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 12, 2019 | NIVOLUMAB 480 MG / 100 ML NS IVPB; NIVOLUMAB 200 mg / 100 ML NS IVPB; NIVOLUM... | Lack of Assurance of Sterility | Class II | Infusion Options, Inc. |
| Jun 12, 2019 | AZACITIDINE 125 MG / 5 ML SUB-Q SYRINGE; AZACITIDINE 75 MG (3 ML) SYRINGE, AZ... | Lack of Assurance of Sterility | Class II | Infusion Options, Inc. |
| Jun 12, 2019 | RITUXIMAB 575 MG / 250 ml 0.9% NACL IVPB; RITUXIMAB 675 MG / 250 ml 0.9% NACL... | Lack of Assurance of Sterility | Class II | Infusion Options, Inc. |
| Jun 12, 2019 | ORENCIA 750 mg QS 100 ml 0.9% NACL IVPB, Rx Only, Infusion Options, Inc. 5924... | Lack of Assurance of Sterility | Class II | Infusion Options, Inc. |
| Jun 12, 2019 | PANITUMUMAB 400 MG / 100 ml NS IVPB, Rx Only, Infusion Options, Inc. 5924 13t... | Lack of Assurance of Sterility | Class II | Infusion Options, Inc. |
| Jun 12, 2019 | DARZALEX 1008 MG / 500 ML NS IVPB, Rx Only, Infusion Options, Inc. 5924 13the... | Lack of Assurance of Sterility | Class II | Infusion Options, Inc. |
| Jun 12, 2019 | Oxytocin 60 units/1000 mL Lactated Ringers Intravenous Solution, Rx Only, Inf... | Lack of Assurance of Sterility | Class II | Infusion Options, Inc. |
| Jun 12, 2019 | CARBOPLATIN 174 MG / 250ml NS IVPB; CARBOPLATIN 240 MG / 250 ML NS IVPB; CARB... | Lack of Assurance of Sterility | Class II | Infusion Options, Inc. |
| Jun 12, 2019 | Fluorouracil 560 MG / 11.2 ML IVP; Fluorouracil 3340 MG QS 92 ML 0.9% NACL; F... | Lack of Assurance of Sterility | Class II | Infusion Options, Inc. |
| Jun 12, 2019 | DECITABINE 40 MG / 100 ml NS IVPB, Rx Only, Infusion Options, Inc. 5924 13the... | Lack of Assurance of Sterility | Class II | Infusion Options, Inc. |
| Jun 12, 2019 | ERIBULIN 1.12 MG / 100 ML NS IVPB; ERIBULIN 1.87 MG / 100 ML NS IVPB; ERIBUL... | Lack of Assurance of Sterility | Class II | Infusion Options, Inc. |
| Jun 12, 2019 | CETUXIMAB 335 MG / 167.5 ML IVPB, Rx Only, Infusion Options, Inc. 5924 13the ... | Lack of Assurance of Sterility | Class II | Infusion Options, Inc. |
| Jun 12, 2019 | OXALIPLATIN 145 MG /250 ML D5W IVPB; OXALIPLATIN 154 MG / 250 ML D5W IVPB; OX... | Lack of Assurance of Sterility | Class II | Infusion Options, Inc. |
| Jun 12, 2019 | CALCIUM GLUCONATE 1 GM /100 ML NACL 0.9% IVPB, Rx Only, Infusion Options, Inc... | Lack of Assurance of Sterility | Class II | Infusion Options, Inc. |
| Jun 12, 2019 | PEMBROLIZUMAB 200 MG / 100 ML NS IVPB, Rx Only, Infusion Options, Inc. 5924 1... | Lack of Assurance of Sterility | Class II | Infusion Options, Inc. |
| Jun 12, 2019 | Testosterone Topical Solution 30mg of testosterone per pump actuation * each ... | Defective Container; actuator may improperly function and affect dose delivery. | Class III | InvaGen Pharmaceuticals, Inc. |
| Jun 10, 2019 | Robafen DM, Generic for Robitussin DM, In each teaspoonful (5mL): Dextrometho... | CGMP Deviations: Potential product contamination with Burkholderia cepacia (B.cepacia) and Ralsto... | Class II | Preferred Pharmaceuticals, Inc |
| Jun 7, 2019 | Myorisan (isotretinoin capsules, USP), 40 mg, packaged in cartons of 30 Capsu... | Labeling: Label mix-up: Product secondary carton erroneously states 40mg instead of 30 mg, primar... | Class III | Akorn Inc |
