Browse Drug Recalls

18,008 FDA drug safety recalls.

FDA Drug Recall Enforcement Database

Browse 18,008 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 18,008 FDA drug recalls.

DateProductReasonClassFirm
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 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 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 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 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, 0.4 mg/10 mL (40 mcg/mL) syringe, packaged ... 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 Fentanyl Citrate in 0.9% Sodium Chloride Injection, USP, 2500 mcg/250 mL (10 ... 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 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 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 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 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 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 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 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 Atropine Sulfate Injection, USP 1.2 mg/3 mL (0.4 mg/mL) syringe, packaged in ... 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 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 Morphine Sulfate Injection, USP, 50 mg/50 mL (1 mg/mL) syringe, packaged in 5... 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 Glycopyrrolate Injection, USP, 1 mg/5 mL (0.2 mg/mL) syringes, packaged in 5 ... Lack of Assurance of Sterility Class II Nephron Sterile Compounding Center LLC
Jun 30, 2022 HYDROmorphone HCl Injection, USP, 50 mg/50 mL (1 mg/mL) syringes, packaged in... Lack of Assurance of Sterility Class II Nephron Sterile Compounding Center LLC
Jun 30, 2022 0.125% Bupivacaine HCl Injection, USP, 62.5 mg/50 mL (1.25 mg/mL) syringes, p... 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 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 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 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 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 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 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 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 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 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 Juice Beauty, The Organic Solution, SPF 8, Joyful Lip Moisturizer, Hydratant ... Failed Dissolution Specifications Class III Eco Lips, Inc
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 Juice Beauty, The Organic Solution, SPF 8, Naturally Clear Lip Moisturizer, H... Failed Dissolution Specifications Class III Eco Lips, Inc
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 Desmopressin Acetate Tablets, 0.2 mg, 100-count bottles, Rx Only, Manufacture... CGMP Deviations Class II Glenmark Pharmaceuticals Inc., USA
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 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 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 Aspirin and Extended-Release Dipyridamole Capsules, 25mg/200 mg, 60-count bot... Failed Tablet/Capsule Specification : Capsule breakage Class III Glenmark Pharmaceuticals Inc., USA
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

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.