Recall of Cinacalcet Hydrochloride Tablets by Cipla USA
Areazine synthesizes this FDA recall directly from FDA's official public data feed. See our methodology for full source attribution and refresh cadence.
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 verify its scope, source, and timestamp, then compare related notices without assuming that one record proves a broader trend.
Areazine pairs this record with the original agency URL so you can check the primary source before acting. Its related labels are recall, product-safety, cpsc, Drugs.
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 ↗
Related FDA Recalls
All FDA Recalls →Nationwide notices with similar length or severity timing 8
Two Areazine-derived peer sets for this FDA recall: nearest notices by body length and by same severity near the same agency date. Peers come from other categories so they are not the same-feed Related list above.
Similar body length
Nearest notices by article body length (1,201 characters here).
Similar severity timing
Same severity (medium) notices issued closest in time to May 3, 2026.
Frequently Asked Questions
Common questions about this FDA recall.