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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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Showing 6,181–6,200 of 17,964 drug recalls

Drug Recall Terminated Historical recordClass II

Bi-Est8:2/Progesterone/Testosterone 1.0/50 MG/.5MG/ML Cream 30 GM tube, Rx, The Medicine Shoppe Pharmacy, Port Charlotte, FL

by The Medicine Shoppe Pharmacy

Reason
Lack of Processing Control
Recall initiated
April 6, 2020
Reported by FDA
April 22, 2020
Distribution
Florida

View recall →

Drug Recall Terminated Historical recordClass II

Testosterone W/Cosmetic HRT Base 100 MG (10%) Cream 30 GM, tubes Rx, The Medicine Shoppe Pharmacy, Port Charlotte, FL

by The Medicine Shoppe Pharmacy

Reason
Lack of Processing Control
Recall initiated
April 6, 2020
Reported by FDA
April 22, 2020
Distribution
Florida

View recall →

Drug Recall Terminated Historical recordClass II

Estriol Vaginal Cream (0.1%) 1 mg Cream 30 GM tubes, Rx, The Medicine Shoppe Pharmacy, Port Charlotte, FL

by The Medicine Shoppe Pharmacy

Reason
Lack of Processing Control
Recall initiated
April 6, 2020
Reported by FDA
April 22, 2020
Distribution
Florida

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Drug Recall Terminated Historical recordClass II

Losartan Potassium Tablets, USP, 25 mg, Rx only, a) 30 ct. (NDC 60429-316-30) b) 90ct. (NDC 60429-316-90) c) 1,000 ct. (60429-316-10) bottles, GSMS Incorporated, Manufactured by Arrow Pharm (Malta) Ltd., Packaged by GSMS Incorporated, Camarillo, CA 93012, USA

by Golden State Medical Supply Inc.

Reason
CGMP Deviations: Impurity for N-nitroso-N-methyl-4-aminobutryric Acid (NBMA) detected in active ingredient (API) used to manufacture finished products.
Recall initiated
April 3, 2020
Reported by FDA
April 22, 2020
Distribution
Nationwide

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Drug Recall Terminated Historical recordClass II

Gabapentin Capsules, USP 100mg 1,000-count bottles, Rx only, Distributed by: Aurobindo Pharma USA, Inc. Dayton, NJ 08810, NDC 65862-198-99

by Aurobindo Pharma USA Inc.

Reason
CGMP Deviations: Products were manufactured in a processing area in which water leakage was observed
Recall initiated
March 18, 2020
Reported by FDA
April 22, 2020
Distribution
Nationwide within the United States

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Drug Recall Terminated Historical recordClass II

Paregoric Alternate Elixir 300 mL bottle, Rx, The Medicine Shoppe Pharmacy, Port Charlotte, FL

by The Medicine Shoppe Pharmacy

Reason
Lack of Processing Control
Recall initiated
April 6, 2020
Reported by FDA
April 22, 2020
Distribution
Florida

View recall →

Drug Recall Terminated Historical recordClass II

Estriol/Testosterone Vaginal 0.1/0.1% Cream 30 gm jar, Rx, The Medicine Shoppe Pharmacy, Port Charlotte, FL

by The Medicine Shoppe Pharmacy

Reason
Lack of Processing Control
Recall initiated
April 6, 2020
Reported by FDA
April 22, 2020
Distribution
Florida

View recall →

Drug Recall Terminated Historical recordClass II

Bi-Est (1:1)/Progesterone/Testosterone 2.5/150/1.5 mg/mL Versabase CR 90 mL bottle, Rx, The Medicine Shoppe Pharmacy, Port Charlotte, FL

by The Medicine Shoppe Pharmacy

Reason
Lack of Processing Control
Recall initiated
April 6, 2020
Reported by FDA
April 22, 2020
Distribution
Florida

View recall →

Drug Recall Terminated Historical recordClass II

Paregoric Compound (contains Morphine) Solution 480 mL bottle, Rx, The Medicine Shoppe Pharmacy, Port Charlotte, FL

by The Medicine Shoppe Pharmacy

Reason
Lack of Processing Control
Recall initiated
April 6, 2020
Reported by FDA
April 22, 2020
Distribution
Florida

View recall →

Drug Recall Terminated Historical recordClass II

Bi-Est 1:1/Progest/DHEA 0.5 mg/180 mg/25 mg/mL Cream 30 mL jar, Rx, The Medicine Shoppe Pharmacy, Port Charlotte, FL

by The Medicine Shoppe Pharmacy

Reason
Lack of Processing Control
Recall initiated
April 6, 2020
Reported by FDA
April 22, 2020
Distribution
Florida

View recall →

Drug Recall Terminated Historical recordClass II

Progesterone/Versa Base 20 mg (2%) Cream 30 gm tube, Rx, The Medicine Shoppe Pharmacy, Port Charlotte, FL

by The Medicine Shoppe Pharmacy

Reason
Lack of Processing Control
Recall initiated
April 6, 2020
Reported by FDA
April 22, 2020
Distribution
Florida

