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Browse Drug Recalls

6,250 FDA drug safety recalls.

FDA Drug Recall Enforcement Database

Browse 6,250 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 6,250 FDA drug recalls.

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DateProductReasonClassFirm
Dec 27, 2017 Fentanyl Citrate in 0.9% Sodium Chloride in all strengths, all doses, and all... Lack of sterility assurance. Class II Pharmedium Services, LLC
Dec 27, 2017 Succinylcholine Chloride in all strengths, all doses, and all packaging. Lack of sterility assurance. Class II Pharmedium Services, LLC
Dec 27, 2017 Adenosine Injection in all strengths, all doses, and all packaging. Lack of sterility assurance. Class II Pharmedium Services, LLC
Dec 27, 2017 Dexamethasone Sodium Phosphate added to 5% Dextrose in all strengths, all dos... Lack of sterility assurance. Class II Pharmedium Services, LLC
Dec 27, 2017 Midazolam HCl in 5% Dextrose in all strengths, all doses, and all packaging. Lack of sterility assurance. Class II Pharmedium Services, LLC
Dec 27, 2017 Midazolam HCl Injection in all strengths, all doses, and all packaging. Lack of sterility assurance. Class II Pharmedium Services, LLC
Dec 27, 2017 Fentanyl Citrate and Bupivacaine HCl in 0.9% Sodium Chloride in all strengths... Lack of sterility assurance. Class II Pharmedium Services, LLC
Dec 27, 2017 Nicardipine HCl in 0.9% Sodium Chloride in all strengths, all doses, and all ... Lack of sterility assurance. Class II Pharmedium Services, LLC
Dec 27, 2017 Methadone HCl Injection in all strengths, all doses, and all packaging. Lack of sterility assurance. Class II Pharmedium Services, LLC
Dec 27, 2017 Bupivacaine HCl in 0.9% Sodium Chloride in all doses, all strengths, and pack... Lack of sterility assurance. Class II Pharmedium Services, LLC
Dec 27, 2017 Meperidine HCl in 0.9% Sodium Chloride in all strengths, all doses, and all p... Lack of sterility assurance. Class II Pharmedium Services, LLC
Dec 27, 2017 Dexamethasone Sodium Phosphate in all strengths, all doses, and all packaging. Lack of sterility assurance. Class II Pharmedium Services, LLC
Dec 27, 2017 Lidocaine HCl in all strengths, all doses, and all packaging. Lack of sterility assurance. Class II Pharmedium Services, LLC
Dec 27, 2017 Midazolam HCl in 0.9% Sodium Chloride in all strengths, all doses, and all pa... Lack of sterility assurance. Class II Pharmedium Services, LLC
Dec 27, 2017 Morphine Sulfate in 5% Dextrose in all strengths, all doses, and all packaging. Lack of sterility assurance. Class II Pharmedium Services, LLC
Dec 27, 2017 Potassium Chloride in 5% Dextrose in all strengths, all doses, and all packag... Lack of sterility assurance. Class II Pharmedium Services, LLC
Dec 27, 2017 Phenylephrine HCl in 0.9% Sodium Chloride in all strengths, all doses, and al... Lack of sterility assurance. Class II Pharmedium Services, LLC
Dec 20, 2017 DELFLEX Peritoneal Dialysis Solution, 2.5% Low Mg/Low Ca Single Bag, packaged... Lack of Assurance of Sterility: Leakage of the peritoneal dialysis (PD) solution bag. Class II Fresenius Medical Care Renal Therapies Group, LLC
Nov 30, 2017 All sterile drug preparations remaining within expiry prepared from Morphine ... Lack of sterility assurance. Class II Intrathecal Compounding Specialist, LLC
Nov 30, 2017 All sterile drug preparations remaining within expiry prepared from Fentanyl ... Lack of sterility assurance. Class II Intrathecal Compounding Specialist, LLC
Nov 30, 2017 All sterile drug preparations remaining within expiry prepared from Sufentani... Lack of sterility assurance. Class II Intrathecal Compounding Specialist, LLC
Nov 30, 2017 All sterile drug preparations remaining within expiry prepared from Hydromorp... Lack of sterility assurance. Class II Intrathecal Compounding Specialist, LLC
Nov 13, 2017 0.9% Sodium Chloride Injection, USP, 1000 mL, Rx Only, Fresenius Medical Car... Lack of Assurance of Sterility Class II Fresenius Medical Care Renal Therapies Group, LLC
Nov 9, 2017 GERICARE Eyewash, sterile eye irrigating solution, packaged in a 4 fl oz (118... Non-sterility: confirmed microbial contamination with Achromobacter xylosoxidans Class I Kareway Products Inc
