Browse Drug Recalls

129 FDA drug safety recalls.

FDA Drug Recall Enforcement Database

Browse 129 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 129 FDA drug recalls.

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Date	Product	Reason	Class	Firm
Nov 16, 2017	Sincalide 5 mcg Lyophilized Vials, For IV Use, Rx Only, KRS Global Biotechnol...	Labeling: Incorrect or Missing Lot and/or Exp Date: Beyond Use Date (BUD) exceed the BUD/EXP of a...	Class II	KRS Global Biotechnology, Inc
Nov 16, 2017	PrednisoLONE 10 mg Tablet, Rx Only, KRS Global Biotechnology, 791 Park of Com...	Labeling: Incorrect or Missing Lot and/or Exp Date: Beyond Use Date (BUD) exceed the BUD/EXP of a...	Class II	KRS Global Biotechnology, Inc
Nov 16, 2017	Oxytocin 30 Units in 0.9% Sodium Chloride Solution (PF) IV Bag, For IV Infusi...	Labeling: Incorrect or Missing Lot and/or Exp Date: Beyond Use Date (BUD) exceed the BUD/EXP of a...	Class II	KRS Global Biotechnology, Inc
Nov 16, 2017	Estriol 0.1% (1 mg/gm) Cream packaged in jars, Rx Only, KRS Global Biotechnol...	Labeling: Incorrect or Missing Lot and/or Exp Date: Beyond Use Date (BUD) exceed the BUD/EXP of a...	Class II	KRS Global Biotechnology, Inc
Nov 16, 2017	Cyclopentolate HCl/ Phenylephrine HCl/ Tropicamide/ Ketorolac 1%/ 10%/ 1%/ 0....	Labeling: Incorrect or Missing Lot and/or Exp Date: Beyond Use Date (BUD) exceed the BUD/EXP of a...	Class II	KRS Global Biotechnology, Inc
Nov 16, 2017	Chloramphenicol 500 mg Sulfamethoxazole 500 mg Amphotericin 50 mg Otic Powder...	Labeling: Incorrect or Missing Lot and/or Exp Date: Beyond Use Date (BUD) exceed the BUD/EXP of a...	Class II	KRS Global Biotechnology, Inc
Nov 16, 2017	Iodochlorhydroxyquin 3%/ Boric Acid 10%/ Amphotericin 5% Otic Powder packaged...	Labeling: Incorrect or Missing Lot and/or Exp Date: Beyond Use Date (BUD) exceed the BUD/EXP of a...	Class II	KRS Global Biotechnology, Inc
Nov 16, 2017	Sermorelin, 3 mg/ GHRP6, 1.8 mg/ GHRP2, 1.8 mg/mL in 3 mL Cartridge, For SC U...	Labeling: Incorrect or Missing Lot and/or Exp Date: Beyond Use Date (BUD) exceed the BUD/EXP of a...	Class II	KRS Global Biotechnology, Inc
Nov 16, 2017	Vitamin 9 Lyophilized Vial, For IM Use, Rx Only, KRS Global Biotechnology, 79...	Labeling: Incorrect or Missing Lot and/or Exp Date: Beyond Use Date (BUD) exceed the BUD/EXP of a...	Class II	KRS Global Biotechnology, Inc
Nov 16, 2017	Nicotinamide Adenine Dinucleotide 500 mg packaged in vials, Lyophilized-For I...	Labeling: Incorrect or Missing Lot and/or Exp Date: Beyond Use Date (BUD) exceed the BUD/EXP of a...	Class II	KRS Global Biotechnology, Inc
Nov 16, 2017	Arginine 150 mg/ Lysine HCl 50 mg/ Glutamine 200 mg/g Topical Cream packaged ...	Labeling: Incorrect or Missing Lot and/or Exp Date: Beyond Use Date (BUD) exceed the BUD/EXP of a...	Class II	KRS Global Biotechnology, Inc
Nov 16, 2017	Trimix #22F (Prostaglandin E1 25 mcg/ Papaverine HCl 30 mg/ Phentolamine Mesy...	Labeling: Incorrect or Missing Lot and/or Exp Date: Beyond Use Date (BUD) exceed the BUD/EXP of a...	Class II	KRS Global Biotechnology, Inc
Nov 16, 2017	Cyclopentolate HCl/ Phenylephrine HCl/ Tropicamide/ Ketorolac 1%/ 2.5%/ 1%/ 0...	Labeling: Incorrect or Missing Lot and/or Exp Date: Beyond Use Date (BUD) exceed the BUD/EXP of a...	Class II	KRS Global Biotechnology, Inc
Nov 16, 2017	Hydroxocobalamin 0.5 mg/mL For Diluent Purpose Only 10 mL Vial, Rx Only, KRS ...	Labeling: Incorrect or Missing Lot and/or Exp Date: Beyond Use Date (BUD) exceed the BUD/EXP of a...	Class II	KRS Global Biotechnology, Inc
