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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DateProductReasonClassFirm
Aug 3, 2018 Rexall, Sinus Nasal Pump Mist, (Oxymetazoline Hydrochloride 0.05%), 1 FL OZ (... CGMP Deviations: products manufactured under conditions that could impact its product quality. Class II Product Quest Manufacturing LLC
Aug 3, 2018 Thayers Natural Remedies, Saline Nasal Mist, Allergy & Sinus Relief, Slippery... CGMP Deviations: products manufactured under conditions that could impact its product quality. Class II Product Quest Manufacturing LLC
Aug 3, 2018 FREEZE IT (camphor 0.2% and menthol 3.5%) spray, 118.29 mL (4 fl. oz.) can, D... Superpotent Drug: high out of specification assay results for the camphor ingredient. Class II Product Quest Manufacturing LLC
Aug 3, 2018 Discount Drug Mart, Food Fair, Saline Nasal Spray (sodium chloride) 0.65%, pa... CGMP Deviations: products manufactured under conditions that could impact its product quality. Class II Product Quest Manufacturing LLC
Aug 3, 2018 Walgreens, Nasal Spray (Oxymetazoline HCl 0.05%) Nasal Decongestant, Maximum ... CGMP Deviations: products manufactured under conditions that could impact its product quality. Class II Product Quest Manufacturing LLC
Aug 3, 2018 Walgreens, NO DRIP, Anefrin Nasal Spray (Oxymetazoline HCl 0.05%), Nasal Deco... CGMP Deviations: products manufactured under conditions that could impact its product quality. Class II Product Quest Manufacturing LLC
Aug 3, 2018 DERMATONE (titanium oxide 6% and zinc oxide 4.7%) No-Touch Sunscreen Stick, S... Microbial Contamination of Non-Sterile Products: sample tested positive for Staphylococcus aureus. Class II Product Quest Manufacturing LLC
Aug 3, 2018 Rite Aid Pharmacy, First Aid Antibiotic Ointment, (neomycin sulfate 3.5 mg, p... Subpotent Drug: low out of specification assay results for the bacitracin zinc ingredient. Class II Product Quest Manufacturing LLC
Aug 3, 2018 dr. brandt, BB cream with signature FLEXITONE, SPF 30, 1 oz./30 g tube, Distr... Failed Stability Specifications: separation of product and failure for actives. Class II Product Quest Manufacturing LLC
Aug 3, 2018 Premier Value, Nasal Decongestant, Nasal Spray (oxymetazoline HCl 0.05%), Reg... CGMP Deviations: products manufactured under conditions that could impact its product quality. Class II Product Quest Manufacturing LLC
Aug 3, 2018 HuMist Saline Nasal Mist 1.5 FL OZ (45 mL) bottle, Distributed by: Scherer La... CGMP Deviations: products manufactured under conditions that could impact its product quality. Class II Product Quest Manufacturing LLC
Aug 3, 2018 DG health, No Drip, Nasal Pump Mist (oxymetazoline hydrochloride), 0.05%, 1 F... CGMP Deviations: products manufactured under conditions that could impact its product quality. Class II Product Quest Manufacturing LLC
Aug 3, 2018 CeraVe Healing Lip Balm/SPF 30 (avobenzone 3%, dimethicone 1%, homosalate 10%... Microbial Contamination of Non-Sterile Products: Failed microbiological testing for Staphalococcu... Class II Product Quest Manufacturing LLC
Aug 3, 2018 CVS Health, Saline Nasal Gel with Soothing Aloe, packaged as a) Baby Net Wt. ... CGMP Deviations: products manufactured under conditions that could impact its product quality. Class II Product Quest Manufacturing LLC
Aug 3, 2018 Acne Treatment Pads (2% salicylic acid), packaged in a 50-count jar, OTC, Dis... Subpotent drug: The product active ingredient level not matching the exact levels indicated on th... Class III Huijing (Shanghai) Bio-tech Co., Ltd.
