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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 9,501–9,520 of 17,974 drug recalls

Drug Recall Terminated Historical recordClass II

5% Dextrose Injection, USP, 250 mL bag, Rx Only, Hospira, Inc. Lake Forest, IL 60045, NDC 0409-7922-02

by ICU Medical Inc

Reason
Lack of assurance of sterility: Bags have potential to leak.
Recall initiated
May 31, 2018
Reported by FDA
June 27, 2018
Distribution
Nationwide and Canada

View recall →

Drug Recall Terminated Historical recordClass II

0.9% Sodium Chloride Injection, USP, 100 mL bag, Rx Only ,Hospira, Inc. Lake Forest, IL 60045, NDC 0409-7984-37

by ICU Medical Inc

Reason
Lack of assurance of sterility: Bags have potential to leak.
Recall initiated
May 31, 2018
Reported by FDA
June 27, 2018
Distribution
Nationwide and Canada

View recall →

Drug Recall Terminated Historical recordClass II

0.9% Sodium Chloride Injection, USP, 100 mL bag, Rx Only, Hospira, Inc. Lake Forest, IL 60045, NDC 0409-7984-23

by ICU Medical Inc

Reason
Lack of assurance of sterility: Bags have potential to leak.
Recall initiated
May 31, 2018
Reported by FDA
June 27, 2018
Distribution
Nationwide and Canada

View recall →

Drug Recall Terminated Historical recordClass II

0.9% Sodium Chloride Injection, USP, 250 mL bag, Rx Only, Hospira, Inc. Lake Forest, IL 60045, NDC 0409-7983-02

by ICU Medical Inc

Reason
Lack of assurance of sterility: Bags have potential to leak.
Recall initiated
May 31, 2018
Reported by FDA
June 27, 2018
Distribution
Nationwide and Canada

View recall →

Drug Recall Terminated Historical recordClass II

0.45% Sodium Chloride Injection, USP, 100 mL bag, Rx Only, Hospira, Inc. Lake Forest, IL 60045, NDC 0409-7730-37

by ICU Medical Inc

Reason
Lack of assurance of sterility: Bags have potential to leak.
Recall initiated
May 31, 2018
Reported by FDA
June 27, 2018
Distribution
Nationwide and Canada

View recall →

Drug Recall Terminated Historical recordClass II

Atorvastatin Calcium Tablets, 80 mg*, 90-count bottles, Rx Only, Mfd. By: Dr. Reddy's Laboratories Limited, Srikakulam - 532 409 INDIA, NDC 55111-124-90 UPC 355111124900

by Dr. Reddy's Laboratories, Inc.

Reason
Presence of Foreign Substance: A product complaint was received for a defective tablet with an embedded foreign object observed in a bottle.
Recall initiated
May 30, 2018
Reported by FDA
June 27, 2018
Distribution
Nationwide in the USA

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Drug Recall Terminated Historical recordClass III

Maxzide-25 (Triamterene and hydrochlorothiazide) tablets, USP, 37.5 mg/ 25 mg, 100-count bottle, Rx only, Mylan Pharmaceuticals Inc., Morgantown, WV 26505, NDC 0378-0464-01

by Mylan Pharmaceuticals Inc.

Reason
Superpotent Drug: Composite assay results obtained during routine stability testing were slightly above specification.
Recall initiated
June 7, 2018
Reported by FDA
June 20, 2018
Distribution
Product was distributed throughout the United States

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Drug Recall Terminated Historical recordClass I

Allergan Taytulla Softgel Capsules, 1 mg/20 mcg, 6x28 blister card Physicians's Sample - Not for Sale Distributed by: Allergan USA INC Irvine, CA 92612 NDC 0023-5862-28 (Blister Card) NDC 0023-5862-29 (Blister Carton) NDC 0023-5862-31 (Outer carton) UPC 300235862290

by Allergan, PLC.

Reason
Contraceptive Tablets Out of Sequence.
Recall initiated
May 24, 2018
Reported by FDA
June 20, 2018
Distribution
US Nationwide

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Drug Recall Terminated Historical recordClass II

Monsel's Solution (Ferric Subsulfate), 20%, packaged as 12 single application vials and 12 applicators, 8 mL per box, Manufactured For: MedGyn Products, Inc., 100 W. Industrial Rd., Addison, IL 60101 USA; Manufactured By: BioDiagnostics Intl, 555 West Lambert Road Unit-C, Brea, CA 92821, NDC 42721-112-08.

by BioDiagnostic International

Reason
CGMP Deviations: Products not manufactured under current good manufacturing practices.
Recall initiated
June 11, 2018
Reported by FDA
June 20, 2018
Distribution
Product was distributed to one sole customer in Illinois who further distributed Nationwide in the USA.

