Browse Drug Recalls

2,002 FDA drug safety recalls.

FDA Drug Recall Enforcement Database

Browse 2,002 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 2,002 FDA drug recalls.

Clear

Date	Product	Reason	Class	Firm
Jan 15, 2021	Benzonatate capsules, 100mg, repackaged in 30-count bottles, Distributed by C...	Labeling: Label Mix-up: Bottle labeled as Benzonatate 100 mg capsules contained Benzphetamine 50 ...	Class I	Calvin Scott & Company, Inc.
Jan 11, 2021	Testosterone Cypionate Injection, USP CIII 200mg/ml FOR INTRAMUSCULAR USE ONL...	Incorrect Labeling: Incorrect lot number on secondary packaging	Class III	SUN PHARMACEUTICAL INDUSTRIES INC
Jan 6, 2021	Sulfur Ointment 10%, Pomada de Azufre, 2.6 OZ (73.7g) jar; Manufactured by/ F...	Labeling: Label Mix-Up. THe English label with Drug Facts panel for Camphor was incorrectly place...	Class II	DLC Laboratories, Inc
Dec 30, 2020	Refresh Relieva PF Preservative-Free Lubricant Eye Drops 0.33 fl oz (10 mL) S...	Labeling: Missing instructions for use insert	Class II	Allergan, PLC.
Dec 23, 2020	IMC Wash-Free Hand Sanitizer, (ethyl alcohol), 75%, 10.1 fl. oz. (300 ml), Ma...	CGMP Deviations: product manufactured at the same facility that produced product that FDA sampled...	Class II	Shane Erickson Inc
Dec 23, 2020	IMC Wash-Free Hand Sanitizer, (ethyl alcohol), 75%, 3.4 fl. oz. (100 ml), Mad...	CGMP Deviations: product manufactured at the same facility that produced product that FDA sampled...	Class II	Shane Erickson Inc
Dec 23, 2020	IMC Wash-Free Hand Sanitizer, (ethyl alcohol), 75%, 1.7 fl. oz. (50 ml) bottl...	CGMP Deviations: product manufactured at the same facility that produced product that FDA sampled...	Class II	Shane Erickson Inc
Dec 22, 2020	Epinephrine/Lidocaine HCl, Sterile Ophthalmic Solution for Injection, 0.8 mL ...	Labeling: Incorrect or Missing Lot and/or Exp Date	Class III	Edge Pharma, LLC
Dec 17, 2020	Rocuronium Br 50 mg/5mL (10 mg/mL), a) 5 mL Single Dose Syringe Red Label(bar...	Lack of Assurance of Sterility; potential for a defective syringe cap, resulting in a non-integra...	Class II	SCA Pharmaceuticals
Dec 17, 2020	ManukaGuard Medical Grade Manuka Honey Allercleanse Nasal Spray, 1.3 FL OZ (4...	Microbial Contamination of Non-Sterile Products: Product confirmed to have yeast	Class I	NDAL Mfg Inc.
Dec 16, 2020	Succinylcholine Chloride PF Inj. 200 mg/10 mL, 10 mL single use syringes, Rx ...	Labeling: Incorrect or Missing lot and/or expiration date: The lot number and BUD were printed in...	Class III	US Compounding Inc
Nov 25, 2020	Neostigmine Methylsulfate PF Inj. 5 mg/5 mL, 5 mL Single Use Syringes, Hospit...	Labelling: Missing label.	Class III	US Compounding Inc
Nov 20, 2020	Scandonest 3% Plain (Mepivacaine Hydrochloride 3% without Vasoconstrictor), p...	Labeling: Label mix-up	Class III	Novocol Pharmaceutical of Canada, Inc.
Oct 22, 2020	Fluent Children's Fever + Pain IBUPROFEN Oral Suspension USP 100 mg per 5 mL ...	Labeling Not Elsewhere Classified: Ibuprofen Oral Suspension is missing dosing cups.	Class III	Aurobindo Pharma USA Inc.
Oct 9, 2020	Dextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphet...	Labeling: Incorrect expiration date. Product dated with 24-month expiration date instead of 18-m...	Class III	ANI Pharmaceuticals, Inc.
Oct 9, 2020	Dextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphet...	Labeling: Incorrect expiration date. Product dated with 24-month expiration date instead of 18-m...	Class III	ANI Pharmaceuticals, Inc.
Oct 9, 2020	Dextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphet...	Labeling: Incorrect expiration date. Product dated with 24-month expiration date instead of 18-m...	Class III	ANI Pharmaceuticals, Inc.
