Browse Drug Recalls

1,681 FDA drug safety recalls.

FDA Drug Recall Enforcement Database

Browse 1,681 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 1,681 FDA drug recalls in 2018.

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Date	Product	Reason	Class	Firm
May 17, 2018	My Way (Levonorgestrel) Tablets TWO PACK, 1.5 mg each, packaged as 2 Treatmen...	Marketed Without an Approved NDA/ANDA: 2-pack configuration did not receive appropriate regulator...	Class II	Lupin Pharmaceuticals Inc.
May 17, 2018	My Way (levonorgestrel) Tablets TWO PACK, 1.5 mg each, packaged as 2 Treatmen...	Marketed Without an Approved NDA/ANDA: 2-pack configuration did not receive appropriate regulator...	Class II	Lupin Pharmaceuticals Inc.
May 17, 2018	Cefazolin 2 Gm/20 mL 20 ml. Rx Only. Packaged in 20 mL syringes. Compounded G...	Lack of sterility assurance.	Class II	Guardian Pharmacy Services
May 17, 2018	Glycopyrrolate 0.2 mg/mL 2ml. Rx Only. Packaged in 2 mL syringes. Compounded ...	Lack of sterility assurance.	Class II	Guardian Pharmacy Services
May 17, 2018	POSEIDON Xtreme PLATINUM 4500,1000mg, packaged in single packs sold in 24-cou...	Marketed Without An Approved NDA/ANDA: FDA analysis found products to contain undeclared sildenaf...	Class I	Shoreside Enterprises Inc.
May 17, 2018	Ropivacaine HCl 2 mg/mL 400 mL. Rx Only. Packaged in a ON-Q Pump. Compounded ...	Lack of sterility assurance.	Class II	Guardian Pharmacy Services
May 17, 2018	B-Complex Rx only. packaged in a) 100 mL bag b) 100 ml MDV vial. Compounded G...	Lack of sterility assurance.	Class II	Guardian Pharmacy Services
May 17, 2018	Ropivacaine HCl 2 mg/mL 550 mL. Rx Only. Packaged in a ON-Q Pump. Compounded ...	Lack of sterility assurance.	Class II	Guardian Pharmacy Services
May 17, 2018	Ropivacaine HCl 2 mg/mL 750 mL. Rx Only. Packaged in a ON-Q Pump. Compounded ...	Lack of sterility assurance.	Class II	Guardian Pharmacy Services
May 17, 2018	Medroxyprogesterone 150 mg/mL 5ml. Rx Only. Packaged in 5 mL vials. Compounde...	Lack of sterility assurance.	Class II	Guardian Pharmacy Services
May 17, 2018	Fentanyl Citrate 50 mcg/mL 2ml. Rx Only. Packaged in 2 mL syringes. Compounde...	Lack of sterility assurance.	Class II	Guardian Pharmacy Services
May 17, 2018	Methylcobalamin 1000 mcg/mL 100 mL. RX Only. Packaged in 100ml MDV vials. Com...	Lack of sterility assurance.	Class II	Guardian Pharmacy Services
May 17, 2018	Hyaluronidase 150 units/mL 1ml. Rx Only. Packaged in 1 mL vials. Compounded G...	Lack of sterility assurance.	Class II	Guardian Pharmacy Services
May 17, 2018	Magnesium Sulfate 200 mg/mL, 100ml. Rx. Only. Packaged in 100 mL MDV vials. C...	Lack of sterility assurance.	Class II	Guardian Pharmacy Services
May 17, 2018	EDTA Disodium 30 mg/mL PF. Rx Only. Packaged in 1 mL pre filled syringe. Comp...	Lack of sterility assurance.	Class II	Guardian Pharmacy Services
May 17, 2018	Lidocaine 3% 10 ml. Rx Only. Packaged in 10 mL syringes. Compounded Guardian ...	Lack of sterility assurance.	Class II	Guardian Pharmacy Services
