Browse Drug Recalls

1,733 FDA drug safety recalls.

FDA Drug Recall Enforcement Database

Browse 1,733 FDA drug recall enforcement actions. Each entry includes the product description, reason for recall, classification (Class I through III based on severity), recalling firm, and distribution details. Use the filters below to search by year, classification, state, or keyword.

Drug Safety Recalls

Browse 1,733 FDA drug recalls in 2015.

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Date	Product	Reason	Class	Firm
Oct 6, 2015	TRI-MIX 10MCG+0.5MG+15MG/ML,5 mL vial, Rx only, Park Compounding Pharmacy 280...	Lack of Assurance of Sterility: all sterile compounded products within expiry	Class II	Chen Shwezin, Inc. dba Park Compounding Pharmacy
Oct 6, 2015	PROSTAGLANDIN PGE-1 40MCG/ML, 10mL vial, Rx only, Park Compounding Pharmacy 2...	Lack of Assurance of Sterility: all sterile compounded products within expiry	Class II	Chen Shwezin, Inc. dba Park Compounding Pharmacy
Oct 6, 2015	CAFFEINE + SODIUM BENZOATE 500MG/ML, 35 mL vial, Rx only, Park Compounding Ph...	Lack of Assurance of Sterility: all sterile compounded products within expiry	Class II	Chen Shwezin, Inc. dba Park Compounding Pharmacy
Oct 6, 2015	METHYLCOBALAMIN 1000MCG/ML, 10mL vial, Rx only, Park Compounding Pharmacy 280...	Lack of Assurance of Sterility: all sterile compounded products within expiry	Class II	Chen Shwezin, Inc. dba Park Compounding Pharmacy
Oct 6, 2015	TRI-MIX 20MCG+0.5MG+15MG/ML, 10 mL vial, Rx only, Park Compounding Pharmacy 2...	Lack of Assurance of Sterility: all sterile compounded products within expiry	Class II	Chen Shwezin, Inc. dba Park Compounding Pharmacy
Oct 5, 2015	NATUREAL BURN FAT NATURE, 30-count capsules, packaged in clear plastic bottle...	Marketed Without an Approved NDA/ANDA: Product contains undeclared sibutramine.	Class I	Inaffit, LLC
Oct 1, 2015	Rhino 7 Platinum 3000, Single Blister Packs, distributed By Rhino 7, Made in USA	Marketed without an Approved NDA/ANDA: Products contain undeclared active pharmaceutical ingredie...	Class I	MSNV, Inc dba National Video Supply
Oct 1, 2015	Fenofibric Acid Tablets, 35 mg, 30-count bottles, labeled as a) FIBRICOR (fen...	Chemical Contamination: The product may contain trace amounts of benzophenone, a component of the...	Class III	Tribute Pharmaceuticals US Inc.
Oct 1, 2015	Rhino 7 3000, 6 count bottles, Distributed by Rhino 7, Made in USA.	Marketed without an Approved NDA/ANDA: Products contain undeclared active pharmaceutical ingredie...	Class I	MSNV, Inc dba National Video Supply
Oct 1, 2015	Fenofibric Acid Tablets 105 mg, Rx only, labeled as a) FIBRICOR (fenofibric a...	Chemical Contamination: The product may contain trace amounts of benzophenone, a component of the...	Class III	Tribute Pharmaceuticals US Inc.
Sep 30, 2015	Rhino 7 Platinum 3000, 1 count Blister Pack, Distributed by Rhino 7, Made in USA	Marketed without an Approved NDA/ANDA: Products contain undeclared active pharmaceutical ingredie...	Class I	Premiere Sales Group
Sep 30, 2015	Rhino 7 3000, 6 count Bottle, Distributed by Rhino 7, Made in USA	Marketed without an Approved NDA/ANDA: Products contain undeclared active pharmaceutical ingredie...	Class I	Premiere Sales Group
Sep 29, 2015	Ultimate Herbal Slimcap Capsules, 350 mg*, 30-count bottles, labeled Part 1 o...	Marketed Without An Approved NDA/ANDA: product marketed as a dietary supplement was found to be t...	Class I	Fit Firm and Fabulous
Sep 29, 2015	Amidate (Etomidate Injection, USP), 40 mg/20 mL (2 mg/mL), LifeShield, 20 mL,...	Failed Impurities/Degradation Specifications: Out of Specification(OOS) results for degradation p...	Class III	Hospira Inc.
