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Browse Drug Recalls

1,788 FDA drug safety recalls.

FDA Drug Recall Enforcement Database

Browse 1,788 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 1,788 FDA drug recalls in 2019.

Clear
DateProductReasonClassFirm
Aug 9, 2019 PRE-TAT (lidocaine) 3 in 1 Pre Tattoo Prep With Lidocaine Cream, 4%, packaged... Microbial Contamination of Non-Sterile Products: products were found to be contaminated and above... Class II Ridge Properties, LLC
Aug 9, 2019 Superior Pain & Itch Relief (lidocaine) Liquid Gel, 4%, packaged in a) 1 Oz (... Superpotent Drug: products were found to be contaminated and above specification for lidocaine as... Class II Ridge Properties, LLC
Aug 9, 2019 PRE-TAT (lidocaine) 3 in 1 Pre Tattoo Prep With Lidocaine Liquid Gel, 4%, pac... Microbial Contamination of Non-Sterile Products: products were found to be contaminated and above... Class II Ridge Properties, LLC
Aug 8, 2019 Vivitrol (naltrexone for extended-release injectable suspension) 380 mg/vial.... Labeling: Not Elsewhere Classified. Drug product kit recalled due to 1 inch needles being placed... Class II Alkermes Inc
Aug 7, 2019 Clotrimazole and Betamethasone Dipropionate Cream USP, 1%/0.05%, 15 gram tube... Temperature Abuse: Complaints received of liquidy texture. Class III Glenmark Pharmaceuticals Inc., USA
Aug 6, 2019 Eptifibatide Injection, 75 mg/100 mL (0.75 mg/mL), 100 mL Single-use Vial, Fo... Short Fill: fill volume was out of specification at 94 mL (specification: no less than 100 mL) an... Class III Akorn, Inc.
Aug 6, 2019 Eptifibatide Injection, a) 20 mg/10 mL (2 mg/mL),10 mL Single Use Vial, NDC 1... Failed Impurities/Degradation Specifications: Out of Specification (OOS) for known impurity, D-as... Class III Akorn, Inc.
Aug 6, 2019 Eptifibatide Injection, 75 mg/100 mL (0.75 mg/mL), 100 mL Single-use Vial, Fo... Failed Impurities/Degradation Specifications: Out of Specification (OOS) for known impurity, D-as... Class III Akorn, Inc.
Aug 5, 2019 Lisinopril/HCTZ 20mg/12.5mg Tablet, QTY: 30 tablets per blister card, MFG: Lu... Presence of Foreign Tablets/Capsules: This is a spin-off recall of D-1581-2019 due to a product c... Class II RemedyRepack Inc.
Jul 29, 2019 Bexarotene Capsules, 75 mg, 100 capsules per bottle, Rx Only, Manufactured fo... Failed Dissolution Specifications Class II Upsher Smith Laboratories, Inc.
Jul 29, 2019 Simvastatin Tablets, USP 40 mg. Rx Only 1000 Count Bottles Manufactured by: A... Labeling; Incorrect or Missing Lot and/or Exp Date; some bottles labeled with lot number 05318054... Class III Aurobindo Pharma USA Inc.
Jul 26, 2019 Clear Eyes Maximum Redness and Itchy Eye Relief Sidekick Display; each displa... CGMP Deviations: concerns regarding the sufficiency of Quality Assurance controls over critical s... Class II Medtech Products, Inc.
Jul 26, 2019 Clear eyes MAXIMUM ITCHY EYE RELIEF (Glycerin 0.25%, Naphazoline hydrochlorid... CGMP Deviations: concerns regarding the sufficiency of Quality Assurance controls over critical s... Class II Medtech Products, Inc.
Jul 26, 2019 Clear Eyes Redness Relief Hand Pocket Pal Tray Display; each display (UPC 6 7... CGMP Deviations: concerns regarding the sufficiency of Quality Assurance controls over critical s... Class II Medtech Products, Inc.
Jul 26, 2019 Clear eyes MAXIMUM REDNESS RELIEF (Glycerin 0.5%, Naphazoline hydrochloride 0... CGMP Deviations: concerns regarding the sufficiency of Quality Assurance controls over critical s... Class II Medtech Products, Inc.
