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
Haloperidol Decanoate Injection 50mg/mL, 1mL Single-Dose Vial, Rx Only, Manufactured by: Somerset
Date: 03/21/2025
Product: Haloperidol Decanoate Injection 50mg/mL, 1mL Single-Dose Vial, Rx Only, Manufactured by: Somerset Therapeutics Limited, Kamataka India, Manufactured for: BluePoint Laboratories NDC 68001-580-41
Company: Somerset Therapeutics Private Limited
Recall Reason: Lack of Assurance of Sterility: Media fill with bacterial contamination
Category: Class II
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Cetirizine Hydrochloride Tablets, USP, 10mg, 365-count packs, Rx Only, Manufactured for: Glenmark
Date: 03/13/2025
Product: Cetirizine Hydrochloride Tablets, USP, 10mg, 365-count packs, Rx Only, Manufactured for: Glenmark Therapeutics Inc., Distributed by: Amazon. NDC# 72657-129-35
Company: Glenmark Pharmaceuticals Inc., USA
Recall Reason: CGMP Deviations
Category: Class II
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Little Moon Essentials, Crampy Belly Rub (Camphor 1.1%), Packaged as a) 4
Date: 06/20/2024
Product: Little Moon Essentials, Crampy Belly Rub (Camphor 1.1%), Packaged as a) 4 FL OZ (118ML) glass jar, UPC Code 6 73673 88260 2, NDC 70722-260-04; b) 2 FL OZ (59ML) glass jar, UPC Code 6 73673 88204 6, NDC 70722-260-02, Little Moon Essentials LLC Dania Beach, Fl 33004
Company: Little Moon Essentials LLC
Recall Reason: CGMP deviations
Category: Class II
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Cathflo activase (ALTEPLASE), 2mg vials, Rx only, Genentech Inc., South San Francisco,
Date: 05/20/2024
Product: Cathflo activase (ALTEPLASE), 2mg vials, Rx only, Genentech Inc., South San Francisco, CA 94080, NDC 50242-041-64
Company: Genentech, Inc.
Recall Reason: Lack of Assurance of Sterility: Deformed stoppers observed during filling operations for Cathflo Activase.
Category: Class II
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CABTREO (clindamycin phosphate, adapalene and benzoyl peroxide) Topical Gel 1.2%/0.15%/3.1%, Not for
Date: 02/12/2024
Product: CABTREO (clindamycin phosphate, adapalene and benzoyl peroxide) Topical Gel 1.2%/0.15%/3.1%, Not for Oral, Ophthalmic or Intravaginal Use, Rx Only, Net Wt. 50g, Distributed by Bausch Health US, LLC Bridgewater, NJ 08807 USA, Manufactured by: Bausch Health Companies, Inc. Laval Quebec H7L 448, Canada, NDC 0187-0006-25.
Company: MCKESSON CORPORATION
Recall Reason: CGMP Deviations: Product was stored outside labeled storage temperature requirements. Product was exposed to controlled room temperature environment instead of remaining refrigerated.
Category: Class II
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Nortrel (norethindrone and ethinyl estradiol tablets USP) 0.5/35, packaged in cartons, each
Date: 01/25/2024
Product: Nortrel (norethindrone and ethinyl estradiol tablets USP) 0.5/35, packaged in cartons, each carton contains 3 blister cards, each card contains 28 tablets, Rx only, TEVA PHARMACEUTICALS USA, INC., North Wales, PA 19454, NDC 0555-9008-67
Company: Teva Pharmaceuticals USA, Inc
Recall Reason: Discoloration: discolored tablets (shades of blue) mixed in with the white inert remainder tablets.
Category: Class III
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PHENYLephrine HCl 5000 mcg/50 mL in 0.9% Sodium Chloride Injection, (Concentration =
Date: 11/09/2023
Product: PHENYLephrine HCl 5000 mcg/50 mL in 0.9% Sodium Chloride Injection, (Concentration = 100 mcg/mL), 50 mL Syringe, Rx Only, SCA Pharmaceuticals, 755 Rainbow Rd. Windsor, CT 06095, NDC 70004-0810-22, Bar Code 70004081022.
Company: SCA Pharmaceuticals, LLC
Recall Reason: Lack of Assurance of Sterility
Category: Class II
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EPINEPHrine added to dextrose 5%, 4mg/250ml (16 mcg/mL), IV Bag, Rx Only,
Date: 08/17/2023
Product: EPINEPHrine added to dextrose 5%, 4mg/250ml (16 mcg/mL), IV Bag, Rx Only, Central Admixture Pharmacy Services, Inc., 2200 South 43rd Avenue, Phoenix, AZ 85043, NDC: 72196-7018-1.
Company: Central Admixture Pharmacy Services, Inc.
Recall Reason: Lack of Assurance of Sterility:Lack of validation data for sanitization cycles
Category: Class II
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FentaNYL 500 mcg/250 mL – Bupivacaine HCl 0.1% in 0.9% Sodium Chloride
Date: 07/20/2023
Product: FentaNYL 500 mcg/250 mL - Bupivacaine HCl 0.1% in 0.9% Sodium Chloride 250mL Bag, Injection for Epidural Use (fentaNYL Concentration - 2 mcg/mL), Rx Only, Single Dose Container, SCA Pharmaceuticals, 755 Rainbow Rd, Windsor, CT 06095, NDC# 70004-0253-40
Company: SCA Pharmaceuticals
Recall Reason: cGMP deviations: due to shipment of rejected units.
Category: Class II
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Tramadol Hydrochloride Tablets, USP 50 mg, Unit Dose 100-Count Tablets Rx only,
Date: 06/16/2023
Product: Tramadol Hydrochloride Tablets, USP 50 mg, Unit Dose 100-Count Tablets Rx only, Manufactured by: Sun Pharmaceutical Industries Ltd. Survey No. 259/15, Dadra-396 191, (U.T. of D & NH), India. Distributed by: Sun Pharmaceutical Industries, Inc. Cranbury, NJ 08512, Distributed by: Major Pharmaceuticals Livonia, MI 48152 USA, NDC 0904-7179-61
Company: The Harvard Drug Group
Recall Reason: Packaging defect: blister packaging inadequately sealed.
Category: Class II
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Alprazolam C-IV, 1 mg, packaged in a) 30 Tabs per bottle, NDC
Date: 03/22/2023
Product: Alprazolam C-IV, 1 mg, packaged in a) 30 Tabs per bottle, NDC 72189-213-30; b) 60 Tabs per bottle, NDC 72189-213-60; Rx only, Packaged and Distributed By: Direct Rx Dawsonville, GA 30534.
Company: Direct Rx
Recall Reason: CGMP Deviations: Repackaging firm recalling due to potential product cross contamination concerns at the manufacturer.
Category: Class II
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Unguentine Original Maximum Strength Pain Relieving/Antiseptic Ointment (Camphor 3.0%, Phenol 2.5%, Tannic
Date: 02/24/2023
Product: Unguentine Original Maximum Strength Pain Relieving/Antiseptic Ointment (Camphor 3.0%, Phenol 2.5%, Tannic Acid 2.2%, Oxide 6.6%), packaged in 1 oz. (28.3g) metal tubes, Distributed by: Oakhurst Company Levittown, NY 11756
Company: Ecometics, Inc.
Recall Reason: CGMP DEVIATIONS
Category: Class II
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