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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 5,801–5,820 of 17,964 drug recalls

Drug Recall Terminated Historical recordClass II

Strides Pharma Inc.Potassium Chloride Extended-Release Tablets, USP 8mEq (600 mg) 100 Tablets Rx Only Manufactured by: Strides Pharma Science Limited Bengaluru -562106 India Distributed by: Strides Pharma Inc., East Brunswick NJ 08816 NDC 64380-860-06

by Strides Inc.

Reason
Failed Dissolution Specifications
Recall initiated
August 24, 2020
Reported by FDA
October 7, 2020
Distribution
nationwide

View recall →

Drug Recall Terminated Historical recordClass II

Nature-Throid, 1.5 Grain, (97.5 mg), (Thyroid U.S.P. 1.5 gr. (97.5mg)/Liothyronine (T3) 13.5mcg/Levothyroxine (T4) 57mcg, 90-count bottles, Rx Only, Mfg: RLC Labs; Cave Creek, AZ, Preferred Pharmaceuticals, Inc. NDC 68788-7605-09

by Preferred Pharmaceuticals, Inc.

Reason
CGMP Deviations
Recall initiated
September 2, 2020
Reported by FDA
September 30, 2020
Distribution
Repackaged tablets sold to three physicians located in CA and GA.

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Drug Recall Terminated Historical recordClass II

Nature-Throid, 1 Grain, 65 mg (Thyroid U.S.P. 1 gr. (65mg)/Liothyronine (T3) 9mcg/Levothyroxine (T4) 38mcg, packaged in a) 90-count bottles (NDC 68788-7604-09), b) 100-count tablets (NDC 68788-7604-01), Rx Only, Mfg: RLC Labs; Cave Creek, AZ, Preferred Pharmaceuticals, Inc.

by Preferred Pharmaceuticals, Inc.

Reason
CGMP Deviations
Recall initiated
September 2, 2020
Reported by FDA
September 30, 2020
Distribution
Repackaged tablets sold to three physicians located in CA and GA.

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Drug Recall Terminated Historical recordClass II

Nature-Throid, 3/4 Grain (48.75 mg) Thyroid U.S.P. 3/4 gr. (48.75 mg)/Liothyronine (T3) 6.75mcg/Levothyroxine (T4) 28.5mcg, 90-count tablets, Rx Only, Mfg: RLC Labs; Cave Creek, AZ, Preferred Pharmaceuticals, Inc. NDC 68788-6860-09

by Preferred Pharmaceuticals, Inc.

Reason
CGMP Deviations
Recall initiated
September 2, 2020
Reported by FDA
September 30, 2020
Distribution
Repackaged tablets sold to three physicians located in CA and GA.

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Drug Recall Terminated Historical recordClass II

Nature-Throid, 1/2 Grain, 32.5 mg (Thyroid U.S.P. 1/2 gr. (32.5 mg)/Liothyronine (T3) 4.5mcg/Levothyroxine (T4) 19mch, 100-count tablets, Rx Only, Mfg: RLC Labs; Cave Creek, AZ, Preferred Pharmaceuticals, Inc. NDC 68788-9283-01

by Preferred Pharmaceuticals, Inc.

Reason
CGMP Deviations
Recall initiated
September 2, 2020
Reported by FDA
September 30, 2020
Distribution
Repackaged tablets sold to three physicians located in CA and GA.

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Drug Recall Terminated Historical recordClass II

bio aaa Alcohol en Gel Antibacterial, Alcohol al 70% Cont. Neto 480 ml bottle, Hecho en Mexico por: AAA Cosmetica S.A. DE C.V. Recursos Hidraulicos No. 1 Secc. A, Col La Loma Zona Industrial, Tlalnepantla de Baz C.P. 54060 Edo. Mexico. UPC 7 502272 12108 5

by AJR TRADING LLC

Reason
CGMP Deviations: Product manufactured in a facility where methanol was found in other distributed lots of product.
Recall initiated
September 3, 2020
Reported by FDA
September 30, 2020
Distribution
Distributed in Florida

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Drug Recall Terminated Historical recordClass I

Red-E Tablet, Proprietary Blend 3000 mg**, packaged in 1-count plastic bag stapled with cardboard labeling.

by The Protein Shoppe

Reason
Marketed Without An Approved NDA/ANDA: product found to be tainted with sildenafil, an FDA approved drug for the treatment of male erectile dysfunction, making this an unapproved drug fro which the safety and efficacy have not been established and therefore subject to recall.
Recall initiated
September 1, 2020
Reported by FDA
September 30, 2020
Distribution
Nationwide in the USA

