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Browse Drug Recalls

1,018 FDA drug safety recalls.

FDA Drug Recall Enforcement Database

Browse 1,018 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 1,018 FDA drug recalls in NY.

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DateProductReasonClassFirm
Dec 28, 2023 Nasal Spray Original No Drip Oxymetazoline HCl Nasal Solution, 12 Hour Pump M... CGMP Deviations: Firm reported possible microbial contamination in the purified water used in the... Class II Seaway Pharma Inc.
Dec 28, 2023 Quality Choice No Drip Extra Moisturizing Nasal Pump Mist Oxymetazoline hydro... CGMP Deviations: Firm reported possible microbial contamination in the purified water used in the... Class II Seaway Pharma Inc.
Dec 26, 2023 Divalproex Sodium Extended-release Tablets, USP 250 mg, Rx Only, 100 tablets,... Failed dissolution specifications Class II Amneal Pharmaceuticals of New York, LLC
Dec 21, 2023 Atropine Sulfate Injection, USP 1 mg/10 mL (0.1 mg/mL), Lifeshield, Glass ABB... Presence of Particulate Matter; identified as glass Class I Pfizer Inc.
Dec 21, 2023 Americaine, (benzocaine 20%) Benzocaine Topical Anesthetic Spray, Aerosol Can... Chemical Contamination: presence of benzene Class I Insight Pharmaceuticals LLC, a Prestige Consume...
Dec 21, 2023 8.4 % Sodium Bicarbonate Injection, USP 50 mEq/50 mL (1 mEq/mL), Lifeshield, ... Presence of Particulate Matter; identified as glass Class I Pfizer Inc.
Dec 21, 2023 Bleomycin for Injection, USP, 15 units per vial, 1 single dose glass fliptop ... Presence of particulate matter: glass Class I PFIZER
Dec 21, 2023 4.2% Sodium Bicarbonate Injection, USP 5 mEq/10 mL (0.5 mEq/mL), Glass ABBOJE... Presence of Particulate Matter; identified as glass Class I Pfizer Inc.
Nov 29, 2023 Magnum XXL 9800, 2000 mg per capsule, 1 capsule per blister pack, Distributed... Marketed without an approved NDA/ANDA: Magnum XXL found to contain undeclared active pharmaceutic... Class I Meta Herbal
Nov 17, 2023 Vigabatrin for Oral Solution, USP 500 mg per packet, 50 packets per box, Rx O... Defective Container: powder may leak out of the pouch Class I InvaGen Pharmaceuticals, Inc.
Oct 27, 2023 Extended Phenytoin Sodium Capsules, USP, 100 mg, 100-count bottle, Distribute... Failed Dissolution Specifications Class II Amneal Pharmaceuticals of New York, LLC
Oct 2, 2023 1% Lidocaine HCl Injection, USP, 50mg/5mL(10mg/mL), Glass ABBOJECT Unit of Us... Presence of Particulate Matter: identified as glass. Class I Pfizer Inc.
Oct 2, 2023 Tropi-Phen (Tropicamide 1% phenylephrine HCl 2.5%) ophthalmic solution, 15 mL... Lack of Assurance of Sterility Class II Pine Pharmaceuticals, LLC
Oct 2, 2023 Foscarnet Sodium 2.4mg/0.1 mL solution for injection, 0.2 mL single-dose Sta... Lack of Assurance of Sterility Class II Pine Pharmaceuticals, LLC
Oct 2, 2023 Endophth Kit (Vancomycin 1mg/0.1 mL - Ceftazidime 2.25mg/0.1 mL), Rx only, Co... Lack of Assurance of Sterility Class II Pine Pharmaceuticals, LLC
Oct 2, 2023 Bevacizumab 1.25 MG/0.05 ML Solution for Injection, 1 mL syringes, Rx only, C... Lack of Assurance of Sterility Class II Pine Pharmaceuticals, LLC
Oct 2, 2023 Tropi-Phen (tropicamide 1%, phenylephrine 2.5%) ophthalmic solution, 5mL mult... Lack of Assurance of Sterility Class II Pine Pharmaceuticals, LLC
Oct 2, 2023 Vancomycin 1 MG/0.1 ML Solution for Intraocular Injection, 0.8 ML Single Dose... Lack of Assurance of Sterility Class II Pine Pharmaceuticals, LLC
Oct 2, 2023 Calcium Gluconate 2.5% solution for inhalation, 5mL pre-filled syringes, Rx o... Lack of Assurance of Sterility Class II Pine Pharmaceuticals, LLC
Oct 2, 2023 Lidocaine HCL 2% and Oxymetazoline HCl 0.025% Solution for intranasal adminis... Lack of Assurance of Sterility Class II Pine Pharmaceuticals, LLC
Oct 2, 2023 Calcium Gluconate Ophthalmic Irrigation Solution 1%, 500 mL bags, Rx only, C... Lack of Assurance of Sterility Class II Pine Pharmaceuticals, LLC
Oct 2, 2023 4.2% Sodium Bicarbonate Injection, USP 5 mEq/10 mL (0.5mEq/mL), Glass ABBOJEC... Presence of Particulate Matter: identified as glass. Class I Pfizer Inc.
Oct 2, 2023 TPC Drops (tropicamide 1%- phenylephrine 2.5%- cyclopentolate HCl 1% ophthalm... Lack of Assurance of Sterility Class II Pine Pharmaceuticals, LLC
Oct 2, 2023 Moxifloxacin in Balanced Salt Solution, Solution for Intraocular Injection, 6... Lack of Assurance of Sterility Class II Pine Pharmaceuticals, LLC
