Browse Drug Recalls

1,198 FDA drug safety recalls.

FDA Drug Recall Enforcement Database

Browse 1,198 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 1,198 FDA drug recalls in 2016.

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Date	Product	Reason	Class	Firm
Jan 15, 2016	papaverine phentolamine prostaglandin; 12/0.83 mg/10 mcg/ml; 5 mL and 10 mL u...	Lack of Assurance of Sterility: Firm is recalling all unexpired lots of sterile compounded produc...	Class II	Abbott's Compounding Pharmacy, Inc.
Jan 15, 2016	papaverine phentolamine prostaglandin; 35/1.5 mg/50 mcg/mL, 5 mL unit size, ...	Lack of Assurance of Sterility: Firm is recalling all unexpired lots of sterile compounded produc...	Class II	Abbott's Compounding Pharmacy, Inc.
Jan 15, 2016	Folic Acid, 10 mg/mL, 6 mL unit size, refrigerate, This Rx is Compounded, Abb...	Lack of Assurance of Sterility: Firm is recalling all unexpired lots of sterile compounded produc...	Class II	Abbott's Compounding Pharmacy, Inc.
Jan 15, 2016	papaverine phentolamine prostaglandin; 30 mg/0.25 mg/10 mcg/mL; 10 mL unit si...	Lack of Assurance of Sterility: Firm is recalling all unexpired lots of sterile compounded produc...	Class II	Abbott's Compounding Pharmacy, Inc.
Jan 15, 2016	papaverine phentolamine prostaglandin; 35/1.2 mg/20 mcg/mL; 10 mL unit size, ...	Lack of Assurance of Sterility: Firm is recalling all unexpired lots of sterile compounded produc...	Class II	Abbott's Compounding Pharmacy, Inc.
Jan 15, 2016	papaverine phentolamine prostaglandin; 30/1.5 mg/40 mcg/mL; 5 mL unit size, ...	Lack of Assurance of Sterility: Firm is recalling all unexpired lots of sterile compounded produc...	Class II	Abbott's Compounding Pharmacy, Inc.
Jan 15, 2016	Bupivacaine, 0.25%, 450 mL, This Rx is Compounded, Abbott's Compounding Pharm...	Lack of Assurance of Sterility: Firm is recalling all unexpired lots of sterile compounded produc...	Class II	Abbott's Compounding Pharmacy, Inc.
Jan 15, 2016	Insulin, 70/30, 10 mL unit size, refrigerate, This Rx is Compounded, Abbott's...	Lack of Assurance of Sterility: Firm is recalling all unexpired lots of sterile compounded produc...	Class II	Abbott's Compounding Pharmacy, Inc.
Jan 15, 2016	papaverine phentolamine prostaglandin; 12/1 mg/9 mcg/mL; 5 mL and 10 mL unit...	Lack of Assurance of Sterility: Firm is recalling all unexpired lots of sterile compounded produc...	Class II	Abbott's Compounding Pharmacy, Inc.
Jan 15, 2016	papaverine phentolamine, 35 mg/2.5 mg/mL; 5 mL unit size; refrigerate,This...	Lack of Assurance of Sterility: Firm is recalling all unexpired lots of sterile compounded produc...	Class II	Abbott's Compounding Pharmacy, Inc.
Jan 15, 2016	papaverine prostaglandin 30 mg/30 mcg/mL, 5 mL unit size, refrigerate, This R...	Lack of Assurance of Sterility: Firm is recalling all unexpired lots of sterile compounded produc...	Class II	Abbott's Compounding Pharmacy, Inc.
Jan 15, 2016	testosterone cypionate, 100 mg/mL, 10 mL unit size, This Rx is Compounded, Ab...	Lack of Assurance of Sterility: Firm is recalling all unexpired lots of sterile compounded produc...	Class II	Abbott's Compounding Pharmacy, Inc.
Jan 15, 2016	papaverine phentolamine prostaglandin; 30/2 mg/20 mcg/mL; 5 mL and 10 mL un...	Lack of Assurance of Sterility: Firm is recalling all unexpired lots of sterile compounded produc...	Class II	Abbott's Compounding Pharmacy, Inc.
