Browse Drug Recalls

18,041 FDA drug safety recalls.

FDA Drug Recall Enforcement Database

Browse 18,041 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 18,041 FDA drug recalls.

DateProductReasonClassFirm
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
May 23, 2019 Human Chorionic Gonadotropin 5,000 IU vials, Rx only, Pharm D. Solutions 1304... Lack of Sterility Assurance. Class II Pharm D Solutions, LLC
May 23, 2019 Testosterone 200 mg/mL, 30 mL vials, Rx only, Pharm D. Solutions 1304 South L... Lack of Sterility Assurance. Class II Pharm D Solutions, LLC
May 23, 2019 Human Chorionic Gonadotropin 12,000 IU vials Pharm D. Solutions 1304 South L... Lack of Sterility Assurance. Class II Pharm D Solutions, LLC
May 23, 2019 Ipamorelin Acetate 9 mg/9mL Injectable vials, Rx only, Pharm D. Solutions 130... Lack of Sterility Assurance. Class II Pharm D Solutions, LLC
May 23, 2019 Testosterone Cypionate 200 mg/mL, in a) 5mL vials and b)10 mL vials, Rx only,... Lack of Sterility Assurance. Class II Pharm D Solutions, LLC
May 23, 2019 Sermorelin/GHRP-2 9 mg/6 mg vials, Rx only, Pharm D. Solutions 1304 South Loo... Lack of Sterility Assurance. Class II Pharm D Solutions, 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.