View recall →

Drug Recall Terminated Historical recordClass II

Silver-Zinc Throat Spray, HOMEOPATHIC IMMUNE DEFENSE, 50PPM, 4oz/50 ppm/ 120ml,amber PET bottle with white sprayer. MBi Nutraceuticals Lindon, Utah 84042 USA. Bar Code: 3 58301 18118 9

by MBi Distributing Inc. dba MBi Nutraceuticals

Reason
Lack of Processing Controls: Firm is voluntarily recalling all lots of homeopathic Teething Drops, Nausea Drops, Intestinal Colic Drops, Stomach Calm, Expectorant Cough Syrup, Silver-Zinc Throat Spray, and Argentum Elixir, within expiry, due to lack of adequate controls during manufacturing.
Recall initiated
May 15, 2018
Reported by FDA
June 20, 2018
Distribution
Nationwide in the USA

View recall →

Drug Recall Terminated Historical recordClass II

Argentum Elixir Colloidal Silver, 50 PPM Homeopathic Infection Fighter, 8 fl oz. amber PET bottle with white sprayer. MBi nutraceuticals Lindon UT, 84042. Bar COde: 3 58301 18114 1

by MBi Distributing Inc. dba MBi Nutraceuticals

Reason
Lack of Processing Controls: Firm is voluntarily recalling all lots of homeopathic Teething Drops, Nausea Drops, Intestinal Colic Drops, Stomach Calm, Expectorant Cough Syrup, Silver-Zinc Throat Spray, and Argentum Elixir, within expiry, due to lack of adequate controls during manufacturing.
Recall initiated
May 15, 2018
Reported by FDA
June 20, 2018
Distribution
Nationwide in the USA

View recall →

Drug Recall Terminated Historical recordClass II

Expectorant Cough Syrup, Homeopathic Syrup for Temporary Relief of Cough & Bronchitis. 8 Fl Ounces amber PET bottle with black cap. MBi Nutraceuticals 211 N 1800 W, Lindon, UT 84042. Bar Code: 3 58301 08214 1

by MBi Distributing Inc. dba MBi Nutraceuticals

Reason
Lack of Processing Controls: Firm is voluntarily recalling all lots of homeopathic Teething Drops, Nausea Drops, Intestinal Colic Drops, Stomach Calm, Expectorant Cough Syrup, Silver-Zinc Throat Spray, and Argentum Elixir, within expiry, due to lack of adequate controls during manufacturing.
Recall initiated
May 15, 2018
Reported by FDA
June 20, 2018
Distribution
Nationwide in the USA

View recall →

Drug Recall Terminated Historical recordClass II

Stomach Calm, Calms Upset Stomach and Aids in Treatment of Simple Diarrhea, 8 fl. oz., liquid 8 ounce amber PET bottle with Black CRC Cap, MBi Nutraceuticals Lindon, UT 84042. Bar Code: 3 58301 38414 2

by MBi Distributing Inc. dba MBi Nutraceuticals

Reason
Lack of Processing Controls: Firm is voluntarily recalling all lots of homeopathic Teething Drops, Nausea Drops, Intestinal Colic Drops, Stomach Calm, Expectorant Cough Syrup, Silver-Zinc Throat Spray, and Argentum Elixir, within expiry, due to lack of adequate controls during manufacturing.
Recall initiated
May 15, 2018
Reported by FDA
June 20, 2018
Distribution
Nationwide in the USA

View recall →

Drug Recall Terminated Historical recordClass II

Intestinal Colic Drops, Homeopathic Drops for Temporary Relief of Flatulent Colic, 1 ounce amber glass bottle with glass dropper, liquid, Meteorism, and Porphyrinuria. MBi Nutraceuticals Lindon, UT 84042

by MBi Distributing Inc. dba MBi Nutraceuticals

Reason
Lack of Processing Controls: Firm is voluntarily recalling all lots of homeopathic Teething Drops, Nausea Drops, Intestinal Colic Drops, Stomach Calm, Expectorant Cough Syrup, Silver-Zinc Throat Spray, and Argentum Elixir, within expiry, due to lack of adequate controls during manufacturing.
Recall initiated
May 15, 2018
Reported by FDA
June 20, 2018
Distribution
Nationwide in the USA

