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FDA Drug Recalls

Every FDA drug enforcement recall Public Health Trace has on record, republished from openFDA's official drug enforcement database. See Health Alerts for current, active recalls alongside outbreaks and advisories.

Drug recall information is sourced from the FDA's structured openFDA Enforcement Reports. Newly announced recalls may appear on FDA.gov before they become available in the structured dataset. See Methodology for how Public Health Trace imports and refreshes this data.

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Drug Recall Ongoing Historical recordClass II

NANDROLONE, 200 MCG/ML, 2 ML, The Guyer Institute of Molecular Medicine, Indianapolis, IN

by Advanced Nutriceuticals, LLC

Reason: Lack of Assurance of Sterility: due to concerns with production processes which cannot assure sterility of products intended to be sterile.
Recall initiated: November 30, 2020
Reported by FDA: December 23, 2020
Distribution: CA, CO, FL, IN, KY, OH, TX

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Drug Recall Ongoing Historical recordClass II

GHRP, 2000 MCG/ML, 5 ML vial, The Guyer Institute of Molecular Medicine, Indianapolis, IN

by Advanced Nutriceuticals, LLC

Reason: Lack of Assurance of Sterility: due to concerns with production processes which cannot assure sterility of products intended to be sterile.
Recall initiated: November 30, 2020
Reported by FDA: December 23, 2020
Distribution: CA, CO, FL, IN, KY, OH, TX

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Drug Recall Ongoing Historical recordClass II

IPAMORELIN, 2000 MCG/ML, 5 ML vial, The Guyer Institute of Molecular Medicine, Indianapolis, IN

by Advanced Nutriceuticals, LLC

Reason: Lack of Assurance of Sterility: due to concerns with production processes which cannot assure sterility of products intended to be sterile.
Recall initiated: November 30, 2020
Reported by FDA: December 23, 2020
Distribution: CA, CO, FL, IN, KY, OH, TX

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Drug Recall Ongoing Historical recordClass II

THYMOSIN ALPHA, 2000 MCG/ML, 5 ML vial, The Guyer Institute of Molecular Medicine, Indianapolis, IN

by Advanced Nutriceuticals, LLC

Reason: Lack of Assurance of Sterility: due to concerns with production processes which cannot assure sterility of products intended to be sterile.
Recall initiated: November 30, 2020
Reported by FDA: December 23, 2020
Distribution: CA, CO, FL, IN, KY, OH, TX

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Drug Recall Ongoing Historical recordClass II

BPC-157, 2000 MCG/ML, 5 ML vial, The Guyer Institute of Molecular Medicine, Indianapolis, IN

by Advanced Nutriceuticals, LLC

Reason: Lack of Assurance of Sterility: due to concerns with production processes which cannot assure sterility of products intended to be sterile.
Recall initiated: November 30, 2020
Reported by FDA: December 23, 2020
Distribution: CA, CO, FL, IN, KY, OH, TX

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Drug Recall Ongoing Historical recordClass II

AOD-9604, 1200 MCG/ML, 5 ML vial The Guyer Institute of Molecular Medicine, Indianapolis, IN

by Advanced Nutriceuticals, LLC

Reason: Lack of Assurance of Sterility: due to concerns with production processes which cannot assure sterility of products intended to be sterile.
Recall initiated: November 30, 2020
Reported by FDA: December 23, 2020
Distribution: CA, CO, FL, IN, KY, OH, TX

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Drug Recall Ongoing Historical recordClass II

PT-141, 10 MG/ML, 2 ML vial, The Guyer Institute of Molecular Medicine, Indianapolis, IN

by Advanced Nutriceuticals, LLC

Reason: Lack of Assurance of Sterility: due to concerns with production processes which cannot assure sterility of products intended to be sterile.
Recall initiated: November 30, 2020
Reported by FDA: December 23, 2020
Distribution: CA, CO, FL, IN, KY, OH, TX

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Drug Recall Ongoing Historical recordClass II

