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
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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Nizatidine Oral Solution, 15 mg/mL (75 mg/5mL) USP 480 mL bottles, Rx
Date: 04/15/2020
Product: Nizatidine Oral Solution, 15 mg/mL (75 mg/5mL) USP 480 mL bottles, Rx Only Distributed by: Gemini Laboratories, LLC Bridgewater, NJ 08807 NDC 60846-301-15
Company: Amneal Pharmaceuticals of New York, LLC
Recall Reason: CGMP Deviations: potential N-Nitrosodimethylamine (NDMA) amounts above levels established by the FDA.
Category: Class II
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Edema Off, Distributed by Herbal Doctor Remedies Alhambra, CA 91801-7081 USA, 1(800)
Date: 03/24/2020
Product: Edema Off, Distributed by Herbal Doctor Remedies Alhambra, CA 91801-7081 USA, 1(800) 600-0808
Company: Herbal Doctor Remedies
Recall Reason: CGMP Deviations: These products have been found to be misbranded as  unapproved new drugs
Category: Class II
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Polyoxyl Lauryl Ether (Polidocanol) Injection, LAURETH-9 (POLIDOCANOL) 5% INJECTABLE, For IV Use,
Date: 01/15/2020
Product: Polyoxyl Lauryl Ether (Polidocanol) Injection, LAURETH-9 (POLIDOCANOL) 5% INJECTABLE, For IV Use, 30 mL Multi-dose Vial, Rx only, Axia Pharmaceutical 1990 Westwood Blvd. Ste 135, Los Angeles, CA 90025; NDC 71283-060-3
Company: Fusion IV Pharmaceuticals, Inc. dba Axia Pharmaceutical
Recall Reason: Lack of Assurance of Sterility
Category: Class II
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Bevacizumab, 2.5 mg/0.1 mL, Norm-Ject Syringe Intravitreal Injection, Single use only, Rx
Date: 08/30/2019
Product: Bevacizumab, 2.5 mg/0.1 mL, Norm-Ject Syringe Intravitreal Injection, Single use only, Rx only, Repackaged by AmEx Pharmacy 1515 Elizabeth St. Suite J Melbourne, FL 32901
Company: Pacifico National, Inc. dba AmEx Pharmacy
Recall Reason: Lack of assurance of sterility.
Category: Class II
View Details View FDA Recall Listings
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