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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
May 17, 2016 CLINIQUE moisture surge tinted moisturizer broad spectrum SPF 15, 1 FL. OZ.LI... Subpotent Drug: Two of the active sunscreen ingredients, octinoxate and octisalate, are below the... Class III Clinique International
May 17, 2016 SUPER TRI-MIX #1, packaged in 5mL vials, Rx only, Well Care Compounding Pharm... Lack of Assurance of Sterility: FDA inspection identified GMP violations potentially impacting pr... Class II Well Care Compounding Pharmacy
May 17, 2016 VITAMIN B COMPLEX # 1; packaged in 5mL vials, Rx only, Well Care Compoundin... Lack of Assurance of Sterility: FDA inspection identified GMP violations potentially impacting pr... Class II Well Care Compounding Pharmacy
May 17, 2016 METHYLCOBALAMIN 5MG/ML, packaged in 1mL and 5mL vials, Rx only, Well Care Com... Lack of Assurance of Sterility: FDA inspection identified GMP violations potentially impacting pr... Class II Well Care Compounding Pharmacy
May 17, 2016 CLOTRIMAZOLE 1%/ BETAMETHASONE DIPROPIONATE 0.05% OTIC SOLUTION, 15mL dropper... Lack of Assurance of Sterility: FDA inspection identified GMP violations potentially impacting pr... Class II Well Care Compounding Pharmacy
May 17, 2016 TRI-MIX # 1, packaged in 5mL vials, Rx only, Well Care Compounding Pharmacy L... Lack of Assurance of Sterility: FDA inspection identified GMP violations potentially impacting pr... Class II Well Care Compounding Pharmacy
May 17, 2016 ALPHA LIPOIC ACID 25MG/ML, packaged in 5mL vials, Rx only, Well Care Compound... Lack of Assurance of Sterility: FDA inspection identified GMP violations potentially impacting pr... Class II Well Care Compounding Pharmacy
May 17, 2016 SUPER TRI-MIX #4, packaged in 5mL vials, Rx only, Well Care Compounding Pha... Lack of Assurance of Sterility: FDA inspection identified GMP violations potentially impacting pr... Class II Well Care Compounding Pharmacy
May 17, 2016 MYERS' COCKTAIL, packaged in 37 mL vials, Rx only, Well Care Compounding Pha... Lack of Assurance of Sterility: FDA inspection identified GMP violations potentially impacting pr... Class II Well Care Compounding Pharmacy
May 17, 2016 ITRACONAZOLE 0.2%/MUPIROCIN 0.2% NASAL SPRAY; 30 mL Spray, Rx only, Well Car... Lack of Assurance of Sterility: FDA inspection identified GMP violations potentially impacting pr... Class II Well Care Compounding Pharmacy
May 17, 2016 METHYLCOBALAMIN 12.5MG/ML, packaged in 5mL vials, Rx only, Well Care Compound... Lack of Assurance of Sterility: FDA inspection identified GMP violations potentially impacting pr... Class II Well Care Compounding Pharmacy
May 17, 2016 QUAD-MIX #2, packaged in 5mL vial, Rx only, Well Care Compounding Pharmacy La... Lack of Assurance of Sterility: FDA inspection identified GMP violations potentially impacting pr... Class II Well Care Compounding Pharmacy
May 17, 2016 QUAD-MIX #3, packaged in 5mL vials, Rx only, Well Care Compounding Pharmacy L... Lack of Assurance of Sterility: FDA inspection identified GMP violations potentially impacting pr... Class II Well Care Compounding Pharmacy
May 17, 2016 METHYLCOBALAMIN 1 MG/ML, packaged in 1mL and 5mL vials, Rx only, Well Care Co... Lack of Assurance of Sterility: FDA inspection identified GMP violations potentially impacting pr... Class II Well Care Compounding Pharmacy
May 17, 2016 GLUTATHIONE 100MG/ML, packaged in 10 mL vials, Well Care Compounding Pharmacy... Lack of Assurance of Sterility: FDA inspection identified GMP violations potentially impacting pr... Class II Well Care Compounding Pharmacy
May 17, 2016 ESTRADIOL CYPIONATE 10 MG/ML, packaged in 5mL vials, Rx only, Well Care Compo... Lack of Assurance of Sterility: FDA inspection identified GMP violations potentially impacting pr... Class II Well Care Compounding Pharmacy
May 16, 2016 VP-CH-PNV Prenatal/Postnatal capsules, prenatal supplement, 30-count bottle, ... Defective delivery system: Softgel capsules are leaking. Class III Virtus Pharmaceuticals, Llc
May 16, 2016 Potassium CHLORide added to 5% Dextrose Injection, 20 mEq 250 mL Bag, PharMED... Labeling: Not Elsewhere Classified: Potassium Chloride was printed on Potassium Phosphate label s... Class II Pharmedium Services, LLC
May 13, 2016 MANGANESE CHL 0.1MG/ML PF, 10ML Vials, MEDAUS PHARMACY Lack of Assurance of Sterility Class II Medaus, Inc.