View recall →

Drug Recall Terminated Historical recordClass II

Nausea Drops, Homeopathic Drops for Temporary Relief of Motion Sickness, Morning Sickness, and General Nausea, 1 Fl. Ounce amber glass bottle with glass dropper. MBi Nutraceuticals Lindon, UT 84042. Bar Code: 1 58301 04711 4

by MBi Distributing Inc. dba MBi Nutraceuticals

Reason
Lack of Processing Controls: Firm is voluntarily recalling all lots of homeopathic Teething Drops, Nausea Drops, Intestinal Colic Drops, Stomach Calm, Expectorant Cough Syrup, Silver-Zinc Throat Spray, and Argentum Elixir, within expiry, due to lack of adequate controls during manufacturing.
Recall initiated
May 15, 2018
Reported by FDA
June 20, 2018
Distribution
Nationwide in the USA

View recall →

Drug Recall Terminated Historical recordClass II

Teething Drops, Homeopathic Drops for Temporary Relief of Pain Caused by Teething, 1 Fl Ounce glass amber bottle with glass dropper, MBi Nutraceuticals, Lindon, UT 84042. Bar Code: 3 58301 04011 0

by MBi Distributing Inc. dba MBi Nutraceuticals

Reason
Lack of Processing Controls: Firm is voluntarily recalling all lots of homeopathic Teething Drops, Nausea Drops, Intestinal Colic Drops, Stomach Calm, Expectorant Cough Syrup, Silver-Zinc Throat Spray, and Argentum Elixir, within expiry, due to lack of adequate controls during manufacturing.
Recall initiated
May 15, 2018
Reported by FDA
June 20, 2018
Distribution
Nationwide in the USA

View recall →

Drug Recall Terminated Historical recordClass II

Option Systems Antibacterial Foaming Hand Wash with .3% PCMX, 1000 mL pouches, Inopak, LTD, Ringwood, NJ

by Inopak Ltd

Reason
Microbial contamination of NonSterile Product; FDA analysis returned out of specification results for total aerobic microbial counts
Recall initiated
May 16, 2018
Reported by FDA
June 20, 2018
Distribution
Nationwide

View recall →

Drug Recall Terminated Historical recordClass II

Acne Shave 3 Step Shaving System, contains one tube Acne Shave (salicylic acid) Shave Cream Acne Shield, one tube Acne Shave Post-Shave Moisturizer (salicylic acid), 0.5% tube, and one Power Shaver per box, Distributed by: United Exchange Corp., 17311 Valley View Blvd, Cerritos CA 90703 USA, UPC 7 80707 73114 7.

by Shadow Holdings DBA Bocchi Labs

Reason
CGMP Deviations: products may be contaminated with bacteria.
Recall initiated
May 25, 2018
Reported by FDA
June 20, 2018
Distribution
Nationwide in the USA

View recall →

Drug Recall Terminated Historical recordClass II

Acne Shave (salicylic acid) Shave Cream Acne Shield, 0.5%, 5.1 FL OZ (150 mL) tube, Distributed by: United Exchange Corp., 17311 Valley View Blvd, Cerritos, CA 90703 USA, UPC 7 80707 73111 6.

by Shadow Holdings DBA Bocchi Labs

Reason
CGMP Deviations: products may be contaminated with bacteria.
Recall initiated
May 25, 2018
Reported by FDA
June 20, 2018
Distribution
Nationwide in the USA

View recall →

Drug Recall Terminated Historical recordClass II

Acne Shave Post-Shave Moisturizer (salicylic acid), 0.5%, 3.3 FL OZ (98 mL) tube, Distributed by: United Exchange Corp., 17211 Valley View Blvd., Cerritos, CA 90703 USA, UPC 7 80707 73112 3.

by Shadow Holdings DBA Bocchi Labs

Reason
CGMP Deviations: products may be contaminated with bacteria.
Recall initiated
May 25, 2018
Reported by FDA
June 20, 2018
Distribution
Nationwide in the USA

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.