Browse Drug Recalls
14,380 FDA drug safety recalls.
FDA Drug Recall Enforcement Database
Browse 14,380 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 14,380 FDA drug recalls, Class II.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| Sep 9, 2021 | Metoprolol Tartrate Tablets USP 100 mg, 1000-count bottles, Rx only, Distribu... | Presence of Foreign Substance: Product complaints received for the presence of metal wire in one ... | Class II | Aurobindo Pharma USA Inc. |
| Sep 9, 2021 | Kroger 70% Isopropyl Alcohol First Aid Antiseptic 32 FL OZ (1 QT) 946 mL 5 Di... | Labeling: Label Mix-Up.The recall has been initiated after receiving one complaint about incorrec... | Class II | Vi-Jon, Inc. |
| Sep 8, 2021 | TheraTears Extra (sodium carboxymethylcellulose) 0.25% Lubricant Eye Drops, 3... | Lack of Assurance of Sterility | Class II | Akorn, Inc. |
| Sep 3, 2021 | Promethazine Syrup Plain, 6.25 mg/5 mL (Promethazine Hydrochloride Syrup, USP... | CGMP Deviations: Potential concern with products manufactured using liquid sugar batches contamin... | Class II | Morton Grove Pharmaceuticals, Inc. |
| Sep 3, 2021 | Valproic Acid Oral Solution USP, (250 mg/5 mL), 1 Pint (473 mL), Rx Only, M... | CGMP Deviations: Potential concern with products manufactured using liquid sugar batches contamin... | Class II | Morton Grove Pharmaceuticals, Inc. |
| Sep 3, 2021 | Promethazine With Codeine Oral Solution, (Promethazine Hydrochloride 6.25 mg/... | CGMP Deviations: Potential concern with products manufactured using liquid sugar batches contamin... | Class II | Morton Grove Pharmaceuticals, Inc. |
| Sep 2, 2021 | Meclizine HCl Tablets, 25 mg, packaged in 100-count HDPE bottle, Distributed ... | Labeling: Incorrect Instructions | Class II | RISING PHARMACEUTICALS |
| Aug 27, 2021 | Arformoterol Tartrate Inhalation Solution 15 mcg*/2 mL For Oral Inhalation On... | Lack of Assurance of Sterility | Class II | Glenmark Pharmaceuticals Inc., USA |
| Aug 27, 2021 | Chlorzoxazone Tablets USP 375 mg 100 Tablets Rx Only NDC 68462-724-01 Manufa... | CGMP Deviations | Class II | Glenmark Pharmaceuticals Inc., USA |
| Aug 27, 2021 | Fulvestrant Injection 250 mg/5 mL (50 mg/mL) For Intramuscular Use Only Conta... | Lack of Assurance of Sterility | Class II | Glenmark Pharmaceuticals Inc., USA |
| Aug 27, 2021 | Zonisamide Capsules USP 100 mg Rx Only Manufactured by: Glenmark Pharmaceutic... | CGMP Deviations | Class II | Glenmark Pharmaceuticals Inc., USA |
| Aug 27, 2021 | Naproxen Sodium Tablets, USP 275 mg 100 Tablets Rx Only NDC 68462-178-01 Manu... | CGMP Deviations | Class II | Glenmark Pharmaceuticals Inc., USA |
| Aug 27, 2021 | Naproxen Sodium Tablets, USP 550 mg Rx Only Manufactured by: Glenmark Pharmac... | CGMP Deviations | Class II | Glenmark Pharmaceuticals Inc., USA |
| Aug 27, 2021 | Chlorzoxazone Tablets USP 750 mg 100 Tablets Rx Only NDC 68462-725-01 Manufa... | CGMP Deviations | Class II | Glenmark Pharmaceuticals Inc., USA |
| Aug 27, 2021 | Zonisamide Capsules USP 50 mg 100 Capsules Rx Only NDC 68462-129-01 Manufactu... | CGMP Deviations | Class II | Glenmark Pharmaceuticals Inc., USA |
| Aug 26, 2021 | Betadine Solution Swabstick Povidone-Iodine Solution USP, 10 % single and th... | Subpotent Drug | Class II | AVRIO HEALTH L.P |
| Aug 24, 2021 | Rompe Pecho Max Multi-Symptoms Maximum Strength, 8 Fl. Oz. (237 mL) bottles, ... | Microbial Contamination of Non-Sterile Products | Class II | Efficient Laboratories, Inc. |
| Aug 24, 2021 | Rompe Pecho Ex Expectorant, packaged in a) 4 Fl. Oz. (118 mL) bottles NDC 58... | Microbial Contamination of Non-Sterile Products | Class II | Efficient Laboratories, Inc. |
| Aug 24, 2021 | Rompe Pecho CF Cold & Flu Advanced Formula, 6 Fl. oz. (178 mL) bottles, Dist... | Microbial Contamination of Non-Sterile Products | Class II | Efficient Laboratories, Inc. |