May 16, 2018	screamin' hot (capsaicin) Pain Relieving Gel, 0.03%, packaged in a) 2 OZ (57g...	CGMP Deviations: Products manufactured with an ingredient that exceed the benzene levels allowed ...	Class II	Ideaz Llc
May 16, 2018	screamin' menthol (menthol) Pain Relieving Gel, 4%, packaged in a) 2 OZ (57g)...	CGMP Deviations: Products manufactured with an ingredient that exceed the benzene levels allowed ...	Class II	Ideaz Llc
May 16, 2018	Option Systems Antibacterial Foaming Hand Wash with .3% PCMX, 1000 mL pouches...	Microbial contamination of NonSterile Product; FDA analysis returned out of specification results...	Class II	Inopak Ltd
May 15, 2018	Argentum Elixir Colloidal Silver, 50 PPM Homeopathic Infection Fighter, 8 fl...	Lack of Processing Controls: Firm is voluntarily recalling all lots of homeopathic Teething Drops...	Class II	MBi Distributing Inc. dba MBi Nutraceuticals
May 15, 2018	Stomach Calm, Calms Upset Stomach and Aids in Treatment of Simple Diarrhea, ...	Lack of Processing Controls: Firm is voluntarily recalling all lots of homeopathic Teething Drops...	Class II	MBi Distributing Inc. dba MBi Nutraceuticals
May 15, 2018	Intestinal Colic Drops, Homeopathic Drops for Temporary Relief of Flatulent C...	Lack of Processing Controls: Firm is voluntarily recalling all lots of homeopathic Teething Drops...	Class II	MBi Distributing Inc. dba MBi Nutraceuticals
May 15, 2018	Expectorant Cough Syrup, Homeopathic Syrup for Temporary Relief of Cough & Br...	Lack of Processing Controls: Firm is voluntarily recalling all lots of homeopathic Teething Drops...	Class II	MBi Distributing Inc. dba MBi Nutraceuticals
May 15, 2018	Nausea Drops, Homeopathic Drops for Temporary Relief of Motion Sickness, Morn...	Lack of Processing Controls: Firm is voluntarily recalling all lots of homeopathic Teething Drops...	Class II	MBi Distributing Inc. dba MBi Nutraceuticals
May 15, 2018	Silver-Zinc Throat Spray, HOMEOPATHIC IMMUNE DEFENSE, 50PPM, 4oz/50 ppm/ 120m...	Lack of Processing Controls: Firm is voluntarily recalling all lots of homeopathic Teething Drops...	Class II	MBi Distributing Inc. dba MBi Nutraceuticals
May 15, 2018	Teething Drops, Homeopathic Drops for Temporary Relief of Pain Caused by Teet...	Lack of Processing Controls: Firm is voluntarily recalling all lots of homeopathic Teething Drops...	Class II	MBi Distributing Inc. dba MBi Nutraceuticals
May 11, 2018	Scopolamine Transdermal Therapeutic System, 1 mg/3 days, a) 4-count (NDC 4580...	Defective delivery system	Class II	L. Perrigo Company
May 8, 2018	Piperacillin and Tazobactam for Injection, USP 4.5 gram/vial* 10-count Single...	Subpotent Drug: High Levels of Impurities Resulting in Decrease Potency	Class I	Apotex Inc.
May 8, 2018	Piperacillin and Tazobactam for Injection, USP 3.375 gram/vial* 10-count Sing...	Subpotent Drug: High Levels of Impurities Resulting in Decrease Potency	Class I	Apotex Inc.