| Jun 7, 2019 | Hydromorphone HCl in 0.9% sodium chloride, 0.5mg per mL, 1 mL in 3mL BD Syri... | Incorrect Product Formulation; Firm's customer resource center (CRC) statement indicates that the... | Class I | PharMEDium Services, LLC |
| Jun 6, 2019 | LOSARTAN POTASSIUM 50 mg TABLET BULK 90 count bottles and 1000 count bottles... | CGMP Deviations: impurity for N-Nitroso-N-methyl-4-aminobutyric acid (NMBA) detected in the activ... | Class II | Teva Pharmaceuticals USA |
| Jun 6, 2019 | LOSARTAN POTASSIUM 100 mg TABLET BULK 90 count bottles, NDC 00591-3747-00 | CGMP Deviations: impurity for N-Nitroso-N-methyl-4-aminobutyric acid (NMBA) detected in the activ... | Class II | Teva Pharmaceuticals USA |
| Jun 5, 2019 | Allergy Relief D, Fexofenadine HCl 60 mg/ Pseudoephedrine HCl 120 mg, Exten... | Testing of Fexofenadine HCl and Pseudoephedrine Failed Impurities/Degradation Specifications: ele... | Class II | Sun Pharmaceutical Industries, Inc. |
| Jun 5, 2019 | Cetirizine Oral Solution 1 mg/mL, Up & Up, Children's allergy relief, Antihis... | cGMP Deviations: Firm was notified by their supplier of Cetirizine HCL Oral Solution, USP, 1mg/mL... | Class II | P & L Developments, LLC |
| Jun 5, 2019 | Cetirizine HCL Oral Solution 1 mg/mL, Children's Allergy, Antihistamine, Dye ... | cGMP Deviations: Firm was notified by their supplier of Cetirizine HCL Oral Solution, USP, 1mg/mL... | Class II | P & L Developments, LLC |
| Jun 5, 2019 | Cetirizine Oral Solution 1 mg/mL, Children's Allergy, Antihistamine, Dye Free... | cGMP Deviations: Firm was notified by their supplier of Cetirizine HCL Oral Solution, USP, 1mg/mL... | Class II | P & L Developments, LLC |
| Jun 5, 2019 | Allergy Relief D, Fexofenadine HCl 60 mg/ Pseudoephedrine HCl 120 mg, Extende... | Testing of Fexofenadine HCl and Pseudoephedrine Failed Impurities/Degradation Specifications: ele... | Class II | Sun Pharmaceutical Industries, Inc. |
| Jun 5, 2019 | Wal-Fex D Fexofenadine HCl 60 mg/ Pseudoephedrine HCl 120 mg, Extended-Releas... | Testing of Fexofenadine HCl and Pseudoephedrine Failed Impurities/Degradation Specifications: ele... | Class II | Sun Pharmaceutical Industries, Inc. |
| Jun 5, 2019 | Wal-Fex D Fexofenadine HCl 60 mg/ Pseudoephedrine HCl 120 mg/ Extended-Relea... | Testing of Fexofenadine HCl and Pseudoephedrine Failed Impurities/Degradation Specifications: ele... | Class II | Sun Pharmaceutical Industries, Inc. |
| Jun 3, 2019 | Estradiol Vaginal Inserts USP 10 mcg, packaged in box of 8 Vaginal Inserts (... | Defective Delivery System: Estradiol Vaginal Inserts USP plunger is not functioning properly. | Class II | Glenmark Pharmaceuticals Inc., USA |
| May 31, 2019 | Preferred Plus Dioctyl Liquid Stool Softener (Docusate Sodium), 50mg/5mL, 16 ... | cGMP Deviations: Products may have microbial contamination. | Class II | Geritrex, LLC |
| May 31, 2019 | Zileuton Extended-Release Tablets, 600 mg, 120-count bottles, Rx only, Distri... | Failed Dissolution Specifications: Out of specification result for dissolution. | Class II | Chiesi USA, Inc. |
| May 31, 2019 | Gericare Geri-Tussin DM, 16 FL OZ (473 mL), Geri-care Phamaceuticals Corp. 16... | cGMP Deviations: Products may have microbial contamination. | Class II | Geritrex, LLC |
