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 |
|---|---|---|---|---|
| May 18, 2022 | Losartan Potassium Tablets, USP 25 mg, Rx only, Manufactured by: Vivimed Lif... | CGMP Deviations- AZIDO Impurity levels observed to be above acceptable limits | Class II | Strides Pharma Inc. |
| May 18, 2022 | Glycopyrrolate Injection, USP, 1 mg/5 mL (0.2 mg/mL), Preservative Free, 5 mL... | Lack of Assurance of Sterility | Class II | Nephron Sterile Compounding Center LLC |
| May 18, 2022 | Hydromorphone HCl Injection, USP, 50 mg/50 mL (1 mg/mL), 50 mL Pre-Filled Syr... | Lack of Assurance of Sterility | Class II | Nephron Sterile Compounding Center LLC |
| May 17, 2022 | AMBI Skincare Even & Clear Exfoliating Wash Salicylic Acid Acne Treatment Wit... | cGMP deviations: product stored outside of labeled temperature requirements. | Class II | Family Dollar Stores, Llc. |
| May 17, 2022 | AMBI Skincare Fade Cream Normal Skin, Net Wt. 2 OZ. (56g) | cGMP deviations: product stored outside of labeled temperature requirements. | Class II | Family Dollar Stores, Llc. |
| May 17, 2022 | Luxury Hygiene Hand Sanitizer Moisturizing Formula with Vitamin E, 8 FL. OZ. ... | cGMP deviations: product stored outside of labeled temperature requirements. | Class II | Family Dollar Stores, Llc. |
| May 17, 2022 | Aveeno Daily Moisturizing lotion Fragrance Free with Soothing Oat & Rich Emol... | cGMP deviations: product stored outside of labeled temperature requirements. | Class II | Family Dollar Stores, Llc. |
| May 17, 2022 | Luxury Hygiene Hand Sanitizer Moisturizing Formula with Vitamin E Advanced Al... | cGMP deviations: product stored outside of labeled temperature requirements. | Class II | Family Dollar Stores, Llc. |
| May 17, 2022 | Only At Family Dollar AMBI Skincare Even & Clear Nourishing Daily Facial Mois... | cGMP deviations: product stored outside of labeled temperature requirements. | Class II | Family Dollar Stores, Llc. |
| May 17, 2022 | AMBI Skincare Fade Cream Oily Skin New & Improved, Net Wt. 2 OZ (56g) | cGMP deviations: product stored outside of labeled temperature requirements. | Class II | Family Dollar Stores, Llc. |
| May 13, 2022 | Pyrogenium, Potency: 15X, 16X, 17X, 19X, 21X, 22X, 25X, 30X, 1M, 200C, 30C, O... | cGMP deviations | Class II | Washington Homeopathic Products, Inc. |
| May 13, 2022 | Tuberculinum, Potency: 1X, 12X, 24X, 30X, 1M, Liquid Pellets, Rx only, Washi... | cGMP deviations | Class II | Washington Homeopathic Products, Inc. |
| May 13, 2022 | Proteus, Potency: 7C, 8C, 9C, 12C, 15C, 16C, 20C, 30C, 200C, OTC, Liquid Pell... | cGMP deviations | Class II | Washington Homeopathic Products, Inc. |
| May 13, 2022 | Medorrhinum, Potency:12C, 30C, 200C, 1M, Liquid Pellets, Rx only, Washington ... | cGMP deviations | Class II | Washington Homeopathic Products, Inc. |
| May 13, 2022 | Zonisamide Capsules USP, 100 mg, 90-count bottle, Rx Only, Packaged and Dist... | CGMP Deviations: Gaps in the quality system in the Quality Control microbiology laboratory. | Class II | Direct Rx |
| May 13, 2022 | Syphilinum, Potency: 9C, 30C, 200C, 10X, 12X, Liquid Pellets, Rx only, Washi... | cGMP deviations | Class II | Washington Homeopathic Products, Inc. |
