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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

LL-37, 2000 MCG/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

HIGH DOSE B12, 10 MG/ML, 10 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

GHK-CU, 10 MG/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 BETA - 4, 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

CEREBROLYSIN, 107.5 MG/ML, 10 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

DSIP, 1000 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

B12 for Injection, 2 MG/ML, 10 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

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.

View recall →

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.