Sensipar Tablets Recall Due to CGMP Deviations
Areazine synthesizes this FDA recall directly from FDA's official public data feed. See our methodology for full source attribution and refresh cadence.
Amgen Inc. is recalling one lot of Sensipar (cinacalcet) 90mg tablets nationwide due to CGMP deviations.
What this FDA recall tells you, and what most readers miss
This notice was issued by FDA on August 4, 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, Drugs.
What Happened
Amgen, Inc. initiated a voluntary recall of Sensipar (cinacalcet hydrochloride) tablets due to CGMP deviations.
Which Products Are Affected
Sensipar (cinacalcet) Tablets, 90mg, 30-count bottles, Rx Only, NDC 55513-075-30, Lot #: 1157056, Exp. Date 02/29/2028. Distributed by Amgen, One Amgen Center Drive, Thousand Oaks, CA 91320-1799, Made in Japan. The recall is classified as Class II and affects nationwide distribution within the United States.
What You Should Do
Consumers should check product lot numbers against the recalled lot and consult their healthcare provider or pharmacist regarding any affected product.
Why This Matters
This Class II recall addresses manufacturing practice deviations for a prescription drug distributed across the United States.
Source
FDA recall D-0616-2026. https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts
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 (896 characters here).
Similar severity timing
Same severity (medium) notices issued closest in time to August 4, 2026.
Frequently Asked Questions
Common questions about this FDA recall.