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Browse Drug Recalls

1,392 FDA drug safety recalls.

FDA Drug Recall Enforcement Database

Browse 1,392 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 1,392 FDA drug recalls in 2022.

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DateProductReasonClassFirm
Jul 15, 2022 Protect U Guard Foaming Hand Sanitizer Ophardt, Fragrance Free, 1000 mL (33.9... CGMP Deviations: product manufactured using deionized water from a system lacking appropriate mic... Class II Aire-Master of America Inc
Jul 15, 2022 meijer, magnesium citrate Saline Laxative, Oral Solution, (1.745 g/fl oz), Le... Microbial contamination of non-sterile products. Class I Vi-Jon, LLC
Jul 15, 2022 Magnesium Citrate SALINE LAXATIVE, Oral Solution, 1.745 g, Grape Flavor, 10 F... CGMP Deviations; Class II Vi-Jon, LLC
Jul 15, 2022 Magnesium Citrate SALINE LAXATIVE, Oral Solution, 1.745 g, Lemon Flavor, 10 F... CGMP Deviations Class II Vi-Jon, LLC
Jul 15, 2022 P, magnesium citrate SALINE LAXATIVE, Oral Solution, (1.745 g/fl oz), Lemon F... Microbial contamination of non-sterile products. Class I Vi-Jon, LLC
Jul 15, 2022 Kroger, Magnesium Citrate SALINE LAXATIVE, Oral Solution, 1.745 g, Lemon Flav... Microbial contamination of non-sterile products. Class I Vi-Jon, LLC
Jul 15, 2022 Walgreens, Dye-Free, Magnesium Citrate, SALINE LAXATIVE, Oral Solution, (1.74... Microbial contamination of non-sterile products. Class I Vi-Jon, LLC
Jul 15, 2022 Common Sense Fragrance Free Hand Sanitizer, 250 Gallon Tote, Microbe Solutio... CGMP Deviations: product manufactured using deionized water from a system lacking appropriate mic... Class II Aire-Master of America Inc
Jul 15, 2022 Fulvestrant Injection 250mg/5mL (50 mg/mL), Contains 2 Single-Dose Prefilled ... Failed Impurities/Degradation Specifications Class II Zydus Pharmaceuticals (USA) Inc
Jul 14, 2022 Difluprednate Ophthalmic Emulsion, 0.05%, 5ml bottles, Rx only, Mfd. by: Cipl... Lack of Assurance of Sterility: customer complaint for defective container where breakage of the ... Class II CIPLA
Jul 13, 2022 Propofol Injectable Emulsion, 1 g/100 mL (10 mg/mL), packaged in 100 mL per g... Presence of particulate matter: particulate identified as a beetle. Class I Pfizer Inc.
Jul 13, 2022 Lansoprazole Delayed-Release Orally Disintegrating Tablets, 35 mg, 100-count ... FAILED DISSOLUTION SPECIFICATIONS Class II Dr. Reddy's Laboratories, Inc.
Jul 13, 2022 Lansoprazole Delayed-Release Orally Disintegrating Tablets, 15 mg, 100-count ... FAILED DISSOLUTION SPECIFICATIONS Class II Dr. Reddy's Laboratories, Inc.
Jul 11, 2022 Lorazepam Injection, USP, 2mg/mL, 1 mL vial, 25 vials per carton, RX Only, M... Failed Impurities/Degradation Specifications: Out-of-specification results observed for total rel... Class II Hikma Pharmaceuticals USA Inc.
Jul 11, 2022 Tacrolimus Ointment, 0.1%, For Dermatological Use Only, Not for Ophthalmic Us... Defective Container: Tube split from side seam Class III Glenmark Pharmaceuticals Inc., USA
Jul 11, 2022 Lorazepam Injection, USP, 4mg/mL, 1 mL vial, 25 vial per carton, Rx Only, No... Failed Impurities/Degradation Specifications: Out-of-specification results observed for total rel... Class II Hikma Pharmaceuticals USA Inc.
Jul 11, 2022 Lorazepam Injection, USP, 2mg/mL, 1 mL vial, 25 vial per carton, Rx Only, No... Failed Impurities/Degradation Specifications: Out-of-specification results observed for total rel... Class II Hikma Pharmaceuticals USA Inc.
Jul 11, 2022 Naftifine Hydrochloride Gel, USP 1%, packaged in cartons with: a) Net Wt. 90g... Failed Impurities/ degradation specifications: Out-of-Specification test results obtained for Uns... Class II Tolmar, Inc.
Jul 11, 2022 Ativan Injection (lorazepam injection, USP), 2mg/mL, 1 mL vial, 25 vials per... Failed Impurities/Degradation Specifications: Out-of-specification results observed for total rel... Class II Hikma Pharmaceuticals USA Inc.
Jul 8, 2022 Crest 3D White Fluoride Anticavity Toothpaste, Advanced Triple Whitening, 0.2... Labeling: Missing label: the product tube was missing a label and contained a different formulation. Class III The Procter & Gamble Company
Jul 7, 2022 Aripiprazole Tablets, USP 20 mg, packaged in a) 1,000-count bottle (NDC 6050... Failed dissolution specifications: OOS for dissolution at the 12-month stability time point. Class II Apotex Corp.
Jul 5, 2022 Insulin Glargine (Insulin glargine-yfgn) Injection, 100 units/mL (U-100), 3 m... Labeling: Missing label: Label missing from some prefilled pens. Class I Mylan Pharmaceuticals Inc
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 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 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 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 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 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 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 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 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 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 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 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 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 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 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 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 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 HYDROmorphone HCl Injection, USP 30 mg/30 mL (1 mg/mL) syringe, 5 x 30 mL Pre... Lack of Assurance of Sterility Class II Nephron Sterile Compounding Center LLC
Jun 30, 2022 Morphine Sulfate Injection, USP, 2 mg/2 mL (1 mg/mL) syringe, packaged in 5 x... Lack of Assurance of Sterility Class II Nephron Sterile Compounding Center LLC
Jun 30, 2022 Neostigmine Methylsulfate Injection, USP, 5 mg/5 mL (1 mg/mL) syringe, packag... Lack of Assurance of Sterility Class II Nephron Sterile Compounding Center LLC
Jun 30, 2022 Ketamine HCl Injection, USP 30 mg/3 mL (10 mg/mL*) syringes, packaged in 5 x ... 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 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 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 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

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.