Browse Drug Recalls
14,449 FDA drug safety recalls.
FDA Drug Recall Enforcement Database
Browse 14,449 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 14,449 FDA drug recalls, Class II.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| Jun 30, 2022 | Succinylcholine Chloride Injection, USP, 200 mg/10 mL (20 mg/mL) syringe, pac... | Lack of Assurance of Sterility | Class II | Nephron Sterile Compounding Center LLC |
| Jun 30, 2022 | Neostigmine Methylsulfate Injection, USP, 4 mg/4 mL (1 mg/mL) syringe, packag... | Lack of Assurance of Sterility | Class II | Nephron Sterile Compounding Center LLC |
| Jun 30, 2022 | HYDROmorphone HCl Injection, USP, 6 mg/30 mL (0.2 mg/mL) syringes, 5 x 30 mL ... | Lack of Assurance of Sterility | Class II | Nephron Sterile Compounding Center LLC |
| Jun 30, 2022 | Rocuronium Bromide Injection, 50 mg/5 mL (10 mg/mL) syringe, packaged in 5 x ... | Lack of Assurance of Sterility | Class II | Nephron Sterile Compounding Center LLC |
| Jun 30, 2022 | Ropivacaine HCl 123 mg (2.46 mg/mL), Clonidine HCl 0.04 mg (0.0008 mg/mL), Ke... | Lack of Assurance of Sterility | Class II | Nephron Sterile Compounding Center LLC |
| Jun 30, 2022 | Amino Acid Injection 50 g/1000 mL (50 mg/mL) bags, Rx Only, Nephron 503B outs... | Lack of Assurance of Sterility | Class II | Nephron Sterile Compounding Center LLC |
| Jun 30, 2022 | Phenylephrine HCl Injection, USP, 1 mg/10 mL (100 mcg/mL) syringe, packaged i... | Lack of Assurance of Sterility | Class II | Nephron Sterile Compounding Center LLC |
| Jun 30, 2022 | Labetalol HCl Injection, USP, 20 mg/4 mL (5 mg/mL) syringe, packaged in 5 x 4... | Lack of Assurance of Sterility | Class II | Nephron Sterile Compounding Center LLC |
| Jun 30, 2022 | Bupivacaine HCl 150 mg (3.0 mg/mL), Ketorolac Tromethamine 60 mg (1.2 mg/mL),... | Lack of Assurance of Sterility | Class II | Nephron Sterile Compounding Center LLC |
| Jun 30, 2022 | 8.4% Sodium Bicarbonate Injection, USP, 4.2 g/50 mL (84 mg/mL) 1 mEq/mL syrin... | Lack of Assurance of Sterility | Class II | Nephron Sterile Compounding Center LLC |
| Jun 30, 2022 | Morphine Sulfate Injection, USP, 30 mg/30 mL (1 mg/mL) syringe, packaged in 5... | Lack of Assurance of Sterility | Class II | Nephron Sterile Compounding Center LLC |
| Jun 30, 2022 | Ketamine HCl Injection, USP, 50 mg/5 mL (10 mg/mL*) syringes, packaged in 5 x... | Lack of Assurance of Sterility | Class II | Nephron Sterile Compounding Center LLC |
| Jun 30, 2022 | Glycopyrrolate Injection, USP, 0.6 mg/3 mL (0.2 mg/mL) syringes, packaged in ... | Lack of Assurance of Sterility | Class II | Nephron Sterile Compounding Center LLC |
| Jun 30, 2022 | Morphine Sulfate Injection, USP, 1 mg/mL syringe, packaged in 5 x 1 mL Pre-Fi... | Lack of Assurance of Sterility | Class II | Nephron Sterile Compounding Center LLC |
| Jun 30, 2022 | Phenylephrine HCl Injection, USP, 0.8 mg/10 mL (80 mcg/mL)syringe, packaged i... | Lack of Assurance of Sterility | Class II | Nephron Sterile Compounding Center LLC |
| Jun 30, 2022 | HYDROmorphone HCl Injection, USP, 10 mg/50 mL (0.2 mg/mL) syringes, 5 x 50 mL... | Lack of Assurance of Sterility | Class II | Nephron Sterile Compounding Center LLC |
| Jun 30, 2022 | del Nido Cardioplegia Solution 1000 mL (1000 mL) Single-Dose Container IV bag... | Lack of Assurance of Sterility | Class II | Nephron Sterile Compounding Center LLC |
| Jun 30, 2022 | EPINEPHrine Injection, USP, 0.1 mg/10 mL (10 mcg/mL) syringes, 5 x 10 mL Pre-... | Lack of Assurance of Sterility | Class II | Nephron Sterile Compounding Center LLC |