Jul 26, 2019 Clear eyes REDNESS RELIEF (Glycerin 0.25%, Naphazoline hydrochloride 0.012%) ... CGMP Deviations: concerns regarding the sufficiency of Quality Assurance controls over critical s... Class II Medtech Products, Inc.
Jul 26, 2019 Clear eyes REDNESS RELIEF (Glycerin 0.25%, Naphazoline hydrochloride 0.012%) ... CGMP Deviations: concerns regarding the sufficiency of Quality Assurance controls over critical s... Class II Medtech Products, Inc.
Jul 26, 2019 Clear Eyes Maximum Itchy Eye Relief Sidekick Floor Stand Display; each displa... CGMP Deviations: concerns regarding the sufficiency of Quality Assurance controls over critical s... Class II Medtech Products, Inc.
Jul 26, 2019 Clear Eyes Maximum Redness Relief Club Pack Display; each display contains 18... CGMP Deviations: concerns regarding the sufficiency of Quality Assurance controls over critical s... Class II Medtech Products, Inc.
Jul 26, 2019 Clear Eyes Redness Relief Club Pack Display; each display contains 18 3-Pack ... CGMP Deviations: concerns regarding the sufficiency of Quality Assurance controls over critical s... Class II Medtech Products, Inc.
Jul 26, 2019 Clear eyes REDNESS RELIEF (Glycerin 0.25%, Naphazoline hydrochloride 0.012%) ... CGMP Deviations: concerns regarding the sufficiency of Quality Assurance controls over critical s... Class II Medtech Products, Inc.
Jul 26, 2019 Clear Eyes Redness Relief Handy Pocket Pal Club Pak Display; each display (ca... CGMP Deviations: concerns regarding the sufficiency of Quality Assurance controls over critical s... Class II Medtech Products, Inc.
Jul 26, 2019 Clear Eyes Maximum Itchy Eye Relief Sidekick Floor Stand Display; each displa... CGMP Deviations: concerns regarding the sufficiency of Quality Assurance controls over critical s... Class II Medtech Products, Inc.
Jul 26, 2019 Clear Eyes Assorted Sidekick Floor Stand Display; each display contains 6 eac... CGMP Deviations: concerns regarding the sufficiency of Quality Assurance controls over critical s... Class II Medtech Products, Inc.
Jul 26, 2019 Clear Eyes Assorted IRC Display; each display contains 6 each of a) Clear eye... CGMP Deviations: concerns regarding the sufficiency of Quality Assurance controls over critical s... Class II Medtech Products, Inc.
Jul 24, 2019 C-EDETATE DISODIUM 1.5% OPHTH SOLUTION, 10 ML droptainer bottle, Rx only, Col... Lack of Assurance of Sterility: product sterility cannot be guaranteed. Class II Colonia Care Pharmacy
Jul 24, 2019 C-PAPAV/PHENTOL/PGE1 18MG/0.6MG/5.8MCG/ML, 5 mL vial, Rx only, Colonia Care P... Lack of Assurance of Sterility: product sterility cannot be guaranteed. Class II Colonia Care Pharmacy
Jul 24, 2019 C-PAPAV/PHENTOL/PGE1 30MG/2MG/5MCG/ML, 5 mL vial, Rx only, Colonia Care Pharm... Lack of Assurance of Sterility: product sterility cannot be guaranteed. Class II Colonia Care Pharmacy
Jul 24, 2019 C-PAPAV/PHENTOL/PGE1 30MG/1MG/30MCG/ML, 5 mL vial, Rx only, Colonia Care Phar... Lack of Assurance of Sterility: product sterility cannot be guaranteed. Class II Colonia Care Pharmacy
Jul 24, 2019 C-PHENOL/COTTONSEED OIL INJ 5%, 5 mL vial, Rx only, Colonia Care Pharmacy, 51... Lack of Assurance of Sterility: product sterility cannot be guaranteed. Class II Colonia Care Pharmacy
Jul 24, 2019 C-PAPAV/PHENTOL/PGE1 18MG/0.6MG/11.8MCG/ML, 10 mL vial, Rx only, Colonia Care... Lack of Assurance of Sterility: product sterility cannot be guaranteed. Class II Colonia Care Pharmacy
Jul 24, 2019 C-GENTAMICIN 30MG/ML INJ SOLUTION SDV, 3 mL vial, Rx only, Colonia Care Pharm... Lack of Assurance of Sterility: product sterility cannot be guaranteed. Class II Colonia Care Pharmacy
