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Browse Drug Recalls

1,198 FDA drug safety recalls.

FDA Drug Recall Enforcement Database

Browse 1,198 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 1,198 FDA drug recalls in 2016.

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DateProductReasonClassFirm
Nov 18, 2016 CVS Health Homeopathic Infants Teething Tablets 135 count bottle Distributed... CGMP Deviations Class II Raritan Pharmaceuticals, Inc.
Nov 18, 2016 CVS pharmacy Kids' Ear Relief Oral Liquid 0.85 oz (25 mL) Distributed by: CVS... CGMP Deviations Class II Raritan Pharmaceuticals, Inc.
Nov 18, 2016 Kids' Relief Ear Relief Oral Liquid 0.85 fl oz. (25 mL) 3025 de'l Assomption... CGMP Deviations Class II Raritan Pharmaceuticals, Inc.
Nov 18, 2016 Phenylephrine HCl 1 mg/10 mL (100 mcg/mL) in 0.9% Sodium Chloride, 10 mL Sing... Lack of Assurance of Sterility - the firm is recalling select sterile drug products. Class II Cantrell Drug Company
Nov 18, 2016 Hydromorphone HCl 1 mg/mL in 0.9% Sodium Chloride 30 mL PCA Vial (1 mg/mL), S... Lack of Assurance of Sterility - the firm is recalling select sterile drug products. Class II Cantrell Drug Company
Nov 18, 2016 Midazolam HCl 50 mg/50 mL in 0.9% Sodium Chloride (1 mg/mL), Single-Dose Syri... Lack of Assurance of Sterility - the firm is recalling select sterile drug products. Class II Cantrell Drug Company
Nov 18, 2016 Fentanyl Citrate 2 mcg/mL & Bupivacaine HCl 0.125% in 0.9% Sodium Chloride, 1... Lack of Assurance of Sterility - the firm is recalling select sterile drug products. Class II Cantrell Drug Company
Nov 18, 2016 Rocuronium Bromide 50 mg/5 mL Injection Solution, 5 mL (10 mg/mL) Single-Dose... Lack of Assurance of Sterility - the firm is recalling select sterile drug products. Class II Cantrell Drug Company
Nov 18, 2016 Neostigmine Methylsulfate 5 mg/5 mL Injection Solution, 5 mL (1 mg/mL) Single... Lack of Assurance of Sterility - the firm is recalling select sterile drug products. Class II Cantrell Drug Company
Nov 18, 2016 Glycopyrrolate 1 mg/5 mL (0.2 mg/mL) Injection Solution, 5 mL Single-Dose Syr... Lack of Assurance of Sterility - the firm is recalling select sterile drug products. Class II Cantrell Drug Company
Nov 18, 2016 Heparin Sodium 5,000 USP Units Added to 0.9% Sodium Chloride 1,000 mL* Bag (5... Lack of Assurance of Sterility - the firm is recalling select sterile drug products. Class II Cantrell Drug Company
Nov 18, 2016 Calcium Chloride (20 mg/mL) in 0.9% Sodium Chloride 500 mL Bag, Rx Only, Sing... Lack of Assurance of Sterility - the firm is recalling select sterile drug products. Class II Cantrell Drug Company
Nov 18, 2016 Succinylcholine Chloride 200 mg/10 mL Injection Solution 10 mL (20 mg/mL) ,Si... Lack of Assurance of Sterility - the firm is recalling select sterile drug products. Class II Cantrell Drug Company
Nov 18, 2016 Ropivacaine HCl 0.25% in 0.9% Sodium Chloride, 100 mL Bag, Epidural Use Only,... Lack of Assurance of Sterility - the firm is recalling select sterile drug products. Class II Cantrell Drug Company
