Browse Drug Recalls
6,274 FDA drug safety recalls.
FDA Drug Recall Enforcement Database
Browse 6,274 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 6,274 FDA drug recalls.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| Jun 12, 2019 | VELCADE 2.1 mg / 0.84 ml SQ SYRINGE; VELCADE 2.5 MG/ 1 ML SUB-Q SYRINGE; VELC... | Lack of Assurance of Sterility | Class II | Infusion Options, Inc. |
| Jun 12, 2019 | InFLIXimab 300 mg / 250 ml 0.9% NACL IVPB, Rx Only, Infusion Options, Inc. 5... | Lack of Assurance of Sterility | Class II | Infusion Options, Inc. |
| Jun 12, 2019 | Cytarabine 128 MG/250 ML D5W IVPB; Cytarabine 20 MG / 1 ML SQ SYRINGE Cytara... | 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 | 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 | OPDIVO 200 mg /100 ML NS VPB; OPDIVO 480 mg/100 ML NS IVPB, Rx Only, Infusion... | Lack of Assurance of Sterility | Class II | Infusion Options, Inc. |
| Jun 12, 2019 | PACLITAXEL PROTEIN 175 MG/100 ML NS IVPB; PACLITAXEL PROTEIN 190 MG/100 ML NS... | Lack of Assurance of Sterility | Class II | Infusion Options, Inc. |
| Jun 12, 2019 | VINCRISTINE 1 MG /50 ML NS IVPB; VINCRISTINE 1.2 MG /50 ML NACL 0.9% IVPB; VI... | Lack of Assurance of Sterility | Class II | Infusion Options, Inc. |
| Jun 12, 2019 | Adcetris 96 MG/100 ML NS IVPB, Rx Only, Infusion Options, Inc. 5924 13the Ave... | 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 | 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 | Gemcitabine 1910 MG / 250 ML NS IVPB; Gemcitabine 1140 MG / 250 ML NS 0.9% IV... | Lack of Assurance of Sterility | Class II | Infusion Options, Inc. |
| Jun 12, 2019 | SOLIRIS 1200 MG QS 240 ML NACL0.9% IVPB; SOLIRIS 900 MG QS 180 ML NACL 0.9% I... | 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 | HERCEPTIN 400 MG / 250 ML NS IVPB; HERCEPTIN 340 MG /250 ml 0.9% NACL IVPB; H... | 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 | INJECTAFER 720 MG in 100 ml NS IVPB; INJECTAFER 210 MG in 100 ml NS IVPB, Rx ... | Lack of Assurance of Sterility | Class II | Infusion Options, 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 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 23, 2019 | Human Chorionic Gonadotropin 10,000 IU vials, Rx only Pharm D. Solutions 130... | Lack of Sterility Assurance. | Class II | Pharm D Solutions, LLC |
| May 23, 2019 | Nandrolone Decanoate 200 mg/mL Injectable, 10 mL vials, Rx only, Pharm D. Sol... | 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 | 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 | Sermorelin/GHRP-2 &6 (9-9-9 mg) vials, Pharm D. Solutions 1304 South Loop Wes... | Lack of Sterility Assurance. | Class II | Pharm D Solutions, LLC |
| May 23, 2019 | Sermorelin/GHRP-2 & 6 (3-3-3 MG) vials, Pharm D. Solutions 1304 South Loop We... | Lack of Sterility Assurance. | Class II | Pharm D Solutions, LLC |
| May 23, 2019 | Bacteriostatic Water for Injection, 10 mL vials, Pharm D. Solutions 1304 Sout... | Lack of Sterility Assurance. | Class II | Pharm D Solutions, LLC |
| May 23, 2019 | Testosterone Cyp/Pro 95/5%, 10 mL vials, Rx only, Pharm D. Solutions 1304 S... | Lack of Sterility Assurance. | Class II | Pharm D Solutions, LLC |
| May 23, 2019 | B-complex (Thiamine 100mg, Riboflavin 2mg, Niacinamide 100 mg, Pyridoxine 2mg... | 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 | Lipo MIC-12 (Methylcobalamin, USP 1mg, Methionine USP 15mg, Inositol, FCC 50m... | Lack of Sterility Assurance. | Class II | Pharm D Solutions, LLC |
