Class II · Moderate risk
Cinacalcet Hydrochloride Tablets
cGMP Deviations: presence of N-nitroso-cinacalcet, above the acceptable daily intake (ADI).
Sensipar (cinacalcet) (Cinacalcet Hydrochloride)
Class II — Moderate risk. May cause temporary or reversible harm; serious harm unlikely.
Why it was recalled
CGMP Deviations
Cause type: cGMP deviation
Departures from current Good Manufacturing Practice found in production or during FDA inspection. A broad quality-system cause: the batch was made under conditions that fall short of FDA manufacturing standards. All cgmp deviation recalls.
What was recalled
Sensipar (cinacalcet) Tablets, 90mg, 30-count bottles, Rx Only, Distributed by: Amge, One Amgen Center Drive, Thousand Oaks, CA 91320-1799, Made in Japan. NDC 55513-075-30
Affected NDC
55513-0075-30
Compare with the code on your package — it is the most precise check available.
Drug: Cinacalcet
Product details
From the FDA NDC directory, for the product code this recall names. Compare with the label on your package.
| Product | Strength | Form & route | Labeler | Type |
|---|---|---|---|---|
| Sensipar cinacalcet hydrochloride NDC 55513-0075 |
90 mg/1 | Tablet, Coated Oral |
Amgen Inc | Rx |
- Recalling firm
- Amgen, Inc.
- NDC code
- 55513-075-30
- Origin
- CA, United States
- Initiated by
- Voluntary: Firm initiated
- FDA recall number
- D-0616-2026 · FDA notice
Check, then ask. Class II means harm is possible but usually temporary or reversible. Find the lot number on your package; if it matches, ask your pharmacist about a replacement. Do not simply stop a prescribed medication on your own - the gap can be riskier than the recall.
Other Cinacalcet recalls
See all
Class II · Moderate risk
Cinacalcet Hydrochloride Tablets
cGMP Deviations: presence of N-nitroso-cinacalcet, above the acceptable daily intake (ADI).
Class II · Moderate risk
Cinacalcet Hydrochloride Tablets
cGMP Deviations: presence of N-nitroso-cinacalcet, above the acceptable daily intake (ADI).
Class II · Moderate risk
Sensipar (cinacalcet)
CGMP Deviations
Class II · Moderate risk
Sensipar (cinacalcet)
CGMP Deviations
Other recalls by Amgen, Inc.
All 2026 recalls
Class II · Moderate risk
Corlanor (ivabradine)
Presence of Foreign Substance.
Class II · Moderate risk
Sensipar (cinacalcet)
CGMP Deviations
Class II · Moderate risk
Sensipar (cinacalcet)
CGMP Deviations
Class II · Moderate risk
Corlanor (ivabradine)
Presence of Foreign Substance.
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