Nov 16, 2017	QUADMIX #17, 5 mL Vial, Rx Only, KRS Global Biotechnology, 791 Park of Commer...	Labeling: Incorrect or Missing Lot and/or Exp Date: Beyond Use Date (BUD) exceed the BUD/EXP of a...	Class II	KRS Global Biotechnology, Inc
Nov 16, 2017	Liothyronine SR (T3) 20 mcg Capsule, Rx Only, KRS Global Biotechnology, 791 P...	Labeling: Incorrect or Missing Lot and/or Exp Date: Beyond Use Date (BUD) exceed the BUD/EXP of a...	Class II	KRS Global Biotechnology, Inc
Nov 16, 2017	Anastrozole 0.5 mg Capsules, Rx Only, KRS Global Biotechnology, 791 Park of C...	Labeling: Incorrect or Missing Lot and/or Exp Date: Beyond Use Date (BUD) exceed the BUD/EXP of a...	Class II	KRS Global Biotechnology, Inc
Nov 16, 2017	Vitamin 9 A/B Lyophilized Vial, For IM Use, Rx Only, KRS Global Biotechnology...	Labeling: Incorrect or Missing Lot and/or Exp Date: Beyond Use Date (BUD) exceed the BUD/EXP of a...	Class II	KRS Global Biotechnology, Inc
Nov 16, 2017	Methylene Blue (PF) 10 mg/mL (1%) Injectable Vial, Rx Only, KRS Global Biotec...	Labeling: Incorrect or Missing Lot and/or Exp Date: Beyond Use Date (BUD) exceed the BUD/EXP of a...	Class II	KRS Global Biotechnology, Inc
Nov 16, 2017	Benzo/Lido/Tetracaine 20%-8%-8% Topical Cream packaged in jars, Rx Only, KRS ...	Labeling: Incorrect or Missing Lot and/or Exp Date: Beyond Use Date (BUD) exceed the BUD/EXP of a...	Class II	KRS Global Biotechnology, Inc
Nov 16, 2017	Bi-Est (Estriol/Estradiol) (80/20) + Progesterone 7.5 mg/200 mg Cream package...	Labeling: Incorrect or Missing Lot and/or Exp Date: Beyond Use Date (BUD) exceed the BUD/EXP of a...	Class II	KRS Global Biotechnology, Inc
Nov 16, 2017	Hydroquinone 8%/ Tretinoin 0.1% Topical Ointment packaged in jars, Rx Only, K...	Labeling: Incorrect or Missing Lot and/or Exp Date: Beyond Use Date (BUD) exceed the BUD/EXP of a...	Class II	KRS Global Biotechnology, Inc
Nov 16, 2017	Human Chorionic Gonadotropin 2,500 Units, Vial-Lyophilized, For SC Use, Rx On...	Labeling: Incorrect or Missing Lot and/or Exp Date: Beyond Use Date (BUD) exceed the BUD/EXP of a...	Class II	KRS Global Biotechnology, Inc
Nov 16, 2017	QUADMIX #18, 5 mL Vial, Rx Only, KRS Global Biotechnology, 791 Park of Commer...	Labeling: Incorrect or Missing Lot and/or Exp Date: Beyond Use Date (BUD) exceed the BUD/EXP of a...	Class II	KRS Global Biotechnology, Inc
Nov 16, 2017	Progesterone 3% Topical Cream packaged in jars, Rx Only, KRS Global Biotechno...	Labeling: Incorrect or Missing Lot and/or Exp Date: Beyond Use Date (BUD) exceed the BUD/EXP of a...	Class II	KRS Global Biotechnology, Inc
Nov 16, 2017	Chloramphenicol 50 mg/ Sulfamethoxazole 50 mg/ Amphotericin-B 5 mg capsules, ...	Labeling: Incorrect or Missing Lot and/or Exp Date: Beyond Use Date (BUD) exceed the BUD/EXP of a...	Class II	KRS Global Biotechnology, Inc
Nov 16, 2017	Savinase 100 mcg/mL Topical Solution, 1 mL in a 3 mL Droptainer, Rx Only, KRS...	Labeling: Incorrect or Missing Lot and/or Exp Date: Beyond Use Date (BUD) exceed the BUD/EXP of a...	Class II	KRS Global Biotechnology, Inc
Nov 16, 2017	Benzocaine 20%, Lidocaine 6%, Tetracaine 4% Cream packaged in jars, Rx Only, ...	Labeling: Incorrect or Missing Lot and/or Exp Date: Beyond Use Date (BUD) exceed the BUD/EXP of a...	Class II	KRS Global Biotechnology, Inc
Nov 16, 2017	Human Chorionic Gonadotropin 6,000 iu/Vial, For SC Use -Lyophilized, Rx Only,...	Labeling: Incorrect or Missing Lot and/or Exp Date: Beyond Use Date (BUD) exceed the BUD/EXP of a...	Class II	KRS Global Biotechnology, 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.