Nov 18, 2016 HYDROmorphone HCl 6 mg/30 mL in 0.9% Sodium Chloride (0.2 mg/mL) Single-Dose ... Lack of Assurance of Sterility - the firm is recalling select sterile drug products. Class II Cantrell Drug Company
Nov 18, 2016 Fentanyl Citrate 1,500 mcg in 0.9% Sodium Chloride (10 mcg/mL) 150 mL Bag, Si... Lack of Assurance of Sterility - the firm is recalling select sterile drug products. Class II Cantrell Drug Company
Nov 18, 2016 Heparin Sodium, 1 USP Unit/2 mL (0.5 USP Units/mL) in 0.45% Sodium Chloride, ... Lack of Assurance of Sterility - the firm is recalling select sterile drug products. Class II Cantrell Drug Company
Nov 18, 2016 Fentanyl Citrate 2,500 mcg in 0.9% Sodium Chloride (10 mcg/mL) 250 mL* Bag, S... Lack of Assurance of Sterility - the firm is recalling select sterile drug products. Class II Cantrell Drug Company
Nov 18, 2016 HYDROmorphone HCl 50 mg/50 mL in 0.9% Sodium Chloride (1 mg/mL) Single-Dose S... Lack of Assurance of Sterility - the firm is recalling select sterile drug products. Class II Cantrell Drug Company
Nov 18, 2016 Calcium Chloride, (1 g/10 mL) Injection Solution 10 mL, 10% Single-Dose Vial,... Lack of Assurance of Sterility - the firm is recalling select sterile drug products. Class II Cantrell Drug Company
Nov 18, 2016 Oxytocin 30 USP Units Added to 0.9% Sodium Chloride, 500 mL Bag, Single-Dose ... Lack of Assurance of Sterility - the firm is recalling select sterile drug products. Class II Cantrell Drug Company
Nov 18, 2016 Lidocaine HCl 1%, 10 mL Syringe, Hospital/Office Use Only, Rx Only, Cantrell ... Lack of Assurance of Sterility - the firm is recalling select sterile drug products. Class II Cantrell Drug Company
Nov 17, 2016 Amino Energy Cocktail (30 ML), (Methionine (L) 12.5 mg/Inositol 25 mg/Cholin... Lack of Assurance of Sterility Class II Tri-Coast Pharmacy
Nov 17, 2016 Amino Acid Recover Eaze (50 ML), Phenylaline (L) 8 mg/ml + Tyrosine (L) 0.45 ... Lack of Assurance of Sterility Class II Tri-Coast Pharmacy
Nov 17, 2016 HCG 5,000 IU Vial. Compounded by Tri-Coast Pharmacy. Lack of Assurance of Sterility Class II Tri-Coast Pharmacy
Nov 17, 2016 HCG 11,000 IU Vial. Compounded by Tri-Coast Pharmacy Lack of Assurance of Sterility Class II Tri-Coast Pharmacy
Nov 17, 2016 L-Arginine HCL 100 mg/mL, (30 ML). Compounded by Tri-Coast Pharmacy Lack of Assurance of Sterility Class II Tri-Coast Pharmacy
Nov 17, 2016 Calm Me (Aminobutyric Acid (GABA) 50 mg/Magnesium Chloride 50 mg/Taurine 50 m... Lack of Assurance of Sterility Class II Tri-Coast Pharmacy
Nov 17, 2016 Dexpanthenol 250 mg/mL (30 ML). Compounded by Tri-Coast Pharmacy Lack of Assurance of Sterility Class II Tri-Coast Pharmacy
Nov 17, 2016 TriMix, Alprostadil/Phentolamine/Papaverine 30mcg/1mg/10mg/mL, (1 ML). Compo... Lack of Assurance of Sterility Class II Tri-Coast Pharmacy