Jan 15, 2016	papaverine phentolamine prostaglandin; 30/1 mg/20 mcg/mL; 5 mL unit size, re...	Lack of Assurance of Sterility: Firm is recalling all unexpired lots of sterile compounded produc...	Class II	Abbott's Compounding Pharmacy, Inc.
Jan 15, 2016	papaverine phentolamine prostaglandin; 22.5/0.83 mg/8.3 mcg/mL; 5 mL and 10 m...	Lack of Assurance of Sterility: Firm is recalling all unexpired lots of sterile compounded produc...	Class II	Abbott's Compounding Pharmacy, Inc.
Jan 15, 2016	Estradiol cypionate/Test cyprionate; 2 mg/50 mg/ml, unit size 5 mL, This Rx i...	Lack of Assurance of Sterility: Firm is recalling all unexpired lots of sterile compounded produc...	Class II	Abbott's Compounding Pharmacy, Inc.
Jan 15, 2016	calcium elemental, 3 mg/10 mL, 200 mL unit: This Rx is Compounded, Abbott's C...	Lack of Assurance of Sterility: Firm is recalling all unexpired lots of sterile compounded produc...	Class II	Abbott's Compounding Pharmacy, Inc.
Jan 14, 2016	risperiDONE ORALLY DISINTEGRATING TABLETS, 2 mg, 30 Ct Bottles, Rx Only. Manu...	Failed Impurities/Degradation Specifications: Out of specification for a known degradant.	Class III	Zydus Pharmaceuticals USA Inc
Jan 11, 2016	Lyrica (pregabalin) capsules, 75 mg, 90-count bottle, Rx only, Distributed by...	FAILED TABLET/CAPSULE SPECIFICATIONS: Firm is recalling specific lots of pregabalin capsules due ...	Class II	Pfizer Inc.
Jan 11, 2016	Lyrica (pregabalin) capsules, 50 mg, 90-count bottle, Rx only, Distributed by...	FAILED TABLET/CAPSULE SPECIFICATIONS: Firm is recalling specific lots of pregabalin capsules due ...	Class II	Pfizer Inc.
Jan 9, 2016	Stree Overlord, packaged in 10 small boxes / 1 capsule per box, Distributed b...	Marketed Without An Approved NDA/ANDA	Class I	R Thomas Marketing, LLC
Jan 9, 2016	Black Ant King, packaged in BIG BOX (10 capsules / can / 12 cans per box / 12...	Marketed Without An Approved NDA/ANDA	Class I	R Thomas Marketing, LLC
Jan 9, 2016	Plant Vigra, packaged in BIG BOX / (18 cans / 6 capsules per can / 108 capsul...	Marketed Without An Approved NDA/ANDA	Class I	R Thomas Marketing, LLC
Jan 9, 2016	Man King, packaged in BIG BOX (8 small boxes / 5 capsules per box / 40 capsul...	Marketed Without An Approved NDA/ANDA	Class I	R Thomas Marketing, LLC
Jan 9, 2016	Bull, packaged in CASE (10 packs / 3 capsules per can / 30 capsules), Distrib...	Marketed Without An Approved NDA/ANDA	Class I	R Thomas Marketing, LLC
Jan 9, 2016	Samurai-X, packaged in BIG BOX (24 individually wrapped capsules), Distribute...	Marketed Without An Approved NDA/ANDA	Class I	R Thomas Marketing, LLC
Jan 9, 2016	Night Man, packaged in SMALL BOX (6 capsules), Distributed by: R Thomas Marke...	Marketed Without An Approved NDA/ANDA	Class I	R Thomas Marketing, LLC
Jan 9, 2016	Happy Passengers, packaged in BIG BOX (30 small boxes / 1 capsule per box / 3...	Marketed Without An Approved NDA/ANDA	Class I	R Thomas Marketing, LLC
Jan 9, 2016	Zhong Hua Niu Bian, packaged in BIG BOX (6 small boxes / 6 capsules per box /...	Marketed Without An Approved NDA/ANDA	Class I	R Thomas Marketing, LLC