| Jun 30, 2022 | Lidocaine HCl Injection, USP 2%, 100 mg/5 mL (20 mg/mL) syringe, packaged in ... | Lack of Assurance of Sterility | Class II | Nephron Sterile Compounding Center LLC |
| Jun 30, 2022 | Oxytocin 30 Units/500 mL (0.06 Units/mL) in 0.9% Sodium Chloride Injection, U... | Lack of Assurance of Sterility | Class II | Nephron Sterile Compounding Center LLC |
| Jun 30, 2022 | EPINEPHrine Injection, USP, 1 mg/10 mL (100 mcg/mL) syringe, packaged in 5 x ... | Lack of Assurance of Sterility | Class II | Nephron Sterile Compounding Center LLC |
| Jun 30, 2022 | Ketamine HCl Injection, USP, 50 mg/1 mL (50 mg/mL*) syringe, packaged in 5 x ... | Lack of Assurance of Sterility | Class II | Nephron Sterile Compounding Center LLC |
| Jun 30, 2022 | Lidocaine HCl Injection, USP 1%, 50 mg/5 mL (10 mg/mL) syringe, packaged in 5... | Lack of Assurance of Sterility | Class II | Nephron Sterile Compounding Center LLC |
| Jun 30, 2022 | 0.9% Buffered Lidocaine HCl (buffered in 8.4% Sodium Bicarbonate), 45 mg/5 mL... | Lack of Assurance of Sterility | Class II | Nephron Sterile Compounding Center LLC |
| Jun 30, 2022 | Anticoagulant Sodium Citrate Solution, USP 4%, 200 mg/5 mL (40 mg/mL) syringe... | Lack of Assurance of Sterility | Class II | Nephron Sterile Compounding Center LLC |
| Jun 30, 2022 | Neostigmine Methylsulfate Injection, USP, 3 mg/3 mL (1 mg/mL) syringe, packag... | Lack of Assurance of Sterility | Class II | Nephron Sterile Compounding Center LLC |
| Jun 29, 2022 | Naphcon A eye drops, Naphazoline HCl 0.025% and Pheniramine Maleate 0.3%, Red... | CGMP Deviations: products were stored outside the drug label specifications. | Class II | Mckesson Medical-Surgical Inc. Corporate Office |
| Jun 29, 2022 | Bisacodyl Suppositories, Fast Acting Stimulant Laxative, 100 suppositories pe... | CGMP Deviations: products were stored outside the drug label specifications. | Class II | Mckesson Medical-Surgical Inc. Corporate Office |
| Jun 29, 2022 | Systane, Lubricant Eye Drops, Polyethylene Glycol 400 0.4% Lubricant, Propyle... | CGMP Deviations: products were stored outside the drug label specifications. | Class II | Mckesson Medical-Surgical Inc. Corporate Office |
| Jun 29, 2022 | Systane Balance, Lubricant Eye Drops, Propylene Glycol 0.6% lubricant, Restor... | CGMP Deviations: products were stored outside the drug label specifications. | Class II | Mckesson Medical-Surgical Inc. Corporate Office |
| Jun 29, 2022 | Debrox, Carbamide Peroxide, Earwax Removal Aid, 0.5 FL OZ (15 mL) bottle per ... | CGMP Deviations: products were stored outside the drug label specifications. | Class II | Mckesson Medical-Surgical Inc. Corporate Office |
| Jun 29, 2022 | A&D Original Ointment, Diaper Rash Ointment & Skin Protectant, 16 oz. Jar, Ba... | CGMP Deviations: products were stored outside the drug label specifications. | Class II | Mckesson Medical-Surgical Inc. Corporate Office |
| Jun 29, 2022 | Telmisartan and Hydrochlorothiazide Tablets USP, 80 mg/12.5 mg, 30 Tablets, R... | Defective Container: Recall of these batches has been initiated due to complaints of difficult t... | Class II | Glenmark Pharmaceuticals Inc., USA |
| Jun 29, 2022 | Desmopressin Acetate Tablets, 0.2 mg, 100-count bottles, Rx Only, Manufacture... | CGMP Deviations | Class II | Glenmark Pharmaceuticals Inc., USA |
| Jun 29, 2022 | Sterile Alcohol Prep Pads, Sterile, Latex Free, 100 large pads per box, manuf... | CGMP Deviations: products were stored outside the drug label specifications. | Class II | Mckesson Medical-Surgical Inc. Corporate Office |
