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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 15,181–15,200 of 17,987 drug recalls

Drug Recall Terminated Historical recordClass I

Meizi Evolution Soft Gel Capsules, supplied in 30 count bottles, 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: N-desmethylsibutramine, benzylsibutramine, and sibutramine
Recall initiated
January 24, 2014
Reported by FDA
June 18, 2014
Distribution
Nationwide

View recall →

Drug Recall Terminated Historical recordClass I

SlimEasy Herbs Capsule, 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: sibutramine and N-desmethylsibutramine
Recall initiated
January 24, 2014
Reported by FDA
June 18, 2014
Distribution
Nationwide

View recall →

Drug Recall Terminated Historical recordClass I

Pill for weight reduction, (Japanese Chinese Formula from Japan Hokkaido Cangye Pharmacy Co, Ltd) 400 mg, supplied in 40 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
Recall initiated
January 24, 2014
Reported by FDA
June 18, 2014
Distribution
Nationwide

View recall →

Drug Recall Terminated Historical 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
Recall initiated
January 24, 2014
Reported by FDA
June 18, 2014
Distribution
Nationwide

View recall →

Drug Recall Terminated Historical 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 .
Recall initiated
January 24, 2014
Reported by FDA
June 18, 2014
Distribution
Nationwide

View recall →

Drug Recall Terminated Historical 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
Recall initiated
January 24, 2014
Reported by FDA
June 18, 2014
Distribution
Nationwide

View recall →

Drug Recall Terminated Historical 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.
Recall initiated
January 24, 2014
Reported by FDA
June 18, 2014
Distribution
Nationwide

View recall →

Drug Recall Terminated Historical 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
Recall initiated
October 10, 2013
Reported by FDA
June 18, 2014
Distribution
Nationwide

View recall →

Drug Recall Terminated Historical 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
Recall initiated
October 10, 2013
Reported by FDA
June 18, 2014
Distribution
Nationwide

View recall →

Drug Recall Terminated Historical 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
Recall initiated
October 10, 2013
Reported by FDA
June 18, 2014
Distribution
Nationwide

View recall →

Drug Recall Terminated Historical 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
Recall initiated
October 10, 2013
Reported by FDA
June 18, 2014
Distribution
Nationwide

View recall →

Drug Recall Terminated Historical 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
Recall initiated
October 10, 2013
Reported by FDA
June 18, 2014
Distribution
Nationwide

View recall →

Drug Recall Terminated Historical 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
Recall initiated
October 10, 2013
Reported by FDA
June 18, 2014
Distribution
Nationwide

View recall →

Drug Recall Terminated Historical 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
Recall initiated
November 19, 2013
Reported by FDA
June 18, 2014
Distribution
Nationwide

View recall →

Drug Recall Terminated Historical recordClass II

Pantoprazole Sodium, Delayed-release tablets, USP, 40 mg tablets, 100 (10x10) unit dose packages, Manufactured by Dr. Reddy's Laboratories Limited, India and Distributed by Major Pharmaceuticals, Livonia, MI --- NDC 0904-6235-61

by Legacy Pharmaceutical Packaging

Reason
Correct Labeled Product Miscart/Mispack: some cartons labeled as Pantoprazole Sodium Delayed-Release may contain correctly labeled blister cards of Lorazepam tablets
Recall initiated
April 9, 2014
Reported by FDA
June 18, 2014
Distribution
IN

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Drug Recall Terminated Historical recordClass I

Midazolam 0.2 mg/2 mL 0.9% Sodium Chloride syringes, Total dosage: 0.4 mg per 2 mL, Rx Only, Pharmakon Pharmaceuticals, Inc., 14450 Getz Rd, Noblesville, Indiana, NDC 45183-0014-69.

by Pharmakon Pharmaceuticals

Reason
Superpotent Drug: Product contains twice the stated amount of midazolam.
Recall initiated
March 26, 2014
Reported by FDA
June 18, 2014
Distribution
IN

View recall →

Drug Recall Terminated Historical 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
Recall initiated
March 6, 2014
Reported by FDA
June 18, 2014
Distribution
Nationwide and Puerto Rico

View recall →

Drug Recall Terminated Historical 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.
Recall initiated
December 20, 2013
Reported by FDA
June 11, 2014
Distribution
Nationwide and Puerto Rico; Bahrain, Germany, Mexico, Philippines

View recall →

Drug Recall Terminated Historical 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.
Recall initiated
December 20, 2013
Reported by FDA
June 11, 2014
Distribution
Nationwide and Puerto Rico; Bahrain, Germany, Mexico, Philippines

View recall →

Drug Recall Terminated Historical 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.
Recall initiated
April 21, 2014
Reported by FDA
June 11, 2014
Distribution
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.