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
Bismuth Subsalicylate Oral Suspension 262mg/15mL, unit dose cups, OTC, Rpkg. By.: Lohxa
Date: 03/25/2019
Product: Bismuth Subsalicylate Oral Suspension 262mg/15mL, unit dose cups, OTC, Rpkg. By.: Lohxa Worcester, MA, NDC 70166-059-01
Company: Lohxa LLC
Recall Reason: Labeling: Incorrect or Missing Lot and/or Exp Date - the label contains an incorrect Exp Date.
Category: Class II
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Testosterone Topical Solution, 30mg/1.5mL, 110mL bottles, Rx only, Manufactured for: Lupin Pharmaceuticals
Date: 03/13/2019
Product: Testosterone Topical Solution, 30mg/1.5mL, 110mL bottles, Rx only, Manufactured for: Lupin Pharmaceuticals Inc. Baltimore, Maryland 21202 United States, Manufactured by: Lupin Limited Pithampur (M.P.) 454 775 INDIA, NDC 68180-943-11
Company: Lupin Pharmaceuticals Inc.
Recall Reason: Defective Container: Repetitive complaints received indicating pump not working.
Category: Class III
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PAPAVERINE-PHENTOLAMINE-PGE1 17.44-0.64MG-5.8MCG/ML* INJECTABLE, 5 ml, Professional Compounding Pharmacy, 996 NW Circle Blvd.
Date: 02/21/2019
Product: PAPAVERINE-PHENTOLAMINE-PGE1 17.44-0.64MG-5.8MCG/ML* INJECTABLE, 5 ml, Professional Compounding Pharmacy, 996 NW Circle Blvd. #105 Corvallis, OR 97330 .
Company: Health Solutions Pharmacy Center Inc dba Professional Compounding Pharmacy
Recall Reason: Lack of Processing Controls: Insanitary conditions observed during compounding of sterile drugs during recent FDA Inspection.
Category: Class II
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Cefdinir for Oral Suspension USP, 125mg/5mL, packaged in a) 60mL (NDC 68180-722-20),
Date: 01/02/2019
Product: Cefdinir for Oral Suspension USP, 125mg/5mL, packaged in a) 60mL (NDC 68180-722-20), b)100mL (NDC 68180-722-10), Rx Only, Manufactured for: Lupin Pharmaceuticals Inc. Baltimore, MD 21202; Manufactured by: Lupin Limited Mandideep 462 046 INDIA
Company: Lupin Pharmaceuticals Inc.
Recall Reason: CGMP Deviations: Product complaints received indicating reconstituted suspension was observed to be thick.
Category: Class II
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Trimix QM10 Papaverine 30 mg/Phentolamine 4 mg/Atropine 1 mg/PGE 150 mcg/mL Injectable,
Date: 09/10/2018
Product: Trimix QM10 Papaverine 30 mg/Phentolamine 4 mg/Atropine 1 mg/PGE 150 mcg/mL Injectable, Pharm D Solutions, Houston, Texas --- NDC 69699-1352-05
Company: Pharm D Solutions, LLC
Recall Reason: Lack of Assurance of Sterility
Category: Class II
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Levothyroxine and Liothyronine (Thyroid Tablets, USP), 1 grain (60 mg), 100-count bottles,
Date: 08/03/2018
Product: Levothyroxine and Liothyronine (Thyroid Tablets, USP), 1 grain (60 mg), 100-count bottles, Rx Only, Manufactured for: Westminster Pharmaceuticals, LLC, 154 Downing Street, Unit 1 & 2, Olive Branch, MS 38654, NDC 69367-156-04.
Company: Westminster Pharmaceuticals LLC
Recall Reason: Failed Content Uniformity Specifications: Product was manufactured using an adulterated active pharmaceutical ingredient; additionally, lack of process controls and good manufacturing practices resulted in finished product failing content uniformity specifications which can result in a product having a strength that is more or less than is labeled.
Category: Class I
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Dr. King’s SafeCare Rx UlcerPlex, 2 fl. oz. (59 mL), King Bio,
Date: 07/20/2018
Product: Dr. King's SafeCare Rx UlcerPlex, 2 fl. oz. (59 mL), King Bio, Inc., 3 Westside Drive, Asheville, NC 28806 USA, UPC 357955175025, NDC 57955-0188-2
Company: King Bio Inc.
Recall Reason: Microbial contamination
Category: Class I
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Dr. King’s SafeCare Rx Lonely Mind & Body High Potency Homeopathic Formula
Date: 07/20/2018
Product: Dr. King's SafeCare Rx Lonely Mind & Body High Potency Homeopathic Formula for Professional Use Only, 2 fl. oz. (59 mL), King Bio, Inc., 3 Westside dr. Asheville, NC 28806 USA,  UPC 357955200024,  NDC 57955-2001-2
Company: King Bio Inc.
Recall Reason: Microbial contamination
Category: Class I
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Dr. King’s Natural Medicine Homeopathic Hydration, 2 fl. oz. (59 mL), King
Date: 07/20/2018
Product: Dr. King's Natural Medicine Homeopathic Hydration, 2 fl. oz. (59 mL), King Bio, Inc., 3 Westside Dr. Asheville, NC 28806, UPC 357955024224, NDC 57955-0242-2
Company: King Bio Inc.
Recall Reason: Microbial contamination
Category: Class I
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Zarxio 300 mcg/0.5 mL PFS NDC 14 days supply
Date: 04/03/2018
Product: Zarxio 300 mcg/0.5 mL PFS NDC 14 days supply
Company: Kroger Specialty Pharmacy, Inc.
Recall Reason: Lack of Processing Controls.
Category: Class II
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Testosterone 40 mg pellet packaged in amber vial, Rx only, Partell Specialty
Date: 03/22/2018
Product: Testosterone 40 mg pellet packaged in amber vial,   Rx only, Partell Specialty Pharmacy, 5835 S. Eastern Ave.   #101, Las Vegas, NV 89119 (702) 791-3800
Company: Partell Specialty Pharmacy
Recall Reason: Lack of Assurance Sterility: Firm is recalling various drug products due to a non-approved method of sterilization.
Category: Class II
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Nifedipine USP for prescription compounding, packaged in a) 5g (NDC 58597-8025-2); b)
Date: 02/09/2018
Product: Nifedipine USP  for prescription compounding, packaged in a) 5g (NDC 58597-8025-2); b) 25g (NDC 58597-8025-4); c) 100g (NDC 58597-8025-6); d) 500g (NDC 58597-8025-7), RX only, packed by American Pharmaceutical Ingredients, LLC 6650 Highland Road, Waterford, MI 48327
Company: American Pharmaceutical Ingredients LLC
Recall Reason: CGMP Deviations: Lack of stability data and controls to support the manufacturers assigned retest or expiration date in firm's container/closure system.
Category: Class II
View Details View FDA Recall Listings
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