May 13, 2016 B-COMPLEX 50 IN NACL 0.9% (PF) B1-50MG, B2-5-PO4-5MG, B3-50MG, B5-50MG, B6-... Lack of Assurance of Sterility Class II Medaus, Inc.
May 13, 2016 THIAMINE 100 MG/ML W/PRES (BENZALKONIUM 0.01%), 5ML Vials, MEDAUS PHARMACY Lack of Assurance of Sterility Class II Medaus, Inc.
May 13, 2016 ESTRADIOLVAL 3MG/TEST CYP 35MG/ TEST PROP 35MG/ML W/PRES. (BENZYL ETOH 2%), ... Lack of Assurance of Sterility Class II Medaus, Inc.
May 13, 2016 PROCAINE 2% (PF), In a) 2ML Vials and b) 10ML Vials, MEDAUS PHARMACY Lack of Assurance of Sterility Class II Medaus, Inc.
May 13, 2016 TESTOSTERONE CYP 50 MG/ML W/PRES (BENZYL ETOH 2%), In a) 1ML Vials, b) 2ML Vi... Lack of Assurance of Sterility Class II Medaus, Inc.
May 13, 2016 CALCIUM SODIUM EDTA 300MG/ML (PF), 10ML Vials, MEDAUS PHARMACY Lack of Assurance of Sterility Class II Medaus, Inc.
May 13, 2016 METHYL B12 5MG/ML (PF) IN NACL 0.9%, 1ML Vials, MEDAUS PHARMACY Lack of Assurance of Sterility Class II Medaus, Inc.
May 13, 2016 TESTOSTERONE CYP 200 MG/ML W/PRES (BENZYL ETOH 2%), In a) 1ML Vials, b) 2ML V... Lack of Assurance of Sterility Class II Medaus, Inc.
May 13, 2016 B-COMPLEX W/CYANO B12 W/PRES., (BENZYL ETOH 2%), B1-100MG, B2-5-PO4-2MG, B3-5... Lack of Assurance of Sterility Class II Medaus, Inc.
May 13, 2016 B-COMPLEX WITHOUT B12 W/PRES (BENZYL ETOH 2%), B1-100MG, B2-5-PO4-2MG, B3-50M... Lack of Assurance of Sterility Class II Medaus, Inc.
May 13, 2016 B-COMPLEX (LIEBERMAN) IN NACL 0.9% (PF), B1-12.5MG, B2-5-PO4-10MG, B3-12.5MG,... Lack of Assurance of Sterility Class II Medaus, Inc.
May 13, 2016 ZINC SO4 1MG/ML (PF), 2ML Vials, MEDAUS PHARMACY Lack of Assurance of Sterility Class II Medaus, Inc.
May 13, 2016 B-COMPLEX #3 (PF), B1-100MG, B2-2-PO4-2MG, B3-100MG, B5-2MG, B6-2MG/ML, 2ML V... Lack of Assurance of Sterility Class II Medaus, Inc.
