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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 7,101–7,120 of 17,964 drug recalls

Drug Recall Completed Historical recordClass II

Ranitidine Tablets, USP 150 mg, a.) 24 count bottles (NDC 63868-480-24), b.) 50-count bottles (NDC 63868-480-50) (CDMA) OTC

by Dr. Reddy's Laboratories, Inc.

Reason
CGMP Deviations: Presence of NDMA impurity detected in product.
Recall initiated
October 1, 2019
Reported by FDA
November 13, 2019
Distribution
Product was distributed to major distributors throughout the United States who may have further distributed the product.

View recall →

Drug Recall Completed Historical recordClass II

Ranitidine Tablets, USP 75 mg, a.) 30- count bottles (NDC 0363-0131-30), b.) 80-count bottles (NDC 0363-0131-80) (Walgreens) OTC

by Dr. Reddy's Laboratories, Inc.

Reason
CGMP Deviations: Presence of NDMA impurity detected in product.
Recall initiated
October 1, 2019
Reported by FDA
November 13, 2019
Distribution
Product was distributed to major distributors throughout the United States who may have further distributed the product.

View recall →

Drug Recall Completed Historical recordClass II

Dr. Reddy's Ranitidine Tablets, USP 150 mg, 24 count bottles, NDC 55111-404-34 (OTC)

by Dr. Reddy's Laboratories, Inc.

Reason
CGMP Deviations: Presence of NDMA impurity detected in product.
Recall initiated
October 1, 2019
Reported by FDA
November 13, 2019
Distribution
Product was distributed to major distributors throughout the United States who may have further distributed the product.

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Drug Recall Completed Historical recordClass II

Dr. Reddy's Ranitidine Tablets, USP 75 mg, 60 count bottles, NDC 55111-131-60, (OTC)

by Dr. Reddy's Laboratories, Inc.

Reason
CGMP Deviations: Presence of NDMA impurity detected in product.
Recall initiated
October 1, 2019
Reported by FDA
November 13, 2019
Distribution
Product was distributed to major distributors throughout the United States who may have further distributed the product.

View recall →

Drug Recall Completed Historical recordClass II

Dr. Reddy's Ranitidine Capsules, USP 300 mg, a.) 30 count bottles (NDC 55111-130-30) b.) 100 count bottles (NDC 55111-130-01)

by Dr. Reddy's Laboratories, Inc.

Reason
CGMP Deviations: Presence of NDMA impurity detected in product.
Recall initiated
October 1, 2019
Reported by FDA
November 13, 2019
Distribution
Product was distributed to major distributors throughout the United States who may have further distributed the product.

View recall →

Drug Recall Completed Historical recordClass II

Ranitidine Tablets, USP 150 mg, 40 count bottles, NDC 11673-849-40 (Target) OTC.

by Dr. Reddy's Laboratories, Inc.

Reason
CGMP Deviations: Presence of NDMA impurity detected in product.
Recall initiated
October 1, 2019
Reported by FDA
November 13, 2019
Distribution
Product was distributed to major distributors throughout the United States who may have further distributed the product.

View recall →

Drug Recall Completed Historical recordClass II

Ranitidine Tablets, USP 75 mg, NDC 57896-715 (GeriCare) OTC.

by Dr. Reddy's Laboratories, Inc.

Reason
CGMP Deviations: Presence of NDMA impurity detected in product.
Recall initiated
October 1, 2019
Reported by FDA
November 13, 2019
Distribution
Product was distributed to major distributors throughout the United States who may have further distributed the product.

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Drug Recall Completed Historical recordClass II

Ranitidine Tablets, USP 150 mg, a.) 24 count bottles (NDC 71713-203-02), b.)95 count bottles (NDC 71713-203-05) (Thirty Madison) OTC.

by Dr. Reddy's Laboratories, Inc.

Reason
CGMP Deviations: Presence of NDMA impurity detected in product.
Recall initiated
October 1, 2019
Reported by FDA
November 13, 2019
Distribution
Product was distributed to major distributors throughout the United States who may have further distributed the product.

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Drug Recall Completed Historical recordClass II

Ranitidine Tablets, USP 150 mg, a.) 95 count bottles (NDC 43598-808-62), b.) 220 count bottles (NDC 43598-808-65) (HCA) OTC.

by Dr. Reddy's Laboratories, Inc.

Reason
CGMP Deviations: Presence of NDMA impurity detected in product.
Recall initiated
October 1, 2019
Reported by FDA
November 13, 2019
Distribution
Product was distributed to major distributors throughout the United States who may have further distributed the product.

View recall →

Drug Recall Completed Historical recordClass II

Ranitidine Tablets 75 mg, a.) 30 count bottles (NDC 63868-482-30), 60 count bottles (NDC 63868-482-60) (CDMA) OTC

by Dr. Reddy's Laboratories, Inc.

Reason
CGMP Deviations: Presence of NDMA impurity detected in product.
Recall initiated
October 1, 2019
Reported by FDA
November 13, 2019
Distribution
Product was distributed to major distributors throughout the United States who may have further distributed the product.

View recall →

Drug Recall Completed Historical recordClass II

Ranitidine Tablets, USP 75 mg 30 count bottles (NDC 30142-131-30) (Kroger)

by Dr. Reddy's Laboratories, Inc.

