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Product Safety9,700+ CPSC product recalls Food Safety28,600+ FDA food recalls Pet Safety1.3M FDA animal adverse events Drug Safety17,500+ FDA drug recalls Device Safety38,400+ FDA device recalls Workplace Safety102,900+ OSHA injury reports Brand HistoryRecall lookup by company

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Browse Drug Recalls

6,306 FDA drug safety recalls.

FDA Drug Recall Enforcement Database

Browse 6,306 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 6,306 FDA drug recalls.

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DateProductReasonClassFirm
Jun 19, 2019 PHENYLEPHRINE HCL 100 MCG/ML IN NACL 0.9% SYR, 10 ML per syringe, RXQ Compoun... Lack of Assurance of Sterility Class II RXQ Compounding LLC
Jun 19, 2019 MIC B12 W/B6 (LIPOSTAT PLUS) 25/50/50/1/.175 MG/ML, 30 ML per vial, RXQ Compo... Lack of Assurance of Sterility Class II RXQ Compounding LLC
Jun 19, 2019 PROCAINE HCL 20 MG/ML (MDV) INJECTABLE SOLUTION, 30 ML per vial. RXQ Compoun... Lack of Assurance of Sterility Class II RXQ Compounding LLC
Jun 19, 2019 ZINC SULFATE 1MG/ML INJECTION SOLUTION (PFV), 10ML per VIAL, RXQ Compounding,... Lack of Assurance of Sterility Class II RXQ Compounding LLC
Jun 19, 2019 DEXTROSE 50% INJECTION SOLUTION (PF) VIAL, 50 ML per vial, RXQ Compounding, 3... Lack of Assurance of Sterility Class II RXQ Compounding LLC
Jun 19, 2019 EDETATE DISODIUM 15% INJECTABLE, 30 ML per vial, RXQ Compounding, 340 West St... Lack of Assurance of Sterility Class II RXQ Compounding LLC
Jun 19, 2019 LIDOCAINE 0.75%/Epinephrine 0.025%/BSS 0.56ML SYR, 1 ML PER Syringe, RXQ Comp... Lack of Assurance of Sterility Class II RXQ Compounding LLC
Jun 19, 2019 PYRIDOXINE (PFV) 100MG/ML, 30ML PER VIAL. RXQ Compounding, 340 West State Str... Lack of Assurance of Sterility Class II RXQ Compounding LLC
Jun 19, 2019 METHYLCOBALAMIN (PFV) 10 MG/ML INJECTABLE, 10 ML per vial, RXQ Compounding, 3... Lack of Assurance of Sterility Class II RXQ Compounding LLC
Jun 19, 2019 KETAMINE 10 MG/ML INJ SOL SYR (C-III), [a) 2 ML NDC: 70731-0132-02; b) 5 ML N... Lack of Assurance of Sterility Class II RXQ Compounding LLC
Jun 19, 2019 EPHEDRINE 5MG/ML (PF) SYRINGE, 5 ML per syringe, RXQ Compounding, 340 West St... Lack of Assurance of Sterility Class II RXQ Compounding LLC
Jun 19, 2019 METHYLCOBALAMIN 10MG/ML INJECTABLE SOLUTION (MDV), 10 ML per vial, RXQ Compou... Lack of Assurance of Sterility Class II RXQ Compounding LLC
Jun 19, 2019 TURBO CAINE 2.5 (PHEN2.5/CYCLO1/ TROP1/TETRA 0.5), 0.4 ML per Syringe, RXQ Co... Lack of Assurance of Sterility Class II RXQ Compounding LLC
Jun 19, 2019 MIC (METHIONINE/INOSITOL/CHOLINE CHLORIDE) 25/50/50 MG/ML INJ, 30 ML per vial... Lack of Assurance of Sterility Class II RXQ Compounding LLC