View recall →

Drug Recall Terminated Historical recordClass II

Fluorouracil (5-FU) 4.5% Cream 100 GM, tube Rx, The Medicine Shoppe Pharmacy, Port Charlotte, FL

by The Medicine Shoppe Pharmacy

Reason
Lack of Processing Control
Recall initiated
April 6, 2020
Reported by FDA
April 22, 2020
Distribution
Florida

View recall →

Drug Recall Terminated Historical recordClass I

Tetracycline HCL Capsules, USP, 250 mg, 100-count Bottle, Rx Only, Manufactured for: Heritage Pharmaceuticals Inc. East Brunswick NJ 08816. NDC 23155-017-01

by Avet Pharmaceuticals, Inc.

Reason
Failed Dissolution Specifications: Out of specification result during long term testing in Tetracycline HCl capsules.
Recall initiated
March 23, 2020
Reported by FDA
April 15, 2020
Distribution
Distributed Nationwide in the US

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Drug Recall Terminated Historical recordClass I

Tetracycline HCL Capsules, USP, 500 mg, 100-count Bottle, Rx Only, Manufactured for: Heritage Pharmaceuticals Inc. East Brunswick NJ 08816. NDC 23155-018-01

by Avet Pharmaceuticals, Inc.

Reason
Failed Dissolution Specifications: Out of specification result during long term testing in Tetracycline HCl capsules.
Recall initiated
March 23, 2020
Reported by FDA
April 15, 2020
Distribution
Distributed Nationwide in the US

View recall →

Drug Recall Terminated Historical recordClass II

Thyro-H, 500mg Capsules, 90-count bottles, Distributed by Herbal Doctor Remedies Alhambra, CA 91801-7081 USA, 1(800) 600-0808

by Herbal Doctor Remedies

Reason
CGMP Deviations: These products have been found to be misbranded as unapproved new drugs
Recall initiated
March 24, 2020
Reported by FDA
April 15, 2020
Distribution
Products are sold online within the United States and internationally to the following countries: Australia, Canada, Israel, Italy, Japan, Norway, and United Kingdom

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Drug Recall Terminated Historical recordClass II

BioMycin, 500mg Capsules, 90-count bottles, Distributed by Herbal Doctor Remedies Alhambra, CA 91801-7081 USA, 1(800) 600-0808

by Herbal Doctor Remedies

Reason
CGMP Deviations: These products have been found to be misbranded as unapproved new drugs
Recall initiated
March 24, 2020
Reported by FDA
April 15, 2020
Distribution
Products are sold online within the United States and internationally to the following countries: Australia, Canada, Israel, Italy, Japan, Norway, and United Kingdom

View recall →

Drug Recall Terminated Historical recordClass II

Worm Off, 500mg Capsules, 90-count bottles, Distributed by Herbal Doctor Remedies Alhambra, CA 91801-7081 USA, 1(800) 600-0808

by Herbal Doctor Remedies

Reason
CGMP Deviations: These products have been found to be misbranded as unapproved new drugs
Recall initiated
March 24, 2020
Reported by FDA
April 15, 2020
Distribution
Products are sold online within the United States and internationally to the following countries: Australia, Canada, Israel, Italy, Japan, Norway, and United Kingdom

View recall →

Drug Recall Terminated Historical recordClass II

Voice Rescue, 500mg Capsules, 90-count bottles, Distributed by Herbal Doctor Remedies Alhambra, CA 91801-7081 USA, 1(800) 600-0808

by Herbal Doctor Remedies

Reason
CGMP Deviations: These products have been found to be misbranded as unapproved new drugs
Recall initiated
March 24, 2020
Reported by FDA
April 15, 2020
Distribution
Products are sold online within the United States and internationally to the following countries: Australia, Canada, Israel, Italy, Japan, Norway, and United Kingdom

View recall →

Drug Recall Terminated Historical recordClass II

Vitiligo Off Ointment, Distributed by Herbal Doctor Remedies Alhambra, CA 91801-7081 USA, 1(800) 600-0808

by Herbal Doctor Remedies

Reason
CGMP Deviations: These products have been found to be misbranded as unapproved new drugs
Recall initiated
March 24, 2020
Reported by FDA
April 15, 2020
Distribution
Products are sold online within the United States and internationally to the following countries: Australia, Canada, Israel, Italy, Japan, Norway, and United Kingdom

View recall →

Drug Recall Terminated Historical recordClass II

Vigo-XXX, 500mg Capsules, 90-count bottles, Distributed by Herbal Doctor Remedies Alhambra, CA 91801-7081 USA, 1(800) 600-0808

by Herbal Doctor Remedies

Reason
CGMP Deviations: These products have been found to be misbranded as unapproved new drugs
Recall initiated
March 24, 2020
Reported by FDA
April 15, 2020
Distribution
Products are sold online within the United States and internationally to the following countries: Australia, Canada, Israel, Italy, Japan, Norway, and United Kingdom

View recall →

Data last updated:

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.