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

17-HP Hydroxyprogesterone 250mg/1ml Injection, Health Innov Pharmacy, 295 Pinehurst Ave, Southern Pines, NC 28387, (910) 246-5155

by Health Innovations Pharmacy, Inc

Reason: Lack of Assurance of Sterility and Stability Data does not Support Expiry: recent inspection observations associated with certain quality control procedures that present a risk to sterility and quality assurance.
Recall initiated: February 12, 2015
Reported by FDA: May 20, 2015
Distribution: NC

View recall →

Drug Recall Terminated Historical recordClass II

SULFAMETHOXAZOLE AND TRIMETHOPRIM ORAL SUSPENSION, USP 800 mg/ 160 mg per 5mL, GRAPE FLAVOR, 20 mL unit dose cup (NDC 50383-0824-20), Rx only, HI-TECH PHARMACAL CO. INC, Amityville, NY 11701

by Akorn, Inc.

Reason: Failed Dissolution Specifications: Out of specification for dissolution of sulfamethoxazole.
Recall initiated: March 17, 2015
Reported by FDA: May 20, 2015
Distribution: Nationwide and Puerto Rico

View recall →

Drug Recall Terminated Historical recordClass II

SULFAMETHOXAZOLE AND TRIMETHOPRIM ORAL SUSPENSION, USP,200 mg/ 40 mg per 5mL, GRAPE FLAVOR, 16 fl oz (473 mL) bottles (NDC 50383-0824-16), Rx only, HI-TECH PHARMACAL CO. INC, Amityville, NY 11701

by Akorn, Inc.

Reason: Failed Dissolution Specifications: Out of specification for dissolution of sulfamethoxazole.
Recall initiated: March 17, 2015
Reported by FDA: May 20, 2015
Distribution: Nationwide and Puerto Rico

View recall →

Drug Recall Terminated Historical recordClass II

SULFAMETHOXAZOLE AND TRIMETHOPRIM ORAL SUSPENSION, USP,200 mg/ 40 mg per 5mL, CHERRY FLAVOR, 16 fl oz (473 mL) bottles (NDC 50383-0823-16), Rx only, HI-TECH PHARMACAL CO. INC, Amityville, NY 11701

by Akorn, Inc.

Reason: Failed Dissolution Specifications: Out of specification for dissolution of sulfamethoxazole.
Recall initiated: March 17, 2015
Reported by FDA: May 20, 2015
Distribution: Nationwide and Puerto Rico

View recall →

Drug Recall Terminated Historical recordClass I

Forever Beautiful BEE POLLEN, capsules, 250mg in 60-count bottles, 900 Commonwealth Place, Ste 104, Virginia Beach, VA

by REFA Enterprises, LLC

Reason: Marketed Without an Approved NDA/ANDA: FDA analysis found product to contain sibutramine and phenolphthalein
Recall initiated: November 3, 2014
Reported by FDA: May 13, 2015
Distribution: Nationwide

View recall →

Drug Recall Terminated Historical recordClass I

Forever Beautiful INFINITY, capsules, 300mg in 60-count bottles, 900 Commonwealth Place, Ste 104, Virginia Beach, VA

by REFA Enterprises, LLC

Reason: Marketed Without an Approved NDA/ANDA: FDA analysis found product to contain sibutramine and phenolphthalein
Recall initiated: November 3, 2014
Reported by FDA: May 13, 2015
Distribution: Nationwide

View recall →

Drug Recall Terminated Historical recordClass II

C-Topical 4% CII (cocaine hydrochloride), topical solution, 4 ml bottle, (NDC 0527-1728-74), Rx Only, Manufactured for Lannett Company, Inc. Philadelphia, PA 19136 by Cody Laboratories, Inc. Cody, WY 82414

by Cody Laboratories, Inc.

