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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 5,821–5,840 of 17,964 drug recalls

Drug Recall Terminated Historical recordClass II

WP Thyroid, Westhroid Pure, 2 Grain (130 mg) Thyroid USP packaged in a) 1,000 Tablets, NDC 64727-5950-2 ; b) 30 Tablets, NDC 64727-5950-4; c) 60 Tablets, NDC 64727-5950-5; d) 90 Tablets, NDC 64727-5950-6; e) 100 Tablets, NDC 64727-5950-1; Rx Only, Manufactured by: RLC Labs Phoenix, AZ 85034

by RLC Labs Inc.

Reason
CGMP Deviations: manufactured under the same conditions as those found 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 II

WP Thyroid, Westhroid Pure, 1.75 Grain (113.75 mg) Thyroid USP, packaged in a) 1,000 Tablets, NDC 64727-6150-2 ; b) 30 Tablets, NDC 64727-6150-4; c) 60 Tablets, NDC 64727-6150-5; d) 90 Tablets, NDC 64727-6150-6; e) 100 Tablets, NDC 64727-6150-1; Rx only, Manufactured by: RLC Labs Phoenix, AZ 85034

by RLC Labs Inc.

Reason
CGMP Deviations: manufactured under the same conditions as those found 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 II

WP Thyroid, Westhroid Pure, 1.5 Grain (97.5 mg) Thyroid USP packaged in a) 1,000 Tablets, NDC 64727-5850-2 ; b) 30 Tablets, NDC 64727-5850-4; c) 60 Tablets, NDC 64727-5850-5; d) 90 Tablets, NDC 64727-5850-6; e) 100 Tablets, NDC 64727-5850-1; Rx only, Manufactured by: RLC Labs Phoenix, AZ 85034

by RLC Labs Inc.

Reason
CGMP Deviations: manufactured under the same conditions as those found 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 II

WP Thyroid, Westhroid Pure, 1.25 Grain (81.25 mg) Thyroid USP packaged in a) 1,000 Tablets, NDC 64727-6050-2 ; b) 30 Tablets, NDC 64727-6050-4; c) 60 Tablets, NDC 64727-6050-5; d) 90 Tablets, NDC 64727-6050-6; e) 100 Tablets, NDC 64727-6050-1; Rx only, Manufactured by: RLC Labs Phoenix, AZ 85034

by RLC Labs Inc.

Reason
CGMP Deviations: manufactured under the same conditions as those found 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 II

WP Thyroid, Westhroid Pure, 1 Grain (65 mg) Thyroid USP, packaged in a) 1,000 Tablets, NDC 64727-5750-2 ; b) 30 Tablets, NDC 64727-5750-4; c) 60 Tablets, NDC 64727-5750-5; d) 90 Tablets, NDC 64727-5750-6; e) 100 Tablets, NDC 64727-5750-1; Rx only, Manufactured by: RLC Labs Phoenix, AZ 85034

by RLC Labs Inc.

Reason
CGMP Deviations: manufactured under the same conditions as those found 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 II

WP Thyroid, Westhroid Pure, 3/4 Grain (48.75 mg) Thyroid USP, packaged in a) 1,000 Tablets, NDC 64727-5650-2 ; b) 30 Tablets, NDC 64727-5650-4; c) 60 Tablets, NDC 64727-5650-5; d) 90 Tablets, NDC 64727-5650-6; e) 100 Tablets, NDC 64727-5650-1; Rx only, Manufactured by: RLC Labs Phoenix, AZ 85034

by RLC Labs Inc.

Reason
CGMP Deviations: manufactured under the same conditions as those found 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 II

WP Thyroid, Westhroid Pure, 1/2 Grain (32.5 mg) Thyroid USP packaged in a) 1,000 Tablets, NDC 64727-5550-2 ; b) 30 Tablets, NDC 64727-5550-4; c) 60 Tablets, NDC 64727-5550-5; d) 90 Tablets, NDC 64727-5550-6; e) 100 Tablets, NDC 64727-5550-1; Rx only, Manufactured by: RLC Labs Phoenix, AZ 85034

by RLC Labs Inc.

