Browse Drug Recalls
17,874 FDA drug safety recalls.
FDA Drug Recall Enforcement Database
Browse 17,874 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 17,874 FDA drug recalls.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| Nov 10, 2022 | Phenoxybenzamine Hydrochloride Capsules, USP 10mg, 100-count bottles, RX only... | Failed Impurities/Degradation Specifications | Class II | Par Formulations Private Limited |
| Nov 9, 2022 | 0.9% Sodium Chloride Injection, USP, 100 mL flexible container bag, Rx Only, ... | Lack of assurance of sterility: Bags have the potential to leak in the flexible containers which ... | Class II | ICU Medical Inc |
| Nov 9, 2022 | Timolol-Latanoprost (0.5/0.005%) ophthalmic drops, Compounded, 5 mL bottle, I... | Subpotent Drug: The batches contain less than 90% of the labeled amount of latanoprost. | Class II | ImprimisRx NJ |
| Nov 9, 2022 | Triamterene and Hydrochlorothiazide Capsules, USP (37.5 mg/25 mg), Rx Only, [... | Failed Impurity/Degradation Specifications | Class III | Lannett Company Inc. |
| Nov 9, 2022 | Conzerol zero molluscum contagiosum, Homeopathic treatment for Molluscum Cont... | CGMP deviations | Class II | DISCOVERY PHARMA LLC |
| Nov 9, 2022 | Triamterene and Hydrochlorothiazide Capsules, USP (37.5 mg/25 mg), Rx Only, 1... | Failed Impurity/Degradation Specifications | Class III | Lannett Company Inc. |
| Nov 5, 2022 | Adam's Polishes ALCOHOL BASED HAND SANITIZER, isopropyl alcohol 75% v/v, pack... | CGMP Deviations: Other lots of hand sanitizer are being recalled because they were manufactured u... | Class II | Adam's Polishes LLC |
| Nov 5, 2022 | Adam's Polishes ALCOHOL BASED HAND SANITIZER, isopropyl alcohol 75% v/v, pack... | Chemical Contamination: FDA analysis found 1 lot of Adam's Polishes ALCOHOL BASED HAND SANITIZER ... | Class I | Adam's Polishes LLC |
| Nov 2, 2022 | Moxifloxacin Ophthalmic Solution, 0.5%, 3 mL, Rx Only, Packaged and Distribut... | cGMP deviation: discontinue of stability support for product. | Class II | Direct Rx |
| Oct 21, 2022 | Carvedilol Tablets, USP, 25 mg, 500-count bottles, Rx Only, Mfg: Mylan Pharma... | Failed Tablet/Capsule Specifications: Tablets exceeds specification for weight and thickness. | Class II | Viatris Inc |
| Oct 18, 2022 | Buprenorphine and Naloxone Sublingual Tablets 8 mg/2 mg, 30-count bottles, Rx... | Presence of Foreign Substance | Class II | SUN PHARMACEUTICAL INDUSTRIES INC |
| Oct 18, 2022 | Susvimo (ranibizumab injection), 100mg/mL, sold together as a) carton contain... | Defective Delivery System: Commercial implants do not meet the filed specification for the intend... | Class III | Genentech Inc |
| Oct 13, 2022 | Tobramycin Ophthalmic Solution, USP, 0.3%, 5 mL per bottle, Rx Only, Manufact... | CGMP Deviations: | Class II | Akorn, Inc. |
| Oct 13, 2022 | Neomycin and Polymyxin B Sulfates, and Bacitracin Zinc Ophthalmic Ointment, U... | CGMP Deviations: | Class II | Akorn, Inc. |
| Oct 13, 2022 | Lidocaine Hydrochloride Jelly USP, 2%, Packaged as (a) 5 mL tube (NDC 17478-7... | CGMP Deviations: | Class II | Akorn, Inc. |