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Drug Recall Terminated Historical recordClass II

Albuterol Sulfate Inhalation Aerosol, 90 mcg per actuation, 200 metered inhalations, Manufactured by: Catalent Pharma Solutions, 160 N Pharma Drive, Morrisville, NC 27560, Distributed by: Perrigo, Allegan, MI 49010 NDC 45802-088-01

by Perrigo Company PLC

Reason
Defective Delivery System: Sustained trend of failure to dispense complaints.
Recall initiated
September 16, 2020
Reported by FDA
September 30, 2020
Distribution
Nationwide in the U.S.

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Drug Recall Terminated Historical recordClass II

Zanilast+ Gel Antiseptic Hand Sanitizer (70% Ethyl Alcohol) Packaged in 25 kg bottles, Distributed by Fujimura Trading S.A. DE C.V. Juventino Rosas 1902, Col. Caracol, 64810, Monterrey, N.L., Mexico Nanomateriales S.A. DE C.V. NDC 69912-006-01

by Nanomateriales Sa De Cv

Reason
GMP Deviations: Potential to contain 1-propanol.
Recall initiated
August 18, 2020
Reported by FDA
September 30, 2020
Distribution
CA, NY and Mexico

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Drug Recall Terminated Historical recordClass II

Zanilast+ Gel Antiseptic Hand Sanitizer (70% Ethyl Alcohol) Packaged in a) 33.8 fl oz (1.06 qt) (1L) (NDC 69912-008-01 UPC 2 000000 531151); b) 1 gal (3.76L) (NDC 69912-008-02 UPC 2 000000 531144) bottles, Distributed by Fujimura Trading S.A. DE C.V. Juventino Rosas 1902, Col. Caracol, 64810, Monterrey, N.L., Mexico Nanomateriales S.A. DE C.V.

by Nanomateriales Sa De Cv

Reason
GMP Deviations: Potential to contain 1-propanol.
Recall initiated
August 18, 2020
Reported by FDA
September 30, 2020
Distribution
CA, NY and Mexico

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Drug Recall Terminated Historical recordClass II

Yacana Alcohol Antiseptic 70% Topical Solution 8.5 oz (250 mL), OTC, Manufactured by: Greensys of North America LLC. 5001 W Military Hwy Ste 100 McAllen, TX USA 78503, NDC# 76562-000-85, UPC 6 64213 64350 0

by GRUPO YACANA MEXICO SAS DE CV

Reason
cGMP Deviations
Recall initiated
August 18, 2020
Reported by FDA
September 30, 2020
Distribution
TX

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Drug Recall Terminated Historical recordClass II

Yacana Alcohol Antiseptic 70% Topical Solution 8.5 oz (250 mL), OTC, Manufactured by: Grupo Yacana Mexico SAS de CV Ave. Alfonso reyes 714 Col. Contry La Silla, Monterrey, Nuevo Leon, Mexico Tel. +52 812473-8453, NDC # 76592-002-04, UPC 6 03765 37699 3

by GRUPO YACANA MEXICO SAS DE CV

Reason
cGMP Deviations
Recall initiated
August 18, 2020
Reported by FDA
September 30, 2020
Distribution
TX

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Drug Recall Terminated Historical recordClass I

Incredible Products Gelbac T Antibacterial Hand Gel (ethyl alcohol 80%), Kills 99.9% bacteria and germs, a) 4.2 Oz./125 mL bottle, NDC: 71761-000-00, UPC: 7502278002555, Distributed by Pacific Coast Global Inc. Chula Vista, CA 91911, Made in Mexico b) 33.8 Oz./1 L, UPC: 7502278002586, Made in Mexico By Incredible Products S.A. de C.V. alle Castellanos y Tapia 921, Oblatos, 44350 Guadalajara, Jal, MX.

by Incredible Products, SA de CV

Reason
Chemical Contamination: Product contains methanol as an active ingredient and is sub-potent for ethanol.
Recall initiated
August 6, 2020
Reported by FDA
September 30, 2020
Distribution
CA and GA

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Drug Recall Terminated Historical recordClass I

Leafree Instant Hand Sanitizer Aloe Vera (ethyl alcohol 70% v/v), Kills 99.99% Germs, EDIBLE ALCOHOL, a) 100 mL bottles, UPC code 6970495860325, b) 300 mL bottles, UPC code 6970495860318, and c) 500 mL bottles, UPC code 6970495860301, Exclusively Distributed by: Corgiomed LLC, McLean, VA 22102, USA, Made in China.