May 13, 2016 METHYL B12 10MG/ML W/PRES (BENZALKONIUM 0.01%) IN NACL 0.9%, In a) 1ML Vials,... Lack of Assurance of Sterility Class II Medaus, Inc.
May 13, 2016 LIPO B CYANO 1MG/ML W/PRES. (BENZYL ETOH 1%) METHIONINE 25MG, INOSITOL 50MG, ... Lack of Assurance of Sterility Class II Medaus, Inc.
May 13, 2016 NA ASCORBATE 500MG/ML NON-CORN (PF), In a) 10ML Vials, b) 50ML Vials, and c)... Lack of Assurance of Sterility Class II Medaus, Inc.
May 13, 2016 M.I.C B-COMPLEX W/PRES. (BENZYL ETOH 2%) B1-50MG;B2-5-PO4-5MG;B3-50MG;B5-5MG... Lack of Assurance of Sterility Class II Medaus, Inc.
May 13, 2016 B-COMPLEX W/METHYL B12/LIDO W/PRES (BENZYL ETOH 2%), B1-100MG, B2-5-PO4-2MG, ... Lack of Assurance of Sterility Class II Medaus, Inc.
May 13, 2016 TESTOSTERONE CYP 25 MG/ML W/PRES (BENZYL ETOH 2%), 5ML Vials, MEDAUS PHARMACY Lack of Assurance of Sterility Class II Medaus, Inc.
May 13, 2016 METHYL B12 1000MCG/ML/PYRIDOXINE 100MG W/PRES. (BENZALKONIUM 0.01%), In a) 1... Lack of Assurance of Sterility Class II Medaus, Inc.
May 13, 2016 L-CARNITINE 50MG/ML (PF), 10ML Vials, MEDAUS PHARMACY Lack of Assurance of Sterility Class II Medaus, Inc.
May 13, 2016 NA ASCORBATE 500MG/ML (PF), In a) 10ML Vials, b) 50ML Vials, and c) 100ML Vi... Lack of Assurance of Sterility Class II Medaus, Inc.
May 13, 2016 TRYPTOPHAN 10MG/ML (PF), In a) 10ML Vials and b) 50ML Vials, MEDAUS PHARMACY Lack of Assurance of Sterility Class II Medaus, Inc.
May 13, 2016 CESIUM CHLORIDE 600MG/ML (PF), 10ML Vials, MEDAUS PHARMACY Lack of Assurance of Sterility Class II Medaus, Inc.
May 13, 2016 PROLINE 100MG/ML (PF), 5ML Vials, MEDAUS PHARMACY Lack of Assurance of Sterility Class II Medaus, Inc.
May 13, 2016 SELENIUM 200MCG/ML (PF), 10ML Vials, MEDAUS PHARMACY Lack of Assurance of Sterility Class II Medaus, Inc.
May 13, 2016 DEXPANTHENOL 250MG/ML (PF), In a) 2ML Vials and b) 5ML Vials, MEDAUS PHARMACY Lack of Assurance of Sterility Class II Medaus, Inc.
May 13, 2016 LIPO-INJECTION W/LIDOCAINE NO METHIONINE W/PRES. (BENZYL ETOH 2%) ASCORBIC A... Lack of Assurance of Sterility Class II Medaus, Inc.
May 13, 2016 NIACINAMIDE 100 MG/ML (PF), In a) 1ML Vials, b) 5ML Vials, and c) 10ML Vials,... Lack of Assurance of Sterility Class II Medaus, Inc.
May 13, 2016 LIPO-INJECTION W/LIDOCAINE (PF), ASCORBIC ACID 50MG; B1-50MG; B2-5-PO4-5MG; B... Lack of Assurance of Sterility Class II Medaus, Inc.
May 13, 2016 FOLIC ACID 10MG/ML IN NACL (PF), 1ML Vials, MEDAUS PHARMACY Lack of Assurance of Sterility Class II Medaus, 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.