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Browse Drug Recalls

1,681 FDA drug safety recalls.

FDA Drug Recall Enforcement Database

Browse 1,681 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 1,681 FDA drug recalls in 2018.

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DateProductReasonClassFirm
Sep 10, 2018 Trimix Papaverine/Phentolamine/Alprostadil 30 mg/1 mg/60 mcg Powder Pharm D S... Lack of Assurance of Sterility Class II Pharm D Solutions, LLC
Sep 10, 2018 HCG 3000 Unit Powder, Pharm D Solutions, Houston, Texas --- NDC 69699-1738-10 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 Arginine Injections 100 mcg/mL, Pharm D Solutions, Houston, Texas NDC 69699-1... Lack of Assurance of Sterility Class II Pharm D Solutions, LLC
Sep 10, 2018 Calcium Gluconate 10%, 100 mg/mL Injectable, Pharm D Solutions, Houston, Texa... Lack of Assurance of Sterility Class II Pharm D Solutions, LLC
Sep 10, 2018 Zinc Sulfate 1 mg/mL MDV Injectable, Pharm D Solutions, Houston, Texas --- ND... 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 T105 PGE/Phentolamine/Papaverine 10 mcg/30 mg/1 mg Injectable Pharm D ... 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 HCG Reconstitued 50,000 IU Injectable, Pharm D Solutions, Houston, Texas --- ... Lack of Assurance of Sterility Class II Pharm D Solutions, LLC
Sep 10, 2018 Sermorelin/Ipamorelin 18 mg/15 mg Powder, Pharm D Solutions, Houston, Texas -... 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 Sterile Water 50 mL Aqueous Solution, Pharm D Solutions, Houston, Texas --- N... 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 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 Bi-Mix Injection (Alprostadil 80 mcg/Lidocaine 2 mg/mL) Pharm D Solutions, Ho... Lack of Assurance of Sterility Class II Pharm D Solutions, LLC
Sep 10, 2018 Prostaglandin E1 80 mcg/mL Injectable, Pharm D Solutions, Houston, Texas --- ... Lack of Assurance of Sterility Class II Pharm D Solutions, LLC
Sep 10, 2018 Pyridoxine 100 mg/mL, 30 mL MDV Injectable, Pharm D Solutions, Houston, Texas... Lack of Assurance of Sterility Class II Pharm D Solutions, LLC
Sep 10, 2018 HCG 50,000 unit/0.3 gm Mannitol Lyophilized Powder Pharm D Solutions, Houston... Lack of Assurance of Sterility Class II Pharm D Solutions, LLC
Sep 10, 2018 Sermorelin/GHRP-2/GHRP-6 Mannitol 9 mg/9 mg/9 mg/300 mg Powder, Pharm D Solut... 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 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 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 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 Glutamine 10 mg/mL Solution, Pharm D Solutions, Houston, Texas ---- NDC 69699... 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 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 Trimix Alprostadil/ Phentolamine/Papavarin 40 mcg/1 mg/30 mg 10 mL Injectable... 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 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 Bacteriostatic Water for Injection 10 mL, Pharm D Solutions, Houston, Texas -... Lack of Assurance of Sterility Class II Pharm D Solutions, LLC
Sep 10, 2018 Trimix ST-9B 30 PA-2PH-100A Aqueous Solution Pharm D Solutions, Houston, Texa... Lack of Assurance of Sterility Class II Pharm D Solutions, LLC
Sep 10, 2018 Phentolamine 1 mg/Papaverine 15 mg/Alprostadil 150 mcg Aqueous Solution Pharm... Lack of Assurance of Sterility Class II Pharm D Solutions, LLC
Sep 10, 2018 Levocarnitine 170 mg/mL Injectable, Pharm D Solutions, Houston, Texas --- NDC... 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 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 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 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 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 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 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/Lidocaine 30 mg/1 mg/175 mcg/1 mg ... Lack of Assurance of Sterility Class II Pharm D Solutions, LLC
Sep 10, 2018 Trimix T-106 30PA-1PH-25A Aqueous Solution Pharm D Solutions, Houston, Texas ... Lack of Assurance of Sterility Class II Pharm D Solutions, LLC
Sep 10, 2018 Ascorbic Acid 500 mg/mL Solution Pharm D Solutions, Houston, Texas --- NDC 69... Lack of Assurance of Sterility Class II Pharm D Solutions, LLC
Sep 10, 2018 Acetylcysteine Injection 10 mg/5 mL (2 mg/mL), Pharm D Solutions, Houston, Te... Lack of Assurance of Sterility Class II Pharm D Solutions, LLC
Sep 10, 2018 Glutathione 200 mg/mL Solution, Pharm D Solutions, Houston, Texas --- NDC 696... 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 Methylcobalamin 1 mg/mL a) 10 mL Injectable NDC 69699-1501-10; b) 30 mL Injec... 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

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.