May 7, 2018	Geritrex Senna Syrup (sennosides 8.8mg), packaged in 8 FL OZ. (236 mL) bottle...	CGMP Deviations: Products are being recalled due to an out of specification total aerobic microbi...	Class II	RIJ Pharmaceutical LLC
May 7, 2018	Preferred Plus Pharmacy Antacid Extra Strength (Aluminum Hydroxide 400mg, Mag...	CGMP Deviations: Products are being recalled due to an out of specification total aerobic microbi...	Class II	RIJ Pharmaceutical LLC
May 7, 2018	Hydrocortisone Ointment, USP 2.5%, Net Wt. 20g, Rx Only, Manufactured By Perr...	Failed Stability Specifications	Class II	Perrigo New York
May 7, 2018	RPC Children's Non-Aspirin (Acetaminophen 160 mg) Elixir, packaged in 4 FL. O...	CGMP Deviations: Products are being recalled due to an out of specification total aerobic microbi...	Class II	RIJ Pharmaceutical LLC
May 7, 2018	Gericare Liquid Pain Relief Acetaminophen Cherry Flavor 160mg/5mL, packaged i...	CGMP Deviations: Products are being recalled due to an out of specification total aerobic microbi...	Class II	RIJ Pharmaceutical LLC
May 7, 2018	RPC Senna Syrup (Sennosides 8.8mg), packaged in 8 fl oz (237 mL) bottles, RIJ...	CGMP Deviations: Products are being recalled due to an out of specification total aerobic microbi...	Class II	RIJ Pharmaceutical LLC
May 7, 2018	Gericare Iron Supplement Elixir Ferrous Sulfate 220 mg, packaged in 16 fl oz....	CGMP Deviations: Products are being recalled due to an out of specification total aerobic microbi...	Class II	RIJ Pharmaceutical LLC
May 7, 2018	RPC APAP Elixir (Acetaminophen 160mg), Packaged in 16 FL. OZ. (473 mL) bottle...	CGMP Deviations: Products are being recalled due to an out of specification total aerobic microbi...	Class II	RIJ Pharmaceutical LLC
May 7, 2018	Preferred Plus Pharmacy Antacid (Aluminum Hydroxide 200mg, Magnesium Hydroxid...	CGMP Deviations: Products are being recalled due to an out of specification total aerobic microbi...	Class II	RIJ Pharmaceutical LLC
May 7, 2018	GeriCare Senna Syrup (Sennosides 8.8 mg), 8 fl oz (237 mL) bottles, Dist, by ...	CGMP Deviations: Products are being recalled due to an out of specification total aerobic microbi...	Class II	RIJ Pharmaceutical LLC
May 7, 2018	Ritussin DM Dextromethorphan Hydrobormide (Dextromethorphan HBr, USP 10 mg, G...	CGMP Deviations: Products are being recalled due to an out of specification total aerobic microbi...	Class II	RIJ Pharmaceutical LLC
May 7, 2018	SDA Senna Syrup (Sennosides 8.8mg), packaged in 8 FL. OZ. (236 mL) bottles, D...	CGMP Deviations: Products are being recalled due to an out of specification total aerobic microbi...	Class II	RIJ Pharmaceutical LLC
May 7, 2018	Gericare Diocto Liquid (Docusate Sodium 50mg), 50 mg/5 mL, packaged in 16 FL ...	CGMP Deviations: Products are being recalled due to an out of specification total aerobic microbi...	Class II	RIJ Pharmaceutical LLC
May 4, 2018	T Shampoo For Hair and Body, Solution Coal Tar 3% (0.6% coal tar), 300 ml/10....	Subpotent	Class III	Milbar Laboratories, Inc.
May 4, 2018	MD Complete Clarifying Cleanser (Salicylic Acid 2.0%), 3 fl oz, (88.7mL), MD ...	GMP Deviations	Class II	Milbar Laboratories, Inc.
May 4, 2018	Minivelle (estradiol transdermal system) 0.1 mg/day, 1 System per pouch (NDC ...	Defective Delivery System: no longer meets the specification for shear, an attribute related to t...	Class II	Noven Pharmaceuticals, Inc.
May 4, 2018	Minivelle (estradiol transdermal system) 0.0375 mg/day, 1 System per pouch (N...	Defective Delivery System: no longer meets the specification for shear, an attribute related to t...	Class II	Noven Pharmaceuticals, Inc.
May 4, 2018	Naturmetic SPF 50 Sunscreen (Octinoxate 7.5%, Zinc Oxide 10.5%), 2.0 fl oz/60...	GMP Deviations	Class II	Milbar Laboratories, Inc.
May 4, 2018	Zoma Shampoo, Zinc Pyrithione 1.92%, 300 ml/10.01 fl. oz. bottles, Dermatolog...	Subpotent	Class III	Milbar Laboratories, Inc.
May 4, 2018	B Prox 10 Anti-blemish Wash, (Benzoyl peroxide 10%), 200 mL bottles, Dermatol...	Microbial Contamination of Non-sterile Product	Class II	Milbar Laboratories, Inc.
May 4, 2018	Solar Defense Sheer Sunscreen Broad Spectrum SPF50 (Octinoxate 7.5%, Zinc Oxi...	GMP Deviations	Class II	Milbar Laboratories, 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.