Browse Drug Recalls
201 FDA drug safety recalls.
FDA Drug Recall Enforcement Database
Browse 201 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 201 FDA drug recalls.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| 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 | Tuberculinum Bovinum, Potency: 12C, 30C, 200C, Liquid Pellets, Rx only, Wash... | cGMP deviations | Class II | Washington Homeopathic Products, Inc. |
| 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 |
| Sep 1, 2021 | Sodium Sulfacetamide, 10%, Wash, packaged in bottles: a) 6 fl oz (177 mL) NDC... | Subpotency: one product for active ingredient assay and another one for preservative assay | Class III | Monarch PCM, LLC |
| Sep 1, 2021 | Hydroquinone, USP, 4% Skin Bleaching Cream, packaged in 1 oz (28.35g) tube, R... | Subpotency: one product for active ingredient assay and another one for preservative assay | Class III | Monarch PCM, LLC |
| Nov 20, 2020 | HUMAN CHORIONIC GONADOTROPIN 5,000 IU per vial Aso contains Mannitol 9%, Sodi... | CGMP deviations: Lack of potency testing. | Class II | Complete Pharmacy and Medical Solutions, LLC. |
| Nov 20, 2020 | Fentanyl, 250 mcg/ 5mL, Injection for IV or IM use, Rx only, SCA Pharmaceutic... | Subpotency: Out-of-specification stability test result for low potency was obtained. | Class III | SCA Pharmaceuticals |
| Nov 20, 2020 | HUMAN CHORIONIC GONADOTROPIN 6,000 IU per vial Aso contains Mannitol 9%, Sodi... | CGMP deviations: Lack of potency testing. | Class II | Complete Pharmacy and Medical Solutions, LLC. |
| Nov 20, 2020 | HUMAN CHORIONIC GONADOTROPIN 11,000 IU per vial Aso contains Mannitol 9%, Sod... | CGMP deviations: Lack of potency testing. | Class II | Complete Pharmacy and Medical Solutions, LLC. |
| Nov 20, 2020 | HUMAN CHORIONIC GONADOTROPIN 1,250 IU per vial Aso contains Mannitol 9%, Sodi... | CGMP deviations: Lack of potency testing. | Class II | Complete Pharmacy and Medical Solutions, LLC. |
| Aug 24, 2020 | Cephalexin for Oral Suspension, USP 250 mg per 5 mL, For Reconstitution, For ... | Sub-Potent Drug: Out of specification test results for potency (below specification). | Class II | Teva Pharmaceuticals USA |
| Jul 29, 2020 | Heparin Sodium 5,000 units in 0.9% Sodium Chloride 1000 mL bag (5 units/mL), ... | Subpotent Drug: Out-of-Specification potency results at the 30-day stability timepoint. | Class II | SCA Pharmaceuticals |
| Jun 16, 2020 | Heparin Sodium 5,000 units in 0.9% Sodium Chloride 1000 mL bag (5 units/mL), ... | Subpotent Drug: Out-of-Specification potency results at the 30-day stability timepoint. | Class II | SCA Pharmaceuticals |
| Feb 7, 2020 | Phenytoin Oral Suspension USP, 125 mg/5 mL potency, 8 fl oz (237 mL) Rx Only... | Resuspension Problems: Two lots of Phenytoin Oral Suspension USP 125mg/5mL may coagulate and may ... | Class I | Taro Pharmaceuticals U.S.A., Inc. |
| Jun 13, 2019 | Heparin Sodium 25,000 USP units per 250 mL (100 USP units per mL) in 5% Dextr... | Subpotent Drug: low out-of-specification results were identified for the drug anti-factor IIa pot... | Class II | B. Braun Medical Inc |
| Apr 26, 2019 | HYDROmorphone 20 mg/100 mL Injectable Solution, Hydromorphone HCl 20 mg 0.9% ... | Sub-potency | Class II | Advanced Pharma Inc. |
| Jul 20, 2018 | Dr. King's SafeCare Rx Children's Cough Children High Potency Homeopathic For... | Microbial contamination | Class I | King Bio Inc. |
| Jul 20, 2018 | Dr. King's SafeCare Rx Upper GI Restoration Digestion High Potency Homeopathi... | Microbial contamination | Class I | King Bio Inc. |
| Jul 20, 2018 | Dr. King's SafeCare Rx Tummy Aches Children High Potency Homeopathic Formula ... | Microbial contamination | Class I | King Bio Inc. |
| Jul 20, 2018 | Dr. King's SafeCare Rx Chicken Pox Symptom Relief Children High Potency Homeo... | Microbial contamination | Class I | King Bio Inc. |
| Jul 20, 2018 | Dr. King's SafeCare Rx Children's Growth & Development Children High Potency ... | Microbial contamination | Class I | King Bio Inc. |
