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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 17, 2016 Sermorelin Acetate 9 mg. Compounded by Tri-Coast Pharmacy Lack of Assurance of Sterility Class II Tri-Coast Pharmacy
Nov 17, 2016 Calcium Gluconate 10% Injection (30 ML). Compounded by Tri-Coast Pharmacy Lack of Assurance of Sterility Class II Tri-Coast Pharmacy
Nov 17, 2016 Nandrolone Decanoate 200 mg/ml, (5 ML). Compounded by Tri-Coast Pharmacy Lack of Assurance of Sterility Class II Tri-Coast Pharmacy
Nov 17, 2016 Sermorelin Forte 12 mg (Sermorelin Acetate 6 mg/GHRP-6 6 mg). Compounded by T... Lack of Assurance of Sterility Class II Tri-Coast Pharmacy
Nov 17, 2016 TriMix, Alprostadil/Phentolamine/Papaverine 30mcg/0.5mg/10mg/mL, (1 ML). Com... Lack of Assurance of Sterility Class II Tri-Coast Pharmacy
Nov 17, 2016 Quad Mix, Alprostadil/Phentolamine/Papaverine/Atropine 10mcg/3mg/30mg/200mg/m... Lack of Assurance of Sterility Class II Tri-Coast Pharmacy
Nov 17, 2016 GAC, L-Glutamine/L-Arginine/L-Carnitine 25 mg/100 mg/200 mg/mL (30 mL). Tri-... Lack of Assurance of Sterility Class II Tri-Coast Pharmacy
Nov 17, 2016 Testosterone Cypionate 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 18mcg/1mg/1.8mg/0.02mg... Lack of Assurance of Sterility Class II Tri-Coast Pharmacy
Nov 17, 2016 Slim Shot (Methionine (L) 25mg/Inositol 50mg/Choline Chloride 50mg/Methylcoba... Lack of Assurance of Sterility Class II Tri-Coast Pharmacy
Nov 17, 2016 Testosterone Cypionate in Sesame, 150 mg/mL, (5 ML). Compounded by Tri-Coast... Lack of Assurance of Sterility Class II Tri-Coast Pharmacy
Nov 17, 2016 Lipo-C (Methionine 25 mg/Inositol 50 mg/Choline Chloride 50 mg/Carnitine (L) ... Lack of Assurance of Sterility Class II Tri-Coast Pharmacy
Nov 17, 2016 Testosterone Cypionate in Sesame, 100 mg/mL, (5 ML). Compounded by Tri-Coast... Lack of Assurance of Sterility Class II Tri-Coast Pharmacy
Nov 17, 2016 Lipotropic with MIC (Methionine (L) 12.5mg/Inositol 25mg/Choline Chloride 25m... Lack of Assurance of Sterility Class II Tri-Coast Pharmacy
Nov 17, 2016 Testosterone Cypionate/Enanthate/Propionate, 160 mg/20 mg/20 mg/mL, (5 ML). ... Lack of Assurance of Sterility Class II Tri-Coast Pharmacy
Nov 17, 2016 TriMix, Alprostadil/Phentolamine/Papaverine 10mcg/1mg/30mg/mL, (1 ML). Compo... Lack of Assurance of Sterility Class II Tri-Coast Pharmacy
Nov 17, 2016 TriMix, Alprostadil/Phentolamine/Papaverine 30mcg/1mg/30mg/mL, (1 ML). Compo... 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
Nov 17, 2016 HCG/Hydroxycobalamin 5,000 IU/5 mg Vial. Compounded by Tri-Coast Pharmacy Lack of Assurance of Sterility Class II Tri-Coast Pharmacy
Nov 17, 2016 TriMix, Alprostadil/Phentolamine/Papaverine 20mcg/1mg/30mg/mL, (1 ML). Compo... Lack of Assurance of Sterility Class II Tri-Coast Pharmacy
Nov 17, 2016 TriMix, Alprostadil/Phentolamine/Papaverine 40mcg/2mg/30mg/mL, (1 ML). Compo... Lack of Assurance of Sterility Class II Tri-Coast Pharmacy
Nov 17, 2016 TriMix, Alprostadil/Phentolamine/Papaverine 40mcg/2mg/30mg/mL, (1 ML). Compo... Lack of Assurance of Sterility Class II Tri-Coast Pharmacy
Nov 17, 2016 TriMix, Alprostadil/Phentolamine/Papaverine 10mcg/0.5mg/30mg/mL, (1 ML). Com... Lack of Assurance of Sterility Class II Tri-Coast Pharmacy
Nov 17, 2016 Quad Mix, Alprostadil/Phentolamine/Papaverine/Atropine 10mcg/1mg/9mg/0.1mg/ml... Lack of Assurance of Sterility Class II Tri-Coast Pharmacy
Nov 17, 2016 Myers Cocktail #4 (Ascorbic Acid 2000 mg + Magnesium Chloride 1000 mg + Calci... Lack of Assurance of Sterility Class II Tri-Coast Pharmacy