| May 13, 2022 | Diphtherinum, Potency: 14C, 30C, 200C, Liquid Pellets, Rx only, Washington Ho... | cGMP deviations | Class II | Washington Homeopathic Products, Inc. |
| May 13, 2022 | Tuberculinum Bovinum, Potency: 12C, 30C, 200C, Liquid Pellets, Rx only, Wash... | cGMP deviations | Class II | Washington Homeopathic Products, Inc. |
| May 13, 2022 | Streptococcinum, Potency: 8C, 9C, 30C, 200C, Liquid Pellets, Rx only, Washin... | cGMP deviations | Class II | Washington Homeopathic Products, Inc. |
| May 13, 2022 | Morbillinum, Potency:7C, 8C, 9C, 10C 12C, 13C, 15C, 20C, 21C, 30C, 200 C,Liqu... | cGMP deviations | Class II | Washington Homeopathic Products, Inc. |
| May 13, 2022 | Colibacillinum, Potency: 12C, 14C, 15C, 18C, 20C, 30C, Liquid Pellets, OTC, W... | cGMP deviations | Class II | Washington Homeopathic Products, Inc. |
| May 13, 2022 | Anthracinum, Potency: 6C, 7C, 8C, 9C, 12C, 14C, 30C, 200C, 11X, 14X, 30X Liqu... | cGMP deviations | Class II | Washington Homeopathic Products, Inc. |
| May 13, 2022 | Vaccinotoxinum, Potency: 32X, 11C, 30C, Liquid Pellets, Rx only, Washington ... | cGMP deviations | Class II | Washington Homeopathic Products, Inc. |
| May 13, 2022 | Bacillinum Pulmo, Potency: 30C, 200C, Liquid Pellets, Rx only, Washington Hom... | cGMP deviations | Class II | Washington Homeopathic Products, Inc. |
| May 13, 2022 | Pertussinum, Potency: 19C, 30C, 200C, 1M, Liquid Pellets, OTC, Washington Hom... | cGMP deviations | Class II | Washington Homeopathic Products, Inc. |
| May 13, 2022 | Candida Albicans, Potency: 9C, 10C, 12C, 13C, 14C 15C 16C, 19C, 24C, 25C, 26C... | cGMP deviations | Class II | Washington Homeopathic Products, Inc. |
| May 13, 2022 | Influenzinum, Potency: 9X, 10X, 12X, 15X, 25X, 30X, 200C, 12C, 30C 1M, Liquid... | cGMP deviations | Class II | Washington Homeopathic Products, Inc. |
| May 13, 2022 | Candida Parapsilosis, Potency: 14X, 15X, 16X, 20X, 28X, 30X, 9C, 10C, 13C, 15... | cGMP deviations | Class II | Washington Homeopathic Products, Inc. |
| May 11, 2022 | Losartan Pot/HCTZ 50/12.5 mg 90 Tabs NDC 72189-297-90 Packaged and Distribute... | CGMP Deviations- AZIDO Impurity levels observed to be above acceptable limits . | Class II | Direct Rx |
| May 11, 2022 | Losartan Pot/HCTZ 100/25 mg 90 Tabs NDC 72189-289-90 Packaged and Distributed... | CGMP Deviations- AZIDO Impurity levels observed to be above acceptable limits . | Class II | Direct Rx |
| May 11, 2022 | Losartan Pot/HCTZ 100/12.5 mg 90 Tabs NDC 72189-290-90 Packaged and Distribut... | CGMP Deviations- AZIDO Impurity levels observed to be above acceptable limits . | Class II | Direct Rx |
| May 11, 2022 | Alcohol Antiseptic 80%, Topical Solution, Hand Sanitizer, Non-Sterile Solutio... | CGMP Deviations: FDA analysis found product to contain acetaldehyde and acetal above specificatio... | Class II | A.P. Nonweiler |
| May 10, 2022 | Premium Nature Instant Hand Sanitizer, (ethyl alcohol 65%), 8 oz/ 236 ML plas... | Subpotent Drug: FDA analysis has revealed some bottles of these products were sub potent for etha... | Class II | AMS Packaging Inc |
| May 9, 2022 | Sodium Tetradecyl Sulfate 1.5% MDV Injection, Multi-Dose 30 mL vial, Rx Only,... | Lack of assurance of sterility. | Class II | Olympia Compounding Pharmacy dba Olympia Pharmacy |
