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Browse Drug Recalls

6,274 FDA drug safety recalls.

FDA Drug Recall Enforcement Database

Browse 6,274 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 6,274 FDA drug recalls.

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DateProductReasonClassFirm
May 17, 2016 TESTOSTERONE CYPIONATE 175MG/ML, packaged in 5mL vials, Rx only, Well Care C... Lack of Assurance of Sterility: FDA inspection identified GMP violations potentially impacting pr... Class II Well Care Compounding Pharmacy
May 17, 2016 TRI-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 TESTOSTERONE CYPIONATE 200MG/ML, packaged in 5mL vials, Rx only, Well Care C... Lack of Assurance of Sterility: FDA inspection identified GMP violations potentially impacting pr... Class II Well Care Compounding Pharmacy
May 17, 2016 TESTOSTERONE CYPIONATE 150MG/ML, packaged in 5mL vials, Rx only, Well Care C... Lack of Assurance of Sterility: FDA inspection identified GMP violations potentially impacting pr... Class II Well Care Compounding Pharmacy
May 17, 2016 TESTOSTERONE CYPIONATE 100MG/ML, packaged in 5mL vials, Rx only, Well Care C... Lack of Assurance of Sterility: FDA inspection identified GMP violations potentially impacting pr... Class II Well Care Compounding Pharmacy
May 17, 2016 Sulfacetamide Sodium Ophthalmic Solution, USP, 10%, Sterile, Rx Only, 15 mL b... Lack of Assurance of Sterility; some lots failed Antimicrobial Effectiveness Testing on stability Class II Akorn, Inc.
May 17, 2016 TESTOSTERONE CYPIONATE 10MG/ML, packaged in 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 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 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.
May 13, 2016 HYDROXY B12 1000MCG/ML IN NACL 0.9% (PF), 1ML Vials, MEDAUS PHARMACY Lack of Assurance of Sterility Class II Medaus, Inc.
May 13, 2016 LIPO-BOOST W/PRES. (BENZYL ETOH 2%) B1-50MG, B2-5-PO4-2MG, B3-100MG, B5-2MG, ... Lack of Assurance of Sterility Class II Medaus, Inc.
May 13, 2016 PYRIDOXINE HCL 100MG/ML W/PRES (BENZYL ETOH 0.02%), 5ML Vials, MEDAUS PHARMACY Lack of Assurance of Sterility Class III Medaus, Inc.
May 13, 2016 NANDROLONE DEC 200MG/ML W/PRES. (BENZYL ETOH 10%), In a) 2ML Vials, b) 4ML Vi... Lack of Assurance of Sterility Class II Medaus, Inc.
May 13, 2016 HYDROXY B12 5MG/ML W/PRES (BENZALKONIUM 0.01%), 5ML Vials, MEDAUS PHARMACY Lack of Assurance of Sterility Class II Medaus, Inc.
May 13, 2016 EDTA DISODIUM 15% (150MG/ML), 20ML Vials, MEDAUS PHARMACY Lack of Assurance of Sterility Class II Medaus, Inc.
May 13, 2016 HCL 2MG/ML (PF), 5ML Vials, MEDAUS PHARMACY Lack of Assurance of Sterility Class II Medaus, Inc.
May 13, 2016 B-COMPLEX #3 W/PRES (BENZYL ETOH 2%), B1-100MG, B2-5-PO4-2MG, B3-100MG, B5-2M... Lack of Assurance of Sterility Class II Medaus, Inc.
May 13, 2016 LIPO W/LIDOCAINE #3 W/PRES. (BENZYL ETOH 2%) ASCORBIC ACID 50MG; B1-50MG;B2-5... Lack of Assurance of Sterility Class II Medaus, Inc.
May 13, 2016 M.I.C. 25/50/50 (PF) METHIONINE 25MG;INOSITOL 50MG;CHOLINE CHL 50MG/ML, In 2... Lack of Assurance of Sterility Class II Medaus, Inc.
May 13, 2016 THIAMINE 100 MG/ML, 2ML Vials, MEDAUS PHARMACY Lack of Assurance of Sterility Class II Medaus, Inc.
May 13, 2016 LIDOCAINE 2% (PF) IN NACL, 10ML Vials, MEDAUS PHARMACY Lack of Assurance of Sterility Class II Medaus, Inc.
May 13, 2016 DMSO 99.9 (PF), In a) 5ML Vials and b) 10ML Vials, MEDAUS PHARMACY Lack of Assurance of Sterility Class II Medaus, Inc.
May 13, 2016 TESTOSTERONE CYP 20 MG/ML W/PRES (BENZYL ETOH 2%), In a) 1ML Vials and b) 3ML... Lack of Assurance of Sterility Class II Medaus, Inc.
May 13, 2016 PYRIDOXINE HCL 100MG/ML (PF), In a) 2ML Vials and b) 5ML Vials, MEDAUS PHARMACY Lack of Assurance of Sterility Class II Medaus, Inc.
May 13, 2016 B-COMPLEX WITHOUT B12 (PF) IN NACL 0.9%, B1-100MG, B2-5-PO4-2MG, B3-50MG, B5-... Lack of Assurance of Sterility Class II Medaus, Inc.
May 13, 2016 DMPS 50MG/ML (PF), 5ML Vials, MEDAUS PHARMACY Lack of Assurance of Sterility Class II Medaus, Inc.
May 13, 2016 MOLYBDENUM 250MCG/ML (PF), 10ML Vials, MEDAUS PHARMACY Lack of Assurance of Sterility Class II Medaus, Inc.
May 13, 2016 LIPO-INJECTION W/METHYL B12 1 MG/ML W/PRES. (BENZYL ETOH 2%) ASCORBIC ACID-5... Lack of Assurance of Sterility Class II Medaus, Inc.
May 13, 2016 TAURINE 50 MG/ML (PF), In a) 1ML Vials, b) 10ML Vials, and c) 20ML Vials, MED... Lack of Assurance of Sterility Class II Medaus, Inc.
May 13, 2016 L-PHENYLALANINE 15MG/ML (PF), 50ML Vials, MEDAUS PHARMACY Lack of Assurance of Sterility Class II Medaus, Inc.
May 13, 2016 L-CARNITINE 100MG/ML (PF), 10ML 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.