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Browse Drug Recalls

35 FDA drug safety recalls.

FDA Drug Recall Enforcement Database

Browse 35 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 35 FDA drug recalls.

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DateProductReasonClassFirm
Jul 7, 2023 Norepinephrine 32 mg per 250 mL (128 mcg per mL) in 0.9% Sodium Chloride, 250... Lack of Assurance of Sterility Class II SterRx, LLC
Jul 7, 2023 Norepinephrine 8 mg per 250 mL (32 mcg per mL) in 0.9% Sodium Chloride, 250 m... Lack of Assurance of Sterility Class II SterRx, LLC
Jul 7, 2023 Norepinephrine 16 mg per 250 mL (64 mcg per mL) in 0.9% Sodium Chloride, 250 ... Lack of Assurance of Sterility Class II SterRx, LLC
Jul 7, 2023 Sodium Bicarbonate in 5% Dextrose Injection, 150 mEq per 1,000 mL (12.6 mg pe... Lack of Assurance of Sterility Class II SterRx, LLC
Jul 7, 2023 Norepinephrine 4 mg per 250 mL (16 mcg per mL) in 0.9% Sodium Chloride, 250 m... Lack of Assurance of Sterility Class II SterRx, LLC
Jul 25, 2022 FentaNYL Citrate in 0.9% Sodium Chloride 1 mg per 100 mL (10 mcg per mL) IV b... Lack of Assurance of Sterility Class II SterRx, LLC
Jul 25, 2022 fentaNYL Citrate in 0.9% Sodium Chloride, 2.5 mg per 250 mL, (10 mcg per mL) ... Lack of Assurance of Sterility Class II SterRx, LLC
Nov 12, 2021 NOREPINEPHRINE in 5% Dextrose Injection, 8 mg per 250 mL (32 mg per mL) Injec... Lack of Assurance of Sterility Class II SterRx, LLC
Nov 12, 2021 Morphine Sulfate in 0.9% Sodium Chloride Injection, 100 mg per 100 mL (1 mg p... Lack of Assurance of Sterility Class II SterRx, LLC
Nov 12, 2021 EPINEPHIrine in 0.9% Sodium Chloride Injection, 5 mg per 250 mL (20 mcg per m... Lack of Assurance of Sterility Class II SterRx, LLC
Nov 12, 2021 PHENYLephrine HCl, 50 mg per 250 mL, (200 mg per mL) in 0.9% Sodium Chloride ... Lack of Assurance of Sterility Class II SterRx, LLC
Nov 12, 2021 EPINEPHIrine in 0.9% Sodium Chloride Injection, 4 mg per 250 mL (16 mcg per m... Lack of Assurance of Sterility Class II SterRx, LLC
Nov 12, 2021 dilTIAZem HCl in 5% Dextrose Injection, 125 mg per 125 mL, (32 mcg per mL), R... Lack of Assurance of Sterility Class II SterRx, LLC
Nov 12, 2021 EPINEPHrine, 2 mg per 250 mL (8 mcg per mL) in 0.9% Sodium Chloride Injection... Lack of Assurance of Sterility Class II SterRx, LLC
Nov 12, 2021 EPINEPHrine in 0.9% Sodium Chloride Injection, 16 mg per 250 mL (64 mcg per m... Lack of Assurance of Sterility Class II SterRx, LLC
Nov 12, 2021 EPINEPHIrine in 0.9% Sodium Chloride Injection, 8 mg per 250 mL (32 mcg per m... Lack of Assurance of Sterility Class II SterRx, LLC
Nov 12, 2021 Fentanyl Citrate, in 0.9% Sodium Chloride Injection, 2.5 mg per 250 mL, (10 m... Lack of Assurance of Sterility Class II SterRx, LLC
Nov 12, 2021 NOREPINEPHRINE 4 mg per 250 mL (16 mcg per mL) in 5% Dextrose Injection, Rx o... Lack of Assurance of Sterility Class II SterRx, LLC
Nov 12, 2021 PHENYLepherine HCL in 0.9% Sodium Chloride, 20 mg per 250 mL (80 mcg per mL),... Lack of Assurance of Sterility Class II SterRx, LLC
Nov 12, 2021 Sodium Bicarbonate in 5% Dextrose Injection, Rx Only, SterRx, 141 Idaho Ave.,... Lack of Assurance of Sterility Class II SterRx, LLC
Nov 12, 2021 NOREPINEPHRINE, 4 mg per 250 mL, (18 mcg per mL) in 0.9% Sodium Chloride Inje... Lack of Assurance of Sterility Class II SterRx, LLC
Nov 12, 2021 Midazolam in 0.9% Sodium Chloride Injection, 100 mg per 100 mL (1 mg per mL),... Lack of Assurance of Sterility Class II SterRx, LLC
Nov 12, 2021 dilTIAZem HCl 125 mg per 125 mL (1 mg per mL) in 0.7% Sodium Chloride Injecti... Lack of Assurance of Sterility Class II SterRx, LLC
Nov 12, 2021 Morphine Sulfate in 5% Dextrose Injection, 100 mg per 100 mL (1 mg per mL), R... Lack of Assurance of Sterility Class II SterRx, LLC
Nov 12, 2021 Midazolam in 0.9% Sodium Chloride Injection, 50 mg per 50 mL (1 mg per mL), R... Lack of Assurance of Sterility Class II SterRx, LLC
Nov 12, 2021 Sodium Bicarbonate in 5% Dextrose Injection, 150 mEq per 1000 mL (12.6 mg per... Lack of Assurance of Sterility Class II SterRx, LLC
Nov 12, 2021 Succinylcholine Chloride Injection, 200 mg per 10 mL (20 mg per mL), 1,000 mL... Lack of Assurance of Sterility Class II SterRx, LLC
Nov 12, 2021 PHENYLephrine HCl, 40 mg per 250 mL, (160 mcg per mL) in 0.9% Sodium Chloride... Lack of Assurance of Sterility Class II SterRx, LLC
Nov 12, 2021 Fentanyl Citrate, in 0.9% Sodium Chloride Injection, 1 mg per 100 mL, (10 mcg... Lack of Assurance of Sterility Class II SterRx, LLC
Nov 12, 2021 NOREPINEPHRINE, 8 mg per 250 mL, (32 mcg per mL) in 0.9% Sodium Chloride Inje... Lack of Assurance of Sterility Class II SterRx, LLC
Nov 12, 2021 NOREPINEPHRINE, 16 mg per 250 mL, (64 mcg per mL) in 0.9% Sodium Chloride Inj... Lack of Assurance of Sterility Class II SterRx, LLC
Nov 12, 2021 NOREPINEPHRINE, 16 mg per 250 mL, (64 mcg per mL) in 5% Dextrose Injection, R... Lack of Assurance of Sterility Class II SterRx, LLC
Nov 12, 2021 MORPHINE SULFATE, in 0.9% Sodium Chloride Injection, 50 mg per 50 mL, (1 mg p... Lack of Assurance of Sterility Class II SterRx, LLC
Aug 10, 2021 Sodium Bicarbonate in 5% Dextrose Injection, 150 mEq per 1,000 mL (12.6 mg pe... Lack of Assurance of Sterility Class II SterRx, LLC
Aug 10, 2021 Sodium Bicarbonate in 5% Dextrose Injection, 150 mEq per 1,000 mL (12.6 mg pe... Non-Sterility: firm's third party lab confirmed microbial contamination. Class I SterRx, LLC

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.