| Oct 13, 2022 | Ofloxacin Ophthalmic Solution, USP 0.3%, 5 mL per bottle, Rx Only, Manufactur... | CGMP Deviations: | Class II | Akorn, Inc. |
| Oct 13, 2022 | Proparacaine Hydrochloride Ophthalmic Solution, USP 0.5%, 15 mL per bottle, R... | CGMP Deviations: | Class II | Akorn, Inc. |
| Oct 13, 2022 | Olopatadine HCL Ophthalmic Solution, USP 0.1%, Antihistamine and Redness Reli... | CGMP Deviations: | Class II | Akorn, Inc. |
| Oct 13, 2022 | Betaxolol Ophthalmic Solution, USP 0.5%, (Betaxolol HCl 5.6 mg/mL), 5 mL per... | CGMP Deviations: | Class II | Akorn, Inc. |
| Oct 13, 2022 | GONAK Hypromellose Ophthalmic Demulcent Solution, (25 mg) 2.5%, 15 mL per dro... | CGMP Deviations: | Class II | Akorn, Inc. |
| Oct 13, 2022 | Levofloxacin Ophthalmic Solution 0.5%, 5 mL per bottle, Rx Only, Manufacture... | CGMP Deviations: | Class II | Akorn, Inc. |
| Oct 13, 2022 | Erythromycin Ophthalmic Ointment USP, 0.5%, Net Weight: 1 g per tube (50 unit... | CGMP Deviations: | Class II | Akorn, Inc. |
| Oct 13, 2022 | Olopatadine HCl Ophthalmic Solution, USP 0.1%, 5 mL per bottle, Rx Only, Manu... | CGMP Deviations: | Class II | Akorn, Inc. |
| Oct 13, 2022 | Ketorolac Tromethamine Ophthalmic Solution, 0.5%, Packaged as a) 10 mL droppe... | CGMP Deviations: | Class II | Akorn, Inc. |
| Oct 13, 2022 | Sodium Chloride Ophthalmic Ointment, USP, 5%, Net Wt. 3.5 g (1/8 oz.) per tub... | CGMP Deviations: | Class II | Akorn, Inc. |
| Oct 13, 2022 | Olopatadine HCl Ophthalmic Solution, USP 0.2%, 2.5 mL per bottle, Rx Only, Ma... | CGMP Deviations: | Class II | Akorn, Inc. |
| Oct 13, 2022 | Tobramycin Ophthalmic Solution, USP, 0.3%, 5 mL per dropper bottle, Rx Only, ... | CGMP Deviations: | Class II | Akorn, Inc. |
| Oct 13, 2022 | PAREMYD (hydroxyamphetamine hydrobromide/ tropicamide ophthalmic solution) 1%... | CGMP Deviations: | Class II | Akorn, Inc. |
| Oct 13, 2022 | AK-POLY-BAC brand of Bacitracin cand Polymixin B Sulfate Ophthalmic Ointment ... | CGMP Deviations: | Class II | Akorn, Inc. |
| Oct 13, 2022 | Olopatadine HCl Ophthalmic Solution, USP 0.1%, 5 mL (0.17 FL OZ) per bottle, ... | CGMP Deviations: | Class II | Akorn, Inc. |
| Oct 13, 2022 | ERYTHROMYCIN OPHTHALMIC OINTMENT USP 0.5%, Net Weight: 3.5g (1/8 oz) per tube... | CGMP Deviations: | Class II | Akorn, Inc. |
| Oct 13, 2022 | Fyarro (sirolimus protein-bound particles for injectable suspension (albumin-... | Failed Stability Specifications | Class III | Aadi Bioscience |
| Oct 13, 2022 | Proparacaine Hydrochloride Ophthalmic Solution, USP 0.5%, 15 mL per dropper b... | CGMP Deviations: | Class II | Akorn, Inc. |
| Oct 13, 2022 | Timolol Maleate Ophthalmic Solution, USP, 0.5%, Packaged in (a) 5 mL dropper ... | CGMP Deviations: | Class II | Akorn, Inc. |
| Oct 13, 2022 | Cromolyn Sodium Ophthalmic Solution, USP 4%, 10mL per bottle, Rx Only, Manufa... | CGMP Deviations: | Class II | Akorn, Inc. |
| Oct 13, 2022 | Moxifloxacin Ophthalmic Solution, USP, 0.5%, 3 mL per dropper bottle, Rx only... | CGMP Deviations: | Class II | Akorn, Inc. |
| Oct 13, 2022 | Olopatadine HCl Ophthalmic Solution, USP 0.1%, 5 mL per dropper bottle, Rx O... | CGMP Deviations: | Class II | Akorn, Inc. |
