Browse Drug Recalls
14,380 FDA drug safety recalls.
FDA Drug Recall Enforcement Database
Browse 14,380 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 14,380 FDA drug recalls, Class II.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| May 17, 2016 | TRI-MIX # 5, packaged in 5 mL vials, Rx only, 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 VALERATE 20MG/ML, packaged in 5mL vials, Rx only, Well Care Compoun... | Lack of Assurance of Sterility: FDA inspection identified GMP violations potentially impacting pr... | Class II | Well Care Compounding Pharmacy |
| May 17, 2016 | M.I.C. /MB12/B6/DEXPLAN/L-CARN, 25MG/50MG/25MG/10MG/10MG/ML, packaged in 5mL ... | Lack of Assurance of Sterility: FDA inspection identified GMP violations potentially impacting pr... | Class II | Well Care Compounding Pharmacy |
| May 17, 2016 | ATROPINE SULFATE 0.5% Ophthalmic Drops, packaged in 5mL droppers, Rx only, We... | Lack of Assurance of Sterility: FDA inspection identified GMP violations potentially impacting pr... | Class II | Well Care Compounding Pharmacy |
| 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 | 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 | SELENIUM 200MCG/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 | CESIUM CHLORIDE 600MG/ML (PF), 10ML Vials, MEDAUS PHARMACY | 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 | 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 | L-CARNITINE 50MG/ML (PF), 10ML 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | ZINC SO4 1MG/ML (PF), 2ML Vials, MEDAUS PHARMACY | 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 | 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 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 | 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 | 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 | CALCIUM SODIUM EDTA 300MG/ML (PF), 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 | 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 | 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 | 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 | 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 | MANGANESE CHL 0.1MG/ML PF, 10ML Vials, MEDAUS PHARMACY | Lack of Assurance of Sterility | Class II | Medaus, Inc. |
| May 13, 2016 | M.I.C B-COMPLEX PREMIX W/HYDROXY B12 W/PRES. (BENZALKONIUM 0.01%) HYDROXY B... | Lack of Assurance of Sterility | Class II | Medaus, Inc. |
| May 13, 2016 | M.I.C 25/50/50 W/PRES. (BENZYL ETOH 2%) METHIONINE 25MG;INOSITOL 50MG;CHOLIN... | Lack of Assurance of Sterility | Class II | Medaus, Inc. |
| May 13, 2016 | DEXPANTHENOL 250MG/ML W/PRES. (BENZALKONIUM CHL 0.01%), 10ML Vials, MEDAUS P... | Lack of Assurance of Sterility | Class II | Medaus, Inc. |
| May 13, 2016 | L-GLUTATHIONE 100MG/ML (PF), 10 ML Vials, MEDAUS PHARMACY | Lack of Assurance of Sterility | Class II | Medaus, Inc. |
| May 13, 2016 | METHYL B12 10MG/ML (PF) IN NACL 0.9%, 1ML Vials, MEDAUS PHARMACY | Lack of Assurance of Sterility | Class II | Medaus, Inc. |
| May 13, 2016 | L-CARNITINE 500MG/ML (PF), 10ML Vials, MEDAUS PHARMACY | Lack of Assurance of Sterility | Class II | Medaus, Inc. |
| May 13, 2016 | MAGNESIUM CHL 200MG/ML (PF), In a) 5ML Vials and b) 10ML Vials, MEDAUS PHARMACY | Lack of Assurance of Sterility | Class II | Medaus, Inc. |
| May 13, 2016 | METHYL B12 1000MCG/ML IN NACL 0.9% (PF), 2ML Vials, MEDAUS PHARMACY | Lack of Assurance of Sterility | Class II | Medaus, Inc. |
| May 13, 2016 | LIPO-INJECTION W/LIDOCAINE W/PRES. (BENZYL ETOH 2%) ASCORBIC ACID-50MG, B1-5... | Lack of Assurance of Sterility | Class II | Medaus, Inc. |
| May 13, 2016 | B-COMPLEX 50 IN NACL 0.9% W/PRES., (BENZYL ETOH 2%), B1-50MG, B2-5-PO4-5MG, B... | Lack of Assurance of Sterility | Class II | Medaus, Inc. |
| May 13, 2016 | MINOXIDIL 0.5% W/PRES. (BENZYL ETOH 2%), 10ML Vials, MEDAUS PHARMACY | Lack of Assurance of Sterility | Class II | Medaus, Inc. |
| May 13, 2016 | PYRIDOXAL 50 MG/THIAMINE 50 MG/LIDOCAINE 1% NS (PF), 2ML Vials, MEDAUS PHARMACY | Lack of Assurance of Sterility | Class II | Medaus, Inc. |
| May 13, 2016 | ARGININE 100MG/ML (PF), 10ML Vials, MEDAUS PHARMACY | Lack of Assurance of Sterility | Class II | Medaus, Inc. |
| May 13, 2016 | MANGANESE SO4 0.1MG/ML (PF), In a) 2MLVials and b) 10ML Vials, MEDAUS PHARMACY | Lack of Assurance of Sterility | Class II | Medaus, Inc. |
| May 13, 2016 | LIPO #4 W/METHYL B12 500 MCG/ML/NO METHIONINE W/PRES (BENZYL ETOH 2%) ASCORB... | Lack of Assurance of Sterility | Class II | Medaus, Inc. |
| May 13, 2016 | FOLIC ACID 10MG/ML W/PRES. (METHYLPARABEN 0.05%, PROPYLPARABEN 0.025% IN NAC... | Lack of Assurance of Sterility | Class II | Medaus, Inc. |
| May 13, 2016 | HYDROXY B12 5MG/ML IN NACL 0.9% (PF), In a) 1ML Vials and b) 2ML Vials, MEDAU... | 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.