FDA Recall
Terminated
Historical recordClass II
Sodium Sulfacetamide 9% and Sulfur 4.5% Wash Kit, Rx Only, Sodium Sulfacetamide 9% and Sulfur 4.5% Wash, Net Wt. 16 oz (454 g), Daily Moisturizing Wash, 16 fl. oz. (473 mL), Manufactured for: BioComp Pharma Inc., San Antonio, TX 78230, NDC 44523-0609-23
by Mission Pharmacal Co
- Reason
- Microbial Contamination of Non-Sterile Products: Product failed USP Microbial Limits Test.
- Published
- May 20, 2015
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
Ortho-Cept (0.15 mg desogestrel and 0.03 mg ethinyl estradiol) tablets, 28- count blister (21 active tablets and 7 placebo tablets)/ 6 blister packs per carton. Rx only, Jointly Manufactured by: Janssen Ortho, LLC, Manati, Puerto Rico 00674 and NV Organon, Oss, The Netherlands, Manufactured for: Janssen Pharmaceuticals, Inc., Titusville, New Jersey 08560, New Jersey, NDC 50458-0196-15.
by Janssen Pharmaceuticals, Inc.
- Reason
- Subpotent Drug
- Published
- May 20, 2015
- Distribution
- Nationwide
View recall →
FDA 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.
- Published
- May 20, 2015
- Distribution
- Nationwide
View recall →
FDA 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.
- Published
- May 20, 2015
- Distribution
- Nationwide
View recall →
FDA 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.
- Published
- May 20, 2015
- Distribution
- Nationwide
View recall →
FDA 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
- Published
- May 13, 2015
- Distribution
- Nationwide
View recall →
FDA 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
- Published
- May 13, 2015
- Distribution
- Nationwide
View recall →
FDA 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
- Published
- May 13, 2015
- Distribution
- Nationwide
View recall →
FDA 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
- Published
- May 13, 2015
- Distribution
- Nationwide
View recall →
FDA 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.
- Published
- May 13, 2015
- Distribution
- Nationwide
View recall →
FDA 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.
- Published
- May 13, 2015
- Distribution
- Nationwide
View recall →
FDA 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.
- Published
- May 13, 2015
- Distribution
- Nationwide
View recall →
FDA 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.
- Published
- May 13, 2015
- Distribution
- Nationwide
View recall →
FDA 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.
- Published
- May 13, 2015
- Distribution
- Nationwide
View recall →
FDA 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.
- Published
- May 13, 2015
- Distribution
- Nationwide
View recall →
FDA 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.
- Published
- May 13, 2015
- Distribution
- Nationwide
View recall →
FDA 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
- Published
- May 13, 2015
- Distribution
- Nationwide
View recall →
FDA 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.
- Published
- May 13, 2015
- Distribution
- Nationwide
View recall →
FDA 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.
- Published
- May 13, 2015
- Distribution
- Nationwide
View recall →
FDA 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.
- Published
- May 13, 2015
- Distribution
- Nationwide
View recall →
Recall records are summarized from official FDA and USDA sources. Notices may be updated, reclassified, terminated, or withdrawn. Always review the linked official notice for the most current instructions.
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