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Browse Drug Recalls

17,616 FDA drug safety recalls.

FDA Drug Recall Enforcement Database

Browse 17,616 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 17,616 FDA drug recalls.

DateProductReasonClassFirm
Jul 10, 2023 Big Machine Distillery Hand Sanitizer Non-Sterile Solution Alcohol Antiseptic... CGMP Deviation: impurities exceed allowable limits. Class II Tenn South Distillery LLC dba Big Machine Disti...
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 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
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 5, 2023 Sunitinib Malate Capsules, 12.5 mg, 28-count bottles, Rx only, Manufactured B... Failed Moisture Limits: Water (moisture) content above the approved product specifications. Class II Teva Pharmaceuticals USA Inc
Jul 5, 2023 Loteprednol Etabonate Ophthalmic Suspension, 5 mg/mL (0.5%), packaged as one ... Superpotent Drug: Out of Specification (OOS) results observed for unit dose content. Class III SUN PHARMACEUTICAL INDUSTRIES INC
Jul 5, 2023 0.9% Sodium Chloride Injection USP, 1000 mL Excel Plus Container, Rx only, B.... Lack of assurance of sterility: bags have the potential to leak. Class II B. Braun Medical Inc.
Jul 3, 2023 Atropine Sulfate Injection, USP 8 mg per 20 mL (0.4 mg per mL), 20 mL Multipl... Presence of Particulate Matter: Particulate matter identified as fiber. Class II Accord Healthcare, Inc.
Jul 3, 2023 Bivalirudin for Injection 250 mg, 10 Single-Dose Vials, Rx Only, Manufactured... Presence of Particulate Matter: Particulate matter identified as fiber. Class II Accord Healthcare, Inc.
Jun 27, 2023 Albuterol Sulfate Inhalation Aerosol, 90 mcg, 200 Metered Inhalation, net con... Defective container: empty inhaler and leakage observed through the inhaler valve due to partiall... Class I Cipla USA, Inc.
Jun 27, 2023 Amlodipine Besylate Tablets, USP 10 mg, 1000-count bottles, Rx only, Manufact... Subpotent Drug: Out-of-Specification test results observed in assay test at 21-month long term st... Class III Lupin Pharmaceuticals Inc.
Jun 26, 2023 Losartan Potassium Tablets, USP, 25 mg, 1000 film coated tablets per bottle, ... Presence of Foreign Substance: Presence of a small piece of blue plastic embedded in the tablet. Class II Strides Pharma Inc.
Jun 26, 2023 Tizanidine Hydrochloride Tablet 4mg, packaged in a) 20 count-bottles (NDC 687... Failed Stability Specifications Class II Preferred Pharmaceuticals, Inc.
Jun 23, 2023 Safe Tussin DM Cough + Chest Congestion (Dextromethorphan HBr/ Cough Suppress... CGMP Deviations: use of non-food grade lubricant in mixing vessel. Class II Kramer Laboratories, Inc.
Jun 23, 2023 Tizanidine Tablets, USP, 4 mg, 100 Tablets (10 tablets x 10 unit dose blister... Failed Dissolution Specifications: this repackaged product was recalled by the manufacturer, Dr. ... Class II Amerisource Health Services LLC
Jun 23, 2023 Safe Tussin PM Night Time Cough Relief (Cough Suppressant/Antihistamine), pac... CGMP Deviations: use of non-food grade lubricant in mixing vessel. Class II Kramer Laboratories, Inc.
Jun 23, 2023 Tydemy (drospirenone, ethinyl estradiol and levomefolate calcium tablets, 3 m... Failed Stability Specification and Failed Impurities/Degradation Specifications: out of specific... Class I Lupin Pharmaceuticals Inc.
Jun 23, 2023 PANCREAZE (pancrelipase) Delayed-Release Capsules, 100-count bottles, Rx only... Failed Stability Specifications Class III Vivus, Inc.
Jun 22, 2023 Diclofenac Sodium Topical Solution USP, 2% w/w, 3.8 FL.OZ.(112 grams) bottles... Defective Delivery System Class II ALEMBIC PHARMACEUTICALS, INC.
Jun 21, 2023 Tizanidine Tablets USP, 4 mg, 1000-Count bottle, Rx Only, Manufactured by Dr.... Failed dissolution specification: Out of specification results observed in 24-month long term sta... Class II Dr Reddy's Laboratories Limited