Reason
CGMP Deviations: manufactured under the same conditions as those found 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 II

WP Thyroid, Westhroid Pure, Thyroid USP, [liothyronine (T3) 2.25 mcg and levothyroxine (T4) 9.5 mcg], 1/4 Grain (16.25 mg) Tablets, packaged in a) 30-count bottles, NDC 64727-5450-4; b) 60-count bottles, NDC 64727-5450-5; c) 90-count bottles, NDC 64727-5450-6; d) 100-count bottles, NDC 64727-5450-1; and e) 1,000-count bottles, NDC 64727-5450-2; Rx only, Manufactured by: RLC Labs Phoenix, AZ 85034.

by RLC Labs Inc.

Reason
CGMP Deviations: manufactured under the same conditions as those found 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 II

Nature-Throid, Thyroid USP [liothyronine (T3) 27 mcg and levothyroxine (T4) 114 mcg], 3 Grain (195 mg) Tablets, packaged in a) 30-count bottles, NDC 64727-3312-4; b) 60-count bottles, NDC 64727-3312-5; c) 90-count bottles, NDC 64727-3312-6; d) 100-count bottles, NDC 64727-3312-1; and e) 1,000-count bottles, NDC 64727-3312-2; Rx only, Manufactured by: RLC Labs Phoenix, AZ 85034.

by RLC Labs Inc.

Reason
CGMP Deviations: manufactured under the same conditions as those found 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 II

Nature-Throid, Thyroid USP [liothyronine (T3) 22.5 mcg and levothyroxine (T4) 95 mcg], 2.5 Grain (162.5 mg) Tablets, packaged in a) 30-count bottles, NDC 64727-3310-4; b) 60-count bottles, NDC 64727-3310-5; c) 90-count bottles, NDC 64727-3310-6; d) 100-count bottles, NDC 64727-3310-1; and e) 1,000-count bottles, NDC 64727-3310-2; Rx only, Manufactured by: RLC Labs Phoenix, AZ 85034.

by RLC Labs Inc.

Reason
CGMP Deviations: manufactured under the same conditions as those found 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 II

Nature-Throid, Thyroid USP [liothyronine (T3) 20.25 mcg and levothyroxine (T4) 85.5 mcg], 2.25 Grain (146.25 mg) Tablets, packaged in a) 30-count bottles, NDC 64727-3309-4; b) 60-count bottles, NDC 64727-3309-5; c) 90-count bottles, NDC 64727-3309-6; d) 100-count bottles, NDC 64727-3309-1; and e) 1,000-count bottles, NDC 64727-3309-2; Rx only, Manufactured by: RLC Labs Phoenix, AZ 85034.

by RLC Labs Inc.

Reason
CGMP Deviations: manufactured under the same conditions as those found 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 II

Nature-Throid, Thyroid USP [liothyronine (T3) 18 mcg and levothyroxine (T4) 76 mcg], 2 Grain (130 mg) Tablets, packaged in a) 30-count bottles, NDC 64727-3308-4; b) 60-count bottles, NDC 64727-3308-5; c) 90-count bottles, NDC 64727-3308-6; d) 100-count bottles, NDC 64727-3308-1; and e) 1,000-count bottles, NDC 64727-3308-2; Rx only, Manufactured by: RLC Labs Phoenix, AZ 85034.

by RLC Labs Inc.

Reason
CGMP Deviations: manufactured under the same conditions as those found 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 II

Nature-Throid, Thyroid USP [liothyronine (T3) 15.75 mcg and levothyroxine (T4) 66.5 mcg], 1.75 Grain (113.75 mg) Tablets, packaged in a) 30-count bottles, NDC 64727-3307-4; b) 60-count bottles, NDC 64727-3307-5; c) 90-count bottles, NDC 64727-3307-6; d) 100-count bottles, NDC 64727-3307-1; and e) 1,000-count bottles, NDC 64727-3307-2; Rx only, Manufactured by: RLC Labs Phoenix, AZ 85034.

by RLC Labs Inc.

