Drug Recall Records

This page shows recent human drug recall alerts sourced from the FDA. It includes current and some previously imported records, but is not a complete historical archive of all past recalls. For full historical data, visit the official FDA Drug Recalls page. Always consult a healthcare professional for medical advice.

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AllContamination / SterilityLabeling / PackagingUndeclared Ingredient
Klean Touch Hand Sanitizer (Ethyl Alcohol 70%) Ingredients Ethanol and Methanol, in
Date: 11/30/2021
Product: Klean Touch Hand Sanitizer (Ethyl Alcohol 70%) Ingredients Ethanol and Methanol, in 55-gallon drums, Aroma Release Technology, Inc., 7026 Discovery Drive, Chattanooga, TN 37416
Company: Aroma Release Technologies Inc
Recall Reason: Marketed Without an Approved NDA/ANDA: Product labeled to contain methanol making it an unapproved new drug and contains methanol
Category: Class I
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No Drip Nasal Spray, Oxymetazoline HCl 0.05% Nasal Decongestant, 1 FL Oz
Date: 10/26/2021
Product: No Drip Nasal Spray, Oxymetazoline HCl 0.05% Nasal Decongestant, 1 FL Oz (30 mL) per bottle, Distributed by SUPERVALU INC., Eden Prairie, MN 55344 USA. NDC 41163-703-10
Company: Perrigo Company PLC
Recall Reason: CGMP Deviations: Products were manufactured with contaminated excipient that was recalled from the excipient supplier.
Category: Class II
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B COMPLEX INJ CMP-NO B12, NO LIDOCAINE INJECTABLE, Rx only, Talon Compounding
Date: 10/12/2021
Product: B COMPLEX INJ CMP-NO B12, NO LIDOCAINE  INJECTABLE, Rx only, Talon Compounding Pharmacy, 2950 Thousand Oaks Drive Ste 25, San Antonio, Texas 78247
Company: Vita Pharmacy, LLC dba Talon Compounding Pharmacy
Recall Reason: Lack of assurance of sterility
Category: Class II
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ALPROSTADIL 40MCG/ML INJ 40MCG/ML INJECTABLE, Rx only, Talon Compounding Pharmacy, 2950 Thousand
Date: 10/12/2021
Product: ALPROSTADIL 40MCG/ML INJ  40MCG/ML INJECTABLE, Rx only, Talon Compounding Pharmacy, 2950 Thousand Oaks Drive Ste 25, San Antonio, Texas 78247
Company: Vita Pharmacy, LLC dba Talon Compounding Pharmacy
Recall Reason: Lack of assurance of sterility
Category: Class II
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Succinylcholine Chloride 100 mg/5 mL (20 mg/mL), 5 mL Syringes, Rx only,
Date: 07/30/2021
Product: Succinylcholine Chloride 100 mg/5 mL (20 mg/mL), 5 mL Syringes, Rx only, For IV Use only, BayCare Central Pharmacy, 7802 E. Telecom Parkway, Temple Terrace, FL 33837
Company: BayCare Integrated Service Center, LLC /dba BayCare Central Pharmacy
Recall Reason: Lack of sterility assurance
Category: Class II
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Edarbi (azilsartan medoxomil) tablets 80 mg 30 Tablets Rx Only NDC 60631-080-30
Date: 03/15/2021
Product: Edarbi (azilsartan medoxomil) tablets 80 mg 30 Tablets Rx Only NDC 60631-080-30 Manufactured for: arbor Pharmaceuticals Atlanta, GA 30328
Company: Cardinal Health Inc.
Recall Reason: CGMP Deviations: Intermittent exposure to temperature excursion during storage.
Category: Class II
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Belbuca (buprenorphine hydrochloride) buccal film 300 mcg 60 pouches containing 1 buccal
Date: 03/15/2021
Product: Belbuca (buprenorphine hydrochloride) buccal film 300 mcg 60 pouches containing 1 buccal film each Rx only NDC 59385-023-60 Manufactured for: BioDelivery Sciences International, Inc. Raleigh, NC 27612.
Company: Cardinal Health Inc.
Recall Reason: CGMP Deviations: Intermittent exposure to temperature excursion during storage.
Category: Class II
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xigduo XR (dapgliflozin/metformin HCl extended-release) tablets 10 mg/1000 mg 30 Tablets Rx
Date: 03/15/2021
Product: xigduo XR (dapgliflozin/metformin HCl extended-release) tablets 10 mg/1000 mg 30 Tablets Rx only NDC 0310-6280-30 Manufactured for: AstraZeneca Pharmaceuticals LP Wilmington, DE 19850  Manufactured by: Bristol-Myers Squibb Manufacturing Company Humacao, Puerto Rico 00791
Company: Cardinal Health Inc.
Recall Reason: CGMP Deviations: Intermittent exposure to temperature excursion during storage.
Category: Class II
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Tremfya (guselkumab) Injection, 100 mg/mL, one single-dose prefilled syringe per carton, Rx
Date: 03/09/2021
Product: Tremfya (guselkumab) Injection, 100 mg/mL, one single-dose prefilled syringe per carton, Rx only, Manufactured by: Janssen Biotech, Inc., Horsham, PA  19044; NDC 57894-640-01.
Company: Cardinal Health Inc.
Recall Reason: Temperature Abuse
Category: Class III
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SkinGuard 24 All-Day Hand Sanitizer 8 oz. bottle with foam pump, Dist
Date: 08/14/2020
Product: SkinGuard 24 All-Day Hand Sanitizer 8 oz. bottle with foam pump, Dist by: SG24 LLC, Bolingbroke, GA 31004  UPC 793573147125
Company: SG24 LLC
Recall Reason: Marketed without an Approved NDA/ANDA; product labeled to contain 0.56% methanol making it an unapproved new drug
Category: Class I
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Assured Instant Hand Sanitizer Aloe & Moisturizers (Ethyl Alcohol 70% v/v) 8
Date: 07/30/2020
Product: Assured Instant Hand Sanitizer Aloe & Moisturizers (Ethyl Alcohol 70% v/v) 8 fl oz / 237 mL bottle, Distributed By: Greenbrier International, Inc. 500 Volvo Parkway, Chesapeake, VA 23320. Made in Mexico.UPC 639277928610
Company: Albek De Mexico S.A. De C.V.
Recall Reason: CGMP Deviations: Next Advanced Antibacterial Hand Sanitizer was found to be below the label claim for ethanol content and contained methanol. Other products were recalled because they were manufactured in the same facility as the product found to contain methanol.
Category: Class II
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Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate and Amphetamine Sulfate Tablets ( Mixed
Date: 05/22/2020
Product: Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate and Amphetamine Sulfate Tablets ( Mixed Amphetamine Salts Product), 5 mg, 100 count bottles, Rx Only, Teva Pharmaceuticals USA, INC. North Wales, PA 19454, NDC 0555-0971-02
Company: Teva Pharmaceuticals USA
Recall Reason: Some bottles may contain mixed strengths of the product.
Category: Class II
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