Oct 19, 2017 ROCuronium Bromide 10 mg per mL, 5 mL Fill in single dose syringe, (50 mg / 5... Lack Of Assurance Of Sterility. Class II SCA Pharmaceuticals, LLC
Oct 19, 2017 fentaNYL as citrate 2 mcg / mL, ROPIVacaine HCl 0.1%, Total Fentanyl Dose (20... Lack Of Assurance Of Sterility. Class II SCA Pharmaceuticals, LLC
Oct 19, 2017 fentanyl as citrate 2 mcg per mL BUPIvacaine HCl 0.125% (Total FentaNYL Dose ... Lack Of Assurance Of Sterility. Class II SCA Pharmaceuticals, LLC
Oct 19, 2017 Calcium GLUCOnate 2 g added to 0.9% Sodium Chloride 50 mL Bag, Each bag conta... Lack Of Assurance Of Sterility. Class II SCA Pharmaceuticals, LLC
Oct 19, 2017 HYDROmorphone HCL 1 mg per mL in 0.9% Sodium Chloride 25 mL Fill in 30 mL sin... Lack Of Assurance Of Sterility. Class II SCA Pharmaceuticals, LLC
Oct 19, 2017 oxyTOCIN 30 units added to Lactated Ringers 500 mL Bag, Rx Only, SCA Pharmace... Lack Of Assurance Of Sterility. Class II SCA Pharmaceuticals, LLC
Oct 19, 2017 PHENYLephrine HCl 100 mcg per mL In 0.9% Sodium Chloride 10 mL Fill Volume in... Lack Of Assurance Of Sterility. Class II SCA Pharmaceuticals, LLC
Oct 19, 2017 SUCcinylcholine 20 mg per mL, Total Volume 10 mL in single-dose syringe, (SUC... Lack Of Assurance Of Sterility. Class II SCA Pharmaceuticals, LLC
Oct 19, 2017 morphine sulfate 1 mg per mL in 0.9% Sodium Chloride a) Total Volume 100 mL ... Lack Of Assurance Of Sterility. Class II SCA Pharmaceuticals, LLC
Oct 19, 2017 HYDROmorphone HCl 20 mcg / mL BUPIvacaine HCl 0.075% in 0.9% Sodium Chloride ... Lack Of Assurance Of Sterility. Class II SCA Pharmaceuticals, LLC
Oct 10, 2017 Succinylcholine 200 mg/10 mL Syringe, Rx Only, Banner Health Compounding Phar... Lack of Assurance of Sterility. Class II Banner Pharmacy Services, LLC
Oct 10, 2017 ePHEDrine sulfate 50 mg/10 ml syringes in 0.9% Sodium Chloride, Rx Only, Ba... Lack of Assurance of Sterility. Class II Banner Pharmacy Services, LLC
Oct 10, 2017 Hydromorphone HCl 10 mg (0.2mg/ml) 50 mL syringes in 0.9% Sodium Chloride, Rx... Lack of Assurance of Sterility. Class II Banner Pharmacy Services, LLC
Oct 10, 2017 Ropivacaine HCL (PF) 0.2% (2mg/mL) 100 mL Cassette Rx Only Banner Health Com... Lack of Assurance of Sterility. Class II Banner Pharmacy Services, LLC
Oct 10, 2017 OXYtocin 30 units added to 0.9% Sodium Chloride 500 mL bag, Rx Only, Banner ... Lack of Assurance of Sterility. Class II Banner Pharmacy Services, LLC
Oct 10, 2017 fentanyl citrate (PF) 1100 mcg (20 mcg/mL) 55 mL syringes in 0.9% Sodium Chlo... Lack of Assurance of Sterility. Class II Banner Pharmacy Services, LLC
Oct 10, 2017 Norepinephrine Bitartrate16 mg added to 0.9% Sodium Chloride 250 mL bag, Rx O... Lack of Assurance of Sterility. Class II Banner Pharmacy Services, LLC
Oct 10, 2017 Diltiazem HCL 125 mg added to 0.9% Sodium Chloride 100 ml bag, 125 mL bag, Rx... Lack of Assurance of Sterility. Class II Banner Pharmacy Services, LLC
Oct 10, 2017 fentaNYL citrate 1000 mcg (10 mcg/mL) 100 mL Cassette in 0.9% Sodium Chloride... Lack of Assurance of Sterility. Class II Banner Pharmacy Services, LLC
Oct 10, 2017 Magnesium sulfate 10 Gm added to Lactated Ringer's 250 mL bags, Rx Only, Ba... Lack of Assurance of Sterility. Class II Banner Pharmacy Services, LLC
Oct 10, 2017 Norepinephrine Bitartrate 8 mg added to 0.9% Sodium Chloride 250 mL in a bag... Lack of Assurance of Sterility. Class II Banner Pharmacy Services, LLC
Oct 10, 2017 VANCOmycin 1.25 grams added to 0.9% Sodium Chloride 500 mL bag, Rx Only, Bann... Lack of Assurance of Sterility. Class II Banner Pharmacy Services, LLC
Oct 10, 2017 VANCOmycin 1.5 grams added to 0.9% Sodium Chloride 500 mL bag, Rx Only, Bann... Lack of Assurance of Sterility. Class II Banner Pharmacy Services, LLC
Oct 10, 2017 Midazolam HCL 100 mg (1mg/mL) 100 mL Cassette in 0.9% Sodium Chloride, Rx Onl... Lack of Assurance of Sterility. Class II Banner Pharmacy Services, LLC
Sep 25, 2017 methylPREDNIsolone ACETATE, 40 MG/ML INJECTION SUSPENSION, 10 ML Vial, RXQ Co... Lack of Assurance of Sterility; autoclave parameters were not correct for one of two autoclaves u... Class II RXQ Compounding LLC
Sep 20, 2017 Symbio Muc Eye, 0.17 fl.oz. 5mL bottles, Manufactured for and distributed in ... Lack of Assurance of Sterility Class II Deserving Health International Corp

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.