Jan 9, 2016	African Superman, packaged in BIG BOX (6 small boxes / 8 capsules per box / 4...	Marketed Without An Approved NDA/ANDA	Class I	R Thomas Marketing, LLC
Jan 9, 2016	Tiger King, packaged in BIG BOX (10 small bottles / 10 capsules per bottle / ...	Marketed Without An Approved NDA/ANDA	Class I	R Thomas Marketing, LLC
Jan 9, 2016	Zhen Gong Fu, packaged in BIG BOX (16 small boxes / 2 capsules per box / 32 c...	Marketed Without An Approved NDA/ANDA	Class I	R Thomas Marketing, LLC
Jan 9, 2016	Black Storm, packaged in SMALL BOX (6 capsules), Distributed by: R Thomas Mar...	Marketed Without An Approved NDA/ANDA	Class I	R Thomas Marketing, LLC
Jan 9, 2016	Weekend Prince, packaged in 24 individual cards / 2 capsules per card/ 48 cap...	Marketed Without An Approved NDA/ANDA	Class I	R Thomas Marketing, LLC
Jan 9, 2016	Real Skill, packaged in 20 small boxes / 4 capsules per box / 80 capsules tot...	Marketed Without An Approved NDA/ANDA	Class I	R Thomas Marketing, LLC
Jan 9, 2016	Mojo Risen, packaged in BIG BOX (24 individual cards / 2 capsules per card/ 4...	Marketed Without An Approved NDA/ANDA	Class I	R Thomas Marketing, LLC
Jan 9, 2016	Black Ant, packaged in Big Box (20 small boxes / 4 capsules per box / 80 caps...	Marketed Without An Approved NDA/ANDA	Class I	R Thomas Marketing, LLC
Jan 9, 2016	Germany Niubian, packaged in BIG BOX (10 small boxes / 24 capsules per box / ...	Marketed Without An Approved NDA/ANDA	Class I	R Thomas Marketing, LLC
Jan 9, 2016	Herb Viagra, packaged in Big Box (20 small boxes / 4 capsules per box / 80 ca...	Marketed Without An Approved NDA/ANDA	Class I	R Thomas Marketing, LLC
Jan 9, 2016	Bigger Longer More Time More Sperms, packaged in BIG BOX (6 small boxes / 6 c...	Marketed Without An Approved NDA/ANDA	Class I	R Thomas Marketing, LLC
Jan 9, 2016	Super Hard, packaged in BIG BOX (20 small boxes / 6 capsules per box / 120 ca...	Marketed Without An Approved NDA/ANDA	Class I	R Thomas Marketing, LLC
Jan 9, 2016	African Black Ant, packaged in 8 small boxes / 6 capsules per box / 48 capsul...	Marketed Without An Approved NDA/ANDA	Class I	R Thomas Marketing, LLC
Jan 9, 2016	Bull's Genital, packaged in CASE (10 Cans / 10 capsules per can / 100 capsule...	Marketed Without An Approved NDA/ANDA	Class I	R Thomas Marketing, LLC
Jan 9, 2016	Hard Ten Days, packaged in BIG BOX (6 small boxes / 6 capsules per box / 36 c...	Marketed Without An Approved NDA/ANDA	Class I	R Thomas Marketing, LLC
Jan 8, 2016	Guaifenesin DM Cherry liquid (guaifenesin 100 mg/5 mL and Dextromethorphan HB...	Defective Delivery System: Firm recalled Guaifenesin liquid and Guaifenesin DM liquid due incorre...	Class II	Perrigo Company PLC
Jan 8, 2016	Guaifenesin Grape liquid 100 mg/5 mL, packaged in 4oz. bottles, co-packaged w...	Defective Delivery System: Firm recalled Guaifenesin liquid and Guaifenesin DM liquid due incorre...	Class II	Perrigo Company PLC
Jan 5, 2016	Bromfenac Ophthalmic Solution 0.09%, a) 2.5 mL bottles (NDC 0378-7110-35) and...	Lack of Assurance of Sterility: Failed preservative effectiveness test	Class II	Mayne Pharma Usa
Jan 5, 2016	Magnesium Sulfate in Water for Injection, (0.325 mEq Mg++/mL) 40 mg/mL, 2 g T...	Labeling: Incorrect Barcode: Primary bag labeling may be mislabeled with the wrong barcode which ...	Class I	Hospira Inc.

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.