Sep 28, 2015	Cetirizine HCl 10 mg Tablet, 14 count blister packs, sold over the counter un...	Failed Impurity/Degradations Specifications; impurity identified as cetirizine monosaccharide ester	Class III	Perrigo Company PLC
Sep 25, 2015	Metformin Hydrochloride Extended-Release Tablets, 1000 mg, 60-count bottle, R...	Failed Dissolution Specifications: Low Out-of-Specification results for the 8 hour timepoint.	Class II	Actavis Laboratories, FL, Inc.
Sep 25, 2015	FUROSEMIDE Tablets USP, 40 mg, 1000-count bottle, Rx only, Boehringer Ingelhe...	CGMP Deviations: The active pharmaceutical ingredient (API) intended for use in furosemide oral s...	Class III	Boehringer Ingelheim Roxane Inc
Sep 25, 2015	Rhino 7 Platinum 3000, 1 count Blister Pack, Distributed by Rhino 7, Made in ...	Marketed without an Approved NDA/ANDA: Products contain undeclared desmethyl carbondenafil and da...	Class I	Tf Supplements
Sep 25, 2015	FUROSEMIDE Tablets USP, 20 mg, 1000-count bottle, Rx only, Boehringer Ingelhe...	CGMP Deviations: The active pharmaceutical ingredient (API) intended for use in furosemide oral s...	Class III	Boehringer Ingelheim Roxane Inc
Sep 25, 2015	RHINO 7 3000, 6 count Bottle, Distributed by Rhino 7, Made in USA	Marketed without an Approved NDA/ANDA: Products contain undeclared desmethyl carbondenafil and da...	Class I	Tf Supplements
Sep 25, 2015	ACETAMINOPHEN EXTRA-STRENGTH PAIN RELIEVER tablets, 500 mg, 100-count bottle,...	Labeling: Label Error on Declared Strength- Bottles containing 500 mg acetaminophen tablets misla...	Class I	Medline Industries Inc
Sep 25, 2015	ACETAMINOPHEN REGULAR-STRENGTH PAIN RELIEVER tablets, 325 mg, 100-count bottl...	Labeling: Label Error on Declared Strength- Bottles containing 500 mg acetaminophen tablets misla...	Class I	Medline Industries Inc
Sep 24, 2015	Xanax (alprazolam) tablets, 0.25 mg, 100-count bottle, Rx only, Distributed b...	Subpotent Drug	Class II	Pfizer Inc.
Sep 23, 2015	Shorts on The Beach Golden Edition by Pink Bikini, 800 mg, packaged in 30-cou...	Marketed without an approved NDA/ANDA: Product contains undeclared sibutramine and phenolphthalein.	Class I	Lucy's Weight Loss (dba. Waisted With Lucy)
Sep 23, 2015	Pink Bikini Strong Formula capsules, 750 mg, packaged in 30-count plastic bot...	Marketed without an approved NDA/ANDA: Product contains undeclared sibutramine and phenolphthalein.	Class I	Lucy's Weight Loss (dba. Waisted With Lucy)
Sep 23, 2015	Shorts on The Beach Strong Formula by Pink Bikini capsules, 750 mg, packaged ...	Marketed without an approved NDA/ANDA: Product contains undeclared sibutramine and phenolphthalein.	Class I	Lucy's Weight Loss (dba. Waisted With Lucy)
Sep 23, 2015	Sermorelin 6mg/6mL Lyophilized Powder, Sterile Compound for Subcutaneous Inje...	Lack of Assurance of Sterility: A recent FDA inspection found that this product was not being com...	Class II	Diabetes Corporation of America dba DCA Pharmacy
Sep 22, 2015	Sedalmex (Acetaminophen 500 mg with Caffeine 65 mg) Pain Reliever tablets, 20...	Cross Contamination With Other Products: Potential cross-contamination of cephalosporin.	Class II	Midway Importing, Inc
Sep 22, 2015	P-P (COBAL) 300-30/mL, Injection, Bedford Pharmacy, 209 Route 101, Bedford, N...	Lack of assurance of sterility	Class II	Bedford Pharmacy
Sep 22, 2015	Hydroxocobalamin 20 mg/mL Injection, Bedford Pharmacy, 209 Route 101, Bedford...	Lack of assurance of sterility	Class II	Bedford Pharmacy
Sep 22, 2015	P-P (COBAL)30-0.5/mL, Injection, Bedford Pharmacy, 209 Route 101, Bedford, NH...	Lack of assurance of sterility	Class II	Bedford Pharmacy
Sep 22, 2015	P-P-P (COBAL) 30-2- 30/mL, Injection, Bedford Pharmacy, 209 Route 101, Bedfo...	Lack of assurance of sterility	Class II	Bedford Pharmacy
Sep 22, 2015	Methylcobalamin (preservative Free) 1 mg/mL Injection, Bedford Pharmacy, 209 ...	Lack of assurance of sterility	Class II	Bedford Pharmacy
