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Browse Drug Recalls

1,681 FDA drug safety recalls.

FDA Drug Recall Enforcement Database

Browse 1,681 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 1,681 FDA drug recalls in 2018.

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DateProductReasonClassFirm
Jun 20, 2018 Gaia Kratom (mitragyna speciosa) powder, Plantation White MD, 1oz, 250g, 1kg ... Microbal Contamination of Non-Sterile Product; FDA analysis found salmonella contamination Class I Gaia Ethnobotanical LLC
Jun 20, 2018 Gaia Kratom (mitragyna speciosa) powder, Purple 8-1, 1oz, 250g, 1kg packages... Microbal Contamination of Non-Sterile Product; FDA analysis found salmonella contamination Class I Gaia Ethnobotanical LLC
Jun 20, 2018 Gaia Kratom (mitragyna speciosa) powder, Red Bali, 1oz, 250g, 1kg packages, ... Microbal Contamination of Non-Sterile Product; FDA analysis found salmonella contamination Class I Gaia Ethnobotanical LLC
Jun 20, 2018 Gaia Kratom (mitragyna speciosa) powder, Plantation Red MD, 1oz, 250g, 1kg pa... Microbal Contamination of Non-Sterile Product; FDA analysis found salmonella contamination Class I Gaia Ethnobotanical LLC
Jun 20, 2018 fentanyl Citrate USP 5 mcg in 0.9% Sodium Chloride USP 0.5 mL, 10 mcg per mL ... Subpotent Drug: final drug concentration is subpotent as compared to the concentration indicated ... Class II Advanced Pharma Inc.
Jun 20, 2018 Gaia Kratom (mitragyna speciosa) powder, Red Borneo, 1oz, 250g, 1kg packages... Microbal Contamination of Non-Sterile Product; FDA analysis found salmonella contamination Class I Gaia Ethnobotanical LLC
Jun 19, 2018 Enalapril Maleate Tablets USP; 5 mg NDC code 64679-924-03. 1000 Tablets HDPE ... Failed Impurities/Degradation Specifications Class III Wockhardt Limited
Jun 19, 2018 Enalapril Maleate Tablets USP; 2.5 mg NDC code 64679-923-03. 1000 Tablets HDP... Failed Impurities/Degradation Specifications Class III Wockhardt Limited
Jun 15, 2018 Rocaltrol (calcitriol) Oral Solution, 1 mcg/mL, 15 mL bottle, Rx only, Distri... Subpotency: lower than expected potency result was obtained at the 18 month stability time point. Class III Validus Pharmaceuticals, Inc.
Jun 15, 2018 Calcitriol Oral Solution, 1 mcg/mL, 15 mL bottle, Rx Only, Distributed by: Ra... Subpotency: lower than expected potency result was obtained at the 18 month stability time point. Class III Validus Pharmaceuticals, Inc.
Jun 14, 2018 Norepinephrine Bitartrate 8 mg (32 mcg/mL) in 0.9% Sodium Chloride 250 mL bag... Lack of Assurance of Sterility: SCA is conducting a voluntary recall of certain lots of sterile a... Class II SCA Pharmaceuticals, LLC
Jun 14, 2018 Diltiazem HCL 1 mg/mL in 125 mL 0.9% Sodium Chloride 100 mL bag (total volume... Lack of Assurance of Sterility: SCA is conducting a voluntary recall of certain lots of sterile a... Class II SCA Pharmaceuticals, LLC
Jun 14, 2018 Phenylephrine HCL 10 mg in 0.9% Sodium Chloride 250 mL Bag (40 mcg/mL), SCA P... Lack of Assurance of Sterility: SCA is conducting a voluntary recall of certain lots of sterile a... Class II SCA Pharmaceuticals, LLC
Jun 14, 2018 Phenylephrine HCL 20 mg in 0.9% Sodium Chloride 250 mL Bag (160 mcg/mL), SCA ... Lack of Assurance of Sterility: SCA is conducting a voluntary recall of certain lots of sterile a... Class II SCA Pharmaceuticals, LLC