Aug 3, 2018 OCEAN Saline Nasal Spray, packaged in a) 3.5 Fl. Oz. (104 mL) bottle UPC 3 01... CGMP Deviations: products manufactured under conditions that could impact its product quality. Class II Product Quest Manufacturing LLC
Aug 3, 2018 Premier Value, Fast Relief, Muscle Rub, (menthol 10% and methyl salicylate 15... Superpotent Drug: high out of specification assay results for the menthol ingredient. Class II Product Quest Manufacturing LLC
Aug 3, 2018 Rhinall Nasal Decongestant Nasal Spray (phenylephrine HCl), 0.25%, 1 1/3 Fl O... CGMP Deviations: products manufactured under conditions that could impact its product quality. Class II Product Quest Manufacturing LLC
Aug 3, 2018 CVS Health, Saline Nasal Spray, Nasal Moisturizing Spray, Contains: Sodium Ch... CGMP Deviations: products manufactured under conditions that could impact its product quality. Class II Product Quest Manufacturing LLC
Aug 3, 2018 Meijer, Sterile Saline Nasal Mist (0.9% Sodium Chloride Solution), 4.25 OZ (1... CGMP Deviations: products manufactured under conditions that could impact its product quality. Class II Product Quest Manufacturing LLC
Aug 3, 2018 Rexall, Extra Moisturizing No Drip Nasal Spray (Oxymetazoline Hydrochloride 0... CGMP Deviations: products manufactured under conditions that could impact its product quality. Class II Product Quest Manufacturing LLC
Aug 3, 2018 FAMILY wellness, Sterile Saline, Nasal Mist, Saline Nasal Relief (0.9% Sodium... CGMP Deviations: products manufactured under conditions that could impact its product quality. Class II Product Quest Manufacturing LLC
Aug 3, 2018 CVS Health, Sterile Saline Nasal Mist (sodium chloride) Allergy & Sinus Relie... CGMP Deviations: products manufactured under conditions that could impact its product quality. Class II Product Quest Manufacturing LLC
Aug 3, 2018 Walgreens, NO DRIP Severe Anefrin Nasal Spray (Oxymetazoline HCl 0.05%) Nasal... CGMP Deviations: products manufactured under conditions that could impact its product quality. Class II Product Quest Manufacturing LLC
Aug 3, 2018 meijer, Saline Nasal Spray, Nasal Moisturizing Spray, packaged as a) 1.5 FL O... CGMP Deviations: products manufactured under conditions that could impact its product quality. Class II Product Quest Manufacturing LLC
Aug 3, 2018 Harmon Face Values, Saline Nasal Spray (sodium chloride), 0.65%, packaged as ... CGMP Deviations: products manufactured under conditions that could impact its product quality. Class II Product Quest Manufacturing LLC
Aug 3, 2018 QC Quality Choice, Saline Nasal Relief, Moisturizing Nasal Spray, Sodium Chlo... CGMP Deviations: products manufactured under conditions that could impact its product quality. Class II Product Quest Manufacturing LLC
Aug 3, 2018 Mushatt's No. 9, PsoriWash Medicated Wash, Salicylic Acid 1.8%, 8 oz. (226 g)... Microbial Contamination of Non-Sterile Products and Subpotent Drug: failure for microbiological g... Class II Product Quest Manufacturing LLC
Aug 3, 2018 Sinus Relief (oxymetazoline HCl) Nasal decongestant, 0.05%, 0.5 FL OZ (15 mL)... Microbial Contamination of Non-Sterile Products: Failed microbiological testing for Pseudomonas a... Class I Product Quest Manufacturing LLC
Aug 3, 2018 Cicatricure, Scar Cream + Sunscreen SPF 30 (avobenzone 3%, octocrylene 10%, o... Subpotent Drug: low out of specification assay results for the octocrylene and avobenzone ingredi... Class III Product Quest Manufacturing LLC
Aug 3, 2018 Levothyroxine and Liothyronine (Thyroid Tablets, USP), 1 & 1/2 grain (90 mg),... Failed Content Uniformity Specifications: Product was manufactured using an adulterated active ph... Class I Westminster Pharmaceuticals LLC
Aug 3, 2018 Family Dollar Saline Nasal Spray 4.25 oz. can, 24 pk, SKU 0900562. CGMP Deviations: products manufactured under conditions that could impact its product quality. Class II Product Quest Manufacturing LLC
