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 |
|---|---|---|---|---|
| Jun 21, 2019 | Dayma SUPER FORTE XL10 (Camphor 0.5%, Menthol 2%, Methyl Salicylate 2%) Pain ... | CGMP Deviations: products were manufactured with lack of process validation, cleaning validation,... | Class II | Pharma-Natural Inc. |
| Jun 21, 2019 | DOUBLE TUSSIN DM (Dextromethorphan Hbr 20 mg, Guaifenesin 300 mg) in each 5ml... | CGMP Deviations: products were manufactured with lack of process validation, cleaning validation,... | Class II | Pharma-Natural Inc. |
| Jun 21, 2019 | ARMY HEALTH Pain Reliever Gel With CURCUMIN (Menthol 3.00%), 0.5 OZ jar, Manu... | CGMP Deviations: products were manufactured with lack of process validation, cleaning validation,... | Class II | Pharma-Natural Inc. |
| Jun 21, 2019 | AbeeMed cream (Menthol 1.48% and Histamine DHCL 0.05%), 2 OZ jar, Manufacture... | CGMP Deviations: products were manufactured with lack of process validation, cleaning validation,... | Class II | Pharma-Natural Inc. |
| Jun 21, 2019 | Workvie Instant Pain Relieving Roll On (Lidocaine HCL 4% + Menthol 1% & Arnic... | CGMP Deviations: products were manufactured with lack of process validation, cleaning validation,... | Class II | Pharma-Natural Inc. |
| Jun 21, 2019 | SORBUGEN NR (Dextromethorphan HBr, 15 mg; Glyceryl Guaiacolate (Guaifenesin),... | CGMP Deviations: products were manufactured with lack of process validation, cleaning validation,... | Class II | Pharma-Natural Inc. |
| Jun 21, 2019 | LidoAID (Lidocaine HCL 4%) portable pain relieving TOPICAL ANALGESIC GEL, 0.1... | CGMP Deviations: products were manufactured with lack of process validation, cleaning validation,... | Class II | Pharma-Natural Inc. |
| Jun 21, 2019 | Oliver's Harvest CBD+Lidocaine HCL 4% Pain Relief (Lidocaine HCL 4%) Topical ... | CGMP Deviations: products were manufactured with lack of process validation, cleaning validation,... | Class II | Pharma-Natural Inc. |
| Jun 21, 2019 | Lid O Creme (Lidocaine HCL 4% and Menthol 1%) Topical Analgesic Cream, 2.5 Oz... | CGMP Deviations: products were manufactured with lack of process validation, cleaning validation,... | Class II | Pharma-Natural Inc. |
| Jun 20, 2019 | Losartan Potassium Tablets 50 mg 1000 Tablets, USP Rx Only Manufactured for:... | CGMP Deviations: impurity for N-Nitroso-N-methyl-4-aminobutyric acid (NMBA) detected in the activ... | Class II | Macleods Pharma Usa Inc |
| Jun 20, 2019 | Losartan Potassium and Hydrochlorothiazide Tablets, USP 50 mg/12.5 mg 90 Tabl... | CGMP Deviations: impurity for N-Nitroso-N-methyl-4-aminobutyric acid (NMBA) detected in the activ... | Class II | Macleods Pharma Usa Inc |
| Jun 20, 2019 | Losartan Potassium Tablets, USP 50 mg 90 tablets Rx Only Manufactured for: Ma... | CGMP Deviations: impurity for N-Nitroso-N-methyl-4-aminobutyric acid (NMBA) detected in the activ... | Class II | Macleods Pharma Usa Inc |
| Jun 20, 2019 | Losartan Potassium and Hydrochlorothiazide Tablets, USP 100 mg/12.5 mg 90 Tab... | CGMP Deviations: impurity for N-Nitroso-N-methyl-4-aminobutyric acid (NMBA) detected in the activ... | Class II | Macleods Pharma Usa Inc |
| Jun 20, 2019 | Losartan Potassium andHydrochlorothiazide Tablets 100 mg/25 mg 90 tablets, US... | CGMP Deviations: impurity for N-Nitroso-N-methyl-4-aminobutyric acid (NMBA) detected in the activ... | Class II | Macleods Pharma Usa Inc |
| Jun 19, 2019 | BUFFERED LIDOCAINE 1%+EPI 1:100,000 INJ SOL, [3ML NDC: 70731-0137-03 and 30M... | Lack of Assurance of Sterility | Class II | RXQ Compounding LLC |
| Jun 19, 2019 | PREDNISOLONE 1%, MOXIFLOXACIN 0.5% OPHTH SOL, 5ML per dropper bottle, RXQ Com... | 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 | 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 | 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 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 | Ascorbic Acid 500 MG/ML (Non-Corn) INJ (MDV), 50 mL per vial, RXQ Compounding... | Crystallization | Class II | RXQ Compounding LLC |
| Jun 19, 2019 | STERILE WATER FOR INJECTION USP, [10, 30, or 50 ML] per Vial, RXQ Compounding... | Lack of Assurance of Sterility | Class II | RXQ Compounding LLC |
| Jun 19, 2019 | Ascorbic Acid 400 MG/ML (Non-Corn) Injection Solution, 65 mL per vial, RXQ Co... | Crystallization | Class II | RXQ Compounding LLC |
| Jun 19, 2019 | DIMERCAPTO-PROPANESULFONIC 5% (DMPS)( (PFV) INJ SOL, 5 ML per vial, RXQ Compo... | 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 |
| Jun 19, 2019 | KETAMINE 50 MG/ML (NPV) INJECTION SOLUTION (C-III), 10 ML per vial, RXQ Compo... | 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 | 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 | 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 | 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 | 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 | 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 | 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 | Copper 0.4MG/ML (PVF) INJECTION SOLUTION, 10 ML per vial, RXQ Compounding, 34... | Lack of Assurance of Sterility | Class II | RXQ Compounding LLC |
| Jun 19, 2019 | ROPIVICAINE 0.2%, INJ SOLN, 550 ML ON-Q PUMP. RXQ Compounding, 340 West State... | Lack of Assurance of Sterility | Class II | RXQ Compounding LLC |
| Jun 19, 2019 | Ascorbic Acid 500 MG/ML (Non-Corn) Injection (PFV), 50 mL per vial, RXQ Compo... | Crystallization | Class II | RXQ Compounding LLC |
| Jun 19, 2019 | MAGNESIUM 200 MG/ML/ CALCIUM GLUC 6MG/ML/ ZINC 1MG/ML, 5ML per vial, RXQ Comp... | Lack of Assurance of Sterility | Class II | RXQ Compounding LLC |
| Jun 19, 2019 | CYANCOBALAMIN 1200MCG/ML MDV INJECTION, 30 ML per vial, RXQ Compounding, 340 ... | Lack of Assurance of Sterility | Class II | RXQ Compounding LLC |
| 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 | 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 | 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 | 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 CALCIUM DISODIUM 150MG/ML INJECTABLE, 100 ML per vial, RXQ Compoundin... | 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 |
| 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 | 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 | 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 | 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 | 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 | ONDANSETRON 2 MG/ML INJECTION SOLUTION (PFV), 2 ML per vial, RXQ Compounding,... | 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.