FGL, 10 MG/ML, 3 ML vial, The Guyer Institute of Molecular Medicine, Indianapolis, IN

by Advanced Nutriceuticals, LLC

Reason: Lack of Assurance of Sterility: due to concerns with production processes which cannot assure sterility of products intended to be sterile.
Recall initiated: November 30, 2020
Reported by FDA: December 23, 2020
Distribution: CA, CO, FL, IN, KY, OH, TX

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Drug Recall Ongoing Historical recordClass II

CJC-1295, 2000 MCG/ML, 5 ML vial, The Guyer Institute of Molecular Medicine, Indianapolis, IN

by Advanced Nutriceuticals, LLC

Reason: Lack of Assurance of Sterility: due to concerns with production processes which cannot assure sterility of products intended to be sterile.
Recall initiated: November 30, 2020
Reported by FDA: December 23, 2020
Distribution: CA, CO, FL, IN, KY, OH, TX

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Drug Recall Terminated Historical recordClass III

Scandonest 3% Plain (Mepivacaine Hydrochloride 3% without Vasoconstrictor), packaged in cartons of 50 cartridges (1.7 mL each), Rx only, Manufactured for SEPTODONT, Inc., Louisville, CO 80027, by Novocol Pharmaceutical of Canada, Inc., Cambridge, ON N1R 6X3, Canada, NDC 0362-1098-90

by Novocol Pharmaceutical of Canada, Inc.

Reason: Labeling: Label mix-up
Recall initiated: November 20, 2020
Reported by FDA: December 16, 2020
Distribution: U.S. nationwide.

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Drug Recall Terminated Historical recordClass II

Docetaxel Injection USP 160 mg/8mL (20 mg/mL), For Intravenous Infusion Only, Rx Only, 8 mL Single Use Vial, Cytotoxic Agent, Manufactured by: Shilpa Medicare Limited, India, Distributed by: Armas Pharmaceuticals, Inc., Manalapan, NJ 07726, NDC 72485-216-08.

by Shilpa Medicare Limited

Reason: CGMP Deviations
Recall initiated: December 8, 2020
Reported by FDA: December 16, 2020
Distribution: Nationwide in the U.S.

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Drug Recall Terminated Historical recordClass II

Imatinib Mesylate Tablets 400 mg, Rx Only, 30-count Bottle, Manufactured by: Shilpa Medicare Limited, India, Distributed by: Armas Pharmaceuticals Inc., Manalapan, NJ 07726, NDC 72485-203-30.

by Shilpa Medicare Limited

Reason: CGMP Deviations
Recall initiated: December 8, 2020
Reported by FDA: December 16, 2020
Distribution: Nationwide in the U.S.

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Drug Recall Terminated Historical recordClass II

Imatinib Mesylate Tablets 100 mg, Rx Only, 90-count Bottle, Manufactured by: Shilpa Medicare Limited, India, Distributed by: Armas Pharmaceuticals Inc., Manalapan, NJ 07726, NDC 72485-202-90.

by Shilpa Medicare Limited

Reason: CGMP Deviations
Recall initiated: December 8, 2020
Reported by FDA: December 16, 2020
Distribution: Nationwide in the U.S.

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Drug Recall Terminated Historical recordClass II

Azacitidine for Injection 100 mg/vial, For Subcutaneous and Intravenous Use Only, Rx Only, One Single Dose Vial, Cytotoxic Agent, Manufactured by: Shilpa Medicare Limited, India, Distributed by: Armas Pharmaceuticals, Inc., Manalapan, NJ 07726, NDC 72606-558-01.

by Shilpa Medicare Limited

Reason: CGMP Deviations
Recall initiated: December 8, 2020
Reported by FDA: December 16, 2020
Distribution: Nationwide in the U.S.