| May 31, 2019 | Gericare Diocto Liquid Docusate Sodium Stool Softener, 50 mg/5mL, 16 FL OZ (4... | cGMP Deviations: Products may have microbial contamination. | Class II | Geritrex, LLC |
| May 31, 2019 | Diphenhydramine Oral Liquid Alcohol Free, 12.5 mg/5 mL, 4 fl oz (118 mL), RIJ... | cGMP Deviations: Products may have microbial contamination. | Class II | Geritrex, LLC |
| May 31, 2019 | Gericare Iron Supplement Elixir Ferrous Sulfate, 220 mg, 16 fl oz. (473 mL), ... | cGMP Deviations: Products may have microbial contamination. | Class II | Geritrex, LLC |
| May 31, 2019 | Ritussin DM Double Strength, 4 FL. OZ. (118 mL), RIJ Pharmaceutical Corporati... | cGMP Deviations: Products may have microbial contamination. | Class II | Geritrex, LLC |
| May 31, 2019 | ZYFLO CR (zileuton) extended-release tablets, 600 mg, 120-count bottles, Rx o... | Failed Dissolution Specifications: Out of specification result for dissolution. | Class II | Chiesi USA, Inc. |
| May 31, 2019 | Ritussin DM Children & Adults, 4 Fl. Oz. (118 mL), RIJ Pharmaceutical Corpora... | cGMP Deviations: Products may have microbial contamination. | Class II | Geritrex, LLC |
| May 31, 2019 | Preferred Plus Pharmacy Iron Elixir Ferrous Sulfate, 220 mg, 16 fl oz. (473 m... | cGMP Deviations: Products may have microbial contamination. | Class II | Geritrex, LLC |
| May 30, 2019 | Memorial Central TPN. Rx Only, Rx # specific and Patient Specific volumes. M... | Lack of sterility assurance. | Class II | Surgery Pharmacy Services Inc |
| May 30, 2019 | Trisodium Citrate 0.5% CRRT SOLUTION. RX Only. Rx # specific and Patient Spec... | Lack of sterility assurance. | Class II | Surgery Pharmacy Services Inc |
| May 28, 2019 | Sn-Pyrophosphate Kit, 11.9 mg sodium pyrophosphate, Not for Direct Injection,... | Lack of Processing Controls. | Class II | Synthetopes Inc |
| May 28, 2019 | Pentreotide (10 uGm), Not for Direct Injection, Synthetopes, Inc. | Lack of Processing Controls. | Class II | Synthetopes Inc |
| May 28, 2019 | Sn-DMSA solution, Store Frozen, Not for Direct Injection, Synthetopes, Inc. | Lack of Processing Controls. | Class II | Synthetopes Inc |
| May 28, 2019 | Sn-d, l-Exametazime (Sn-d,l-HMPAO), Not for Direct Injection, Store Below 25 ... | Lack of Processing Controls. | Class II | Synthetopes Inc |
| May 28, 2019 | Pecgen DMX Cough Suppressant Expectorant, Contains the same active ingredient... | Labeling: Incorrect Instructions; The product has been found to provide incorrect dosage informat... | Class I | Novis PR, Inc. |
| May 28, 2019 | Sn-DTPA Kit 10 mg, DTPA, Not for Direct Injection, Store at Room Temperature,... | Lack of Processing Controls. | Class II | Synthetopes Inc |
| May 28, 2019 | Sn-Tetrofosmin Kit 5.0 mL, Thaw and Vent before use, Not for Direct Injection... | Lack of Processing Controls. | Class II | Synthetopes Inc |
| May 28, 2019 | Sn-Mertiatide Kit,1 milligram betiatide, Not for Direct Injection, Store at R... | Lack of Processing Controls. | Class II | Synthetopes Inc |
| May 28, 2019 | Sulfur Colloid Reaction Vial 1.0 mL, Thaw Before Use, Not for Direct Injectio... | Lack of Processing Controls. | Class II | Synthetopes 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.