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Browse Drug Recalls

9 FDA drug safety recalls.

FDA Drug Recall Enforcement Database

Browse 9 FDA drug recall enforcement actions. Each entry includes the product description, reason for recall, classification (Class I through III based on severity), recalling firm, and distribution details. Use the filters below to search by year, classification, state, or keyword.

Drug Safety Recalls

Browse 9 FDA drug recalls.

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DateProductReasonClassFirm
Apr 18, 2025 niCARdipine Hydrochloride Injection, USP, 25 mg/10 mL (2.5 mg/mL), 10 mL Sing... Lack of sterility assurance: Product leakage around the vial neck, which could potentially result... Class II American Regent, Inc.
Apr 18, 2025 niCARdipine Hydrochloride Injection, USP, 25 mg/10 mL (2.5 mg/mL), 10 mL Sing... Lack of sterility assurance: Product leakage around the vial neck, which could potentially result... Class II American Regent, Inc.
Nov 11, 2024 Venofer (iron sucrose) Injection, USP 100 mg Elemental Iron per 5 mL (20 mg/m... Presence of Particulate Matter: Potential for glass delamination from the vials. Class II American Regent, Inc.
Nov 11, 2024 Venofer (iron sucrose) Injection, USP 50 mg Elemental Iron per 2.5 mL (20 mg/... Presence of Particulate Matter: Potential for glass delamination from the vials. Class II American Regent, Inc.
Nov 11, 2024 Venofer (iron sucrose) Injection, USP 100 mg Elemental Iron per 5 mL (20 mg/m... Presence of Particulate Matter: Potential for glass delamination from the vials. Class II American Regent, Inc.
May 14, 2024 niCARdipine Hydrochloride Injection, USP, 25 mg/10 mL (2.5 mg/mL), 10 x 10 mL... Lack of Assurance of Sterility. Class II American Regent, Inc.
May 13, 2024 Vasopressin Injection, USP, 200 Units per 10 mL (20 Units per mL), 10 mL Mult... Subpotent product in addition to having out-of-specification results for impurities. Class II American Regent, Inc.
Apr 24, 2012 Epinephrine Injection, USP, 1:1000 (1 mg/mL), 25 x 1 mL Ampules, For SC and I... Presence of Particulate Matter Class II Luitpold Pharmaceuticals, Inc.
Mar 15, 2011 CONCENTRATED SODIUM CHLORIDE INJECTION, USP, 23.4% a) 30 mL SINGLE DOSE VIAL... Presence of Particulate Matter: In the course of inspecting retention samples visual particles w... Class II Luitpold Pharmaceuticals, Inc.

Frequently Asked Questions

When a drug safety issue is identified — through FDA inspections, laboratory testing, adverse event reports, or manufacturer quality checks — the responsible company issues a recall to remove the affected products from the market. Pharmacies pull the product from shelves, and consumers are advised to contact their healthcare provider for alternatives.

The leading causes include cGMP deviations, impurity contamination (including nitrosamines like NDMA), failed dissolution or stability testing, sterility issues, potency problems, labeling errors, and foreign particle contamination.

Use the search and filter tools on this page to look up specific medications, active ingredients, or manufacturers. Each recall entry includes the product description, lot numbers, and distribution details.