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Drug Recall Terminated Historical recordClass II

Azacitidine for Injection 100 mg/vial, For Subcutaneous and Intravenous Use Only, Rx Only, One Single Dose Vial, Cytotoxic Agent, Manufactured by: Shilpa Medicare Limited, Jadcherla, 509301, India, Distributed by: Armas Pharmaceuticals, Inc. Manalapan, NJ 07726 NDC 72485-201-01.

by Shilpa Medicare Limited

Reason: CGMP Deviations
Recall initiated: December 8, 2020
Reported by FDA: December 16, 2020
Distribution: Nationwide in the U.S.

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Drug Recall Terminated Historical recordClass II

Busulfan Injection 60 mg/10 mL (6 mg/mL), For Intravenous Infusion Only, Must be diluted before use, Single Dose Vial, Sterile, Cytotoxic Agent, Rx Only, 10 mL vial, Manufactured by: Shilpa Medicare Limited, India, Distributed by: Armas Pharmaceuticals, Inc., Manalapan, NJ 07726, Vial NDC 72485-210-01, Carton NDC 72485-210-08.

by Shilpa Medicare Limited

Reason: CGMP Deviations
Recall initiated: December 8, 2020
Reported by FDA: December 16, 2020
Distribution: Nationwide in the U.S.

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Drug Recall Terminated Historical recordClass I

Dexmedetomidine HCl in 0.9% Sodium Chloride Injection, 200 mcg / 50 mL (4 mcg / mL), 50 mL Single Dose Bottle, Rx only, Fresenius Kabi, Lake Zurich, IL 60047, NDC 63323-671-05

by Fresenius Kabi USA, LLC

Reason: Cross Contamination with other products: trace amounts of lidocaine
Recall initiated: November 17, 2020
Reported by FDA: December 16, 2020
Distribution: USA Nationwide

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Drug Recall Terminated Historical recordClass II

Protz real protection Antibacterial Hand Sanitizer, Ethyl Alcohol 70%, 13.5 FL OZ (400 mL), Distributed by: Safety-Med Products, Inc. Burlington, WI 53105 Made in Mexico by Asiaticon S.A. de C.V. Conkal No. 62, Mexico, Ciudad de Mexico 14200, Mexico NDC: 75192-600-02 UPC 7 503019 005002

by Asiaticon, SA de CV

Reason: Lack of CGMPs:
Recall initiated: August 25, 2020
Reported by FDA: December 16, 2020
Distribution: Distributed in Texas

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Drug Recall Terminated Historical recordClass II

V-Klean Hand Sanitizer Gel Alcohol 70% packaged as a)8.5 fl oz (250 ml), UPC 7 16053 70499 3; b) 16.9 fl oz (500 ml), UPC 7 16053 70499 3; c) 33.8 fl. oz. (1000 ml) bottles: 716053704993; Manufactured by: Asiaticon S.A. de C.V. Conkar 62, Jardines del Ajusco. Tlalpan Cuidad de Mexico. 14200 ;

by Asiaticon, SA de CV

Reason: Lack of CGMPs:
Recall initiated: August 25, 2020
Reported by FDA: December 16, 2020
Distribution: Distributed in Texas

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Drug Recall Terminated Historical recordClass II

Tizanidine Tablets, USP 4mg, Rx Only, 150 Tablets per Bottle, Manufactured by Alkem Laboratories Ltd, Mumbai - 400 013, INDIA, Distributed by: Ascend Laboratories, LLC Parsippany, NJ 07054, NDC: 67877-614-15.

by Ascend Laboratories LLC

Reason: Failed Dissolution Specifications; Out of Specification (low) results were obtained.
Recall initiated: November 24, 2020
Reported by FDA: December 9, 2020
Distribution: MI

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Data last updated: September 14, 2026 ET

This information is republished from FDA's Recall Enterprise System through openFDA. Public Health Trace does not verify or supplement it, is not affiliated with the FDA, and does not provide medical advice -- always follow the guidance of your pharmacist, physician, or the recalling company for any medication you take. Read the full medical disclaimer.