FDA Recall
TerminatedTerminated: October 2, 2019Historical recordClass I
Super Fat Burning Bomb Capsules, 400 mg, supplied in 30 count boxes, distributed by MyNicKnaxs, LLC, Deltona, FL
by MyNicNaxs, Inc.
- Reason
- Marketed Without an Approved NDA/ANDA: Product was found to contain undeclared active pharmaceutical ingredients: Phenolphthalein and N-desmethylsibutramine
- Published
- June 18, 2014
- Distribution
- Nationwide
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FDA Recall
TerminatedTerminated: October 2, 2019Historical recordClass I
Fruta BIO 400 mg capsules, supplied in 30 count boxes, distributed by MyNicKnaxs, LLC, Deltona, FL
by MyNicNaxs, Inc.
- Reason
- Marketed Without an Approved NDA/ANDA: Product was found to contain undeclared active pharmaceutical ingredients: Sibutramine and Phenolphthalein .
- Published
- June 18, 2014
- Distribution
- Nationwide
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FDA Recall
TerminatedTerminated: October 2, 2019Historical recordClass I
JIANFEIJINDAN Activity Girl Capsules, 400 mg, supplied in 30 count boxes, distributed by MyNicKnaxs, LLC, Deltona, FL
by MyNicNaxs, Inc.
- Reason
- Marketed Without an Approved NDA/ANDA: Product was found to contain undeclared ingredient: N-di-desmethylsibutramine, an analog of sibutramine
- Published
- June 18, 2014
- Distribution
- Nationwide
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FDA Recall
TerminatedTerminated: October 2, 2019Historical recordClass I
REDUCE WEIGHT FRUTA PLANTA Capsules, 400 mg, supplied in 30 count boxes, distributed by MyNicKnaxs, LLC., Deltona, FL
by MyNicNaxs, Inc.
- Reason
- Marketed Without an Approved NDA/ANDA: Product was found to contain undeclared active pharmaceutical ingredient: Phenolphthalein.
- Published
- June 18, 2014
- Distribution
- Nationwide
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FDA Recall
TerminatedTerminated: October 7, 2016Historical recordClass I
Bella Vi AMP'D UP Advanced Weight Loss Dietary Supplement capsules, 60 count bottles, www.BellaViProducts.com, distributed by Pure Edge Nutrition, LLC, Toms River, NJ
by Pure Edge Nutrition
- Reason
- Marketed without an Approved NDA/ANDA; product was found to contain undeclared sibutramine & phenolphthalein
- Published
- June 18, 2014
- Distribution
- Nationwide
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FDA Recall
TerminatedTerminated: October 7, 2016Historical recordClass I
Bella Vi INSANE AMP'D Dietary Supplement capsules, 60 count bottles, www.BellaViProducts.com, distributed by Pure Edge Nutrition, LLC, Toms River, NJ
by Pure Edge Nutrition
- Reason
- Marketed without an Approved NDA/ANDA; product was found to contain undeclared sibutramine & phenolphthalein
- Published
- June 18, 2014
- Distribution
- Nationwide
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FDA Recall
TerminatedTerminated: October 7, 2016Historical recordClass I
Bella Vi eXtreme ACCELERATOR Dietary Supplement Capsules, 30 count bottles, www.BellaViProducts.com, distributed by Pure Edge Nutrition, LLC, Toms River, NJ
by Pure Edge Nutrition
- Reason
- Marketed without an Approved NDA/ANDA; product was found to contain undeclared sibutramine & phenolphthalein
- Published
- June 18, 2014
- Distribution
- Nationwide
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FDA Recall
TerminatedTerminated: October 7, 2016Historical recordClass I
Bella Vi BTrim ULTIMATE BOOST Dietary Supplement capsules, 30 count bottles, www.BellaViProducts.com, distributed by Pure Edge Nutrition, LLC, Toms River, NJ
by Pure Edge Nutrition
- Reason
- Marketed without an Approved NDA/ANDA; product was found to contain undeclared sibutramine & phenolphthalein
- Published
- June 18, 2014
- Distribution
- Nationwide
View recall →
FDA Recall
TerminatedTerminated: October 7, 2016Historical recordClass I
Bella Vi BTrim MAX Dietary Supplement capsules, 60 count bottles, www.BellaViProducts.com, distributed by Pure Edge Nutrition, LLC, Toms River, NJ
by Pure Edge Nutrition
- Reason
- Marketed without an Approved NDA/ANDA; product was found to contain undeclared sibutramine & phenolphthalein
- Published
- June 18, 2014
- Distribution
- Nationwide
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FDA Recall
TerminatedTerminated: October 7, 2016Historical recordClass I
Bella Vi INSANE Bee Pollen Dietary Supplement Capsules, 60 count bottles, www.BellaViProducts.com, distributed by Pure Edge Nutrition, LLC, Toms River, NJ
by Pure Edge Nutrition
- Reason
- Marketed without an Approved NDA/ANDA; product was found to contain undeclared sibutramine & phenolphthalein
- Published
- June 18, 2014
- Distribution
- Nationwide
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FDA Recall
TerminatedTerminated: June 12, 2014Historical recordClass I
vitaliKOR Ready When You Are, Fast Acting Formula Dietary Supplement capsules, 40 count bottle, Distributed by Vitality Research Labs, LLC, Las Vegas, NV 89148.