Nov 17, 2016 Mineral Mix Schrader, Zinc Chloride 5 mg/ml + Vanadium 100 mcg/ml + Manganese... Lack of Assurance of Sterility Class II Tri-Coast Pharmacy
Nov 17, 2016 Sermorelin Forte Plus 27 mg (Sermorelin Acetate 9 mg/GHRP-6 9 mg/GHRP-2 9 mg)... Lack of Assurance of Sterility Class II Tri-Coast Pharmacy
Nov 17, 2016 Vitamin D3 100,000 Unit/mL, in olive oil, (30 ML). Compounded by Tri-Coast P... Lack of Assurance of Sterility Class II Tri-Coast Pharmacy
Nov 17, 2016 Pyridoxine HCL 100 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 20mcg/2mg/30mg/mL, (1 ML). Compo... Lack of Assurance of Sterility Class II Tri-Coast Pharmacy
Nov 17, 2016 L-Carnitine 250 mg/mL, (30 ML). Compounded by Tri-Coast Pharmacy Lack of Assurance of Sterility Class II Tri-Coast Pharmacy
Nov 17, 2016 Sermorelin Forte Plus 18 mg (Sermorelin Acetate 6 mg/GHRP-6 6 mg/GHRP-2 6 mg)... Lack of Assurance of Sterility Class II Tri-Coast Pharmacy
Nov 17, 2016 BiMix Phentolamine/Papaverine 2 mg/30 mg/mL (1 ML). Compounded by Tri-Coast ... Lack of Assurance of Sterility Class II Tri-Coast Pharmacy
Nov 17, 2016 Ultra Slim Shot (Methionine (L) 25mg/Inositol 50mg/Choline Chloride 50 mg/Met... Lack of Assurance of Sterility Class II Tri-Coast Pharmacy
Nov 17, 2016 Ultra Cocktail #2 (Methionine (L) 12.5mg/Inositol 25mg/Choline Chloride 25 mg... Lack of Assurance of Sterility Class II Tri-Coast Pharmacy
Nov 17, 2016 Taurine 50 mg/mL, (30 ML). Compounded by Tri-Coast Pharmacy Lack of Assurance of Sterility Class II Tri-Coast Pharmacy
Nov 17, 2016 Myers Cocktail #5 (Ascorbic Acid 2000 mg + Magnesium Chloride 1000 mg + Calci... Lack of Assurance of Sterility Class II Tri-Coast Pharmacy
Nov 17, 2016 Tri-Amino (Ornithine (L) HCL 100 mg/Arginine HCL 100 mg/Citrulline (L) 100 mg... Lack of Assurance of Sterility Class II Tri-Coast Pharmacy
Nov 17, 2016 Testosterone Cypionate/Propionate, 200 mg/50 mg/mL, (5 ML). Compounded by Tr... Lack of Assurance of Sterility Class II Tri-Coast Pharmacy
Nov 17, 2016 IV Cocktail #2 (Ascorbic Acid 200 mg+Vitamin A Acetate 330 IU+Vitamin D3 200 ... Lack of Assurance of Sterility Class II Tri-Coast Pharmacy
Nov 17, 2016 SODIUM FERRIC GLUCONATE COMPLEX IN SUCROSE INJECTION, 62.5mg elemental iron/5... Subpotent Drug: Product has an an out of specification in iron assay analysis found during 18 mon... Class III West-Ward Pharmaceuticals Corp.
Nov 17, 2016 Quad Mix, Alprostadil/Phentolamine/Papaverine/Atropine 10mcg/2mg/30mg/200mg/m... Lack of Assurance of Sterility Class II Tri-Coast Pharmacy
Nov 17, 2016 Testosterone Suspension 100 mg/mL, (5 ML). Compounded by Tri-Coast Pharmacy Lack of Assurance of Sterility Class II Tri-Coast Pharmacy
Nov 17, 2016 BCAA (30 ML) (Isoleucine (L) 15 mg + Leucine (L) 10 mg+ Valine 40 mg+ Lidocai... Lack of Assurance of Sterility Class II Tri-Coast Pharmacy
Nov 17, 2016 Glucosamine 200 mg/mL (30 ML). Compounded by Tri-Coast Pharmacy Lack of Assurance of Sterility Class II Tri-Coast Pharmacy
Nov 17, 2016 Sermorelin Acetate 6 mg. Compounded by Tri-Coast Pharmacy Lack of Assurance of Sterility Class II Tri-Coast Pharmacy
Nov 17, 2016 Glutathione 200 mg/mL (30 ML). Compounded by Tri-Coast Pharmacy Lack of Assurance of Sterility Class II Tri-Coast Pharmacy
Nov 17, 2016 BiMix Phentolamine/Papaverine 1 mg/30 mg/mL (1 ML). Compounded by Tri-Coast ... Lack of Assurance of Sterility Class II Tri-Coast Pharmacy
Nov 17, 2016 Ultra Amino Energy Cocktail (Methionine (L) 12.5mg/Inositol 25mg/Choline Chlo... Lack of Assurance of Sterility Class II Tri-Coast Pharmacy
Nov 17, 2016 Ultra Amino Blend (Arginine HCL 105 mg + Lysine (L) HCL 150 mg + Ornithine (L... 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.