Oct 9, 2020	Dextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphet...	Labeling: Incorrect expiration date. Product dated with 24-month expiration date instead of 18-m...	Class III	ANI Pharmaceuticals, Inc.
Oct 9, 2020	Dextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphet...	Labeling: Incorrect expiration date. Product dated with 24-month expiration date instead of 18-m...	Class III	ANI Pharmaceuticals, Inc.
Oct 9, 2020	Dextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphet...	Labeling: Incorrect expiration date. Product dated with 24-month expiration date instead of 18-m...	Class III	ANI Pharmaceuticals, Inc.
Oct 9, 2020	N-A-C (N-Acetyl-L-Cysteine, 500 mg, 100 capsules; Veggie Caps, white HDPE bo...	Mislabeling of SUS (N-A-C Sustain 600 mg 100 tab) with N-A-C N-Acetyl-L-Cysteine 500 mg, 100 cap.	Class II	Jarrow Formulas Inc
Oct 1, 2020	Smart Care HAND SANITIZER, Ethyl Alcohol 62%, packaged in 0.84 FL.OZ (25 mL),...	Labeling: Not Elsewhere Classified. Container packaging is made, formed or filled to be misleadin...	Class I	ASHTEL STUDIOS, INC.
Sep 17, 2020	NP Thyroid 120, Thyroid Tablets, USP 2 grain (120 mg) 100-count bottles, Rx O...	Subpotent Drug: FDA analysis found these products to be less than the labeled claim for the levot...	Class I	Acella Pharmaceuticals, LLC
Sep 17, 2020	NP Thyroid 15,Thyroid Tablets, USP 1/4 grain (15 mg) 100-count bottles, Rx On...	Subpotent Drug: FDA analysis found these products to be less than the labeled claim for the levot...	Class I	Acella Pharmaceuticals, LLC
Sep 17, 2020	Homeopathic Energy Catalyst, 1 fl oz (30 mL) Distributed by: Deseret Biologic...	Labeling: Product Contains Undeclared API; Incorrect formulation	Class III	Grato Holdings, Inc.
Sep 11, 2020	Killz Germz Hand Sanitizer, Alcohol Gel, 450 mL (15 fl oz.) bottle, Manufactu...	Sub-Potent Drug; Killz GERMz was recalled due to sub-potent results. Testing revealed ethanol lev...	Class II	Genesis Partnership Company SA
Sep 11, 2020	Killz Germz Hand Sanitizer, Alcohol Gel, 1 Gallon (128 fl. oz.) bottle, Manuf...	Sub-Potent Drug; Killz GERMz was recalled due to sub-potent results. Testing revealed ethanol lev...	Class II	Genesis Partnership Company SA
Sep 9, 2020	M Hand Sanitizer Ethyl Alcohol Antiseptic 80%v/v, Topical Solution 128 oz/3,7...	Chemical Contamination and Subpotent Drug: FDA analysis found product to contain methanol and bel...	Class I	MEDEK LLC
Sep 9, 2020	Nicotine Gum, Nicotine Polacrilex Gum USP, 2 mg (nicotine), 110-count pieces ...	Labeling: Incorrect or Missing Package Insert: The package insert included in the finished produc...	Class III	P & L Developments, LLC
Sep 3, 2020	Leafree Instant Hand Sanitizer Aloe Vera (ethyl alcohol 70% v/v), Kills 99.99...	Marketed without an Approved NDA/ANDA; product labeled as Edible Alcohol rendering the product an...	Class I	CORGIOMED LLC
Sep 1, 2020	Red-E Tablet, Proprietary Blend 3000 mg**, packaged in 1-count plastic bag st...	Marketed Without An Approved NDA/ANDA: product found to be tainted with sildenafil, an FDA approv...	Class I	The Protein Shoppe
Aug 17, 2020	Amiodarone Hydrochloride Injection, USP, 450 mg/9 mL (50 mg/mL), 9 mL Single-...	Labeling: Label Mix-Up; potential for cartons labeled as Tranexamic Acid Injection, USP to contai...	Class I	Mylan Institutional LLC
Aug 17, 2020	Tranexamic Acid Injection, USP, 1000 mg/10 mL (100 mg/mL), 10 mL Single-Dose ...	Labeling: Label Mix-Up; potential for cartons labeled as Tranexamic Acid Injection, USP to contai...	Class I	Mylan Institutional LLC
