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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 4,221–4,240 of 17,937 drug recalls

Drug Recall Terminated Historical recordClass II

Trimix (Alprostadil/Papaverine/Phentolamine) 20 mcg/30 mg/0.5 mg Injectable 5 mL vials, Rx only, Family Pharmacy of Statesville, Inc.

by Family Pharmacy of Statesville

Reason
Lack of Assurance of Sterility
Recall initiated
August 6, 2020
Reported by FDA
March 23, 2022
Distribution
NC only

View recall →

Drug Recall Terminated Historical recordClass II

Hydromorphone HCl 0.1 mg/mL Infusion in 1000 mL bags, Rx only, Family Pharmacy of Statesville, Inc.

by Family Pharmacy of Statesville

Reason
Lack of Assurance of Sterility
Recall initiated
August 6, 2020
Reported by FDA
March 23, 2022
Distribution
NC only

View recall →

Drug Recall Terminated Historical recordClass II

Hydromorphone HCl 5 mg/mL Infusion in 250 mL bags, Rx only, Family Pharmacy of Statesville, Inc.

by Family Pharmacy of Statesville

Reason
Lack of Assurance of Sterility
Recall initiated
August 6, 2020
Reported by FDA
March 23, 2022
Distribution
NC only

View recall →

Drug Recall Terminated Historical recordClass II

Hydromorphone HCl 1 mg/mL 250 mL bags, Rx only, Family Pharmacy of Statesville, Inc.

by Family Pharmacy of Statesville

Reason
Lack of Assurance of Sterility
Recall initiated
August 6, 2020
Reported by FDA
March 23, 2022
Distribution
NC only

View recall →

Drug Recall Terminated Historical recordClass II

Hydromorphone HCl 2 mg/mL Infusion 250 mL bags, Rx only, Family Pharmacy of Statesville, Inc.

by Family Pharmacy of Statesville

Reason
Lack of Assurance of Sterility
Recall initiated
August 6, 2020
Reported by FDA
March 23, 2022
Distribution
NC only

View recall →

Drug Recall Terminated Historical recordClass II

0.9% Sodium Chloride Injection USP, 250 mL Excel Container, Rx only, B. Braun Medical Inc., Bethlehem, PA, NDC 0264-7800-20

by B. Braun Medical, Inc.

Reason
Lack of sterility assurance: leaking bags
Recall initiated
February 25, 2022
Reported by FDA
March 23, 2022
Distribution
USA Nationwide

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Drug Recall Terminated Historical recordClass II

Alprazolam Tablets, USP 1mg, 180-count bottles, Rx only, Manufactured by ULTRAlab Laboratories, Inc., NY; Packaged by GSMS, Inc., CA NDC 60429-504-18.

by Golden State Medical Supply Inc.

Reason
CGMP Deviation: Potential cross-contamination with other drug substance during the manufacturing process.
Recall initiated
March 2, 2022
Reported by FDA
March 23, 2022
Distribution
Distributed to 1 wholesaler/distributor

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Drug Recall Terminated Historical recordClass II

hydrALAZINE HCl Tablets, USP, 10 mg, 100 Tablets per carton (10x10 blister packs), Rx only, Distributed by: MAJOR PHARMACEUTICALS, Livonia, MI 48152 USA. NDC # 0904-6440-61

by The Harvard Drug Group

Reason
Failed Impurities/Degradation Specifications: Out of specification result obtained during routine stability testing for Impurities.
Recall initiated
February 24, 2022
Reported by FDA
March 23, 2022
Distribution
Nationwide within USA

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Drug Recall Terminated Historical recordClass II

Oxycodone Hydrochloride Oral Solution, USP (C-II), 5 mg/5 mL, Delivers 5 mL per Cup, 1 Tray of 10 Cups, Rx Only, For Institutional Use Only, American Health Packaging, Columbus, OH 43217. UPC (01) 003 60687 406 40 4; Case NDC#: 60687-406-77, Unit Dose NDC#: 60687-406-40

by American Health Packaging

Reason
Impurity failure at 0-time of the repackaged lot.
Recall initiated
February 22, 2022
Reported by FDA
March 16, 2022
Distribution
Nationwide in the USA

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Drug Recall Terminated Historical recordClass II

Alprazolam C-IV 2 mg, 60-count bottles, Rx Only, Dist. By: Par Pharmaceutical Chestnut Ridge, NY 10977 Packaged and Distributed By: Direct Rx Dawsonville, GA 30534, NDC 72189-0058-60

by Direct Rx

Reason
CGMP Deviations: The Recall is due to the potential cross-contamination at the contract manufacturer (Ultra Tab Laboratories Inc.)
Recall initiated
March 4, 2022
Reported by FDA
March 16, 2022
Distribution
FL, GA, LA

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Drug Recall Terminated Historical recordClass II

Alprazolam C-IV 1 mg 60-count bottles, Rx Only, Dist. By: Par Pharmaceutical Chestnut Ridge, NY 10977 Packaged and Distributed By: Direct Rx Dawsonville, GA 30534, NDC 61919-836-60

by Direct Rx

Reason
CGMP Deviations: The Recall is due to the potential cross-contamination at the contract manufacturer (Ultra Tab Laboratories Inc.)
Recall initiated
March 4, 2022
Reported by FDA
March 16, 2022
Distribution
FL, GA, LA

