PlainRecalls

American Regent, Inc.

Compiled from official public sources by the publisher.

8 recalls on record · Latest: May 6, 2026

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Agency notice ledger

Federal filing book American Regent, Inc. LIGHT-BOOK · SINGLE-AGENCY

#1,696 of 14,151 · 8 notices · 0.008% archive

  • BOOK 8 notices
  • RANK #1,696 of 14,151
  • SHARE 0.008% archive
  • AGENCY FDA Drug (8)
  • CAT drugs
  • CATS 1 category
  • LATEST May 6, 2026
  • PHOTO Ab Sciex

Nearest notice-volume peer: Ab Sciex (0 notice gap)

American Regent, Inc. accounts for about 0.008% of the 104,423-notice archive on 8 distinct filings — a mid share signal beside absolute volume. FDA · CPSC · USDA FSIS · NHTSA notice stamps for this firm. Read with this firm → · Dominant category → · Similar-volume firm →

American Regent, Inc.'s standing among 14,151 recalling firms

American Regent, Inc. ranks 1,696th of 14,151 tracked firms by distinct recall-event count. Archive size reflects filing volume, not inherent product danger.

American Regent, Inc. vs all firms by recall-notice count

Where this firm's archive sits among every tracked recalling manufacturer

8 1696th of 14151 higher than 12,296 of 14,151 firms

Firms, banded by distinct federal recall-event inventory

Each bar is a band; taller bars hold more firms. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source FDA · CPSC · USDA FSIS · NHTSA federal recall filings · 2026-09-13

American Regent, Inc. in the notice-volume neighbourhood

Distinct federal recall events among this firm and nearest nationwide peers

notices

What this shows American Regent, Inc. holds about 0.008% of archive notices alongside 8 distinct filings.

Source FDA · CPSC · USDA FSIS · NHTSA filings aggregated by PlainRecalls As of September 2026
FDA Drug Low May 6, 2026

Levocarnitine Injection, USP, 1 g/5 mL (200 mg/mL), 5 mL Single-Dose Vial, For intravenous use, Rx Only, American Regent, Inc., Shirley, NY 11967. NDC: 0517-1045-01
FDA Drug Moderate May 7, 2025

niCARdipine Hydrochloride Injection, USP, 25 mg/10 mL (2.5 mg/mL), 10 mL Single Dose Vial, Rx Only, Mfd for: Civica, Inc., Lehi, UT 84043,Mfd by: American Regent, Inc., New Albany, OH 43064. NDC Carton: 72572-470-10/ NDC Vial: 72572-470-01.
FDA Drug Moderate May 7, 2025

niCARdipine Hydrochloride Injection, USP, 25 mg/10 mL (2.5 mg/mL), 10 mL Single Dose Vial, Rx Only, American Regent, Inc., Shirley, NY 11967. NDC carton: 0517-0735-10 / NDC Vial: 0517-0735-01]
FDA Drug Moderate Dec 11, 2024

Venofer (iron sucrose) Injection, USP 100 mg Elemental Iron per 5 mL (20 mg/mL), 5 mL Single-Dose Vials, Rx Only, For Intravenous Use Only, Distributed by: Fresenius Medical Care NA, Waltham, MA 02451, NDC: 49230-534-01 (vial), NDC: 49230-534-25 (25 x 5 mL/vial cartons).
FDA Drug Moderate Dec 11, 2024

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 Intravenous Use Only, Distributed by: Fresenius Medical Care NA, Waltham, MA 02451, NDC: 49230-530-01 (vial), NDC: 49230-530-10 (10 x 2.5mL/vial cartons), NDC: 49230-530-25 (25 x 2.5mL/vial cartons).
FDA Drug Moderate Dec 11, 2024

Venofer (iron sucrose) Injection, USP 100 mg Elemental Iron per 5 mL (20 mg/mL), 5 mL Single-Dose Vials, Rx Only, For Intravenous Use Only, American Regent, Inc. Shirley, NY 11967, NDC: 0517-2340-01 (vial), NDC: 0517-2340-10 (10 x 5 mL/vial cartons), NDC: 0517-2340-25 (25 x 5 mL/vial cartons).
FDA Drug Moderate May 29, 2024

Vasopressin Injection, USP, 200 Units per 10 mL (20 Units per mL), 10 mL Multiple-Dose Vial, Rx only, For Intravenous Infusion, American Regent, Inc., Shirley, NY 11967, NDC 0517-1030-01
FDA Drug Moderate May 29, 2024

niCARdipine Hydrochloride Injection, USP, 25 mg/10 mL (2.5 mg/mL), 10 x 10 mL Single Dose Vials, Rx Only, For Intravenous Use Only, Mfd for: Civica, Inc., Lehi, UT 84043; Mfd by: American Regent, Inc., New Albany, OH 43054. NDC 72572-470-10

American Regent, Inc. holds a measurable archive slice

Drug and device firms outside this manufacturer and state, matched by notice volume and category footprint.

Similar recall count

Nearest multi-notice firms by distinct-event totals (8 here).

Ab Sciex 8 Acumedia Manufacturers, Inc. 8 Adept Medical Ltd 8 Aju Pharm Co., Ltd. 8 Ambriola Co., Inc., The 8

Frequently Asked Questions

How many federal recall notices name American Regent, Inc.? ▼
PlainRecalls indexes 8 distinct federal recall events naming American Regent, Inc., aggregated from FDA, CPSC, USDA FSIS, and NHTSA filings (archive as of September 2026). That count is an issuance inventory, not a hazard score.
Where does American Regent, Inc. sit among other recalling firms? ▼
American Regent, Inc. ranks #1,696 of 14,151 by distinct recall-event count among 14,151 firms in this archive (87th percentile of firms with fewer notices). Rank tracks filing frequency, not product danger.
Which agency issues most of American Regent, Inc.'s notices? ▼
FDA Drug accounts for 8 of this firm's 8 indexed notices.
What product category dominates American Regent, Inc.'s filing book? ▼
Filings for American Regent, Inc. span 1 product category, led by drugs. Browse that category archive for peer firms and related notices.
Is a higher notice count more dangerous? ▼
No. Archive size reflects how often federal agencies publish recalls naming the firm — reporting volume, coverage, and product range all move the number. Always verify the individual notice with the issuing agency before acting on a specific product.
American Regent, Inc.: 8 federal recall notices aggregated from FDA, CPSC, USDA FSIS, and NHTSA filings (lead agency FDA Drug). Verify individual notices with FDA directly before acting on a specific recall.

Firm-level totals aggregate distinct federal recall events naming American Regent, Inc.; individual notices remain authoritative on each linked recall page.

Methodology · Corrections · FDA · CPSC · USDA FSIS · NHTSA · Archive as of September 2026