| Oct 13, 2022 | Artificial Tears OINTMENT, Lubricant Eye Ointment, Net Wt. 3.5 g (1/8 oz.) pe... | CGMP Deviations: | Class II | Akorn, Inc. |
| Oct 13, 2022 | Artificial Tears Solution, Lubricant Eye Drops, Polyvinyl Alcohol 1.4%, 15 m... | CGMP Deviations: | Class II | Akorn, Inc. |
| Oct 13, 2022 | Ciprofloxacin Ophthalmic Solution, USP 0.3% (Ciprofloxacin HCl), 2.5mL per bo... | CGMP Deviations: | Class II | Akorn, Inc. |
| Oct 11, 2022 | 0.9% Sodium Chloride Injection, USP, Each 100 mL contains: SODIUM CHLORIDE, U... | Lack of Assurance of Sterility: Leakage of 0.9% Sodium Chloride for Injection, 1L, 12pk Saline So... | Class II | Fresenius Medical Care Holdings, Inc. |
| Oct 11, 2022 | NDC 0363-6171-09 Walgreens Sinus Pressure, Pain & Cough ACETAMINOPHEN/ PAIN ... | Boxes mislabeled to read "Decongestant Free", but the product contains Phenylephrine HCI 5mg | Class III | LNK International, Inc. |
| Oct 7, 2022 | PAPAVERINE / PHENTOLAMINE / PROSTAGLANDIN 150MG / 2.5MG / 50MCG SOLUTION, 5 m... | Lack of Assurance of Sterility: FDA inspection found the recalled products were produced in a man... | Class II | Pharmacy Plus, Inc. dba Vital Care Compounder |
| Oct 7, 2022 | BRILLIANT BLUE G, 0.04% Solution, 2 mL vials, Rx only, Vital Care Compounder,... | Lack of Assurance of Sterility: FDA inspection found the recalled products were produced in a man... | Class II | Pharmacy Plus, Inc. dba Vital Care Compounder |
| Oct 7, 2022 | PAPAVERINE / PHENTOLAMINE / PROSTAGLANDIN INJ 90MG/3MG/29.4MCG/ BOTTLE SOLUTI... | Lack of Assurance of Sterility: FDA inspection found the recalled products were produced in a man... | Class II | Pharmacy Plus, Inc. dba Vital Care Compounder |
| Oct 7, 2022 | CEFTAZIDIME INTRAVITREAL 2.25MG/0.1ML Solution, 0.5 mL syringe, Rx only, Vita... | Lack of Assurance of Sterility: FDA inspection found the recalled products were produced in a man... | Class II | Pharmacy Plus, Inc. dba Vital Care Compounder |
| Oct 7, 2022 | SEMAGLUTIDE INJECTION 5MG/ML (0.25MG/0.05ML) SOLN, various amounts in unit do... | Lack of Assurance of Sterility: FDA inspection found the recalled products were produced in a man... | Class II | Pharmacy Plus, Inc. dba Vital Care Compounder |
| Oct 7, 2022 | LIDOCAINE EPINEPHRINE BUFFERED 2%/1:1000 Solution, 10 mL syringe, Rx only, Vi... | Lack of Assurance of Sterility: FDA inspection found the recalled products were produced in a man... | Class II | Pharmacy Plus, Inc. dba Vital Care Compounder |
| Oct 7, 2022 | PAP/PHEN/PROSTAG/ATROPINE INJ 150MG/7.5MG/75MCG/1MG bottle solution, 5 mL via... | Lack of Assurance of Sterility: FDA inspection found the recalled products were produced in a man... | Class II | Pharmacy Plus, Inc. dba Vital Care Compounder |
| Oct 7, 2022 | MITOMYCIN INJECTION 0.375 mg/mL SYR, 0.375 mg/mL solution, 1 mL syringe, Rx o... | Lack of Assurance of Sterility: FDA inspection found the recalled products were produced in a man... | Class II | Pharmacy Plus, Inc. dba Vital Care Compounder |
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.