View recall →

Drug Recall Terminated Historical recordClass II

PALIPERIDONE EXTENDED-RELEASE TABLETS, 9 mg, 100 Tablets per carton (10 x 10 blister packs), Rx only, Manufactured by: Sun Pharmaceutical Industries Ltd., Survey No. 259/15, Dadra-396 191, India. Distributed by: MAJOR PHARMACEUTICALS, 17177 N. Laurel Park Dr., Suite 233, Livonia, MI 48152. NDC: 0904-6937-61

by The Harvard Drug Group

Reason
Failed Dissolution Specifications
Recall initiated
February 28, 2022
Reported by FDA
March 16, 2022
Distribution
Nationwide within the United States

View recall →

Drug Recall Terminated Historical recordClass II

Dexamethasone Elixir, USP 0.5 mg/5 mL, Net: 8 fl oz (237 mL) bottle, Rx only, Manufactured By: Morton Grove Pharmaceuticals, Inc., Morton Grove, IL 60053, NDC 60432-466-08.

by Morton Grove Pharmaceuticals, Inc.

Reason
Failed Impurities/Degradation Specifications: higher than permissible levels of unknown impurities were found in the drug product.
Recall initiated
February 21, 2022
Reported by FDA
March 9, 2022
Distribution
Nationwide USA and Puerto Rico

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Drug Recall Terminated Historical recordClass II

HEB 50% Isopropyl Alcohol First Aid Antiseptic, packaged in 16 FL OZ 91 PT) 473 mL brown bottles with brown colored closures. Distributed by HEB San Antonio, TX 78204. UPC 0 41220 25111 7

by Vi-Jon, Inc.

Reason
Labeling: Label Mix-Up-The primary label on the front of the bottles have 50% Isopropyl Alcohol affixed to the containers. However, the product inside the bottle is Hydrogen Peroxide, Topical Solution USP with active ingredient Hydrogen Peroxide (stabilized) 3%, 32 FL Ounces. The back label is correct. Product is packaged in dark bottles.
Recall initiated
March 2, 2022
Reported by FDA
March 9, 2022
Distribution
Product was distributed to one distributor in Texas for further distribution

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Drug Recall Terminated Historical recordClass II

Alprazolam Tablets, USP 1mg, Generic for Xanax, Pkg Size: a) 30 tablets per bottle, NDC: 68788-6381-03, b) 60 tablets per bottle, NDC: 68788-6381-06, c) 90 tablets per bottle, NDC: 68788-6381-09, Mfg: Par Pharmaceutical.

by Preferred Pharmaceuticals, Inc.

Reason
CGMP deviations
Recall initiated
February 22, 2022
Reported by FDA
March 9, 2022
Distribution
Nationwide in the USA.

View recall →

Drug Recall Ongoing Historical recordClass II

All Over-The-Counter (OTC) drug products sold by Family Dollar retail stores located in Alabama, Arkansas, Louisiana, Mississippi, Missouri and Tennessee.

by Dollar Tree Distribution, Inc.

Reason
CGMP Deviations: Potential exposure to rodents and rodent activity in the distribution center.
Recall initiated
February 18, 2022
Reported by FDA
March 9, 2022
Distribution
Alabama, Arkansas, Louisiana, Mississippi, Missouri, Tennessee

View recall →

Drug Recall Terminated Historical recordClass II

Olanzapine Tablets, USP 10 mg, 30-count bottles, Rx only, Manufactured for: Macleods Pharma USA , Inc. Plainsboro, NJ 08536, Manufactured by: Macleods Pharmaceuticals Ltd., Baddi, HImachal Pradesh, India, NDC 33342-070-07.

by Macleods Pharma Usa Inc

Reason
cGmp Deviations
Recall initiated
February 16, 2022
Reported by FDA
March 9, 2022
Distribution
Nationwide within the United States

View recall →

Drug Recall Terminated Historical recordClass II

Moxifloxacin Ophthalmic Solution USP 0.5%, 3 mL, Packaged and Distributed By: Direct Rx Dawsonville, GA 30534 Dist. By Aurobindo Pharma USA, Inc. East Windsor, NJ 08520, NDC 72189-076-05

by Direct Rx

Reason
Failed impurities/degradation specifications
Recall initiated
February 17, 2022
Reported by FDA
March 9, 2022
Distribution
Florida

View recall →

Drug Recall Ongoing Historical recordClass II

Luxury 70% Isopropyl Alcohol, 16 FL. OZ. (1PT) 473 ML bottle, Distributed by: TSM Brands LLC, 540 Equinox Ln, Manalapan, NJ 07726, UPC 868275965734.

by Tsm Brands LLC

Reason
Labeling - product contains undeclared ethyl alcohol
Recall initiated
February 7, 2022
Reported by FDA
March 9, 2022
Distribution
USA Nationwide

View recall →

Drug Recall Ongoing Historical recordClass II

70% Isopropyl Alcohol First Aid Antiseptic with Wintergreen, 12 FL. OZ. 355 ML bottle, Distributed By: TSM Brands LLC, 540 Equinox LN, Manalapan, NJ 07726, www.tsmbrands.com, Made in Turkey, UPC 868275965765

by Tsm Brands LLC

Reason
Labeling - product contains undeclared ethyl alcohol
Recall initiated
February 7, 2022
Reported by FDA
March 9, 2022
Distribution
USA 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.