Sep 22, 2015	P-P-P (COBAL) 30-1-20/mL, Injection, Bedford Pharmacy, 209 Route 101, Bedford...	Lack of assurance of sterility	Class II	Bedford Pharmacy
Sep 22, 2015	P-P-P (COBAL) 30-4-40/mL, Injection, Bedford Pharmacy, 209 Route 101, Bedfor...	Lack of assurance of sterility	Class II	Bedford Pharmacy
Sep 22, 2015	P-P (COBAL) 30-2 /mL, Injection, Bedford Pharmacy, 209 Route 101, Bedford, NH...	Lack of assurance of sterility	Class II	Bedford Pharmacy
Sep 22, 2015	Testosterone Cypionate (Complete Formula) 200 mg/mL, Injection, Bedford Pharm...	Lack of assurance of sterility	Class II	Bedford Pharmacy
Sep 22, 2015	Testosterone Cypionate (Complete Formula) 100 mg/mL, Injection, Bedford Pharm...	Lack of assurance of sterility	Class II	Bedford Pharmacy
Sep 22, 2015	Methylcobalamin (Bacteriostatic) 1 mg/mL Injection, Bedford Pharmacy, 209 Rou...	Lack of assurance of sterility	Class II	Bedford Pharmacy
Sep 22, 2015	Acetylcysteine 10% Opthalmic Solution, Bedford Pharmacy, 209 Route 101, Bedfo...	Lack of assurance of sterility	Class II	Bedford Pharmacy
Sep 22, 2015	P-P-P (COBAL) 30-1-5/mL, Injection,Bedford Pharmacy, 209 Route 101, Bedford, ...	Lack of assurance of sterility	Class II	Bedford Pharmacy
Sep 18, 2015	MORPHINE 10MG/ML in NS, Packaged in a) 150ML Homepumps and b) 250ML Homepumps...	Lack of Assurance of Sterility: Product sterility cannot be guaranteed.	Class II	Sentara Enterprises
Sep 18, 2015	CEFTRIAXONE in NS, Packaged as a) 1GM in 50ML Homepumps, b) 2GM in 100ML Home...	Lack of Assurance of Sterility: Product sterility cannot be guaranteed.	Class II	Sentara Enterprises
Sep 18, 2015	CUBICIN (daptomycin) in NS, Packaged as a) 350MG in 7ML Syringes, b)365MG in ...	Lack of Assurance of Sterility: Product sterility cannot be guaranteed.	Class II	Sentara Enterprises
Sep 18, 2015	FLUCONAZOLE IN NACL 400MG in NS, Packaged in 200ML Homepumps, Rx Only. SENTAR...	Lack of Assurance of Sterility: Product sterility cannot be guaranteed.	Class II	Sentara Enterprises
Sep 18, 2015	POTASSIUM CHLORIDE in D 5 1/2NS, Packaged in a) 40 mEq KCL/LITER 1000ML Homep...	Lack of Assurance of Sterility: Product sterility cannot be guaranteed.	Class II	Sentara Enterprises
Sep 18, 2015	CEFEPIME, Packaged a) 1GM in 50ML Homepumps, b) 2GM in 100ML Homepumps, and c...	Lack of Assurance of Sterility: Product sterility cannot be guaranteed.	Class II	Sentara Enterprises
Sep 18, 2015	ONDANSETRON HCL 8MG, Packaged in 100ML Homepumps. Rx Only. SENTARA HOME HEALT...	Lack of Assurance of Sterility: Product sterility cannot be guaranteed.	Class II	Sentara Enterprises
Sep 18, 2015	MEROPENEM in NS, Packaged as a) 1000MG in 250ML Homepumps, and b) 2GM in 100M...	Lack of Assurance of Sterility: Product sterility cannot be guaranteed.	Class II	Sentara Enterprises
Sep 18, 2015	Parenteral Amino Acid Infusion 10%, Packaged in a) 780ML Homepumps, b) 1000ML...	Lack of Assurance of Sterility: Product sterility cannot be guaranteed.	Class II	Sentara Enterprises

Frequently Asked Questions

When a drug safety issue is identified — through FDA inspections, laboratory testing, adverse event reports, or manufacturer quality checks — the responsible company issues a recall to remove the affected products from the market. Pharmacies pull the product from shelves, and consumers are advised to contact their healthcare provider for alternatives.

The leading causes include cGMP deviations, impurity contamination (including nitrosamines like NDMA), failed dissolution or stability testing, sterility issues, potency problems, labeling errors, and foreign particle contamination.

Use the search and filter tools on this page to look up specific medications, active ingredients, or manufacturers. Each recall entry includes the product description, lot numbers, and distribution details.