Jul 24, 2019 C-PAPAV/PHENTOL/PGE1 30MG/0.5MG/30MCG/ML, 5 mL vial, Rx only, Colonia Care Ph... Lack of Assurance of Sterility: product sterility cannot be guaranteed. Class II Colonia Care Pharmacy
Jul 24, 2019 C-HYDROXOCOBALAMIN 25 MG/ML INJECTION SOLUTION, 1 mL syringe, Rx only, Coloni... Lack of Assurance of Sterility: product sterility cannot be guaranteed. Class II Colonia Care Pharmacy
Jul 24, 2019 C-ATROPINE SULF OPHTH 0.01%, 5 mL droptainer bottles, Rx only, Colonia Care P... Lack of Assurance of Sterility: product sterility cannot be guaranteed. Class II Colonia Care Pharmacy
Jul 24, 2019 C-HYDROXOCOBALAMIN 5 MG/ML INJECTION SOLUTION, 1 mL syringe, Rx only, Colonia... Lack of Assurance of Sterility: product sterility cannot be guaranteed. Class II Colonia Care Pharmacy
Jul 24, 2019 C-PAPAV/PHENTOL/PGE1 30MG/1MG/50MCG/ML, 5 mL vial, Rx only, Colonia Care Phar... Lack of Assurance of Sterility: product sterility cannot be guaranteed. Class II Colonia Care Pharmacy
Jul 24, 2019 C-HYDROXYPROGESTERONE CAPRO 250MG/ML INJECTION, 5 mL vial, Rx only, Colonia C... Lack of Assurance of Sterility: product sterility cannot be guaranteed. Class II Colonia Care Pharmacy
Jul 24, 2019 C-PAPAV/PHENTOL/PGE1 30MG/1MG/20MCG/ML, 5 mL vial, Rx only, Colonia Care Phar... Lack of Assurance of Sterility: product sterility cannot be guaranteed. Class II Colonia Care Pharmacy
Jul 24, 2019 C-CALCIUM GLUCNATE 1% INJECTION SOLN, 10 mL vial, Rx only, Colonia Care Pharm... Lack of Assurance of Sterility: product sterility cannot be guaranteed. Class II Colonia Care Pharmacy
Jul 24, 2019 C-MB12/HB12 5MG/5MG/ML INJ SOLN, 0.9 mL in a 3 mL syringe, Rx only, Colonia C... Lack of Assurance of Sterility: product sterility cannot be guaranteed. Class II Colonia Care Pharmacy
Jul 24, 2019 C-PAPAV/PHENTOL/PGE1 10MG/1MG/10MCG/ML, packaged in a) 5 mL and b) 10 mL vial... Lack of Assurance of Sterility: product sterility cannot be guaranteed. Class II Colonia Care Pharmacy
Jul 24, 2019 C-CROMOLYN SOD 20 MG/2 ML INHALATION SOLUTION, 120 mL in 60 nebulizer vials, ... Lack of Assurance of Sterility: product sterility cannot be guaranteed. Class II Colonia Care Pharmacy
Jul 24, 2019 C-MB12 NAC 13MG/48MG/ML INJ SOLN, 0.29 mL in a 0.3 mL syringe, Rx only, Colon... Lack of Assurance of Sterility: product sterility cannot be guaranteed. Class II Colonia Care Pharmacy
Jul 24, 2019 C-DEXAMETHASONE 24MG/ML INJ SOLUTION, packaged in 1 mL single dose vials, Rx ... Lack of Assurance of Sterility: product sterility cannot be guaranteed. Class II Colonia Care Pharmacy
Jul 24, 2019 C-ACETYLCYSTEINE OPHTH 10% SOLN, packaged in a) 5 mL and b) 10 mL droptainer ... Lack of Assurance of Sterility: product sterility cannot be guaranteed. Class II Colonia Care Pharmacy
Jul 24, 2019 C-TACROLIMUS 0.03% OPHTHAL SUSPENSION, 5 mL droptainer bottle, Rx only, Colon... Lack of Assurance of Sterility: product sterility cannot be guaranteed. Class II Colonia Care Pharmacy
Jul 24, 2019 C-ATROPINE SULF OPHTH 0.02%, 5 mL droptainer bottles, Rx only, Colonia Care P... Lack of Assurance of Sterility: product sterility cannot be guaranteed. Class II Colonia Care Pharmacy
Jul 24, 2019 C-PAPAV/PHENTOL/PGE1 10MG/1MG/20MCG/ML, 5 mL vial, Rx only, Colonia Care Phar... Lack of Assurance of Sterility: product sterility cannot be guaranteed. Class II Colonia Care Pharmacy
Jul 24, 2019 C-INTERFERON ALFA2B 1MILU/ML OPHTHAL SOLUTION, 3 mL droptainer bottle, Rx onl... Lack of Assurance of Sterility: product sterility cannot be guaranteed. Class II Colonia Care Pharmacy

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.