| May 23, 2019 | Sermorelin/GHRP-2 9 mg/9 mg vials Pharm D. Solutions 1304 South Loop West, Ho... | Lack of Sterility Assurance. | Class II | Pharm D Solutions, LLC |
| May 23, 2019 | Sermorelin/GHRP-2 &6 (9-9-9-mg) vials, Pharm D. Solutions 1304 South Loop Wes... | 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 |
| May 23, 2019 | Sermorelin/Ipamorelin 18 mg/15 mg, 10mL vials, Rx only, Pharm D. Solutions 13... | 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 | 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 | Trimix 30mg/1 mg/10mcg/mL ( 30 mg Papaverine, 1mg phentolamine mesylate, 30 m... | Lack of Sterility Assurance. | Class II | Pharm D Solutions, LLC |
| May 21, 2019 | PROCHLORPERAZINE EDISYLATE INJECTION, USP 10 mg/2mL (5mg/mL), 2mL Vial, Rx On... | Non-Sterility:Microbial growth detected in sub lot of Amikacin Sulfate Injection, USP 1gm/4 mL ... | Class I | Heritage Pharmaceuticals, Inc. |
| May 21, 2019 | AMIKACIN SULFATE INJECTION, USP, 1 gram/4 mL (250 mg/ml), 4 mL vial, Rx only,... | Non-Sterility:Microbial growth detected in sub lot of Amikacin Sulfate Injection, USP 1gm/4 mL ... | Class I | Heritage Pharmaceuticals, Inc. |
| May 3, 2019 | Bevacizumab 2.5 mg/0.1 mL, packaged in a Prefilled Syringe, Rx only, AVELLA S... | Lack of assurance of sterility | Class II | Avella of Deer Valley, Inc. Store 38 |
| Apr 30, 2019 | Ketorolac Tromethamine Injection, USP, 60 mg per 2 mL (30 mg per mL), 2 mL V... | Lack of Sterility Assurance: Microbial growth detected during a routine simulation of the manufac... | Class II | Sagent Pharmaceuticals Inc |
| Apr 15, 2019 | Volumex (Iodinated I 131 Albumin) Injection USP, 25 uCi per 1 mL syringe, Rx ... | Lack of Assurance of Sterility: environmental monitoring report exceeds limits, therefore sterili... | Class II | Iso-Tex Diagnostics, Inc |
| Apr 12, 2019 | Phenylephrine 20 mg NS 250 mL bag, Made by: Enterprise Pharmacy, 4400 Golf Ac... | Lack of sterility assurance. | Class II | CMC Enterprise Pharmacy |
| Apr 12, 2019 | Chlorothiazide 100 mg, 3.57 mL syringe, Made by: Enterprise Pharmacy, 4400 Go... | Lack of sterility assurance. | Class II | CMC Enterprise Pharmacy |
| Apr 12, 2019 | CeFAZolin 2 GM a) in NS 100 mL bag; b) 100 mg/mL (20 mL) syringe, Made by: En... | Lack of sterility assurance. | Class II | CMC Enterprise Pharmacy |
| Apr 12, 2019 | Clindamycin 900 mg in NS 50 mL bag, Made by: Enterprise Pharmacy, 4400 Golf A... | Lack of sterility assurance. | Class II | CMC Enterprise Pharmacy |
| Apr 12, 2019 | CefTRIAXone 1 GM, 100 mg/mL, 10 mL syringe, Made by: Enterprise Pharmacy, 440... | Lack of sterility assurance. | Class II | CMC Enterprise Pharmacy |
| Apr 12, 2019 | Magnesium Sulfate 6 GM in NS 50 mL bag, Made by: Enterprise Pharmacy, 4400 Go... | Lack of sterility assurance. | Class II | CMC Enterprise Pharmacy |
| Apr 12, 2019 | Phenylephrine 40 mg in 0.9% Sodium Chloride 250 mL bag, 160 mcg/mL, Made by: ... | Lack of sterility assurance. | Class II | CMC Enterprise Pharmacy |
| Apr 12, 2019 | Alteplase 1 mg/mL 1 mL in 10 mL syringe, Made by: Enterprise Pharmacy, 4400 G... | Lack of sterility assurance. | Class II | CMC Enterprise Pharmacy |
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.