Oct 2, 2023 Lidocaine HCl 4% ophthalmic solution, 3 mL single-use dropper, Rx only, Compo... Lack of Assurance of Sterility Class II Pine Pharmaceuticals, LLC
Oct 2, 2023 2% Lidocaine HCl Injection, USP, 100mg/5mL(20mg/mL), Glass ABBOJECT Unit of U... Presence of Particulate Matter: identified as glass. Class I Pfizer Inc.
Oct 2, 2023 Calcium chloride Solution for Intravenous Injection, 20 mg/mL, 500 mL bags, R... Lack of Assurance of Sterility Class II Pine Pharmaceuticals, LLC
Oct 2, 2023 Moxifloxacin in Balanced Salt Solution 400 mcg/0.4 mL (100 mcg/0.1 mL) 1 mL s... Lack of Assurance of Sterility Class II Pine Pharmaceuticals, LLC
Oct 2, 2023 Cefuroxime 4mg /0.4 mL (10 mg/mL), 1mL syringe, Rx only, Compounded by: Pine ... Lack of Assurance of Sterility Class II Pine Pharmaceuticals, LLC
Oct 2, 2023 Lidocaine-phenylephrine 1%-1.5% 1mL Single Dose Vial, Rx only, Compounded by ... Lack of Assurance of Sterility Class II Pine Pharmaceuticals, LLC
Aug 25, 2023 WEFUN Capsules 825 mg, 1x10 blister pack per carton, Manufactured by WEFUN Br... Marketed Without an Approved NDA/ANDA: FDA analysis found the product to be tainted with sildenaf... Class I Hua Da Trading, Inc. dba Wefun Inc.
Jul 7, 2023 Norepinephrine 32 mg per 250 mL (128 mcg per mL) in 0.9% Sodium Chloride, 250... Lack of Assurance of Sterility Class II SterRx, LLC
Jul 7, 2023 Norepinephrine 8 mg per 250 mL (32 mcg per mL) in 0.9% Sodium Chloride, 250 m... Lack of Assurance of Sterility Class II SterRx, LLC
Jul 7, 2023 Norepinephrine 16 mg per 250 mL (64 mcg per mL) in 0.9% Sodium Chloride, 250 ... Lack of Assurance of Sterility Class II SterRx, LLC
Jul 7, 2023 Sodium Bicarbonate in 5% Dextrose Injection, 150 mEq per 1,000 mL (12.6 mg pe... Lack of Assurance of Sterility Class II SterRx, LLC
Jul 7, 2023 Norepinephrine 4 mg per 250 mL (16 mcg per mL) in 0.9% Sodium Chloride, 250 m... Lack of Assurance of Sterility Class II SterRx, LLC
Jun 5, 2023 Kanjo Homeopathic Pain Relief Cream With Arnica, NET WT 2 oz (56.70G), Manufa... cGMP deviations Class II Homeocare Laboratories, Inc.
Jun 5, 2023 StellaLife VEGA Oral Care Gel, 1 fl oz (30 ml) tubes, Distributed by: StellaL... cGMP deviations Class II Homeocare Laboratories, Inc.
Jun 5, 2023 DoloEar Earache Drops, 0.50 fl. oz. bottles, Distributed by Pharmadel LLC, Ge... cGMP deviations Class II Homeocare Laboratories, Inc.
Jun 5, 2023 StellaLife VEGA Oral Care Rinse, 16 fl oz (473 ml) bottles, Peppermint, Distr... cGMP deviations Class II Homeocare Laboratories, Inc.
Jun 5, 2023 StellaLife VEGA Oral Care Spray, 1 fl oz (30 ml) bottles, Distributed by: Ste... cGMP deviations Class II Homeocare Laboratories, Inc.
Jun 5, 2023 Bebelyn Colic Drops Homeopathic Remedy, 0.5 FL Oz (15 mL) bottles, distribute... cGMP deviations Class II Homeocare Laboratories, Inc.
Jun 5, 2023 StellaLife VEGA Oral Care Gel, 1 fl oz (30 ml) tubes, Peppermint, Distributed... cGMP deviations Class II Homeocare Laboratories, Inc.
Jun 5, 2023 Babelyn Diarrhea Drops Homeopathic Remedy, 0.5 fl. oz. (15 mL) bottles, Distr... cGMP deviations Class II Homeocare Laboratories, Inc.
Jun 5, 2023 SnoreStop Naso Spray Bulk, liquid, Distributed by Green Pharma, NDC 61152-199-99 cGMP deviations Class II Homeocare Laboratories, Inc.
Jun 5, 2023 StellaLife VEGA Oral Care Rinse, 16 fl oz (473 ml) bottles, Coconut, Distribu... cGMP deviations Class II Homeocare Laboratories, Inc.
Jun 5, 2023 Arnica 7 Cream, net wt 2 oz (56.7g), Manufactured for: Brazmedics, LLC, New Y... cGMP deviations Class II Homeocare Laboratories, Inc.
May 30, 2023 Extended Phenytoin Sodium Capsules, USP, 100 mg, Rx Only, 100 capsules per bo... Failed Dissolution Specifications: Out-of-specification results for dissolution (above specificat... Class II Amneal Pharmaceuticals of New York, LLC
May 8, 2023 Methylprednisolone Acetate Injectable Suspension, USP 80 mg/mL, For Intramusc... Labeling: Not Elsewhere Classified; A typographical error was observed in the NDC number on the p... Class III Amneal Pharmaceuticals of New York, LLC
Mar 27, 2023 Bevacizumab 2.5 mg/0.1 mL, Solution for Injection in 1mL, silicone free slip ... Labeling: Incorrect or Missing Lot and/or Exp Date: Lot code on primary packaging is incorrect. Class III Pine Pharmaceuticals, 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.