Reason
CGMP Deviations: Presence of NDMA impurity detected in product.
Recall initiated
October 1, 2019
Reported by FDA
November 13, 2019
Distribution
Product was distributed to major distributors throughout the United States who may have further distributed the product.

View recall →

Drug Recall Completed Historical recordClass II

Ranitidine Tablets, USP 75 mg, a.) 30 count bottles (NDC 69842-871-30) b.) 80 count bottles (NDC 69842-871-80) c.)160 count bottles (NDC 69842-871-37) (CVS) OTC

by Dr. Reddy's Laboratories, Inc.

Reason
CGMP Deviations: Presence of NDMA impurity detected in product.
Recall initiated
October 1, 2019
Reported by FDA
November 13, 2019
Distribution
Product was distributed to major distributors throughout the United States who may have further distributed the product.

View recall →

Drug Recall Completed Historical recordClass II

Ranitidine Tablets, USP 150 mg, a.) 24 count bottles (NDC 30142-505-34), b.) 50 count bottles (NDC 30142-505-50) (Kroger) OTC

by Dr. Reddy's Laboratories, Inc.

Reason
CGMP Deviations: Presence of NDMA impurity detected in product.
Recall initiated
October 1, 2019
Reported by FDA
November 13, 2019
Distribution
Product was distributed to major distributors throughout the United States who may have further distributed the product.

View recall →

Drug Recall Completed Historical recordClass II

Ranitidine Tablets, USP 150 mg, a.) 65 count bottles (NDC 49035-404-61) b.) 130 count bottles (NDC 49035-404-13) c.) 220 count bottles (NDC 49035-404-65) (Walmart) OTC

by Dr. Reddy's Laboratories, Inc.

Reason
CGMP Deviations: Presence of NDMA impurity detected in product.
Recall initiated
October 1, 2019
Reported by FDA
November 13, 2019
Distribution
Product was distributed to major distributors throughout the United States who may have further distributed the product.

View recall →

Drug Recall Completed Historical recordClass II

Ranitidine Tablets, USP 150 mg, a.) 24 count bottles (NDC 0363-0010-34), b.) 65 count bottles (NDC 0363-0010-61) , c.) 95 count bottles (NDC 0363-0010-62), d.) 200 count bottles (NDC 0363-0010-01) (Walgreens) OTC

by Dr. Reddy's Laboratories, Inc.

Reason
CGMP Deviations: Presence of NDMA impurity detected in product.
Recall initiated
October 1, 2019
Reported by FDA
November 13, 2019
Distribution
Product was distributed to major distributors throughout the United States who may have further distributed the product.

View recall →

Drug Recall Completed Historical recordClass II

Ranitidine Tablets, USP 150 mg, 190 count bottles (2x95) Tray (Sam's Club) OTC, NDC 150062076 UPC Code 078742089720

by Dr. Reddy's Laboratories, Inc.

Reason
CGMP Deviations: Presence of NDMA impurity detected in product.
Recall initiated
October 1, 2019
Reported by FDA
November 13, 2019
Distribution
Product was distributed to major distributors throughout the United States who may have further distributed the product.

View recall →

Drug Recall Completed Historical recordClass II

Dr. Reddy's: Ranitidine Capsules 150 mg, Rx a.) 60 count bottles (NDC 55111-129-60) b.) 500 count bottles (NDC 55111-129-05)

by Dr. Reddy's Laboratories, Inc.

Reason
CGMP Deviations: Presence of NDMA impurity detected in product.
Recall initiated
October 1, 2019
Reported by FDA
November 13, 2019
Distribution
Product was distributed to major distributors throughout the United States who may have further distributed the product.

View recall →

Drug Recall Terminated Historical recordClass II

Children's Ibuprofen Oral Suspension USP, 100 mg per 5 mL, Berry Flavor, Dye-Free, Alcohol Free, 4 fl. oz. (120 mL), Distributed by: Taro Pharmaceuticals U.S.A., Inc., Hawthorne, NY 10532, NDC 51672-2130-8

by Taro Pharmaceuticals U.S.A., Inc.

Reason
Presence of Foreign Substance: Ibuprofen Oral Suspension USP may have small particles of an inert plastic material introduced during manufacturing.
Recall initiated
September 27, 2019
Reported by FDA
November 6, 2019
Distribution
U.S.A. Nationwide

View recall →

Drug Recall Ongoing Historical recordClass III

Ranitidine Tablets USP,150 mg, 8-count bottles, Distributed by: Dolgencorp, LLC, 100 Mission Ridge, Goodlettsville, TN 37073 Made in India NDC 55910-092-79

by AuroMedics Pharma LLC

Reason
CGMP DEVIATIONS: One lot of Ranitidine Tablets USP, 150 mg is being recalled because some bottles were empty.
Recall initiated
September 23, 2019
Reported by FDA
November 6, 2019
Distribution
Nationwide within the United States

View recall →

Drug Recall Terminated Historical recordClass II

Lyophilized Sermorelin w/ GHRP2 3 mg For injection, Rx Only, Compounded by: Innoveix Addison, TX 75001 800-370-1910

by Innoveix Pharmaceuticals Inc

Reason
Lack of Sterility Assurance.
Recall initiated
October 10, 2019
Reported by FDA
November 6, 2019
Distribution
Nationwide within 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.