Recall archive
13 recalls · page 1 of 1
Reported Nov 4, 2026
Cyanocobalamin Injection, USP, 1000 mcg/mL, 25 x 1 mL multi-dose vials, Rx only, American Regent INC, Shirley, NY,…
Risk not classifiedThe agency has not ranked the risk yet — treat the notice as a caution.American Regent, Inc.
Matched: Brand · Product · Product details — Presence of Particulate matter: Identified as glass
FDA (weekly enforcement report)
Reported Oct 28, 2026
BetaVet - betamethasone sodium phosphate and betamethasone acetate injectable suspension, 6 mg betamethasone/mL, For…
Risk not classifiedThe agency has not ranked the risk yet — treat the notice as a caution.American Regent Inc.
Matched: Brand · Product details — Defective container: loose/defective crimps/seal.
FDA (weekly enforcement report)
Reported Sep 16, 2026Updated Sep 29, 2026
Epinephrine Injection, USP, 30 mg/30 mL (1mg/mL), 30 mL-Multiple-Dose Vial, Rx Only, For Intravenous Infusion,…
High riskUsing this product could cause serious injury, illness or death — stop using it now.American Regent, Inc.
Matched: Brand · Product details — Presence of Particulate Matter and Lack of Assurance of Sterility. Particulate matter identified as nylon, cellulosic, acrylic, polyethylene and…
1 more product in this recall
FDA (openFDA drug enforcement)
FoodReported Sep 3, 2026Updated Sep 25, 2026
American Regent, Inc. recalls American Regent, Inc. Epinephrine Injection, USP 30 mg/ 30 mL (1 mg/mL) multi dose vial due to Presence of particulate matter and…
Risk not classifiedThe agency has not ranked the risk yet — treat the notice as a caution.American Regent, Inc.
Matched: Brand · Product · Product details — Presence of particulate matter and lack of sterility assurance
FDA (recalls & safety alerts)
Reported Aug 26, 2026Updated Sep 7, 2026
Cyanocobalamin injection USP, 10,000 mcg/10 mL (1,000 mcg/mL), For IM or SC Use Only, packaged in a) 10 mL Multi-Dose…
High riskUsing this product could cause serious injury, illness or death — stop using it now.American Regent, Inc.
Matched: Brand · Product details — Presence of Particulate Matter: Product contaminated with particulate matter identified as hair, glass and/or paraformaldehyde
13 more products in this recall
FDA (openFDA drug enforcement)
DrugsReported Aug 3, 2026Updated Sep 17, 2026
American Regent, Inc. Animal Health recalls American Regent, Inc. Animal Health Adequan Canine Injection and Adequan i.m Injection for horses due to Visible…
Risk not classifiedThe agency has not ranked the risk yet — treat the notice as a caution.American Regent, Inc. Animal Health
Matched: Brand · Product · Product details — Visible glass fiber material in the product
FDA (recalls & safety alerts)
DrugsReported Jul 27, 2026Updated Sep 17, 2026
American Regent, Inc. recalls American Regent, Inc. Papaverine Hydrochloride Injection, USP 60 mg/ 2 mL due to Products were found to contain particulate matter
Risk not classifiedThe agency has not ranked the risk yet — treat the notice as a caution.American Regent, Inc.
Matched: Brand · Product · Product details — Products were found to contain particulate matter
FDA (recalls & safety alerts)
Reported May 6, 2026
Levocarnitine Injection, USP, 1 g/5 mL (200 mg/mL), 5 mL Single-Dose Vial, For intravenous use, Rx Only, American…
Low riskThis product is unlikely to cause harm, but it breaks a safety or labelling rule.American Regent, Inc.
Matched: Brand · Product · Product details — Labeling: Missing Label
FDA (openFDA drug enforcement)
Reported 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,…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.American Regent, Inc.
Matched: Brand · Product details — Lack of sterility assurance: Product leakage around the vial neck, which could potentially result in a lack of sterility assurance.
1 more product in this recall
FDA (openFDA drug enforcement)
Reported 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…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.American Regent, Inc.
Matched: Brand — Presence of Particulate Matter: Potential for glass delamination from the vials.
2 more products in this recall
FDA (openFDA drug enforcement)
Reported 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…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.American Regent, Inc.
Matched: Brand · Product details — Lack of Assurance of Sterility.
1 more product in this recall
FDA (openFDA drug enforcement)
Reported Jul 25, 2012
Epinephrine Injection, USP, 1:1000 (1 mg/mL), 25 x 1 mL Ampules, For SC and IM Use, For IV and IC Use after Dilution,…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Luitpold Pharmaceuticals, Inc.
Matched: Product details — Presence of Particulate Matter
FDA (openFDA drug enforcement)
Reported Jun 20, 2012
CONCENTRATED SODIUM CHLORIDE INJECTION, USP, 23.4% a) 30 mL SINGLE DOSE VIAL, (NDC 0517-2930-25), b) 100 mL PHARMACY…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Luitpold Pharmaceuticals, Inc.
Matched: Product details — Presence of Particulate Matter: In the course of inspecting retention samples visual particles were observed.
FDA (openFDA drug enforcement)
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