by CORGIOMED LLC

Reason
Marketed without an Approved NDA/ANDA; product labeled as Edible Alcohol rendering the product an unapproved new drug and misbranded.
Recall initiated
September 3, 2020
Reported by FDA
September 30, 2020
Distribution
NC and MD

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Drug Recall Terminated Historical recordClass I

Nature Throid, 1.5 Grain (97.5 mg) Thyroid USP [Liothyronine (T3) 13.5 mcg, Levothyroxine (T4) 57 mcg], packaged in a) 30-count bottles (NDC 64727-3305-4), b) 60-count bottles (NDC 64727-3305-5), c) 90-count bottles (NDC 64727-3305-6), and 100-count bottles (NDC 64727-3305-1), Rx only, Manufactured by: RLC Labs Phoenix, AZ 85024, NDC 64727-3305-1

by RLC Labs Inc.

Reason
Subpotent Drug: FDA analysis found product to be subpotent
Recall initiated
August 25, 2020
Reported by FDA
September 23, 2020
Distribution
Nationwide in the United States

View recall →

Drug Recall Terminated Historical recordClass I

Nature Throid, 2 Grain (130 mg) Thyroid USP [Liothyronine (T3) 18 mcg, Levothyroxine (T4) 76 mcg], packaged in a) 30-count bottles (NDC 64727-3308-4) and b)100-count bottles (NDC 64727-3308-1), Rx only, Manufactured by: RLC Labs Phoenix, AZ 85024

by RLC Labs Inc.

Reason
Subpotent Drug: FDA analysis found product to be subpotent
Recall initiated
August 25, 2020
Reported by FDA
September 23, 2020
Distribution
Nationwide in the United States

View recall →

Drug Recall Terminated Historical recordClass I

Nature Throid, 1.25 Grain (81.25 mg) Thyroid USP [Liothyronine (T3) 11.25 mcg, Levothyroxine (T4) 47.5 mcg], 100-count bottles, Rx only, Manufactured by: RLC Labs Phoenix, AZ 85024, NDC 64727-3303-1

by RLC Labs Inc.

Reason
Subpotent Drug: FDA analysis found product to be subpotent
Recall initiated
August 25, 2020
Reported by FDA
September 23, 2020
Distribution
Nationwide in the United States

View recall →

Drug Recall Terminated Historical recordClass I

Nature Throid, 3/4 Grain (48.75 mg) Thyroid USP [Liothyronine (T3) 6.75 mcg, Levothyroxine (T4) 28.5 mcg], packaged in a) 100-count bottles (NDC 64727-3302-1) and b) 1000-count bottles (NDC 64727-3302-2), Rx only, Manufactured by: RLC Labs Phoenix, AZ 85034

by RLC Labs Inc.

Reason
Subpotent Drug: FDA analysis found product to be subpotent
Recall initiated
August 25, 2020
Reported by FDA
September 23, 2020
Distribution
Nationwide in the United States

View recall →

Drug Recall Terminated Historical recordClass I

Nature Throid, 1/2 Grain (32.5 mg) Thyroid USP [Liothyronine (T3) 4.5 mcg, Levothyroxine (T4) 19 mcg], packaged in a) 90-count bottles (NDC 64727-3299-6), b) 100-count bottles (NDC 64727-3299-1), Rx only, Manufactured by: RLC Labs Phoenix, AZ 85034

by RLC Labs Inc.

Reason
Subpotent Drug: FDA analysis found product to be subpotent
Recall initiated
August 25, 2020
Reported by FDA
September 23, 2020
Distribution
Nationwide in the United States

View recall →

Drug Recall Terminated Historical recordClass I

WP Thyroid, Westhroid Pure, 1/2 Grain (32.5 mg) Thyroid USP [Liothyronine (T3) 4.5 mcg, Levothyroxine (T4) 19 mcg], packaged in a) 30-count bottles (NDC 64727-5550-4), b) 90-count bottles (NDC 64727-5550-6), c) 100-count bottles (NDC 64727-5550-1), Rx only, Manufactured by: RLC Labs Phoenix, AZ 85024

by RLC Labs Inc.

Reason
Subpotent Drug: FDA analysis found product to be subpotent
Recall initiated
August 25, 2020
Reported by FDA
September 23, 2020
Distribution
Nationwide in the United States

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.