Amgen

5 recalls on record · Last recall: Jun 4, 2026

Read the history in context

Records, not a safety rating.

Recall counts do not account for sales volume, exposure or differences in reporting. Agency records can overlap. A low count does not establish that a brand or product is safe.

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Severity Breakdown

Class I — Serious

Class II — Moderate

Class III — Low Risk

Recall Timeline

Class IIFDAJun 4, 2026

Amgen — Presence of Foreign Substance.

Corlanor (ivabradine) tablets, 7.5mg, 60-count bottles, Rx Only, Amgen Inc., Thousand Oaks, CA 92130 Made In Italy. NDC 55513-810-60 Presence of Foreign Substance.

Class IIFDAJun 4, 2026

Amgen — Presence of Foreign Substance.

Corlanor (ivabradine) tablets, 5 mg, packaged in a) 14 tablets bottles (NDC 55513-800-99), and b) 60 tablet bottles (NDC 55513-800-60), Rx Only, Amgen Inc., Thousand Oaks, CA 92130 Made In Italy. Presence of Foreign Substance.

Class IIFDAJun 4, 2026

Amgen — CGMP Deviations

Sensipar (cinacalcet) Tablets, 60mg, 30-count bottles, Rx Only, Distributed by: Amge, One Amgen Center Drive, Thousand Oaks ,CA 91320-1799, Made in Japan. NDC 55513-074-30 CGMP Deviations

Class IIFDAJun 4, 2026

Amgen — CGMP Deviations

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 CGMP Deviations

Class IIFDAJun 4, 2026

Amgen — CGMP Deviations

Sensipar (cinacalcet) Tablets, 30mg, 30-count bottles, Rx Only, Distributed by: Amge, One Amgen Center Drive, Thousand Oaks ,CA 91320-1799, Made in Japan. NDC 55513-073-30 CGMP Deviations

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