Browse Drug Recalls
17,897 FDA drug safety recalls.
FDA Drug Recall Enforcement Database
Browse 17,897 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 17,897 FDA drug recalls.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| Jun 26, 2019 | Testosterone Cypionate 150 mg/mL Sesame Oil Injection, 12 mL vial, Rx only, ... | Lack of Assurance of Sterility. | Class II | First Pharma Associates LLC dba Riverpoint Phar... |
| Jun 26, 2019 | PAP/PHEN/PGE1 30 mg/0.83mg/10mcg/mL Injection, 5 mL, Rx only, First Pharma As... | Lack of Assurance of Sterility. | Class II | First Pharma Associates LLC dba Riverpoint Phar... |
| Jun 26, 2019 | Glutathione 100 mg/mL Inhalation Solution (PF), 45 mL vial, Rx only, First P... | Lack of Assurance of Sterility. | Class II | First Pharma Associates LLC dba Riverpoint Phar... |
| Jun 26, 2019 | Testosterone Cyp/Estradiol Cyp 50 mg/2.5 mg/mL Injection, 3mL vial, Rx only, ... | Lack of Assurance of Sterility. | Class II | First Pharma Associates LLC dba Riverpoint Phar... |
| Jun 25, 2019 | Smart Sense Regular Strength Aspirin Tablets, 325 mg packed in a) 100 count U... | Labeling; Incorrect or Missing Lot Number and/or Exp Date; Product has an incorrect expiration da... | Class III | AAA Pharmaceutical, Inc. |
| Jun 24, 2019 | Acetaminophen Children's Liquid, 160 mg/5 mL, 4 oz bottle, Manufactured by To... | Microbial Contamination of Non-sterile Products: Potential product contamination with Burkholderi... | Class II | H J Harkins Company Inc dba Pharma Pac |
| Jun 24, 2019 | Diphenhydramine HCL Liquid, 12.5 mg/5 mL, 4 oz bottle, Manufactured by Torren... | Microbial Contamination of Non-sterile Products: Potential product contamination with Burkholderi... | Class II | H J Harkins Company Inc dba Pharma Pac |
| 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 21, 2019 | TUSSLIN (Dextromethorphan HBr, 28 mg; Guaifenesin, 388 mg; Phenylephrine HCl,... | CGMP Deviations: products were manufactured with lack of process validation, cleaning validation,... | Class II | Pharma-Natural Inc. |
| Jun 21, 2019 | Lido E.R. (Lidocaine HCL 4%) Pain Relieving Topical Analgesic Cream, 4 oz (11... | CGMP Deviations: products were manufactured with lack of process validation, cleaning validation,... | Class II | Pharma-Natural Inc. |
| Jun 21, 2019 | NEOGEN-D (Dextromethorphan HBr, 30 mg; Guaifenesin, 200 mg; Phenylephrine HCl... | CGMP Deviations: products were manufactured with lack of process validation, cleaning validation,... | Class II | Pharma-Natural Inc. |
| Jun 21, 2019 | Dermanak original crema blanqueador (Hydroquinone 2%) Skin Fade Cream, 2 OZ. ... | CGMP Deviations: products were manufactured with lack of process validation, cleaning validation,... | Class II | Pharma-Natural Inc. |
| Jun 21, 2019 | Oliver's Harvest CBD+Capsaicin 0.2% Pain Relief (Capsaicin 0.2%) Topical Anal... | CGMP Deviations: products were manufactured with lack of process validation, cleaning validation,... | Class II | Pharma-Natural Inc. |
| Jun 21, 2019 | ARMY HEALTH With CURCUMIN (Menthol 3.00%) Pain Reliever Roll-On, 2.5 FL OZ (7... | CGMP Deviations: products were manufactured with lack of process validation, cleaning validation,... | Class II | Pharma-Natural Inc. |
| Jun 21, 2019 | GENCONTUSS (Chlorpheniramine Maleate, 2mg; Dextromethorphan HBr, 10 mg; Pheny... | CGMP Deviations: products were manufactured with lack of process validation, cleaning validation,... | Class II | Pharma-Natural Inc. |
| 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 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 | 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 | 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 | 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 | HYDROXOCOBALAMIN 1000 MCG/ML (PFV), 10 ML per vial, RXQ Compounding, 340 West... | Lack of Assurance of Sterility | Class II | RXQ Compounding LLC |
| Jun 19, 2019 | Edetate Disodium150mg/mL PFV, 10 ML per Vial, RXQ Compounding, 340 West State... | Lack of Assurance of Sterility | Class II | RXQ Compounding LLC |
| Jun 19, 2019 | BUFFERED LIDOCAINE HCL 1% INJECTION SOLUTION (PF), 10ML per vial, RXQ Compoun... | 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 | 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 | 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 | FOLIC ACID 5MG/ML INJECTION SOLUTION (MDV), 10 ML per vial, RXQ Compounding, ... | Lack of Assurance of Sterility | Class II | RXQ Compounding LLC |
| 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 |
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.