Reason
CGMP Deviations: manufactured under the same conditions as those found 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 II

Nature-Throid, Thyroid USP [liothyronine (T3) 13.5 mcg and levothyroxine (T4) 57 mcg], 1.5 Grain (97.5 mg) Tablets, 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; d) 100-count bottles, NDC 64727-3305-1; and e) 1,000-count bottles, NDC 64727-3305-2; Rx only, Manufactured by: RLC Labs Phoenix, AZ 85034.

by RLC Labs Inc.

Reason
CGMP Deviations: manufactured under the same conditions as those found 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 II

Nature-Throid, Thyroid USP [liothyronine (T3) 11.25 mcg and levothyroxine (T4) 47.5 mcg], 1.25 Grain (81.25 mg) Tablets, packaged in a) 30-count bottles, NDC 64727-3303-4; b) 60-count bottles, NDC 64727-3303-5; c) 90-count bottles, NDC 64727-3303-6; d) 100-count bottles, NDC 64727-3303-1; e) 1,000-count bottles, NDC 64727-3303-2; Rx only, Manufactured by: RLC Labs Phoenix, AZ 85034.

by RLC Labs Inc.

Reason
CGMP Deviations: manufactured under the same conditions as those found 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 II

Nature-Throid, Thyroid USP [liothyronine (T3) 4.5 mcg and levothyroxine (T4) 19 mcg], 1/2 Grain (32.5 mg) Tablets, packaged in a) 30-count bottles, NDC 64727-3299-4; b) 60-count bottles, NDC 64727-3299-5; c) 90-count bottles, NDC 64727-3299-6; d) 100-count bottles, NDC 64727-3299-1; and e) 1000-count bottles, NDC 64727-3299-2; Rx only, Manufactured by: RLC Labs Phoenix, AZ 85034.

by RLC Labs Inc.

Reason
CGMP Deviations: manufactured under the same conditions as those found 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 II

Nature-Throid, Thyroid USP [liothyronine (T3) 6.75 mcg and levothyroxine (T4) 28.5 mcg], 3/4 Grain (48.75 mg) Tablets, packaged in a) 30-count bottles, NDC 64727-3302-4; b) 60-count bottles, NDC 64727-3302-5; c) 90-count bottles, NDC 64727-3302-6; d) 100-count bottles, NDC 64727-3302-1; and e) 1,000-count bottles, NDC 64727-3302-2; Rx Only, Manufactured by: RLC Labs Phoenix, AZ 85034.

by RLC Labs Inc.

Reason
CGMP Deviations: manufactured under the same conditions as those found 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 II

Nature-Throid, Thyroid USP [liothyronine (T3) 9 mcg and levothyroxine (T4) 38 mcg], 1 Grain (65 mg) Tablets, packaged in a) 30-count bottles, NDC 64727-3300-4; b) 60-count bottles, NDC 64727-3300-5; c) 90-count bottles, NDC 64727-3300-6; d) 100-count bottles, NDC 64727-3300-1; and e) 1,000-count bottles, NDC 64727-3300-2; Rx only, Manufactured by: RLC Labs Phoenix, AZ 85034.

by RLC Labs Inc.

Reason
CGMP Deviations: manufactured under the same conditions as those found 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 III

Potassium Acetate Injection, USP 40 mEq/20 mL (2 mEq/mL) Single Dose Vials, Rx only, Manufactured By: Exela Pharma Sciences, LLC. Lenoir, NC NDC 51754-2001-4

by Exela Pharma Sciences LLC

Reason
Short Fill
Recall initiated
May 5, 2020
Reported by FDA
September 23, 2020
Distribution
Nationwide and Puerto Rico

View recall →

Drug Recall Terminated Historical recordClass I

Goldenseal Root Powder Organic, 1 oz. clear plastic bag, Maison Terre Natural Products, www.maisonterre.net

by Maison Terre, LLC

Reason
Microbial Contamination of Non-Sterile Products: FDA laboratory analysis found product to be contaminated with various microorganisms including Enterobacter cloacae, Cronobacter sakazakii, Cronobacter dublinensis, among others.
Recall initiated
August 17, 2020
Reported by FDA
September 23, 2020
Distribution
Nationwide.

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.