| May 9, 2022 | Lipostat Plus SF Inositol 50 mg/mL Choline Chloride 50 mg/mL Cyanocobalamin 1... | Lack of assurance of sterility. | Class II | Olympia Compounding Pharmacy dba Olympia Pharmacy |
| May 9, 2022 | RE-2 Papaverine 30 mg/mL Phentolamine 3 mg/mL Alprostadil 300 mcg/mL, Package... | Lack of assurance of sterility. | Class II | Olympia Compounding Pharmacy dba Olympia Pharmacy |
| May 9, 2022 | Magnesium Chloride, 200 mg/mL, Multi-Dose 30 mL vial, Rx Only, Olympia Pharma... | Lack of assurance of sterility. | Class II | Olympia Compounding Pharmacy dba Olympia Pharmacy |
| May 9, 2022 | Sodium Bicarbonate 8.4% MDV Injection, Multi-Dose 30 mL vial, Rx Only, Olymp... | Lack of assurance of sterility. | Class II | Olympia Compounding Pharmacy dba Olympia Pharmacy |
| May 9, 2022 | FA Papaverine 20 mg/mL Phentolamine 2 mg/mL Alprostadil 20 mcg/mL Atropine 0.... | Lack of assurance of sterility. | Class II | Olympia Compounding Pharmacy dba Olympia Pharmacy |
| May 9, 2022 | Lidocaine 1%/Epinephrine 1:100,000/mL, Multi-Dose 30 mL vial, Rx Only, Olympi... | Lack of assurance of sterility. | Class II | Olympia Compounding Pharmacy dba Olympia Pharmacy |
| May 9, 2022 | Lidocaine 2% (20 mg/mL), Multi-Dose 30 mL vial , Rx Only, Olympia Pharmaceuti... | Lack of assurance of sterility. | Class II | Olympia Compounding Pharmacy dba Olympia Pharmacy |
| May 9, 2022 | Folic Acid 1 mg/mL Hydroxocobalamin 1 mg/mL, Multi-Dose 30 mL vial, Rx Only, ... | Lack of assurance of sterility. | Class II | Olympia Compounding Pharmacy dba Olympia Pharmacy |
| May 9, 2022 | NB-343 Papaverine 30 mg/mL Phentolamine 3 mg/mL PGE 30 mcg/mL, Multi-Dose 10 ... | Lack of assurance of sterility. | Class II | Olympia Compounding Pharmacy dba Olympia Pharmacy |
| May 9, 2022 | Pyridoxine HCL 100 mg/mL, Multi-Dose 30 mL vial, Rx Only, Olympia Pharmaceuti... | Lack of assurance of sterility. | Class II | Olympia Compounding Pharmacy dba Olympia Pharmacy |
| May 9, 2022 | T-106 Papaverine 30 mg/mL Phentolamine 1 mg/mL Alprostadil 25 mcg/mL, Package... | Lack of assurance of sterility. | Class II | Olympia Compounding Pharmacy dba Olympia Pharmacy |
| May 9, 2022 | Bimix-3 Papaverine 30 mg/mL Phentolamine 3 mg/mL, Packaged as a) 2.5 mL Multi... | Lack of assurance of sterility. | Class II | Olympia Compounding Pharmacy dba Olympia Pharmacy |
| May 9, 2022 | Sodium Selenite 200 mg/mL, Multi-Dose 30 mL vial, Rx Only, Olympia Pharmaceu... | Lack of assurance of sterility. | Class II | Olympia Compounding Pharmacy dba Olympia Pharmacy |
| May 9, 2022 | Ultratest Testosterone Cypionate 160 mg/mL Testosterone Propionate 40 mg/mL, ... | Lack of assurance of sterility. | Class II | Olympia Compounding Pharmacy dba Olympia Pharmacy |
| May 9, 2022 | Tri-Immune Boost Glutathione 200 mg/mL Ascorbic Acid 200 mg/mL Zinc Sulfate 2... | Lack of assurance of sterility. | Class II | Olympia Compounding Pharmacy dba Olympia Pharmacy |
| May 9, 2022 | Testosterone Cypionate 200 mg/mL in Grapeseed Oil, Multi-Dose 10 mL vial, Rx ... | Lack of assurance of sterility. | Class II | Olympia Compounding Pharmacy dba Olympia Pharmacy |
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.