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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.

By Dosage Form:
AllTabletsCapsulesInjectables
By Recall Category:
AllContamination / SterilityLabeling / PackagingUndeclared Ingredient
Ling Zhi capsules
Date: 01/19/2018
Product: Ling Zhi capsules
Company: Flawless Beauty LLC
Recall Reason: Marketed Without An Approved NDA/ANDA: Flawless Beauty, LLC is voluntarily recalling all lots of different products sold individually or as part of multi-unit kits in accordance with Consent Decree of Permanent Injunction ordered by the United States District Court due to misbranding and unapproved new drugs pursuant to the FD&C Act.
Category: Class II
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Glycopyrrolate in all strengths, all doses, and all packaging.
Date: 12/27/2017
Product: Glycopyrrolate in all strengths, all doses, and all packaging.
Company: Pharmedium Services, LLC
Recall Reason: Lack of sterility assurance.
Category: Class II
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Human Chorionic Gonadotropin 6,000 iu/Vial, For SC Use -Lyophilized, Rx Only, KRS
Date: 11/16/2017
Product: Human Chorionic Gonadotropin 6,000 iu/Vial, For SC Use -Lyophilized, Rx Only, KRS Global Biotechnology, 791 Park of Commerce Blvd, Boca Raton, FL 33487.
Company: KRS Global Biotechnology, Inc
Recall Reason: Labeling: Incorrect or Missing Lot and/or Exp Date: Beyond Use Date (BUD) exceed the BUD/EXP of at least one ingredient used to make final product.
Category: Class II
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Benzocaine 20%, Lidocaine 6%, Tetracaine 4% Cream packaged in jars, Rx Only,
Date: 11/16/2017
Product: Benzocaine 20%, Lidocaine 6%, Tetracaine 4% Cream packaged in jars, Rx Only, KRS Global Biotechnology, 791 Park of Commerce Blvd, Boca Raton, FL 33487.
Company: KRS Global Biotechnology, Inc
Recall Reason: Labeling: Incorrect or Missing Lot and/or Exp Date: Beyond Use Date (BUD) exceed the BUD/EXP of at least one ingredient used to make final product.
Category: Class II
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L-Glutamine 100mg, 30 mL vials, Rx only, Bella Pharma 3101 W. Devon
Date: 08/15/2017
Product: L-Glutamine 100mg, 30 mL vials, Rx only, Bella Pharma 3101 W. Devon Ave., Chicago, IL 60659, 1 (877) BELLA.
Company: Bella Pharmaceuticals, Inc.
Recall Reason: Lack of Assurance of Sterility.
Category: Class II
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Methylcobalamin 10mg, (10mg/ml), 30 mL vials, Rx only, Bella Pharma 3101 W.
Date: 08/15/2017
Product: Methylcobalamin 10mg, (10mg/ml), 30 mL vials, Rx only, Bella Pharma 3101 W. Devon Ave., Chicago, IL 60659, 1 (877) BELLA.
Company: Bella Pharmaceuticals, Inc.
Recall Reason: Lack of Assurance of Sterility.
Category: Class II
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PHENYLephrine 40 mg in 0.9% Sodium Chloride 250 mL, Rx only, SCA
Date: 07/14/2017
Product: PHENYLephrine 40 mg in 0.9% Sodium Chloride 250 mL, Rx only, SCA Pharmaceuticals 8821 Knoedl Ct Little Rock, AR 72205 --- NDC# 70004-0812-40
Company: SCA Pharmaceuticals
Recall Reason: Lack of Assurance of Sterility; product has the potential to leak.
Category: Class II
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Phenylephrine HCL in 0.9% Sodium Chloride 10 mL, 1 mg/10 mL (100
Date: 07/14/2017
Product: Phenylephrine HCL in 0.9% Sodium Chloride 10 mL, 1 mg/10 mL (100 mcg/mL) Single-Dose Syringe, Rx Only, Cantrell Drug Company 7321 Cantrell Rd. Little Rock, AR 72207 877-666-5222, NDC 52533-171-12
Company: Cantrell Drug Company
Recall Reason: Lack of Sterility Assurance.
Category: Class II
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Amantadine HCl Capsules, USP, 100 mg, Rx Only, 50 Capsules (5×10) Unit
Date: 06/19/2017
Product: Amantadine HCl Capsules, USP, 100 mg, Rx Only,  50 Capsules (5x10) Unit Dose Cartons, Manufactured for: AvKARE Inc, Pulaski, TN 38478 --- NDC: 50268-0069-15
Company: Apace KY LLC
Recall Reason: Labeling; Label Mix up; cartons labeled as Amantadine HCl 100 mg Capsules contain unit dose blister cards of Cyclobenzaprine HCl Tablet, USP 5 mg
Category: Class II
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Zhonghua Niubian tablets, 2000mg, 6-count bottle, labeling is in foreign language
Date: 03/07/2017
Product: Zhonghua Niubian tablets, 2000mg, 6-count bottle, labeling is in foreign language
Company: A&H Focal Inc.
Recall Reason: Marked Without An Approved NDA/ANDA: FDA analysis found these products to contain sildenafil, an FDA approved drug for the treatment of erectile dysfunction, making these products unapproved drugs for which safety and efficacy have not been establish and therefore, subject to recall.
Category: Class I
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Succinylcholine Chloride all strengths, all dosage forms and all packaging, Rx Only,
Date: 02/22/2017
Product: Succinylcholine Chloride all strengths, all dosage forms and all packaging, Rx  Only, Avella of Houston, Houston, TX 77054
Company: Advanced Pharma Inc.
Recall Reason: Labeling: Not Elsewhere Classified: Products may contain synthetic latex and/or natural latex.
Category: Class II
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Alprostadil 20 mcg/mL Injectable, a) 5 mL and b) 10 mL vials,
Date: 09/21/2016
Product: Alprostadil 20 mcg/mL Injectable, a) 5 mL  and b) 10 mL vials, Compounded by Wells Pharmacy Network LLC, Ocala FL
Company: Wells Pharmacy Network LLC
Recall Reason: Lack of Assurance of Sterility
Category: Class II
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