Browse Drug Recalls

21 FDA drug safety recalls.

FDA Drug Recall Enforcement Database

Browse 21 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 21 FDA drug recalls.

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DateProductReasonClassFirm
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.
Mar 7, 2019 Little Remedies New Baby Essentials Kit. Each kit contains 1 each of the foll... Incorrect/undeclared excipients: Kit carton bear incorrect labeling for two of the five items con... Class II Medtech Products, Inc.
Jun 6, 2017 NasalCrom (cromolyn sodium) Nasal Spray, USP, 5.2 mg per spray, 200 metered s... CGMP Deviations: Possibility of the presence of microbial contamination in the water used to manu... Class II Bausch & Lomb, Inc.
May 21, 2015 SUCRETS Sore Throat & Cough Vapor Cherry lozenges, 18-count tin, Dist. By: In... Labeling: Label Mix-Up: An incorrect book label for Sucrets Sore Throat, Cough & Dry Mouth Honey ... Class II Medtech Products, Inc.
Apr 10, 2015 MONISTAT 1 SIMPLE CURE (Miconazole Nitrate Vaginal Insert) 1200 mg ovule, 1-D... Marketed without an approved NDA/ANDA: The distributed units of Monistat 1 Simple Cure include on... Class III Medtech Products, Inc.
Apr 25, 2014 PediaCare brand DAY & NIGHT Value Pack DAYTIME MULTI-SYMPTOM Cold (dextrometh... Presence of Precipitate; small amounts of diphenhydramine precipitated out of solution Class III Prestige Brands Holdings
Apr 25, 2014 PediaCare brand NIGHTTIME MULTI-SYMPTOM Cold, (diphenhydramine HCl 6.25 mg an... Presence of Precipitate; small amounts of diphenhydramine precipitated out of solution Class III Prestige Brands Holdings
Jun 20, 2012 Little Remedies For Tummys, Stimulant Laxative (sennosides) Drops, 1 FL OZ (3... Subpotent (Single Ingredient) Drug: This product is being recalled because of sub-potency of the ... Class II Medtech Products, 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.