Browse Drug Recalls
6,306 FDA drug safety recalls.
FDA Drug Recall Enforcement Database
Browse 6,306 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 6,306 FDA drug recalls.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| Sep 10, 2018 | Trimix Papaverine/Phentolamine/Alprostadil/Lidocaine 30 mg/1 mg/175 mcg/1 mg ... | Lack of Assurance of Sterility | Class II | Pharm D Solutions, LLC |
| Sep 10, 2018 | Glycerin 72% (Lidocaine/Epi 2:1) Injectable, Pharm D Solutions, Houston, Texa... | Lack of Assurance of Sterility | Class II | Pharm D Solutions, LLC |
| Sep 10, 2018 | Trimix ST9D 30PA-2PH-150A Aqueous Solution Pharm D Solutions, Houston, Texas ... | Lack of Assurance of Sterility | Class II | Pharm D Solutions, LLC |
| Sep 10, 2018 | Trimix Papaverine/Phentolamine/Alprostadil 30 mg/1 mg/20 mcg Powder Pharm D S... | Lack of Assurance of Sterility | Class II | Pharm D Solutions, LLC |
| Sep 10, 2018 | Trimix AT-6 Papa 30 mg/Phent 4 mg/Atrop. 0.3 mg Injectable, Pharm D Solutions... | Lack of Assurance of Sterility | Class II | Pharm D Solutions, LLC |
| Sep 10, 2018 | Trimix ST-1 30PA-1.5PH-50A Aqueous Solution Pharm D Solutions, Houston, Texas... | Lack of Assurance of Sterility | Class II | Pharm D Solutions, LLC |
| Sep 10, 2018 | Phosphate Buffer Solution 0.05 m Aqueous Solution, Pharm D Solutions, Houston... | Lack of Assurance of Sterility | Class II | Pharm D Solutions, LLC |
| Sep 10, 2018 | QM-4A Quadmix 5 mL 30 PA-2PH-150A-Atropine 0.4 mg Aqueous Solution, Pharm D S... | Lack of Assurance of Sterility | Class II | Pharm D Solutions, LLC |
| Sep 10, 2018 | Bi-Mix Injection (Alprostadil 150 mcg/Lidocaine 2 mg/mL), Pharm D Solutions, ... | Lack of Assurance of Sterility | Class II | Pharm D Solutions, LLC |
| Sep 10, 2018 | Trimix BM3 Papaverine 60 mg/Phentolamine 4 mg Injectable, Pharm D Solutions, ... | Lack of Assurance of Sterility | Class II | Pharm D Solutions, LLC |
| Sep 10, 2018 | Oxytocin 30 unit in LR 500 mL 0.06 units/mL IV,Pharm D Solutions, Houston, Te... | Lack of Assurance of Sterility | Class II | Pharm D Solutions, LLC |
| Sep 10, 2018 | Sermorelin/GHRP-2 9 mg/9 mg Powder, Pharm D Solutions, Houston, Texas --- NDC... | Lack of Assurance of Sterility | Class II | Pharm D Solutions, LLC |
| Sep 10, 2018 | Trimix T 101 Alprostadil/Papverine/Phentolamine 5.9 mcg/17.65 mg/0.59 mcg per... | Lack of Assurance of Sterility | Class II | Pharm D Solutions, LLC |
| Sep 10, 2018 | Trimix QM10 Papaverine 30 mg/Phentolamine 4 mg/Atropine 1 mg/PGE 150 mcg/mL I... | Lack of Assurance of Sterility | Class II | Pharm D Solutions, LLC |
| Sep 10, 2018 | HCG Lyopholized 1200 IU Injectable, Pharm D Solutions, Houston, Texas ---- ND... | Lack of Assurance of Sterility | Class II | Pharm D Solutions, LLC |
| Sep 10, 2018 | Calcium Gluconate 2.5% a) 250 mL 25 mg/mL NDC 69699-0908-25; b) Nasal Spray 2... | Lack of Assurance of Sterility | Class III | Pharm D Solutions, LLC |
| Sep 10, 2018 | Trimix T-101 Alprostadil/Phapaverine/Phentolamine 5.9 mcg/17.65 mg/Phentolami... | Lack of Assurance of Sterility | Class II | Pharm D Solutions, LLC |
