Cinacalcet Hydrochloride Tablets Recall Issued 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 31,824 bottles of Cinacalcet Hydrochloride Tablets, 30 mg due to cGMP deviations involving N-nitroso-cinacalcet above acceptable limits.
What this FDA recall tells you, and what most readers miss
This notice was issued by FDA on August 6, 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, fda, drug.
What Happened
Cipla USA, Inc. initiated a voluntary recall of Cinacalcet Hydrochloride Tablets due to cGMP deviations involving the presence of N-nitroso-cinacalcet above the acceptable daily intake (ADI).
Which Products Are Affected
The recall covers Cinacalcet Hydrochloride Tablets, 30 mg, 30-count bottle, Rx Only (NDC 69097-410-02), manufactured by Cipla Ltd., MIDC, Patalganga, India for Cipla USA, Inc. A total of 31,824 bottles are affected, distributed nationwide in the United States. Affected lots include: 5PB0465, 5PB0466, 5PB0557 (Exp 4/30/2027); 5PB0629, 5PB0630, 5PB0633, 5PB0637, 5PB0638 (Exp 6/30/2027). Recall number D-0661-2026.
What You Should Do
Consumers should contact Cipla USA, Inc. regarding the recalled product.
Why This Matters
This Class II recall addresses a drug impurity issue affecting prescription medication distributed across the United States.
Source
FDA recall D-0661-2026 (https://www.fda.gov)
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 (953 characters here).
Similar severity timing
Same severity (medium) notices issued closest in time to August 6, 2026.
Frequently Asked Questions
Common questions about this FDA recall.