| Jun 29, 2022 | Telmisartan and Hydrochlorothiazide Tablets USP, 80 mg/25 mg, 30 Tablets, Rx ... | Defective Container: Recall of these batches has been initiated due to complaints of difficult t... | Class II | Glenmark Pharmaceuticals Inc., USA |
| Jun 29, 2022 | Systane Zaditor, ketotifen fumarate ophthalmic solution 0.035%, Antihistamine... | CGMP Deviations: products were stored outside the drug label specifications. | Class II | Mckesson Medical-Surgical Inc. Corporate Office |
| Jun 29, 2022 | Pataday, Once Daily Relief, Olopatadine hydrochloride ophthalmic solution 0.2... | CGMP Deviations: products were stored outside the drug label specifications. | Class II | Mckesson Medical-Surgical Inc. Corporate Office |
| Jun 29, 2022 | Miralax (Polyethylene Glycol 3350), Powder for Solution, Osmotic Laxative, 30... | CGMP Deviations: products were stored outside the drug label specifications. | Class II | Mckesson Medical-Surgical Inc. Corporate Office |
| Jun 29, 2022 | Triple Antibiotic Ointment, Bacitracin zinc, Neomycin sulfate, Polymixin B su... | CGMP Deviations: products were stored outside the drug label specifications. | Class II | Mckesson Medical-Surgical Inc. Corporate Office |
| Jun 29, 2022 | Eye-stream, eye wash solution, sterile, 4 FL OZ (118 mL) bottle per box, Alco... | CGMP Deviations: products were stored outside the drug label specifications. | Class II | Mckesson Medical-Surgical Inc. Corporate Office |
| Jun 29, 2022 | Alcohol Swabsticks, Antiseptic, 50 4" saturated individual packets per box, M... | CGMP Deviations: products were stored outside the drug label specifications. | Class II | Mckesson Medical-Surgical Inc. Corporate Office |
| Jun 29, 2022 | Dakin's Solution, a) sodium hypochlorite 0.125%, quarter strength, NDC 0436-0... | CGMP Deviations: products were stored outside the drug label specifications. | Class II | Mckesson Medical-Surgical Inc. Corporate Office |
| Jun 29, 2022 | Asthmanefrin Racephinephrine Inhalation Solution Bronchodilator, For temporar... | CGMP Deviations: products were stored outside the drug label specifications. | Class II | Mckesson Medical-Surgical Inc. Corporate Office |
| Jun 29, 2022 | Racepinephrine Inhalation Solution, USP 2.25%, Bronchodilator, For Oral Inhal... | CGMP Deviations: products were stored outside the drug label specifications. | Class II | Mckesson Medical-Surgical Inc. Corporate Office |
| Jun 29, 2022 | Testosterone Gel 1% (25mg testosterone/2.5g of gel) 2.5 g per unit dose, Rx O... | Superpotent Drug: Out of specification assay result was obtained during stability testing. | Class II | Teva Pharmaceuticals USA Inc |
| Jun 29, 2022 | GenTeal Tears, Lubricant Eye Ointment, Night-Time Ointment, Sterile, 3.5 gm (... | CGMP Deviations: products were stored outside the drug label specifications. | Class II | Mckesson Medical-Surgical Inc. Corporate Office |
| Jun 28, 2022 | Hydrogen Peroxide Topical Solution USP, 3%, 16 FL OZ (1 PT) 473 mL bottle, pa... | Cross Contamination With Other Products: Product is cross contaminated with low levels of isoprop... | Class II | Vi-Jon, LLC |
| Jun 27, 2022 | Divalproex Sodium Delayed-Release Tablets, USP 500mg, Rx Only, 100 Tablets, D... | Failed Dissolution Specifications: Failure occurred during routine stability testing of dissoluti... | Class II | SUN PHARMACEUTICAL INDUSTRIES INC |
| Jun 27, 2022 | Launch Sequence Aphrodisia Capsules, 4-count tins, ASIN B07QB3S2LV, UPC Code ... | Marketed Without An Approved NDA/ANDA: Unapproved Drug based on label claims. | Class II | Loud Muscle Science |
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.