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Browse Drug Recalls

88 FDA drug safety recalls.

FDA Drug Recall Enforcement Database

Browse 88 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 88 FDA drug recalls.

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DateProductReasonClassFirm
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 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 FOLIC ACID 10MG/ML INJECTION SOLUTION (MDV), 5 ML 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 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 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 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 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 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 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 MANGANESE SULFATE MONOHYDRATE (PFV) 0.1MG/ML INJ, 10 ML per syringe, RXQ Comp... Lack of Assurance of Sterility Class II RXQ Compounding LLC
Jun 19, 2019 PYRIDOXINE (MDV) 100MG/ML, 30ML PER VIAL, RXQ Compounding, 340 West State Str... 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 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 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 SUCCINYLCHOLINE CHLORIDE 20MG/ML INJ SOL, 10 ML per Vial, RXQ Compounding, 34... 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 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 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 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 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 TURBO DROPS (PHEN 2.5% / CYCLO 1%/ TROP 1%/ KETO 0.5%) OPHTH SOLN, 5 ML per d... 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 SODIUM BICARBONATE 8.4% (1 MEQ/ML) INJ SOLN (PFV), 50 ML PER VIAL, RXQ Compou... Lack of Assurance of Sterility Class II RXQ Compounding LLC
Jun 19, 2019 MAGNESIUM CHLORIDE HEXAHYDRATE (PFV) 20% INJ SOLN, 50 ML per vial, RXQ Compou... 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 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 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 ONDANSETRON 2 MG/ML INJECTION SOLUTION (PFV), 2 ML per vial, RXQ Compounding,... Lack of Assurance of Sterility Class II RXQ Compounding LLC
Jun 19, 2019 HYDROMORPHONE 0.2MG/ML IN NACL 0.9% SYR (C-II) , [a) 50 ML NDC 70731-0114-89;... 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 TRAVASOL 10% (AMINO ACID) INJECTION SOLUTION, 50 ML per Vial, RXQ Compounding... Lack of Assurance of Sterility Class II RXQ Compounding LLC
Jun 19, 2019 MORPHINE 1MG/ML IN NACL 0.9% 55ML SYR (C-II), 55 ML per vial, RXQ Compounding... 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 GLUTATHIONE 200MG/ML (MDV) INJECTION SOLN, 30 ML per vial, RXQ Compounding, 3... Lack of Assurance of Sterility Class II RXQ Compounding LLC
Sep 25, 2018 Lidocaine 1% + Epinephrine 1:100,000 (MDV) INJ SOL, 50 mL per glass vial, Rx ... Subpotent drug: During testing of the retention sample, the firm discovered that the product was ... Class II RXQ Compounding LLC
Sep 25, 2017 methylPREDNIsolone ACETATE, 40 MG/ML INJECTION SUSPENSION, 10 ML Vial, RXQ Co... Lack of Assurance of Sterility; autoclave parameters were not correct for one of two autoclaves u... 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.