| Sep 10, 2018 | Phenol 5% and Glycerin Aqueous Solution 10 mL Injection, Pharm D Solutions, H... | Lack of Assurance of Sterility | Class II | Pharm D Solutions, LLC |
| Sep 10, 2018 | Bi-Mix (Papaverine/Phentolamine 150 mg/5 mg) a) Injectable NDC 69699-1760-15;... | Lack of Assurance of Sterility | Class II | Pharm D Solutions, LLC |
| Sep 10, 2018 | Trimix BM3 Papaverine 30 mg/Phentolamine 1 mg Injectable, Pharm D Solutions, ... | Lack of Assurance of Sterility | Class II | Pharm D Solutions, LLC |
| Sep 10, 2018 | 0.9% Sodium Chloride for Injection, 50 mL bags, Pharm D Solutions, Houston, T... | Lack of Assurance of Sterility | Class II | Pharm D Solutions, LLC |
| Sep 10, 2018 | Caffeine and Sodium Benzoate Injection 125 mg/125 mg/mL Injectable Pharm D So... | Lack of Assurance of Sterility | Class II | Pharm D Solutions, LLC |
| Sep 10, 2018 | HCG 4000 Unit Injectable, Pharm D Solutions, Houston, Texas --- NDC 69699-170... | Lack of Assurance of Sterility | Class II | Pharm D Solutions, LLC |
| Sep 10, 2018 | Reck Injection, Pharm D Solutions, Houston, Texas --- NDC 69699-1459-50 | Lack of Assurance of Sterility | Class II | Pharm D Solutions, LLC |
| Sep 10, 2018 | Sermorelin/GHRP-2 9 mg-6 mg Powder, Pharm D Solutions, Houston, Texas --- NDC... | Lack of Assurance of Sterility | Class II | Pharm D Solutions, LLC |
| Sep 10, 2018 | Epinepherine 1 mg/1 mL 3 mL Injectable Pharm D Solutions, Houston, Texas ----... | Lack of Assurance of Sterility | Class II | Pharm D Solutions, LLC |
| Sep 10, 2018 | Calcium Gluconate1% Eyewash 10 mg/mL, 125 mL bottles, Pharm D Solutions, Hou... | Lack of Assurance of Sterility | Class II | Pharm D Solutions, LLC |
| Sep 10, 2018 | Trimix 30-1-30 Papavarin 30 mg/Phentolamine 1 mg/Alprostadil 30 mg/mL Aqueous... | Lack of Assurance of Sterility | Class II | Pharm D Solutions, LLC |
| Sep 10, 2018 | HCG 6000 unit/0.3 gm Mannitol Lyopholized 6000 IU/vial injectable, Pharm D So... | Lack of Assurance of Sterility | Class II | Pharm D Solutions, LLC |
| Sep 10, 2018 | Tri-Mix XL 150 mg/10 mg/100 mcg a) Injectable NDC 69699-1353-10; b) (LYO) Pow... | Lack of Assurance of Sterility | Class II | Pharm D Solutions, LLC |
| Sep 10, 2018 | Magnesium 40 gm/ns 1000 mL IV, Pharm D Solutions, Houston, Texas --- NDC 6969... | Lack of Assurance of Sterility | Class II | Pharm D Solutions, LLC |
| Sep 10, 2018 | Slenderella Compound Injectable, Pharm D Solutions, Houston, Texas --- NDC 69... | Lack of Assurance of Sterility | Class II | Pharm D Solutions, LLC |
| Sep 10, 2018 | Vigamox Oph. Solution Pharm D Solutions, Houston, Texas --- NDC 69699-0304-05 | Lack of Assurance of Sterility | Class II | Pharm D Solutions, LLC |
| Sep 10, 2018 | Trimix Papaverine/Phentolamine/Alprostadil 30 mg/1 mg/10 mcg Powder Pharm D S... | Lack of Assurance of Sterility | Class II | Pharm D Solutions, LLC |
| Sep 10, 2018 | Dexpanthenol Injection, 250 mg/mL Pharm D Solutions, Houston, Texas --- NDC 6... | Lack of Assurance of Sterility | Class II | Pharm D Solutions, LLC |
| Sep 10, 2018 | HCG 10,000 unit/0.3 gm Mannitol Lyopholized, Pharm D Solutions, Houston, Texa... | Lack of Assurance of Sterility | Class II | Pharm D Solutions, LLC |