Jun 19, 2019 LIDOCAINE HCL 2% INJECTION SOLUTION (NPV), 20ML per vial, RXQ Compounding, 34... Lack of Assurance of Sterility Class II RXQ Compounding LLC
Jun 19, 2019 diazePAM 5 MG/ML INJECTION SOLUTION (C-IV) SYR, 2 ML per syringe, RXQ Compoun... Lack of Assurance of Sterility Class II RXQ Compounding LLC
Jun 19, 2019 TURBO DROPS (PHEN 10% / CYCLO 1%/ TROP 1%/ KETO 0.5%) OPHTH SOLN, 5 ML per dr... Lack of Assurance of Sterility Class II RXQ Compounding LLC
Jun 19, 2019 CALCIUM GLUCONATE 5% INJECTION SOLUTION (MDV), 20 ML per vial, RXQ Compoundin... Lack of Assurance of Sterility Class II RXQ Compounding LLC
Jun 19, 2019 ZINC SULFATE 1MG/ML INJECTION SOLUTION, 30ML per VIAL, RXQ Compounding, 340 W... Lack of Assurance of Sterility Class II RXQ Compounding LLC
Jun 19, 2019 MIDAZOLAM 1MG/ML IN NACL 0.9% INJ SYR C-IV, 55 ML per syringe, RXQ Compoundin... Lack of Assurance of Sterility Class II RXQ Compounding LLC
Jun 19, 2019 NEOSTIGMINE METHYL SULFATE 1MG/ML INJ SOL SYR, 5 ML per syringe, RXQ Compound... Lack of Assurance of Sterility Class II RXQ Compounding LLC
Jun 19, 2019 EDETATE DISODIUM 15% INJECTABLE, 100 ML per vial, RXQ Compounding, 340 West S... Lack of Assurance of Sterility Class II RXQ Compounding LLC
Jun 19, 2019 EPINEPHrine 1:1000 INJECTION SOLUTION (PF) Syringe, 1 ML per syringe, RXQ Com... Lack of Assurance of Sterility Class II RXQ Compounding LLC
Jun 19, 2019 MAGNESIUM CHLORIDE HEXAHYDRATE (MDV) 20% INJ SOLN, 50 ML per vial, RXQ Compou... Lack of Assurance of Sterility Class II RXQ Compounding LLC
Jun 19, 2019 THIAMINE HCL 100MG/ML (MDV) INJECTION, 10 ML per Vial, RXQ Compounding, 340 W... Lack of Assurance of Sterility Class II RXQ Compounding LLC
Jun 19, 2019 MOXIFLOXACIN 0.5% OPHTH SOLUTION SYRINGE, 1 ML per syringe, RXQ Compounding, ... Lack of Assurance of Sterility Class II RXQ Compounding LLC
Jun 19, 2019 VITAMIN B COMPLEX 100 (PFV), [2 or 30 ML] per Vial, RXQ Compounding, 340 West... Lack of Assurance of Sterility Class II RXQ Compounding LLC
Jun 19, 2019 METHYLCOBALAMIN 1 MG/ML (MDV) INJECTABLE SOLUTION, 10 ML per vial, RXQ Compou... Lack of Assurance of Sterility Class II RXQ Compounding LLC
Jun 19, 2019 HYDROXOCOBALAMIN 1000 MCG/ML (MDV), 30 ML per vial, RXQ Compounding, 340 West... Lack of Assurance of Sterility Class II RXQ Compounding LLC
Jun 19, 2019 RXQ CAIN (PHENYLEP 1.5%/ LIDO 1% OPHTH SOL (PF), 1 ML PER VIAL, RXQ Compoundi... Lack of Assurance of Sterility Class II RXQ Compounding LLC
Jun 19, 2019 MITOMYCIN 0.04% (PF) OPH SOLN, 1ML per syringe, RXQ Compounding, 340 West Sta... Lack of Assurance of Sterility Class II RXQ Compounding LLC
Jun 19, 2019 CALCIUM CHLORIDE 100MG/ML (PFV) INJ SOLN, 10 ML per vial, RXQ Compounding, 34... Lack of Assurance of Sterility Class II RXQ Compounding LLC