by Vitality Research Labs LLC
- Reason
- Marketed Without an Approved NDA/ANDA: FDA sampling found undeclared vardenafil and tadalafil in vitaliKOR capsules
- Published
- June 18, 2014
- Distribution
- Nationwide
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FDA Recall
TerminatedTerminated: May 10, 2017Historical recordClass I
Venlafaxine HCl Extended-Release Capsules, 150 mg, 90-count Unit of Use bottles, Rx only, Distributed by: Greenstone LLC, Peapack, NJ 07977, NDC 59762-0182-2, UPC 3 59762-0182-2 9.
by Greenstone Llc
- Reason
- Presence of Foreign Tablets/Capsules: report of a foreign capsule with markings (TKN 250) and identified as a Tikosyn (dofetilide) capsule was found in a bottle of Effexor XR (venlafaxine HCl) 150 mg capsules that was packaged in the same packaging campaign as the recalled lot
- Published
- June 18, 2014
- Distribution
- Nationwide
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FDA Recall
TerminatedTerminated: June 11, 2015Historical recordClass II
CareFusion Scrub Care Surgical Scrub Brush-Sponge/Nail Cleaner With 15% Povidone-iodine (USP) Surgical Hand Scrub; CareFusion, Vernon Hills, IL 60061 USA, NDC 57613-013-15.
by Carefusion 2200 Inc
- Reason
- Subpotent Drug: CareFusion is recalling the CareFusion Scrub Care Surgical Scrub Brush-Sponge/Nail Cleaner. The available iodine in the product is less than as stated on the product label.
- Published
- June 11, 2014
- Distribution
- Nationwide
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FDA Recall
TerminatedTerminated: June 11, 2015Historical recordClass II
CareFusion Scrub Care Surgical Scrub Brush-Sponge/Nail Cleaner With 9% Povidone-iodine (USP) Surgical Hand Scrub; CareFusion, Vernon Hills, IL 60061 USA, NDC 57613-003-18
by Carefusion 2200 Inc
- Reason
- Subpotent Drug: CareFusion is recalling the CareFusion Scrub Care Surgical Scrub Brush-Sponge/Nail Cleaner. The available iodine in the product is less than as stated on the product label.
- Published
- June 11, 2014
- Distribution
- Nationwide
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FDA Recall
TerminatedTerminated: March 16, 2017Historical recordClass I
Marcaine (bupivacaine HCl) injection, USP, 0.25%, Preservative-Free, 10 mL (25 mg) Single-dose Vial, Rx only, Hospira, Inc., Lake Forest, IL 60045 USP, NDC 0409-1559-10.
by Hospira Inc.
- Reason
- Presence of Particulate Matter: Confirmed customer complaint of discolored solution with visible metal particles embedded in the glass vial and visible in the solution.
- Published
- June 11, 2014
- Distribution
- Nationwide
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FDA Recall
TerminatedTerminated: July 9, 2014Historical recordClass II
LOSARTAN POTASSIUM Tablets, USP, 50 mg, 30 count bottles, Rx only, Manufactured by Arrow Pharm (Malta) Ltd., Bizebbugia, Malta, Packaged by GSMS, Inc. Camarillo, CA --- NDC 60429-317-30
by Golden State Medical Supply Inc.
- Reason
- Presence of Foreign Substance; some bottles may contain debris that was swept up during cleaning
- Published
- June 11, 2014
- Distribution
- Nationwide
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FDA Recall
TerminatedTerminated: March 14, 2017Historical recordClass II
GREENSTONE BRAND fluconazole for Oral Suspension, ORANGE FLAVORED, 40 mg/mL, when reconstituted, Rx only, Distributed by Greenstone LLC Peapack, NJ 07977. MADE IN INDIA. NDC 59762-5030-1
by Pfizer Inc.
- Reason
- Defective Container: Tamper evident ring failures discovered on some bottles.
- Published
- June 11, 2014
- Distribution
- Nationwide
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FDA Recall
TerminatedTerminated: August 13, 2015Historical recordClass II
Metoprolol Succinate Extended-Release Tablets, USP, 100 mg, 100-count bottle, Rx only. Manufactured by: Wockhardt Limited, Mumbai, India; Distributed by: Wockhardt USA LLC., 20 Water view Blvd., Parsippany, NJ 07054, USA. NDC: 64679-736-02.
by Wockhardt Usa Inc.
- Reason
- Failed Dissolution Specifications: Failure of dissolution test observed at three month time point.
- Published
- June 4, 2014
- Distribution
- Nationwide
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FDA Recall
TerminatedTerminated: September 15, 2015Historical recordClass III
PediaCare brand DAY & NIGHT Value Pack DAYTIME MULTI-SYMPTOM Cold (dextromethorphan HBr 5 mg and Phenylephrine HCl 2.5 mg) and NIGHTTIME MULTI-SYMPTOM Cold (diphenhydramine HCl 6.25 mg and phenylephrine HCl 2.5 mg), 4 FL oz (118 mL) bottles, one each of DAYTIME MULTI-SYMPTOM Cold, Distributed by Medtech Products, Inc., Tarrytown, NY --- UPC 814832013523
by Prestige Brands Holdings
- Reason
- Presence of Precipitate; small amounts of diphenhydramine precipitated out of solution
- Published
- June 4, 2014
- Distribution
- Nationwide
View recall →
FDA Recall
TerminatedTerminated: September 15, 2015Historical recordClass III
PediaCare brand NIGHTTIME MULTI-SYMPTOM Cold, (diphenhydramine HCl 6.25 mg and phenylephrine HCl 2.5 mg), 4 FL OZ (118 mL), Distributed by Medtech Products, Inc., Tarrytown,NY ---- UPC 814832013544
by Prestige Brands Holdings
- Reason
- Presence of Precipitate; small amounts of diphenhydramine precipitated out of solution
- Published
- June 4, 2014
- 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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