| Sep 10, 2018 | Sermorelin/GHRP-2 6 mg/6 mg Powder, Pharm D Solutions, Houston, Texas --- NDC... | Lack of Assurance of Sterility | Class II | Pharm D Solutions, LLC |
| Sep 10, 2018 | Testosterone in Grapeseed Oil 200 mg/mL, a) 4 mL, b) 5 mL, c) 10 mL and d) 30... | Lack of Assurance of Sterility | Class II | Pharm D Solutions, LLC |
| Sep 10, 2018 | Bacteriostatic Water for Injection 10 mL, Pharm D Solutions, Houston, Texas -... | Lack of Assurance of Sterility | Class II | Pharm D Solutions, LLC |
| Aug 21, 2018 | CoEnzyme-Q10 injectable, 20 mg/mL, 10 mL Multiple Dose vial, Rx only, Central... | Lack of Assurance of Sterility: Inadequate processes and equipment to assure the sterility of pro... | Class II | Auro Pharmacies, Inc. |
| Aug 21, 2018 | Testosterone Cypionate/Enanthate injectable, 200/50 mg/mL, packaged in a) 5 m... | Lack of Assurance of Sterility: Inadequate processes and equipment to assure the sterility of pro... | Class II | Auro Pharmacies, Inc. |
| Aug 21, 2018 | Methyl-Cobalamin injectable, 10 mg/mL, 30 mL Multiple Dose vial, Rx only, Cen... | Lack of Assurance of Sterility: Inadequate processes and equipment to assure the sterility of pro... | Class II | Auro Pharmacies, Inc. |
| Aug 21, 2018 | Testosterone Cypionate/Enanthate injectable, 126/54 mg/mL, packaged in a) 3 m... | Lack of Assurance of Sterility: Inadequate processes and equipment to assure the sterility of pro... | Class II | Auro Pharmacies, Inc. |
| Aug 21, 2018 | Testosterone Enanthate/Cypionate injectable, 126/54 mg/mL, packaged in a) 3 m... | Lack of Assurance of Sterility: Inadequate processes and equipment to assure the sterility of pro... | Class II | Auro Pharmacies, Inc. |
| Aug 21, 2018 | Methyl-Cobalamin injectable, 5 mg/mL, 30 mL Multiple Dose vial, Rx only, Cent... | Lack of Assurance of Sterility: Inadequate processes and equipment to assure the sterility of pro... | Class II | Auro Pharmacies, Inc. |
| Aug 21, 2018 | Dexpanthenol injectable, 250 mg/mL, 10 mL Single Dose vial, Rx only, Central ... | Lack of Assurance of Sterility: Inadequate processes and equipment to assure the sterility of pro... | Class II | Auro Pharmacies, Inc. |
| Aug 21, 2018 | Folic Acid injectable, 10 mg/ml, 30 ml Multiple Dose vial, Rx only, Central ... | Lack of Assurance of Sterility: Inadequate processes and equipment to assure the sterility of pro... | Class II | Auro Pharmacies, Inc. |
| Aug 21, 2018 | Methyl-Cobalamin injectable, 2 mg/mL, 30 ml Multiple Dose vial, Rx only, Cen... | Lack of Assurance of Sterility: Inadequate processes and equipment to assure the sterility of pro... | Class II | Auro Pharmacies, Inc. |
| Aug 21, 2018 | Methyl-Cobalamin injectable, 1 mg/mL, packaged in a) 5 mL and b) 30 mL Multi... | Lack of Assurance of Sterility: Inadequate processes and equipment to assure the sterility of pro... | Class II | Auro Pharmacies, Inc. |
| Aug 21, 2018 | Glutathione injectable, 200 mg/mL, 30 mL Multiple Dose vial, Rx only, Central... | Lack of Assurance of Sterility: Inadequate processes and equipment to assure the sterility of pro... | Class II | Auro Pharmacies, 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.