Public Health Trace

Get Alerts

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.

Filters

Drug Recall Terminated Historical recordClass II

methylcobalamine 1 mg/mL, 1 mL and 10 mL unit sizes, refrigerate, This Rx is Compounded, Abbott's Compounding Pharmacy, Berkeley, CA 94705

by Abbott's Compounding Pharmacy, Inc.

Reason: Lack of Assurance of Sterility: Firm is recalling all unexpired lots of sterile compounded products after FDA inspection found concerns of lack of sterility assurance.
Recall initiated: January 15, 2016
Reported by FDA: February 24, 2016
Distribution: CA

View recall →

Drug Recall Terminated Historical recordClass II

methylcobalamine 10 mg/mL, 10 mL and 12 mL unit sizes, refrigerate, This Rx is Compounded, Abbott's Compounding Pharmacy, Berkeley, CA 94705

by Abbott's Compounding Pharmacy, Inc.

Reason: Lack of Assurance of Sterility: Firm is recalling all unexpired lots of sterile compounded products after FDA inspection found concerns of lack of sterility assurance.
Recall initiated: January 15, 2016
Reported by FDA: February 24, 2016
Distribution: CA

View recall →

Drug Recall Terminated Historical recordClass II

Insulin, 70/30, 10 mL unit size, refrigerate, This Rx is Compounded, Abbott's Compounding Pharmacy, Berkeley, CA 94705

by Abbott's Compounding Pharmacy, Inc.

Reason: Lack of Assurance of Sterility: Firm is recalling all unexpired lots of sterile compounded products after FDA inspection found concerns of lack of sterility assurance.
Recall initiated: January 15, 2016
Reported by FDA: February 24, 2016
Distribution: CA

View recall →

Drug Recall Terminated Historical recordClass II

hydroxyprogesterone w/ pres; 1 mg/mL, 20 mL unit size, refrigerate, This Rx is Compounded, Abbott's Compounding Pharmacy, Berkeley, CA 94705

by Abbott's Compounding Pharmacy, Inc.

Reason: Lack of Assurance of Sterility: Firm is recalling all unexpired lots of sterile compounded products after FDA inspection found concerns of lack of sterility assurance.
Recall initiated: January 15, 2016
Reported by FDA: February 24, 2016
Distribution: CA

View recall →

Drug Recall Terminated Historical recordClass II

hydroxyprogesterone in sesame 250 mg/mL, 2 mL, 5 mL, 6 mL, 8 mL unit sizes, This Rx is Compounded, Abbott's Compounding Pharmacy, Berkeley, CA 94705

by Abbott's Compounding Pharmacy, Inc.

Reason: Lack of Assurance of Sterility: Firm is recalling all unexpired lots of sterile compounded products after FDA inspection found concerns of lack of sterility assurance.
Recall initiated: January 15, 2016
Reported by FDA: February 24, 2016
Distribution: CA

View recall →

Drug Recall Terminated Historical recordClass II

Hydroxycobalamine 30 mg/mL, 90 mL unit size, refrigerate, This Rx is Compounded, Abbott's Compounding Pharmacy, Berkeley, CA 94705

by Abbott's Compounding Pharmacy, Inc.

Reason: Lack of Assurance of Sterility: Firm is recalling all unexpired lots of sterile compounded products after FDA inspection found concerns of lack of sterility assurance.
Recall initiated: January 15, 2016
Reported by FDA: February 24, 2016
Distribution: CA

View recall →

Drug Recall Terminated Historical recordClass II

Folic Acid, 10 mg/mL, 6 mL unit size, refrigerate, This Rx is Compounded, Abbott's Compounding Pharmacy, Berkeley, CA 94705

by Abbott's Compounding Pharmacy, Inc.

Reason: Lack of Assurance of Sterility: Firm is recalling all unexpired lots of sterile compounded products after FDA inspection found concerns of lack of sterility assurance.
Recall initiated: January 15, 2016
Reported by FDA: February 24, 2016
Distribution: CA

View recall →

Drug Recall Terminated Historical recordClass II

Folic Acid, 5 mg/mL, 30 mL unit size, refrigerate, This Rx is Compounded, Abbott's Compounding Pharmacy, Berkeley, CA 94705

by Abbott's Compounding Pharmacy, Inc.

Reason: Lack of Assurance of Sterility: Firm is recalling all unexpired lots of sterile compounded products after FDA inspection found concerns of lack of sterility assurance.
Recall initiated: January 15, 2016
Reported by FDA: February 24, 2016
Distribution: CA

View recall →

Drug Recall Terminated Historical recordClass II

Estradiol cypionate/Test cyprionate; 2 mg/50 mg/ml, unit size 5 mL, This Rx is Compounded, Abbott's Compounding Pharmacy, Berkeley, CA 94705

by Abbott's Compounding Pharmacy, Inc.

Reason: Lack of Assurance of Sterility: Firm is recalling all unexpired lots of sterile compounded products after FDA inspection found concerns of lack of sterility assurance.
Recall initiated: January 15, 2016
Reported by FDA: February 24, 2016
Distribution: CA

View recall →

Drug Recall Terminated Historical recordClass II

calcium elemental, 3 mg/10 mL, 200 mL unit: This Rx is Compounded, Abbott's Compounding Pharmacy, Berkeley, CA 94705

by Abbott's Compounding Pharmacy, Inc.

Reason: Lack of Assurance of Sterility: Firm is recalling all unexpired lots of sterile compounded products after FDA inspection found concerns of lack of sterility assurance.
Recall initiated: January 15, 2016
Reported by FDA: February 24, 2016
Distribution: CA

View recall →

Drug Recall Terminated Historical recordClass II

Bupivacaine, 0.25%, 450 mL, This Rx is Compounded, Abbott's Compounding Pharmacy, Berkeley, CA 94705

by Abbott's Compounding Pharmacy, Inc.