| Aug 24, 2021 | Rompe Pecho DM, 6 Fl Oz (178 mL) bottles, Distributed by: Efficient Laborator... | Microbial Contamination of Non-Sterile Products | Class II | Efficient Laboratories, Inc. |
| Aug 23, 2021 | Lyrica CR (pregabalin) extended release tablets, 330 mg, 30-count bottles, Rx... | Failed Dissolution Specifications | Class II | Viatris |
| Aug 23, 2021 | Betamethasone Dipropionate Lotion USP, 0.05% (Augmented), 30 mL bottle, (29 g... | Failed Stability Specifications: lot did not meet specification for the Active Pharmaceutical Ing... | Class II | Teligent Pharma, Inc. |
| Aug 20, 2021 | Quebracho 4C, 5C, 6C, 12C, 30C, Fever*, Sucrose/Lactose Pills, 5C Packaged as... | Out-of-specification test results obtained for identification testing based on HPTLC analysis. | Class II | Washington Homeopathic Products, Inc. |
| Aug 20, 2021 | Cinnamomum 6X, Flatulence* Sucrose/Lactose Pills, Packaged as a) 4 Dram, b) ... | Out-of-specification test results obtained for identification testing based on HPTLC analysis. | Class II | Washington Homeopathic Products, Inc. |
| Aug 20, 2021 | Z-107 Formula Soft Tissue Healing. Contents 1000ml. For Manufacturing Use Onl... | Out-of-specification test results obtained for identification testing based on HPTLC analysis. | Class II | Washington Homeopathic Products, Inc. |
| Aug 20, 2021 | Haloderm Homeopathic Blend, For Manufacturing Use Only, 1,000 ml 20% Alcohol,... | Out-of-specification test results obtained for identification testing based on HPTLC analysis. | Class II | Washington Homeopathic Products, Inc. |
| Aug 20, 2021 | Z-103 GU DETOXING. Contents 1000ml 20% Alcohol. WHP Homeopathic Medicine. For... | Out-of-specification test results obtained for identification testing based on HPTLC analysis. | Class II | Washington Homeopathic Products, Inc. |
| Aug 20, 2021 | Cistus Canadensis 6X, 10X, 15X, 30X, Coldness* Sucrose/Lactose Pills, 6X Pack... | Out-of-specification test results obtained for identification testing based on HPTLC analysis. | Class II | Washington Homeopathic Products, Inc. |
| Aug 20, 2021 | Occular Allergy Blend 87% Alcohol; In Equal Parts of Apis Mellifica 7x Allium... | Out-of-specification test results obtained for identification testing based on HPTLC analysis. | Class II | Washington Homeopathic Products, Inc. |
| Aug 20, 2021 | ZTE-1020 Formula. Contents 1000ml. WHP Homeopathic Medicine, For Manufacturin... | Out-of-specification test results obtained for identification testing based on HPTLC analysis. | Class II | Washington Homeopathic Products, Inc. |
| Aug 20, 2021 | Quebracho 4C, Fever*, 20% Alcohol, Packaged as 100ml, WHP Homeopathic Medicin... | Out-of-specification test results obtained for identification testing based on HPTLC analysis. | Class II | Washington Homeopathic Products, Inc. |
| Aug 20, 2021 | Z-1050 Formula Hepatodetox. Contents 1000ml. WHP Homeopathic Medicine, For Ma... | Out-of-specification test results obtained for identification testing based on HPTLC analysis. | Class II | Washington Homeopathic Products, Inc. |
| Aug 20, 2021 | Strophanthus hisp 30X, Hives*, 20% Alcohol, Packaged in (a) 15 mL, UPC 7 4064... | Out-of-specification test results obtained for identification testing based on HPTLC analysis. | Class II | Washington Homeopathic Products, Inc. |
| Aug 20, 2021 | Aconitum nap Fear* Sucrose/Lactose Pills HPUS: 4X, 5X, 6X,15X, packaged in 1 ... | Out-of-specification test results obtained for identification testing based on HPTLC analysis. | Class II | Washington Homeopathic Products, Inc. |
| Aug 20, 2021 | Althaea 30X, Iritable Bladder* Sucrose/Lactose Pills, packaged as 4 Dram, W... | Out-of-specification test results obtained for identification testing based on HPTLC analysis. | Class II | Washington Homeopathic Products, Inc. |