Aug 3, 2018 Levothyroxine and Liothyronine (Thyroid Tablets, USP), 2 grain (120 mg), 100-... Failed Content Uniformity Specifications: Product was manufactured using an adulterated active ph... Class I Westminster Pharmaceuticals LLC
Aug 3, 2018 CVS Health, Sterile Saline Nasal Mist (sodium chloride) Saline Nasal Moisturi... CGMP Deviations: products manufactured under conditions that could impact its product quality. Class II Product Quest Manufacturing LLC
Aug 3, 2018 TopCare, Saline Nasal Gel with Soothing Aloe, 0.5 OZ (14 g) tube, Distributed... CGMP Deviations: products manufactured under conditions that could impact its product quality. Class II Product Quest Manufacturing LLC
Aug 3, 2018 Finafta Baby, Oral Gel (benzocaine 7.5%), 7.1 Grams (0.25 Oz.) tube, Distribu... CGMP Deviations: products manufactured under conditions that could impact its product quality. Class II Product Quest Manufacturing LLC
Aug 3, 2018 Rexall, Extra Moisturizing No Drip Nasal Spray (Oxymetazoline Hydrochloride 0... CGMP Deviations: products manufactured under conditions that could impact its product quality. Class II Product Quest Manufacturing LLC
Aug 3, 2018 Well at Walgreens, Scar Cream with SPF 30, (Avobenzone 3%, Octocrylene 10%, O... Subpotent Drug: low out of specification assay results for the octocrylene and avobenzone ingredi... Class III Product Quest Manufacturing LLC
Aug 3, 2018 Best Choice, 12 Hour Extra Moisturizing, Nasal Spray (Oxymetazoline Hydrochlo... CGMP Deviations: products manufactured under conditions that could impact its product quality. Class II Product Quest Manufacturing LLC
Aug 3, 2018 QC Quality Choice, Saline Nasal Gel with Soothing Aloe, 0.5 OZ (14.1 g) tube,... CGMP Deviations: products manufactured under conditions that could impact its product quality. Class II Product Quest Manufacturing LLC
Aug 3, 2018 Premier Value, Saline Nasal Spray, Sodium Chloride 0.65%, packaged as a) 3 FL... CGMP Deviations: products manufactured under conditions that could impact its product quality. Class II Product Quest Manufacturing LLC
Aug 3, 2018 Thayers Natural Remedies, Saline Nasal Spray, Allergy & Sinus Relief, Slipper... CGMP Deviations: products manufactured under conditions that could impact its product quality. Class II Product Quest Manufacturing LLC
Aug 3, 2018 Levothyroxine and Liothyronine (Thyroid Tablets, USP), 1 grain (60 mg), 100-c... Failed Content Uniformity Specifications: Product was manufactured using an adulterated active ph... Class I Westminster Pharmaceuticals LLC
Aug 2, 2018 Atorvastatin Calcium tablets, 40 mg, 500-count bottle, Rx only, Mfd By: Dr. R... Failed Impurities/Degradation Specifications - OOS was observed for ATV Cyclo FP Impurity and Tot... Class III Dr. Reddy's Laboratories, Inc.
Aug 2, 2018 Human Chorionic Gonadotropin 11000 IU Vial Lyophilized 1109 East Hallandale B... Lack of assurance of sterility. Class II Pharmcore Inc.
Aug 2, 2018 Human Chorionic Gonadotropin 2500 IU Vial Lyophilized 1109 East Hallandale Be... Lack of assurance of sterility. Class II Pharmcore Inc.
Aug 2, 2018 Human Chorionic Gonadotropin 4000 IU Vial Lyophilized 1109 East Hallandale Be... Lack of assurance of sterility. Class II Pharmcore Inc.
Aug 2, 2018 Ipamorelin 9 mg vial Lyophilized 1109 East Hallandale Beach Blvd. Hallandale ... Lack of assurance of sterility. Class II Pharmcore Inc.
Aug 2, 2018 Human Chorionic Gonadotropin 5000 IU Vial Lyophilized 1109 East Hallandale Be... Lack of assurance of sterility. Class II Pharmcore Inc.
Aug 2, 2018 Methylcobalamin 10 mg vial Lyophilized 1109 East Hallandale Beach Blvd. Halla... Lack of assurance of sterility. Class II Pharmcore 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.