Reason: Labeling: Label mix-up; bottles were incorrectly labeled as 10 mL instead of correctly labeled as 4 mL
Recall initiated: March 31, 2015
Reported by FDA: May 13, 2015
Distribution: Nationwide

View recall →

Drug Recall Terminated Historical recordClass I

ULTRA ZX DIETARY SUPPLEMENT (Extracto de Naranjo Amargo 70, Extracto de semilla de Sen 47.6, Lagrima de Coix 42, Almidon Medico 84), 30 capsule bottles, Manufactured and distributed by: Ultra ZX Labs, L.L.C. 2525 SW 3rd Ave Apt 1704 Miami, Florida 33129-2068.

by Ultra ZX Supplements

Reason: Marketed Without An Approved NDA/ANDA: FDA laboratory analysis confirmed that ULTRA ZX contains undeclared sibutramine and phenolphthalein
Recall initiated: March 10, 2015
Reported by FDA: May 13, 2015
Distribution: Nationwide and Puerto Rico Foreign: Spain and Ecuador

View recall →

Drug Recall Terminated Historical recordClass I

PROFESSIONAL FORMEXX BLACK (AromaMaXX 250mg: 13-dimethyl-1,2,7,8,9,11,12,14,15,16-decahydro-cyclopenta[a]phenanthrene-3,6,17-trione,4-Androsten 4,17-beta-diol-3one), Capsules, 60 count bottle, Manufactured for: ANABOLIC SCIENCE LABS WINTER PARK, FL 32789

by Anabolic Science Labs, LLC

Reason: Marketed without an approved NDA/ANDA - These products are being recalled due to the presence of synthetic hormone/prohormone (methylated anabolic steroid) ingredient making them unapproved new drugs.
Recall initiated: December 12, 2014
Reported by FDA: May 13, 2015
Distribution: US Nationwide and Singapore

View recall →

Drug Recall Terminated Historical recordClass I

SWOLL-250 SUPER MASS BUILDER QUAD STACK (18-Methylestr-4-en-3-one-17b-ol 15mg, 6-a-Chloro-androst-4-en-17b-ol-3-one 15mg, 13-ethyl-3-methoxy-gona-2,5(10)-diene-17-one 15mg, 2,17a-dimethyl-5a-androsta-1-en-17b-ol-3-one 3 mg), Capsules, 90 count bottle, Manufactured for: Wyked Labs LLC, Winter Park, FL 32789

by Anabolic Science Labs, LLC

Reason: Marketed without an approved NDA/ANDA - These products are being recalled due to the presence of synthetic hormone/prohormone (methylated anabolic steroid) ingredient making them unapproved new drugs.
Recall initiated: December 12, 2014
Reported by FDA: May 13, 2015
Distribution: US Nationwide and Singapore

View recall →

Drug Recall Terminated Historical recordClass I

ESTRASTAIN PRO-ANABOLIC MASS AND HARDENING COMPLEX (Estra-4,9,11-triene-3,17-dione 15mg, 2a-3a-epithio-17a-methyl-5a-androstan-17b-ol 10 mg), Capsules, 60 count bottle, Manufactured for: Wyked Labs LLC, Winter Park, FL 32789

by Anabolic Science Labs, LLC

Reason: Marketed without an approved NDA/ANDA - These products are being recalled due to the presence of synthetic hormone/prohormone (methylated anabolic steroid) ingredient making them unapproved new drugs.
Recall initiated: December 12, 2014
Reported by FDA: May 13, 2015
Distribution: US Nationwide and Singapore

View recall →

Drug Recall Terminated Historical recordClass I

7-MENT ALPHA ADVANCED MASS BUILDER (7a-methyl-estra-4-en-3,17-dione 10 mg), Capsules, 90 count bottle, Manufactured for: Wyked Labs LLC, Winter Park, FL 32789

by Anabolic Science Labs, LLC

Reason: Marketed without an approved NDA/ANDA - These products are being recalled due to the presence of synthetic hormone/prohormone (methylated anabolic steroid) ingredient making them unapproved new drugs.
Recall initiated: December 12, 2014
Reported by FDA: May 13, 2015
Distribution: US Nationwide and Singapore

View recall →

Drug Recall Terminated Historical recordClass I

HALO-70 MEGA MASS BUILDER (4-chloro-17a-methyl-androst-1,4-diene-3b,17b-diol 35mg), Capsules, 60 count bottle, Manufactured for: Wyked Labs LLC, Winter Park, FL 32789

by Anabolic Science Labs, LLC

Reason: Marketed without an approved NDA/ANDA - These products are being recalled due to the presence of synthetic hormone/prohormone (methylated anabolic steroid) ingredient making them unapproved new drugs.
Recall initiated: December 12, 2014
Reported by FDA: May 13, 2015
Distribution: US Nationwide and Singapore