Reason: Lack of Assurance of Sterility: Firm is recalling all unexpired lots of sterile compounded products after FDA inspection found concerns of lack of sterility assurance.
Recall initiated: January 15, 2016
Reported by FDA: February 24, 2016
Distribution: CA

View recall →

Drug Recall Terminated Historical recordClass I

NATUREAL BURN FAT NATURE, 30-count capsules, packaged in clear plastic bottle, Manufactured for: Inaffit, LLC. P.O. Box 34056, Bethesda, MD 20827.

by Inaffit, LLC

Reason: Marketed Without an Approved NDA/ANDA: Product contains undeclared sibutramine.
Recall initiated: October 5, 2015
Reported by FDA: February 24, 2016
Distribution: Nationwide

View recall →

Drug Recall Terminated Historical recordClass I

CITRULLINE (L) in 25 g, 100 g, 500 g and 1 kg plastic bottles, White crystals or crystalline powder, odorless, For Use and distribution in prescription compounding, manufacturing, processing, or repackaging only in accordance with FDA regulations and applicable law, Packaged by Medisca Inc. Plattsburgh, NY 12901, USA, NDC #s: 38779-1186-4 (25 g), 38779-1186-5 (100 g), 38779-1186-8 (500 g), 38779-1186-9 (1 kg).

by Medisca Inc

Reason: Labeling: Label Mix-Up: FDA tested samples of API from Medisca, labeled as to contain L-Citrulline, and results revealed no L-Citrulline was present. Levels of N-acetyl-leucine were found instead.
Recall initiated: February 14, 2014
Reported by FDA: February 24, 2016
Distribution: Nationwide and Australia

View recall →

Drug Recall Terminated Historical recordClass I

Rhino 7 Platinum 3000, 1 count Blister Pack, Distributed by Rhino 7, Made in USA

by Premiere Sales Group

Reason: Marketed without an Approved NDA/ANDA: Products contain undeclared active pharmaceutical ingredients; desmethyl carbondenafil and dapoxetine.
Recall initiated: September 30, 2015
Reported by FDA: February 24, 2016
Distribution: Nationwide

View recall →

Drug Recall Terminated Historical recordClass I

Rhino 7 3000, 6 count Bottle, Distributed by Rhino 7, Made in USA

by Premiere Sales Group

Reason: Marketed without an Approved NDA/ANDA: Products contain undeclared active pharmaceutical ingredients; desmethyl carbondenafil and dapoxetine.
Recall initiated: September 30, 2015
Reported by FDA: February 24, 2016
Distribution: Nationwide

View recall →

Drug Recall Terminated Historical recordClass I

Rhino 7 Platinum 3000, Single Blister Packs, distributed By Rhino 7, Made in USA

by MSNV, Inc dba National Video Supply

Reason: Marketed without an Approved NDA/ANDA: Products contain undeclared active pharmaceutical ingredients; desmethyl carbondenafil and dapoxetine.
Recall initiated: October 1, 2015
Reported by FDA: February 24, 2016
Distribution: Nationwide

View recall →

Drug Recall Terminated Historical recordClass I

Rhino 7 3000, 6 count bottles, Distributed by Rhino 7, Made in USA.

by MSNV, Inc dba National Video Supply

Reason: Marketed without an Approved NDA/ANDA: Products contain undeclared active pharmaceutical ingredients; desmethyl carbondenafil and dapoxetine.
Recall initiated: October 1, 2015
Reported by FDA: February 24, 2016
Distribution: Nationwide

View recall →

Drug Recall Ongoing Historical recordClass I

Vitamin Supplement (Vial) D3, (cholecalciferol (vit D3)/lipoic acid/ubiquinol/ methylcobalamin/pyridoxine/methionine/inositol/choline bitartrate USP) capsules, 60, 120 or 180 count vials, Glades Drugs, 109 S. Lake Ave., Pahokee, FL 33476.

by Glades Drugs Inc.

Reason: Superpotent Drug: The vitamin supplement contains an extremely high level of vitamin D3 (Cholecalciferol).
Recall initiated: November 6, 2015
Reported by FDA: February 24, 2016
Distribution: New York and Georgia

View recall →

Drug Recall Terminated Historical recordClass I

Magnesium Sulfate in Water for Injection, (0.325 mEq Mg++/mL) 40 mg/mL, 2 g Total, 50 mL Single-Dose Container bag, Hospira, Inc., Lake Forest, IL 60045, NDC 0409-6729-24.

by Hospira Inc.

Reason: Labeling: Incorrect Barcode: Primary bag labeling may be mislabeled with the wrong barcode which scans in as heparin sodium.
Recall initiated: January 5, 2016
Reported by FDA: February 24, 2016
Distribution: Nationwide

View recall →

Drug Recall Ongoing Historical recordClass I

APEXXX tablets, 300 mg, packaged in 1-count blister cards, Distributed Exclusively by: Nuway Distributors, LLC, Orlando, FL USA; UPC 7 05105 96361 7.

by Nuway Distributors, LLC

Reason: Marketed Without An Approved NDA/ANDA: tainted product marketed as a dietary supplement. Product found to be tainted with sildenafil, an FDA approved drug for the treatment of male erectile dysfunction, making this an unapproved drug.
Recall initiated: December 23, 2015
Reported by FDA: February 24, 2016
Distribution: All product is sold to Ace Distributors, LLC in Orlando, FL, a retail store, who sells directly to owners of gas stations, convenience stores, and smoke shops where it can be further distributed nationwide.

View recall →

Data last updated: September 26, 2026 ET

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.