Aug 14, 2020	SkinGuard 24 All-Day Hand Sanitizer 2.67 oz. bottle with foam pump, Dist by: ...	Marketed without an Approved NDA/ANDA; product labeled to contain 0.56% methanol making it an una...	Class I	SG24 LLC
Aug 14, 2020	Skin Guard 24 All-Day Hand Sanitizer 10 mL Pocket Pen Dist by: SG24 LLC, Boli...	Marketed without an Approved NDA/ANDA; product labeled to contain 0.56% methanol making it an una...	Class I	SG24 LLC
Aug 14, 2020	Volu-Sol Handrub Sanitizing Solution (Ethyl Alcohol, 69% v/v and Isopropyl Al...	Marketed Without an Approved NDA/ANDA: product lists methanol as an inactive ingredient on the la...	Class I	Volu-Sol, Inc.
Aug 14, 2020	Skin Guard 24 All-Day Hand Sanitizer 1 4"x6" Hand Sanitizing Towelette packag...	Marketed without an Approved NDA/ANDA; product labeled to contain 0.56% methanol making it an una...	Class I	SG24 LLC
Aug 14, 2020	SkinGuard 24 All-Day Hand Sanitizer 8 oz. bottle with foam pump, Dist by: SG2...	Marketed without an Approved NDA/ANDA; product labeled to contain 0.56% methanol making it an una...	Class I	SG24 LLC
Aug 10, 2020	Prednisone Tablets, USP 2.5 mg, 100 tablets, Rx only, Distributed by: Lannet...	Labeling: Label Mix Up: bottle labeled to contain Prednisone Tablets, USP 2.5 mg actually contai...	Class II	Lannett Company, Inc.
Aug 7, 2020	Always Be Clean Hand Sanitizer (73% Alcohol) 0.04 FL OZ (1.2 mL) packaged in ...	Labeling Not Elsewhere Classified: Product labeled to contain methanol	Class II	Open Book Extracts
Aug 7, 2020	Just Hand Sanitizer (Ethyl Alcohol 73%) Single Use-Packs 100-count NDC 78065-...	Labeling Not Elsewhere Classified: Product labeled to contain methanol	Class II	Open Book Extracts
Aug 3, 2020	Leiper's Fork Distillery, Alcohol Antiseptic Topical Solution, Ethyl Alcohol ...	Labeling Not Elsewhere Classified: Product labeled to contain methanol.	Class II	Leiper's Fork Distillery
Jul 31, 2020	Red Cross Oral Pain (Oral Anesthetic benzocaine 20%), Maximum Strength, 1/8 F...	Labeling; Not Elsewhere Classified: The Mentholatum Company is initiating a voluntary recall due ...	Class III	The Mentholatum Company
Jul 30, 2020	Assured Instant Hand Sanitizer Vitamin E and Aloe (Ethyl Alcohol 70% v/v), 8 ...	CGMP Deviations: Next Advanced Antibacterial Hand Sanitizer was found to be below the label claim...	Class II	Albek De Mexico S.A. De C.V.
Jul 30, 2020	NEXT ADVANCED ANTIBACTERIAL HAND SANITIZER (Ethyl Alcohol 70%), 8 FL OZ (236 ...	CGMP Deviations: Next Advanced Antibacterial Hand Sanitizer was found to be below the label claim...	Class II	Albek De Mexico S.A. De C.V.
Jul 30, 2020	NuuxSan Instant ANTIBACTERIAL HAND SANITIZER, 70% Ethyl Alcohol (ethyl alcoho...	CGMP Deviations: Next Advanced Antibacterial Hand Sanitizer was found to be below the label claim...	Class II	Albek De Mexico S.A. De C.V.
Jul 30, 2020	Modesa INSTANT HAND SANITIZER with Moisturizers and Aloe Vera (ethyl alcohol ...	CGMP Deviations: Next Advanced Antibacterial Hand Sanitizer was found to be below the label claim...	Class II	Albek De Mexico S.A. De C.V.
Jul 30, 2020	Assured Instant Hand Sanitizer Aloe & Moisturizers (Ethyl Alcohol 70% v/v) 8 ...	CGMP Deviations: Next Advanced Antibacterial Hand Sanitizer was found to be below the label claim...	Class II	Albek De Mexico S.A. De C.V.
Jul 29, 2020	Heparin Sodium 5,000 units in 0.9% Sodium Chloride 500 mL, Single Dose Contai...	Cross Contamination with Other Product(s): containers labeled as having methylparaben and propylp...	Class I	SCA Pharmaceuticals
Jul 29, 2020	Heparin Sodium 5,000 units in 0.9% Sodium Chloride 1000 mL, Single Dose Conta...	Cross Contamination with Other Product(s): containers labeled as having methylparaben and propylp...	Class I	SCA Pharmaceuticals

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.