View recall →

Drug Recall Terminated Historical recordClass I

M14-MENT ADVANCED MASS BUILDER (7a-Methyl-estra-4-en-3,17-dione MENT 5mg, M14D 20 mg), Capsules, 90 count bottle, Manufactured for: Wyked Labs LLC, Winter Park, FL 32789

by Anabolic Science Labs, LLC

Reason: Marketed without an approved NDA/ANDA - These products are being recalled due to the presence of synthetic hormone/prohormone (methylated anabolic steroid) ingredient making them unapproved new drugs.
Recall initiated: December 12, 2014
Reported by FDA: May 13, 2015
Distribution: US Nationwide and Singapore

View recall →

Drug Recall Terminated Historical recordClass I

M1-ALPHA LABS MEGA MASS BUILDER (M1A, Methyl-1-Etiocholenolol- 20mg, Epietiocholanolone) Capsules, 60 count bottle, Manufactured for: Wyked Labs LLC, Winter Park, FL 32789

by Anabolic Science Labs, LLC

Reason: Marketed without an approved NDA/ANDA - These products are being recalled due to the presence of synthetic hormone/prohormone (methylated anabolic steroid) ingredient making them unapproved new drugs.
Recall initiated: December 12, 2014
Reported by FDA: May 13, 2015
Distribution: US Nationwide and Singapore

View recall →

Drug Recall Terminated Historical recordClass II

Alinia (nitazoxanide), powder for oral suspension, 100mg/5mL, 60 mL/bottle. Rx only, Manufactured for Lupin Pharmaceuticals Inc, Baltimore, Maryland 21202 for Romark Laboratories 3000 Bayport Dr. Suite 200, Tampa, FL 33607

by Romark Laboratories, L.C.

Reason: Failed Stability Specifications: Product failed to meet 12 months long term stability specification for viscosity
Recall initiated: April 24, 2015
Reported by FDA: May 13, 2015
Distribution: Nationwide

View recall →

Drug Recall Terminated Historical recordClass I

Epel 18 mg Estradiol Pellet, For In Office Use Only, For In Office Administration Only, Not for Resale or Dispensing to an Individual Patient, Rx Only, Preferred Physician Medical LLC, 405-551-8216

by Physician Preferred Medical, LLC

Reason: Non-Sterility: The recalled lot failed sterility testing.
Recall initiated: July 24, 2014
Reported by FDA: May 13, 2015
Distribution: AZ and KS

View recall →

Drug Recall Terminated Historical recordClass I

iNSANE Bee Pollen capsules, 200 mg, 60-count bottle, Developed by Signature, 1027 Highway 70 W, Suite 227, Garner, NC 27529, UPC 8 52175 00408 2.

by Detox Transforms

Reason: Marketed Without An Approved NDA/ANDA: Product was found to contain undeclared phenolphthalein and fluoxetine, making iNSANE an unapproved drug.
Recall initiated: January 25, 2015
Reported by FDA: May 13, 2015
Distribution: WV who distributed Nationwide.

View recall →

Drug Recall Terminated Historical recordClass I

BtRiM Max capsules, 60-count bottle, Developed by Signature, 1027 Highway 70 W, Suite 227, Garner, NC 27529, UPC 8 52175 00406 8.

by Detox Transforms

Reason: Marketed Without An Approved NDA/ANDA: Product was found to contain undeclared phenolphthalein, making BtRiM Max an unapproved drug.
Recall initiated: January 25, 2015
Reported by FDA: May 13, 2015
Distribution: WV who distributed Nationwide.

View recall →

Drug Recall Terminated Historical recordClass I

AMPD GOLD Bee Pollen capsules, 350 mg, 60-count bottle, Signature, 1027 Highway 70 W, Suite 227, Garner, NC 27529, UPC 8 52175 00418 1.

by Detox Transforms

Reason: Marketed Without An Approved NDA/ANDA: Product was found to contain undeclared sildenafil, making AMPD GOLD an unapproved drug.
Recall initiated: January 25, 2015
Reported by FDA: May 13, 2015
Distribution: WV who distributed Nationwide.

View recall →

Data last updated: September 28, 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.