Recall of Cinacalcet Hydrochloride Tablets by Cipla USA

Source: FDA · United States

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Cipla USA, Inc. is recalling 63,192 bottles of Cinacalcet Hydrochloride Tablets due to CGMP deviations and N-Nitroso Cinacalcet exceeding acceptable limits, affecting nationwide distribution.

What this FDA recall tells you, and what most readers miss

This notice was issued by FDA on May 3, 2026 and geographically references United States. Its severity classification of "medium" signals how the issuing agency weighs the risk of harm if no action is taken - "critical" and "high" tier alerts typically carry direct consumer actions, while "medium" and "low" tend toward informational guidance or monitoring advisories. The category it belongs to - FDA Recalls - determines the consumer-protection framework behind it, which shapes what remedies (refunds, replacements, repairs, or the recall itself) are available to affected consumers and which agency holds statutory responsibility for enforcement.

Most readers skim a notice like this, check whether they are personally affected, and move on. The more useful lens is to read it as a data point about the issuing system: how quickly FDA detected the hazard, how precise the geographic or product-identifier scope is, and whether similar notices have clustered in the same category or region in the last 90 days. Cluster patterns frequently precede a broader regulatory action, a single localized FDA recall is isolated; three of them within a quarter often indicate a supply-chain, infrastructure, or seasonal driver that will keep producing notices until something structural changes.

For decision-making, Areazine pairs each alert with the original agency URL, the full agency name, and a timestamp so you can verify the notice against the primary source before acting on it. Tags on this item (recall, product-safety, cpsc, Drugs) map to related alerts in the same area of risk - browsing them together gives a clearer picture than any single notice alone, because the shape of an ongoing issue only becomes visible across multiple sequential alerts.

Recall Article

What Happened

Cipla USA, Inc. is conducting a voluntary recall of certain lots of Cinacalcet Hydrochloride Tablets due to CGMP deviations and the presence of N-Nitroso Cinacalcet above the acceptable daily intake limit.

Which Products Are Affected

The affected product is Cinacalcet Hydrochloride Tablets, 90 mg, 30 tablets per bottle, manufactured by Cipla Ltd. and distributed by Cipla USA, Inc. The NDC is 69097-412-02, and the recall involves 63,192 bottles with the following lots and expiry dates: 4PB0224 (exp. March 2026), 4PB0505 (exp. September 2026), 4PB0506 (exp. September 2026), 4PB0507 (exp. September 2026), and 5PB0564 (exp. April 2027). These products were distributed nationwide in the USA.

What You Should Do

Consumers with the affected lots should contact Cipla USA, Inc. for instructions on returning the product. The firm can be reached at their address: 10 Independence Blvd, Warren, NJ 07059.

Why This Matters

This recall affects over 63,000 bottles of a prescription drug, potentially impacting patients who rely on it for treatment and underscoring the need for adherence to manufacturing standards.

Source

FDA Recall Notice: D-0451-2026

Original source: FDA Official Notice ↗

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Frequently Asked Questions

Common questions about this FDA recall.

What is this FDA recall about?
Cipla USA, Inc. is recalling 63,192 bottles of Cinacalcet Hydrochloride Tablets due to CGMP deviations and N-Nitroso Cinacalcet exceeding acceptable limits, affecting nationwide distribution.
Which agency issued this alert?
This alert was issued by FDA. The original notice is available at the source link at the bottom of this article.
How severe is this alert?
This alert is classified as "medium" severity. Stay informed and follow agency guidance.
What area is affected?
This alert affects United States. Check with FDA for the most current geographic scope.
Where can I find more FDA Recalls updates?
Browse the full FDA Recalls feed on Areazine at areazine.com/recalls/fda/ for the latest updates from FDA and other agencies.