Jun 19, 2019 FENTANYL 2MCG/ML BUPIVACAINE 0.125% IN NACL 0.9% SRY C-II, 50ML per syringe (... Lack of Assurance of Sterility Class II RXQ Compounding LLC
Jun 19, 2019 Inositol/Choline B12:B6, 50/50/1/0.175 MG/ML INJ SOLN(Sulfa Free Lipostat), 3... Lack of Assurance of Sterility Class II RXQ Compounding LLC
Jun 19, 2019 SOD-PHOS (PHOS 3MMOL/ML-SOD 4MEQ/ML) PFV INJ SOLN, 10 ML PER VIAL, RXQ Compo... Lack of Assurance of Sterility Class II RXQ Compounding LLC
Jun 19, 2019 NIACINAMIDE 100MG/ML, 10ML per vial, RXQ Compounding, 340 West State Street, ... Lack of Assurance of Sterility Class II RXQ Compounding LLC
Jun 19, 2019 MIDAZOLAM 1MG/ML IN NACL 0.9% INJ SOL SYR (C-IV), 10 ML per syringe, RXQ Comp... Lack of Assurance of Sterility Class II RXQ Compounding LLC
Jun 19, 2019 POTASSIUM CHLORIDE 15% (2MEQ/ML) INJ SOLN, 30 ML per vial, RXQ Compounding, 3... Lack of Assurance of Sterility Class II RXQ Compounding LLC
Jun 19, 2019 PROCAINE HCL (PFV) 20 MG/ML INJECTABLE SOLUTION, 30 ML per vial, RXQ Compound... Lack of Assurance of Sterility Class II RXQ Compounding LLC
Jun 19, 2019 BUFFERED LIDOCAINE HCL 1% INJECTION SOL (PF) SYR, 0.5 ML per vial, RXQ Compou... Lack of Assurance of Sterility Class II RXQ Compounding LLC
Jun 19, 2019 fentaNYL 0.05MG/ML INJ SOL (PF), 55ML per syringe (C-II) RXQ Compounding, 340... Lack of Assurance of Sterility Class II RXQ Compounding LLC
Jun 19, 2019 VITAMIN B COMPLEX 100 (MDV), 30 ML per Vial, RXQ Compounding, 340 West State ... Lack of Assurance of Sterility Class II RXQ Compounding LLC
Jun 19, 2019 EDETATE DISODIUM 30% INJECTABLE, 100 ML per vial, RXQ Compounding, 340 West S... Lack of Assurance of Sterility Class II RXQ Compounding LLC
Jun 19, 2019 RIBOFLAVIN 0.1% OPHTHALMIC SOLUTION SYRINGE, 2 ML per syringe. RXQ Compoundin... Lack of Assurance of Sterility Class II RXQ Compounding LLC
Jun 19, 2019 PHO-TID-CHOL 50MG/ DEOXYCHOLIC 42 MG/ML INJ, 30 ML per vial, RXQ Compounding,... Lack of Assurance of Sterility Class II RXQ Compounding LLC
Jun 19, 2019 GLUTATHIONE 200MG/ML (PFV) INJECTION SOLN, 10 ML per vial, RXQ Compounding, 3... Lack of Assurance of Sterility Class II RXQ Compounding LLC
Jun 19, 2019 DEXPANTHENOL 250MG/ML (MDV) INJECTION SOLN, 30ML per vial, RXQ Compounding, 3... Lack of Assurance of Sterility Class II RXQ Compounding LLC
Jun 19, 2019 ONDANSETRON 2 MG/ML INJECTION SOLUTION (NPF), 20ML per vial, RXQ Compounding,... Lack of Assurance of Sterility Class II RXQ Compounding LLC
Jun 19, 2019 PROCAINE HCL 8% (PFV) INJECTABLE, 10ML PER VIAL, RXQ Compounding, 340 West St... Lack of Assurance of Sterility Class II RXQ Compounding LLC
Jun 19, 2019 LIDOCAINE HCL 1% INJECTION SOLUTION (NPV), 20ML per vial, RXQ Compounding, 34... Lack of Assurance of Sterility Class II RXQ Compounding LLC

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.