Sensipar cinacalcet hydrochloride tablets recalled for CGMP deviations
Amgen, Inc. is recalling Sensipar (cinacalcet) 90mg tablets nationwide due to Current Good Manufacturing Practice (CGMP) deviations. The affected lot was distributed across the United States.
The agency’s classification
FDA (Drugs): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 2/5 (Moderate).
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The FDA classified this as Class II, and the source text states the reason is CGMP deviations. The source does not report any illnesses, injuries, or hospitalizations. CGMP deviations without reported harm are typically Moderate severity unless other aggravating factors are present.
Plain-English summary
Amgen, Inc. is voluntarily recalling Sensipar (cinacalcet hydrochloride) 90mg tablets, 30-count bottles, nationwide in the United States. The recall was initiated on June 4, 2026, and classified as Class II by the FDA on June 23, 2026. The affected product is NDC 55513-075-30, Lot #1157056, with an expiration date of February 29, 2028.
The recall is due to Current Good Manufacturing Practice (CGMP) deviations identified during manufacturing. Sensipar is a prescription medication used to treat secondary hyperparathyroidism in patients with chronic kidney disease.
Patients currently taking this medication should contact their healthcare provider or pharmacist for guidance. Healthcare providers and pharmacists should check their inventory for the affected lot number and quarantine the product. Customers with questions may contact the FDA's Emergency Operations Center.
The recalled product
- Product
- SENSIPAR (CINACALCET HYDROCHLORIDE)
- Brand
- SENSIPAR
- Manufacturer
- Amgen, Inc.
- Category
- Drug — Prescription Tablet
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (2)
- Lot #: 1157056
- Exp. Date 02/29/2028
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 5 recalled by Amgen, Inc. under a single FDA (Drugs) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
See all 5 products in this recall →Related recalls
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