Jun 14, 2018 Morphine Sulfate 1 mg/mL (preservative free; sulfite free) 2 mL fill 3 mL syr... Lack of Assurance of Sterility: SCA is conducting a voluntary recall of certain lots of sterile a... Class II SCA Pharmaceuticals, LLC
Jun 14, 2018 Fentanyl (as citrate) 10 mcg/mL in 0.9% Sodium Chloride 250 mL bag, SCA Pharm... Lack of Assurance of Sterility: SCA is conducting a voluntary recall of certain lots of sterile a... Class II SCA Pharmaceuticals, LLC
Jun 14, 2018 Norepinephrine Bitartrate 4 mg (16 mcg/mL) in 0.9% Sodium Chloride 250 mL bag... Lack of Assurance of Sterility: SCA is conducting a voluntary recall of certain lots of sterile a... Class II SCA Pharmaceuticals, LLC
Jun 14, 2018 Norepinephrine Bitartrate 16 mg (64 mcg/mL) in 0.9% Sodium Chloride 250 mL ba... Lack of Assurance of Sterility: SCA is conducting a voluntary recall of certain lots of sterile a... Class II SCA Pharmaceuticals, LLC
Jun 14, 2018 Phenylephrine HCL 50 mg in 0.9% Sodium Chloride 250 mL Bag (200 mcg/mL), SCA ... Lack of Assurance of Sterility: SCA is conducting a voluntary recall of certain lots of sterile a... Class II SCA Pharmaceuticals, LLC
Jun 14, 2018 Fentanyl (as citrate) 2 mcg/mL + Bupivacaine HCL 0.0625% in 0.9% Sodium Chlor... Lack of Assurance of Sterility: SCA is conducting a voluntary recall of certain lots of sterile a... Class II SCA Pharmaceuticals, LLC
Jun 14, 2018 Phenylephrine HCL 40 mg in 0.9% Sodium Chloride 250 mL Bag (160 mcg/mL), SCA ... Lack of Assurance of Sterility: SCA is conducting a voluntary recall of certain lots of sterile a... Class II SCA Pharmaceuticals, LLC
Jun 14, 2018 Phenylephrine HCL 80mg in 0.9% Sodium Chloride 250 mL Bag (320 mcg/mL), SCA P... Lack of Assurance of Sterility: SCA is conducting a voluntary recall of certain lots of sterile a... Class II SCA Pharmaceuticals, LLC
Jun 13, 2018 Equate ClearLAX, Polyethylene Glycol 3350 Powder for Solution, OS Osmotic Lax... Labeling: Not Elsewhere Classified - A private label distributor noted unfiled NDC numbers on EQ... Class III LUPIN SOMERSET
Jun 12, 2018 0.2% ROPivacaine, (Ropivacaine HCL PF, USP 500mg, 0.9% Sodium Chloride, USP Q... Lack of Assurance of Sterility: Potential leakage of bags. Class II Avella of Deer Valley, Inc. Store 38
Jun 12, 2018 fentaNYL (10 mcg per mL) in 0.95 Sodium Chloride, USP QS 1mL. Volume 1mL. Sin... Lack of Assurance of Sterility: Potential leakage of bags. Class II Avella of Deer Valley, Inc. Store 38
Jun 12, 2018 ePHEDrine Sulfate, USP 50 mg in 0.9% Sodium Chloride, USP QS 10mL. 50 mg/10 ... Lack of Assurance of Sterility: Potential leakage of bags. Class II Avella of Deer Valley, Inc. Store 38
Jun 12, 2018 Midazolam 0.5mg/mL (Midazolam HCL (USP) 50 mg, 0.9% Sodium Chloride, USP QS ... Lack of Assurance of Sterility: Potential leakage of bags. Class II Avella of Deer Valley, Inc. Store 38
Jun 12, 2018 Atorvastatin Calcium Tablets, 40 mg*, packaged as a) 90-count bottle (NDC 551... Failed Impurities/Degradation Specifications Class III Dr. Reddy's Laboratories, Inc.
Jun 12, 2018 Atorvastatin Calcium Tablets, 20 mg*, 90-count bottle, Rx Only, Mfd. By: Dr. ... Failed Impurities/Degradation Specifications Class III Dr. Reddy's Laboratories, Inc.