Jun 16, 2023 Tramadol Hydrochloride Tablets, USP 50 mg, Unit Dose 100-Count Tablets Rx onl... Packaging defect: blister packaging inadequately sealed. Class II The Harvard Drug Group
Jun 13, 2023 Tranexamic Acid USP Tablets, 650 mg, 30 tablets (3X10) Unit Dose, Rx Only, Ma... Failed Impurities/Degradation Specifications: Out of specification results obtained for conductiv... Class III AVKARE LLC
Jun 13, 2023 Dry Eye Relief Lubricant Eye Drops, (Glycerin 0.2%, Hypromellose 0.2 %, Polye... CGMP Deviations: good manufacturing deficiencies related to a lack of documentation of the fill l... Class II K.C. Pharmaceuticals, Inc
Jun 13, 2023 Original Eye Drops; Redness Reliever; (Tetrahydrozoline HCl), 0.05%, 0.5 FL O... CGMP Deviations: good manufacturing deficiencies related to a lack of documentation of the fill l... Class II K.C. Pharmaceuticals, Inc
Jun 12, 2023 Endometrin (progesterone) Vaginal Insert 100mg, packaged in a carton of 21 va... cGMP deviations: potential for Microbial Contamination of Non-Sterile Products Class II Ferring Pharmaceuticals Inc
Jun 12, 2023 Lysteda (tranexamic acid) USP Tablets, 650 mg, 30 tablets per bottle, Rx Only... Failed Impurities/Degradation Specifications: Out of specification results obtained for conductiv... Class III Amring Pharmaceuticals Inc
Jun 6, 2023 GLYCOPYRROLATE INJECTION, USP 0.2MG/ML, 1mL VIAL, manufactured by HF Acquisit... Labeling: Label Mix-up Class III HF Acquisition Co LLC
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 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 Gel, 1 fl oz (30 ml) tubes, Distributed by: StellaL... cGMP deviations Class II Homeocare Laboratories, Inc.
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 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 Babelyn Diarrhea Drops Homeopathic Remedy, 0.5 fl. oz. (15 mL) bottles, Distr... 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 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 31, 2023 ZIPRASIDONE HYDROCHLORIDE CAPSULES 20 mg, Unit Dose Carton 40 Capsules, Rx on... Labeling: Label Mix-up: Unit Dose cartons labeled as Ziprasidone Hydrochloride Capsules, 20 mg we... Class I The Harvard Drug Group LLC dba Major Pharmaceut...
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 30, 2023 Amphotericin B Liposome for Injection, 50mg/vial, Rx only, Distributed by Sun... Subpotent drug Class II SUN PHARMACEUTICAL INDUSTRIES INC
May 25, 2023 Levsin injection (hyoscyamine sulfate injection, USP), 0.5 mg per ml in water... CGMP Deviations: Discontinuation of the Quality program by manufacturer that would assure product... Class II Viatris Inc
May 25, 2023 Travoprost Ophthalmic Solution, USP (Ionic Buffered Solution), 0.004%, Rx onl... Lack of Assurance of Sterility: Tamper Evidence Seal is missing on secondary container. Class II Golden State Medical Supply Inc.
May 23, 2023 Sodium Chloride 0.9% Injection, USP, 1000 mL bags, 12 bags per carton, Rx onl... Lack of assurance of sterility: The product was potentially exposed to below-recommended storage ... Class II Fresenius Medical Care Holdings, Inc.
May 22, 2023 Phenylephrine HCl 20 mg added to 0.9% Sodium Chloride 250mL Bag, Rx Only, Com... Product Mix up; Product was compounded in 250 mL 5% Dextrose instead of 250 mL 0.9% Sodium Chloride Class III New England Life Care, Inc. dba Advanced Compou...
May 22, 2023 Pain Reliever, Acetaminophen USP Caplets, 500 mg, 225-count bottles packaged ... Failed Impurities/Degradation Specifications: firm's investigation due to customer complaints for... Class II Aurobindo Pharma USA Inc.
May 19, 2023 Nafcillin for Injection, USP, 2 gram per vial, Rx only, Mfd. for SAGENT Pharm... Lack of Assurance of Sterility Class II Sagent Pharmaceuticals Inc
May 19, 2023 Nafcillin for Injection, USP, 1 gram per vial, Rx only, Mfd. for SAGENT Pharm... Lack of Assurance of Sterility Class II Sagent Pharmaceuticals Inc

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.