FDA Recall of Cipla's Cinacalcet Hydrochloride Tablets
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 voluntarily recalling 113,336 bottles of Cinacalcet Hydrochloride Tablets due to CGMP deviations and presence of N-Nitroso Cinacalcet above acceptable limits.
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.
What Happened
Cipla USA, Inc. is recalling 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, 30 mg, 30 tablets per bottle, manufactured by Cipla Ltd. for Cipla USA, Inc., with NDC: 69097-410-02. The recall includes lots: 4PB0526, 4PB0527, 4PB0528 with expiration September 2026, and 5PB0173 with expiration January 2027. A total of 113,336 bottles distributed nationwide in the USA are involved, under recall number D-0449-2026.
What You Should Do
Consumers should check if they have the affected lots and contact Cipla USA, Inc. as the recall was initiated via letter for further instructions on returns or refunds.
Why This Matters
This recall highlights potential risks from pharmaceutical manufacturing issues, affecting a large number of distributed bottles and underscoring the need for adherence to safety standards in drug production.
Source
Information from the FDA recall database, specifically recall event ID 98670.
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 (1,131 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.