Jun 12, 2018 HYDROmorphone 1 mg/mL (HYDROmorphone HCL (USP) 30 mg, 0.9% Sodium Chloride (U... Lack of Assurance of Sterility: Potential leakage of bags. Class II Avella of Deer Valley, Inc. Store 38
Jun 12, 2018 ceFAZolin 2 gm in NS 100mL. ceFAZolin Sodium (USP) 2gm, 0.9% Sodium Chloride ... Lack of Assurance of Sterility: Potential leakage of bags. Class II Avella of Deer Valley, Inc. Store 38
Jun 12, 2018 ePHEDrine Sulfate, USP 50mg in 0.9% Sodium Chloride USP QS 10mL. 50 mg/10 mL ... Lack of Assurance of Sterility: Potential leakage of bags. Class II Avella of Deer Valley, Inc. Store 38
Jun 12, 2018 PHENYLephrine 40 mg (PHENYLephrine HCL (USP) 40 mg, 5%Dextrose Inj., USP 250 ... Lack of Assurance of Sterility: Potential leakage of bags. Class II Avella of Deer Valley, Inc. Store 38
Jun 12, 2018 NORepiNEPHrine 8 mg (norepinephrine Bitartrate (USP) 8 mg added to 5% Dextros... Lack of Assurance of Sterility: Potential leakage of bags. Class II Avella of Deer Valley, Inc. Store 38
Jun 12, 2018 NORepiNEPHrine Bitartrate, USP 160 mcg in 5% Dextrose, USP QS 10mL. Volume 10... Lack of Assurance of Sterility: Potential leakage of bags. Class II Avella of Deer Valley, Inc. Store 38
Jun 12, 2018 HEPARIN 25,000 Units in 5% Dextrose (Heparin Sodium, USP 25,000 Units, 5% Dex... Lack of Assurance of Sterility: Potential leakage of bags. Class II Avella of Deer Valley, Inc. Store 38
Jun 12, 2018 MORphine 150 mg (Morphine Sulfate, USP 150mg in 0.9% Sodium Chloride, USP QS ... Lack of Assurance of Sterility: Potential leakage of bags. Class II Avella of Deer Valley, Inc. Store 38
Jun 12, 2018 HEPARIN 12,500 Units in 5% Dextrose. (Heparin Sodium, USP 12,500 Units, 5% De... Lack of Assurance of Sterility: Potential leakage of bags. Class II Avella of Deer Valley, Inc. Store 38
Jun 12, 2018 ePHEDrine Sulfate, USP 25 mg in 0.9% Sodium Chloride, USP QS 5mL. Volume 5 mL... Lack of Assurance of Sterility: Potential leakage of bags. Class II Avella of Deer Valley, Inc. Store 38
Jun 12, 2018 MAGnesium 1gm in NS 100 mL (MAGnesium SULfate (USP) 1 gm, 0.9% Sodium Chlorid... Lack of Assurance of Sterility: Potential leakage of bags. Class II Avella of Deer Valley, Inc. Store 38
Jun 12, 2018 Midazolam 1 mg/mL (Midazolam HCL (USP) 100 mg, Sodium Chloride, USP QS 100 mL... Lack of Assurance of Sterility: Potential leakage of bags. Class II Avella of Deer Valley, Inc. Store 38
Jun 12, 2018 PHENYLephrine 20 mg (PHENYLephrine HCL (USP) 20 mg, 5% Dextrose (USP) 250 mL)... Lack of Assurance of Sterility: Potential leakage of bags. Class II Avella of Deer Valley, Inc. Store 38
Jun 12, 2018 NORepiNEPHrine4mg (Norepinephrine Bitartrate (USP) 4 mg added to 0.9% Sodium ... Lack of Assurance of Sterility: Potential leakage of bags. Class II Avella of Deer Valley, Inc. Store 38
Jun 12, 2018 MAGnesium 2gm in NS 100 mL (MAGnesium SULfate (USP) 2 gm, 0.9% Sodium Chlorid... Lack of Assurance of Sterility: Potential leakage of bags. Class II Avella of Deer Valley, Inc. Store 38
Jun 12, 2018 fentaNYL 5 mcg Citrate, USP 5 mcg in 0.9% Sodium Chloride, USP QS 0.5mL. (10... Lack of Assurance of Sterility: Potential leakage of bags. Class II Avella of Deer Valley, Inc. Store 38
Jun 12, 2018 PHENYLephrine 10 mg (PHENYLephrine HCL (USP) 10mg, 0.9% Sodium Chloride (USP)... Lack of Assurance of Sterility: Potential leakage of bags. Class II Avella of Deer Valley, Inc. Store 38
Jun 12, 2018 MORphine 1 mg/mL (Morphine Sulfate, USP 250mg, 0.9% Sodium Chloride, USP 250 ... Lack of Assurance of Sterility: Potential leakage of bags. Class II Avella of Deer Valley, Inc. Store 38
Jun 12, 2018 EPINEPHrine (USP) 4 mg, 5% Dextrose For Inj. (USP) 250 mL Volume: 254 mL sing... Lack of Assurance of Sterility: Potential leakage of bags. Class II Avella of Deer Valley, Inc. Store 38
Jun 12, 2018 Midazolam 1 mg/mL (Midazolam HCL USP 30 mg, 0.9% Sodium Chloride, USP QS 30 m... Lack of Assurance of Sterility: Potential leakage of bags. Class II Avella of Deer Valley, Inc. Store 38
Jun 12, 2018 Atorvastatin Calcium Tablets, 10 mg*, 90-count bottle, Rx Only, Mfd. By: Dr. ... Failed Impurities/Degradation Specifications Class III Dr. Reddy's Laboratories, 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.