| Aug 20, 2021 | Yeast Guard Blend, Calcarea Carbonica 6X, Collinsonia Canadensis 3X, Kali Mu... | Out-of-specification test results obtained for identification testing based on HPTLC analysis. | Class II | Washington Homeopathic Products, Inc. |
| Aug 20, 2021 | Althaea Officinalis 6X, Iritable Bladder* Sucrose/Lactose Pills, packaged as ... | Out-of-specification test results obtained for identification testing based on HPTLC analysis. | Class II | Washington Homeopathic Products, Inc. |
| Aug 20, 2021 | Aconitum Napellus Fear* 20% Alcohol HPUS: 5X, 6X, 26X, 30X, packaged in 15mL ... | Out-of-specification test results obtained for identification testing based on HPTLC analysis. | Class II | Washington Homeopathic Products, Inc. |
| Aug 20, 2021 | ZTE-105 Formula Gentle Detoxing. Contents 1000 mL, RX Only, REMEDY: Bryoni Al... | Out-of-specification test results obtained for identification testing based on HPTLC analysis. | Class II | Washington Homeopathic Products, Inc. |
| Aug 20, 2021 | Cedar Fever Drops, 20% USP ALCOHOL, 30 mL, homeopathic drug for symptoms of c... | Out-of-specification test results obtained for identification testing based on HPTLC analysis. | Class II | Washington Homeopathic Products, Inc. |
| Aug 20, 2021 | Viola Odorata 4X, 10X, 12X, Bee Stings*, Sucrose/Lactose Pills, 4X Packaged ... | Out-of-specification test results obtained for identification testing based on HPTLC analysis. | Class II | Washington Homeopathic Products, Inc. |
| Aug 20, 2021 | ZTE-1034 Formula Antimicrobial Bowel. Contents 1000ml. WHP Homeopathic Medici... | Out-of-specification test results obtained for identification testing based on HPTLC analysis. | Class II | Washington Homeopathic Products, Inc. |
| Aug 20, 2021 | ZTE 1013 Formula Antimicrobial - F&M , Contents 1000 ml, REMEDY: Bryonia Alba... | Out-of-specification test results obtained for identification testing based on HPTLC analysis. | Class II | Washington Homeopathic Products, Inc. |
| Aug 20, 2021 | Aconitum nap Fear* 87% Alcohol HPUS: 5X, 7X, 18X, 30X, packaged in 30 mL cont... | Out-of-specification test results obtained for identification testing based on HPTLC analysis. | Class II | Washington Homeopathic Products, Inc. |
| Aug 20, 2021 | Verbena Officinalis 6X, Nervousness* Sucrose/Lactose Pills, Packaged 2 Dram, ... | Out-of-specification test results obtained for identification testing based on HPTLC analysis. | Class II | Washington Homeopathic Products, Inc. |
| Aug 20, 2021 | Humulus 6X, 15X, Sucrose/Lactose Pills, 6X Packaged as a) 4dr, UPC 7 40640 33... | Out-of-specification test results obtained for identification testing based on HPTLC analysis. | Class II | Washington Homeopathic Products, Inc. |
| Aug 20, 2021 | ZTE-1035 Formula, Antimicrobial Combination, Contents 1006 ml, REMEDY: Arseni... | Out-of-specification test results obtained for identification testing based on HPTLC analysis. | Class II | Washington Homeopathic Products, Inc. |
| Aug 20, 2021 | Kali Sulphuricum 3X, 960ml 20% Alcohol, WHP Homeopathic Medicine, For Manufac... | Out-of-specification test results obtained for identification testing based on HPTLC analysis. | Class II | Washington Homeopathic Products, Inc. |
| Aug 20, 2021 | La Core LCL-2-0191 Blend, 149,980ml 20% Alcohol, WHP Homeopathic Medicine, Fo... | Out-of-specification test results obtained for identification testing based on HPTLC analysis. | Class II | Washington Homeopathic Products, Inc. |
| Aug 20, 2021 | Aconitum Napellus 12X Fear* 87% Alcohol HPUS: packaged in 30 mL containers; W... | Out-of-specification test results obtained for identification testing based on HPTLC analysis. | Class II | Washington Homeopathic 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.