supply matters more than cash, and that is what pharmacies are set up to provide.

  • Ask the dispensing pharmacy for a like-for-like replacement from an unaffected lot. This is the fastest route and usually costs nothing.
  • For a mail-order or online pharmacy, use the recall line listed on this page rather than the general support queue.
  • If the recall voided a fill you had already paid for, your insurer will normally authorise a replacement ahead of schedule. Quote the recall number.
  • If you paid out of pocket, ask for a refund of the co-pay or purchase price and keep the receipt the pharmacy issues.

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

How do I know if I have the recalled product?

Match the codes printed on your package against the notice: lot code 5PB0465, 5PB0466, 5PB0557; best-by date 30 or 2027. 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?

Ask the dispensing pharmacy for a like-for-like replacement from an unaffected lot. This is the fastest route and usually costs nothing.

Where was the recalled product sold?

It was distributed nationwide.

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