FDA recall record · openFDA

American Regent, Inc.

8 FDA recalls on record (2024–2026) — 8 drug. 6 still ongoing.

Class I (most serious)

Class II

Class III

ongoing

How to read this. A recall count is not a quality verdict — large manufacturers recall more simply by volume, and a voluntary recall is the safety system working as intended. The signal to weight is the Class I count (the FDA's most-serious tier — reasonable probability of serious harm or death) and whether recalls are still ongoing. Most recalls are Class II/III. "Ongoing" reflects openFDA's last-published status — device recalls often stay marked ongoing long after they're resolved in practice; confirm current status at the FDA.

Most common reasons

Presence of Particulate Matter: Potential for glass delamination from the vials. 3

Lack of sterility assurance: Product leakage around the vial neck, which could potentially result in a lack of sterility 2

Subpotent product in addition to having out-of-specification results for impurities. 1

Lack of Assurance of Sterility. 1

Labeling: Missing Label 1

Recalls

niCARdipine Hydrochloride Injection, USP, 25 mg/10 mL (2.5 mg/mL), 10 mL Single Dose Vial, Rx Only, Mfd for: Civica, Inc Class II 2025-04-18 niCARdipine Hydrochloride Injection, USP, 25 mg/10 mL (2.5 mg/mL), 10 mL Single Dose Vial, Rx Only, American Regent, Inc Class II 2025-04-18 Venofer (iron sucrose) Injection, USP 100 mg Elemental Iron per 5 mL (20 mg/mL), 5 mL Single-Dose Vials, Rx Only, For In Class II 2024-11-11 Venofer (iron sucrose) Injection, USP 50 mg Elemental Iron per 2.5 mL (20 mg/mL), 2.5 mL Single-Dose Vials, Rx Only, For Class II 2024-11-11 Vasopressin Injection, USP, 200 Units per 10 mL (20 Units per mL), 10 mL Multiple-Dose Vial, Rx only, For Intravenous I Class II 2024-05-13 Venofer (iron sucrose) Injection, USP 100 mg Elemental Iron per 5 mL (20 mg/mL), 5 mL Single-Dose Vials, Rx Only, For In Class II 2024-11-11 niCARdipine Hydrochloride Injection, USP, 25 mg/10 mL (2.5 mg/mL), 10 x 10 mL Single Dose Vials, Rx Only, For Intravenou Class II 2024-05-14 Levocarnitine Injection, USP, 1 g/5 mL (200 mg/mL), 5 mL Single-Dose Vial, For intravenous use, Rx Only, American Regent Class III 2026-04-16

RECORDED — these are the FDA's published recall enforcement records (openFDA). Recalls are listed under the exact firm name as filed; a large manufacturer may also file under name variants, so this may not be the company's complete cross-variant record — confirm at the FDA recall database. This page informs and routes; it is not medical advice or a verdict on the company.

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