Browse Drug Recalls
989 FDA drug safety recalls.
FDA Drug Recall Enforcement Database
Browse 989 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 989 FDA drug recalls in TN.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| Nov 5, 2024 | Hydralazine HCl Tablets, USP, 25mg, Rx only, 100 tablets per carton, Distribu... | Failed Impurities/Degradation Specifications; during routine stability testing for impurities. | Class III | The Harvard Drug Group LLC dba Major Pharmaceut... |
| Oct 18, 2024 | Sunitinib Malate Capsules, 25 mg, 28-count bottles, Rx Only, Manufactured for... | Labeling: Label Mix-Up | Class II | AvKARE |
| Oct 18, 2024 | Sunitinib Malate Capsules, 12.5 mg, 28-count bottles, Rx Only, Manufactured f... | Labeling: Label Mix-Up | Class II | AvKARE |
| Aug 5, 2024 | HAND-I-SAN, No-Rinse Hand Sanitizer (75% Isopropyl Alcohol), packaged in a) ... | CGMP Deviations: sterile water not used for production | Class II | Zeco LLC |
| Aug 5, 2024 | Rubbing Alcohol (70% Isopropyl Alcohol), First-Aid Antiseptic, packaged in a)... | CGMP Deviations: sterile water not used for production | Class II | Zeco LLC |
| Jun 18, 2024 | Venlafaxine Hydrochloride, extended-release capsules, USP, 37.5mg, 10 x 10 bl... | Failed dissolution specifications: out of specification result obtained during routine stability ... | Class II | The Harvard Drug Group LLC dba Major Pharmaceut... |
| May 28, 2024 | Petroleum Jelly, White Petrolatum USP, NET WT 13 OZ (368g), sold under the fo... | Labeling: Label Mix up; product labeled as pure white petroleum jelly actually contains petroleum... | Class II | Consumer Product Partners, LLC |
| Mar 28, 2024 | Atovaquone Oral Suspension USP, 750 mg per 5 mL sachets, 20 Units x 5 mL cart... | Microbial contamination of a non-sterile product: potential Bacillus cereus contamination. | Class I | AvKARE |
| Feb 9, 2024 | HydrALAZINE Hydrochloride Tablets, USP 10mg, packaged in 100-count (10x10 bli... | an out of specification result obtained during routine stability testing for Impurities. There i... | Class II | The Harvard Drug Group LLC dba Major Pharmaceut... |
| Oct 31, 2023 | Lubricating Tears Eye Drops (Dextran/Hypromellose), 0.1%/0.3%, packaged in 0.... | Non-Sterility: FDA found insanitary conditions and positive bacterial test results from environme... | Class I | The Harvard Drug Group LLC dba Major Pharmaceut... |
| Oct 31, 2023 | Polyvinyl Alcohol 1.4% Lubricating Eye Drops, packaged in 0.5 FL OZ (15mL) bo... | Non-Sterility: FDA found insanitary conditions and positive bacterial test results from environme... | Class I | The Harvard Drug Group LLC dba Major Pharmaceut... |
| Oct 23, 2023 | Phenytoin Oral Suspension, USP, 100 mg/4 mL, packaged in packaged in 4 mL uni... | Failed Content Uniformity Specifications | Class I | The Harvard Drug Group LLC dba Major Pharmaceut... |
| Sep 5, 2023 | Kroger Mint Burst ANTISEPTIC MOUTH RINSE ANTIGINGIVITIS/ANTIPLAQUE (Eucalypto... | Incorrect/Undeclared Excipients. | Class III | Vi-Jon, LLC |
| Aug 11, 2023 | Sodium Fluoride 1.1%, SODIUM FLUORIDE Prescription Dental Toothpaste, 5000 pp... | Cases of Sodium Fluoride 1.1% Prescription Dental Toothpaste may contain cartons labeled as Capsa... | Class II | AVKARE LLC |
| Aug 11, 2023 | Capsaicin Cream 0.025%, External Analgesic Cream, Penetrating Pain Relief, NE... | Product mix-up: Cartons labeled Capsaicin Cream 0.025% may contain tubes of Sodium Fluoride 1.1% ... | Class II | AVKARE LLC |