Nov 17, 2016 Infuvite IV (Ascorbic Acid 200 mg+ Vitamin A Acetate 330 IU+Vitamin D3 200 IU... Lack of Assurance of Sterility Class II Tri-Coast Pharmacy
Nov 17, 2016 Sermorelin Acetate 15 mg. Compounded by Tri-Coast Pharmacy Lack of Assurance of Sterility Class II Tri-Coast Pharmacy
Nov 17, 2016 Sermorelin GT (Sermorelin Acetate 15 mg/GHRP-2 5.4 mg/Theanine (L) 75 mg). C... Lack of Assurance of Sterility Class II Tri-Coast Pharmacy
Nov 17, 2016 Testosterone Cypionate in Grapeseed, 200 mg/mL, (5 ML and 10 ML). Compounded... Lack of Assurance of Sterility Class II Tri-Coast Pharmacy
Nov 17, 2016 Testosterone Enanthate in Sesame Oil, 200 mg/mL, (5 ML). Compounded by Tri-C... Lack of Assurance of Sterility Class II Tri-Coast Pharmacy
Nov 17, 2016 Quad Mix, Alprostadil/Phentolamine/Papaverine/Atropine 10mcg/1mg/19mg/190mg/m... Lack of Assurance of Sterility Class II Tri-Coast Pharmacy
Nov 17, 2016 TriMix, Alprostadil/Phentolamine/Papaverine 20mcg/0.5mg/30mg/mL, (1 ML). Com... Lack of Assurance of Sterility Class II Tri-Coast Pharmacy
Nov 17, 2016 Methylcobalamin 1,000 mcg/mL, 10 mL and 30 mL. Compounded by Tri-Coast Pharmacy Lack of Assurance of Sterility Class II Tri-Coast Pharmacy
Nov 17, 2016 MIC Ultra Cocktail (Methionine (L) 25mg/Inositol 50mg/Choline Chloride 50mg/M... Lack of Assurance of Sterility Class II Tri-Coast Pharmacy
Nov 17, 2016 Ascorbic Acid 500 mg/mL (50 ML). Compounded by Tri-Coast Pharmacy. Lack of Assurance of Sterility Class II Tri-Coast Pharmacy
Nov 17, 2016 Testosterone Cypionate/Zinc Gluconate in Sesame Oil, 200 mg/2 mg/mL, (5 ML an... Lack of Assurance of Sterility Class II Tri-Coast Pharmacy
Nov 17, 2016 Glutamine 25 mg/mL (30 ML). Compounded by Tri-Coast Pharmacy Lack of Assurance of Sterility Class II Tri-Coast Pharmacy
Nov 17, 2016 L-Tyrosine 10 mg/mL, (30 ML). Compounded by Tri-Coast Pharmacy Lack of Assurance of Sterility Class II Tri-Coast Pharmacy
Nov 17, 2016 Methylcobalamin/Folic Acid/Pyridoxine 1 mg/1 mg/50 mg/mL, 1 ML). Compounded ... Lack of Assurance of Sterility Class II Tri-Coast Pharmacy
Nov 17, 2016 Testosterone Cypionate in Sesame Oil, 250 mg/mL, (5 ML). Compounded by Tri-C... Lack of Assurance of Sterility Class II Tri-Coast Pharmacy
Nov 17, 2016 Sermorelin Forte 6 mg (Sermorelin Acetate 6 mg/GHRP-6 3 mg). Compounded by T... Lack of Assurance of Sterility Class II Tri-Coast Pharmacy
Nov 17, 2016 BiMix Phentolamine/Papaverine 0.06 mg/1.8 mg/mL (1 ML). Compounded by Tri-Coa... Lack of Assurance of Sterility Class II Tri-Coast Pharmacy
Nov 17, 2016 TriMix, Alprostadil/Phentolamine/Papaverine 100mcg/3mg/30mg/mL, (1 ML). Comp... Lack of Assurance of Sterility Class II Tri-Coast Pharmacy
Nov 17, 2016 B-Complex (30 ML), (Thiamine HCL 100 mg/Riboflavin-5-Phosphate 2 mg/Pyridoxin... Lack of Assurance of Sterility Class II Tri-Coast Pharmacy
Nov 17, 2016 Quad Mix, Alprostadil/Phentolamine/Papaverine/Atropine 40mcg/2mg/40mg/0.04mg/... Lack of Assurance of Sterility Class II Tri-Coast Pharmacy

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.