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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
Nov 22, 2022 Sensorcaine-MPF (Bupivacaine HCl and Epinephrine Injection, USP) with Epineph... Subpotent Drug: Testing results below the defined limit for the epinephrine portion of this product. Class II Fresenius Kabi USA, LLC
Nov 22, 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.
Nov 22, 2022 Sensorcaine (Bupivacaine HCl and Epinephrine Injection, USP) with Epinephrine... Subpotent Drug: Testing results below the defined limit for the epinephrine portion of this product. Class II Fresenius Kabi USA, LLC
Nov 21, 2022 Allergy Relief D, Fexofenadine HCL 60mg/Antihistamine, Pseudoephedrine HCL 12... Failed dissolution specifications Class III Dr. Reddy's Laboratories, Inc.
Nov 16, 2022 Daytrana (methylphenidate transdermal system), Delivers 15 mg over 9 hours, (... Defective Delivery System: Recalled lot was found to be out of specification for shear. Shear is ... Class II Noven Pharmaceuticals Inc
Nov 14, 2022 Phenytoin Sodium Injection, USP 100 mg/2 mL, NDC 42192-614-02, packaged in 10... Labeling: Not elsewhere classified; the product is being recalled because of customer complaints ... Class III Acella Pharmaceuticals, LLC
Nov 14, 2022 Phenytoin Sodium Injection, USP, 250 mg/5 mL, NDC 42192-614-05, packaged in 1... Labeling: Not elsewhere classified; the product is being recalled because of customer complaints ... Class III Acella Pharmaceuticals, LLC
Nov 14, 2022 Sodium Sulfacetamide 10% Sulfur 4% Cleansing Pads, Net weight 3.7g (60 cleans... Subpotent drug: Out of specification for assay at the end-of-shelf-life 24-month period. Class III Acella Pharmaceuticals, LLC
Nov 10, 2022 PF-Labetalol HCl Injection, USP 20 mg/4 mL (5 mg/mL) vial, Rx Only, Nephron 5... CGMP Deviations: Potential for cross contamination due to product carry over. Class II Nephron Sterile Compounding Center LLC
Nov 10, 2022 PF-Neostigmine Methylsulfate Injection, USP 3 mg/3 mL (1 mg/mL) vial, Rx Only... CGMP Deviations: Potential for cross contamination due to product carry over. Class II Nephron Sterile Compounding Center LLC
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 Triamterene and Hydrochlorothiazide Capsules, USP (37.5 mg/25 mg), Rx Only, 1... 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 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 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 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 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 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 Olopatadine HCl Ophthalmic Solution, USP 0.1%, 5 mL (0.17 FL OZ) per bottle, ... 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 Ciprofloxacin Ophthalmic Solution, USP 0.3% (Ciprofloxacin HCl), 2.5mL per bo... 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 Artificial Tears OINTMENT, Lubricant Eye Ointment, Net Wt. 3.5 g (1/8 oz.) pe... 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 Cromolyn Sodium Ophthalmic Solution, USP 4%, 10mL per bottle, Rx Only, Manufa... 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 ERYTHROMYCIN OPHTHALMIC OINTMENT USP 0.5%, Net Weight: 3.5g (1/8 oz) per tube... 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 PAREMYD (hydroxyamphetamine hydrobromide/ tropicamide ophthalmic solution) 1%... 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 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 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 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 Ketorolac Tromethamine Ophthalmic Solution, 0.5%, Packaged as a) 10 mL droppe... 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 GONAK Hypromellose Ophthalmic Demulcent Solution, (25 mg) 2.5%, 15 mL per dro... 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 Lidocaine Hydrochloride Jelly USP, 2%, Packaged as (a) 5 mL tube (NDC 17478-7... CGMP Deviations: Class II Akorn, Inc.
Oct 13, 2022 Tobramycin Ophthalmic Solution, USP, 0.3%, 5 mL per bottle, Rx Only, Manufact... CGMP Deviations: Class II Akorn, 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.