| Jul 10, 2023 | Big Machine Distillery Hand Sanitizer Non-Sterile Solution Alcohol Antiseptic... | CGMP Deviation: impurities exceed allowable limits. | Class II | Tenn South Distillery LLC dba Big Machine Disti... |
| Jun 16, 2023 | Tramadol Hydrochloride Tablets, USP 50 mg, Unit Dose 100-Count Tablets Rx onl... | Packaging defect: blister packaging inadequately sealed. | Class II | The Harvard Drug Group |
| Jun 13, 2023 | Tranexamic Acid USP Tablets, 650 mg, 30 tablets (3X10) Unit Dose, Rx Only, Ma... | Failed Impurities/Degradation Specifications: Out of specification results obtained for conductiv... | Class III | AVKARE LLC |
| May 31, 2023 | ZIPRASIDONE HYDROCHLORIDE CAPSULES 20 mg, Unit Dose Carton 40 Capsules, Rx on... | Labeling: Label Mix-up: Unit Dose cartons labeled as Ziprasidone Hydrochloride Capsules, 20 mg we... | Class I | The Harvard Drug Group LLC dba Major Pharmaceut... |
| Apr 24, 2023 | Gabapentin Tablets, USP 600 mg, packaged in Cartons of 100 tablets (10 tablet... | Product mixup: one foreign tablet found in product. | Class III | The Harvard Drug Group |
| Mar 16, 2023 | Epinephrine Professional EMS, Epinephrine Convenience Kit, Epinephrine 1 mg/m... | Labeling; Incorrect NDC number on outer carton of product. | Class III | Focus Health Group Inc |
| Feb 23, 2023 | Carbidopa and Levodopa Tablets, USP 25 mg/100 mg, 10x10 Unit Dose carton, Rx ... | Packaging defect: observed packaging defect, blister packaging inadequately sealed. | Class II | The Harvard Drug Group |
| Dec 22, 2022 | Glycopyrrolate Tablets, USP, 1 mg, 50 Tablets (5x10) Unit Dose carton, Rx Onl... | Failed impurities/degradation specifications: Out of specification for unknown impurities. | Class II | AVKARE LLC |
| Aug 8, 2022 | Maxim Instant Foam Hand Sanitizer (benzalkonium chloride 0.1%) packaged in a)... | CGMP Deviations: Product manufactured using expired active ingredient, Benzalkonium chloride. | Class II | Midlab Incorporated |
| Aug 8, 2022 | Corsair Personal Care 99X Instant Foam Hand Sanitizer (benzalkonium chloride ... | CGMP Deviations: Product manufactured using expired active ingredient, Benzalkonium chloride. | Class II | Midlab Incorporated |
| Jul 20, 2022 | Lamotrigine Tablets, USP 100 mg, 1000-count bottles, Rx Only, Manufactured fo... | Labeling: Label Error on Declared Strength | Class III | AVKARE Inc. |
| Jul 15, 2022 | equate Magnesium Citrate, SALINE LAXATIVE, (1.745g/fl oz) 10 FL OZ (296mL), G... | Microbial contamination of non-sterile products. | Class I | Vi-Jon, LLC |
| Jul 15, 2022 | EQUALINE magnesium citrate saline laxative, oral solution, (1.745 g/fl oz), D... | Microbial contamination of non-sterile products. | Class I | Vi-Jon, LLC |
| Jul 15, 2022 | Topcare health, Magnesium Citrate, SALINE LAXATIVE, Oral Solution, (1.745 g/f... | Microbial contamination of non-sterile products. | Class I | Vi-Jon, LLC |
| Jul 15, 2022 | Walgreens, Dye-Free, Magnesium Citrate, SALINE LAXATIVE, Oral Solution, (1.74... | Microbial contamination of non-sterile products. | Class I | Vi-Jon, LLC |
| Jul 15, 2022 | Magnesium Citrate SALINE LAXATIVE, Oral Solution, 1.745 g, Cherry Flavor, 10 ... | CGMP Deviations | Class II | Vi-Jon, LLC |
| Jul 15, 2022 | CVS Health, Magnesium Citrate SALINE LAXATIVE, Oral Solution, (1.745 g/fl oz)... | Microbial contamination of non-sterile products. | Class I | Vi-Jon, LLC |
| Jul 15, 2022 | Rexall, Magnesium Citrate Saline Laxative, Oral Solution, (1.745 g/fl oz), Le... | Microbial contamination of non-sterile products. | Class I | Vi-Jon, LLC |
| Jul 15, 2022 | SWAN, Citroma MAGNESIUM CITRATE, Saline Laxative, Oral Solution, (1.745 g/fl ... | Microbial contamination of non-sterile products. | Class I | Vi-Jon, LLC |
