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.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| 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.