| Jul 15, 2022 | meijer, magnesium citrate Saline Laxative, Oral Solution, (1.745 g/fl oz), Le... | Microbial contamination of non-sterile products. | Class I | Vi-Jon, LLC |
| Jul 15, 2022 | Magnesium Citrate SALINE LAXATIVE, Oral Solution, 1.745 g, Grape Flavor, 10 F... | CGMP Deviations; | Class II | Vi-Jon, LLC |
| Jul 15, 2022 | Magnesium Citrate SALINE LAXATIVE, Oral Solution, 1.745 g, Lemon Flavor, 10 F... | CGMP Deviations | Class II | Vi-Jon, LLC |
| Jul 15, 2022 | P, magnesium citrate SALINE LAXATIVE, Oral Solution, (1.745 g/fl oz), Lemon F... | Microbial contamination of non-sterile products. | Class I | Vi-Jon, LLC |
| Jul 15, 2022 | Kroger, Magnesium Citrate SALINE LAXATIVE, Oral Solution, 1.745 g, Lemon Flav... | Microbial contamination of non-sterile products. | Class I | Vi-Jon, LLC |
| Jul 15, 2022 | Walgreens, Dye-Free, Magnesium Citrate, SALINE LAXATIVE, Oral Solution, (1.74... | Microbial contamination of non-sterile products. | Class I | Vi-Jon, LLC |
| Jun 28, 2022 | Hydrogen Peroxide Topical Solution USP, 3%, 16 FL OZ (1 PT) 473 mL bottle, pa... | Cross Contamination With Other Products: Product is cross contaminated with low levels of isoprop... | Class II | Vi-Jon, LLC |
| Jun 24, 2022 | Hydrogen Peroxide Topical Solution, USP, 32 fl. oz. (1 QT) 946 mL, Distribute... | Labeling: Label Mix-Up-The primary label on the front of the bottles have Hydrogen Peroxide affix... | Class II | Vi-Jon, LLC |
| Jun 15, 2022 | 70% ISOPROPYL ALCOHOL First aid antiseptic, 4 FL OZ (118 mL) bottle, Made in ... | Defective Container: Product may leak when squeezed or when not in an upright position determined... | Class II | Vi-Jon, LLC |
| Jun 13, 2022 | CVS Health Magnesium Citrate SALINE LAXATIVE, Oral Solution, 1.745 g, Lemon F... | Microbial Contamination of a Non-Sterile Products: Testing of product onfirmed the presence of G... | Class I | Vi-Jon, LLC |
| May 5, 2022 | Equate Tartar Control Plus (Eucalyptol 0.092%, Menthol 0.042%, Methyl salicyl... | Superpotent Drug: product complaint for milky blue appearance and consistency, further investigat... | Class II | Vi-Jon, LLC |
| Apr 21, 2022 | Betamethasone Dipropionate Ointment USP, 0.05%* (Augmented) (Potency expresse... | CGMP Deviations: all products within expiry are being recalled because the manufacturing firm, Te... | Class II | McKesson Corporation dba McKesson Drug Company |
| Apr 21, 2022 | Lidocaine Prilocaine Cream USP, 2.5%/2.5% Net Wt. 30 gram tube, Rx Only, Dist... | CGMP Deviations: all products within expiry are being recalled because the manufacturing firm, Te... | Class II | McKesson Corporation dba McKesson Drug Company |
| Apr 21, 2022 | Halobetasol Propionate Ointment 0.05% Net Wt., 50 gram tube, Rx Only, Manufac... | CGMP Deviations: all products within expiry are being recalled because the manufacturing firm, Te... | Class II | McKesson Corporation dba McKesson Drug Company |
| Apr 21, 2022 | Erythromycin Topical Gel USP, 2%, Net Wt 60 g tube, Rx only, Manufactured by:... | CGMP Deviations: all products within expiry are being recalled because the manufacturing firm, Te... | Class II | McKesson Corporation dba McKesson Drug Company |
| Apr 21, 2022 | Lidocaine Hydrochloride Topical Solution USP 4% (40 mg/mL), 50 mL bottle, Rx ... | CGMP Deviations: all products within expiry are being recalled because the manufacturing firm, Te... | Class II | McKesson Corporation dba McKesson Drug Company |
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.