| Jul 20, 2018 | Dr. King's SafeCare Rx Hyperactive High Potency Homeopathic Formula, 2 fl oz ... | Microbial contamination | Class I | King Bio Inc. |
| Jul 20, 2018 | Dr. King's SafeCare Rx Bed Wetting Prevention Children High Potency Homeopath... | Microbial contamination | Class I | King Bio Inc. |
| Jul 20, 2018 | Dr. King's SafeCare Rx Newborn Tonic Children High Potency Homeopathic Formul... | Microbial contamination | Class I | King Bio Inc. |
| Jul 20, 2018 | Aquaflora High Potency Candida Control Program Homeopathic Formula, Net 16 fl... | Microbial contamination | Class I | King Bio Inc. |
| Jul 20, 2018 | Dr. King's SafeCare Rx Children's Appetite & Weight Control Children High Pot... | Microbial contamination | Class I | King Bio Inc. |
| Jul 20, 2018 | Dr. King's SafeCareRx CS-Lung High Potency Homeopathic Formula for Profession... | Microbial contamination | Class I | King Bio Inc. |
| Jul 20, 2018 | Dr. King's aquaflora Candida High Potency, 8 fl. oz. (236 mL), King Bio, Inc... | Microbial contamination | Class I | King Bio Inc. |
| Jul 20, 2018 | Dr. King's SafeCare Rx Children's Appetite Enhancer Children High Potency Hom... | Microbial contamination | Class I | King Bio Inc. |
| Jul 20, 2018 | Dr. King's SafeCare Rx Children's Ear Relief Children High Potency Homeopathi... | Microbial contamination | Class I | King Bio Inc. |
| Jul 20, 2018 | Dr. King's SafeCare Rx Colic Relief Children High Potency Homeopathic Formula... | Microbial contamination | Class I | King Bio Inc. |
| Jul 20, 2018 | Dr. King's SafeCare Rx Influenza Multi-Strain Flu Medicine Immune High Potenc... | Microbial contamination | Class I | King Bio Inc. |
| Jul 20, 2018 | Dr. King's SafeCare Rx Soothing Advanced Arnica Pure Homeopathic Cream High P... | Microbial contamination | Class I | King Bio Inc. |
| Jul 20, 2018 | Dr. King's SafeCare Rx Aversion to Change High Potency Homeopathic Formula fo... | Microbial contamination | Class I | King Bio Inc. |
| Jul 20, 2018 | Dr. King's SafeCare Rx Sinus Relief High Potency Homeopathic Formula, 2 fl oz... | Microbial contamination | Class I | King Bio Inc. |
| Jul 20, 2018 | Dr. King's Natural Medicine Aquaflora Candida High Potency 9 Multi-Strain Can... | Microbial contamination | Class I | King Bio Inc. |
| Jul 20, 2018 | Dr. King's SafeCare Rx Children's Fever Reliever Children High Potency Homeop... | Microbial contamination | Class I | King Bio Inc. |
| Jul 20, 2018 | Dr. King's SafeCare Rx Breast Cyst & Discomforts High Potency Homeopathic For... | Microbial contamination | Class I | King Bio Inc. |
| Jul 20, 2018 | Dr. King's SafeCare Rx Attention & Learning Enhancement Children High Potency... | Microbial contamination | Class I | King Bio Inc. |
| Jul 20, 2018 | Dr. King's SafeCare Rx Lower GI Restoration Digestion High Potency Homeopathi... | Microbial contamination | Class I | King Bio Inc. |
| Jul 20, 2018 | Dr. King's SafeCare Rx Teething Children High Potency Homeopathic Formula for... | Microbial contamination | Class I | King Bio Inc. |
| Jul 20, 2018 | Dr. King's SafeCare Rx Lonely Mind & Body High Potency Homeopathic Formula fo... | Microbial contamination | Class I | King Bio Inc. |
| Jun 15, 2018 | Calcitriol Oral Solution, 1 mcg/mL, 15 mL bottle, Rx Only, Distributed by: Ra... | Subpotency: lower than expected potency result was obtained at the 18 month stability time point. | Class III | Validus Pharmaceuticals, Inc. |
| Jun 15, 2018 | Rocaltrol (calcitriol) Oral Solution, 1 mcg/mL, 15 mL bottle, Rx only, Distri... | Subpotency: lower than expected potency result was obtained at the 18 month stability time point. | Class III | Validus Pharmaceuticals, Inc. |
| Jun 8, 2018 | Irinotecan Hydrochloride Injection, USP, 40 mg/2 mL (20 mg/mL), 1 x 2 mL Sing... | Superpotent Drug: High out of specification assay value results for potency. | Class II | Ingenus Pharmaceuticals Llc |
| Jun 8, 2018 | Irinotecan Hydrochloride Injection, USP, 100 mg/5 mL (20 mg/mL), 1 x 5 mL Sin... | Superpotent Drug: High out of specification assay value results for potency. | Class II | Ingenus Pharmaceuticals Llc |
| May 8, 2018 | Piperacillin and Tazobactam for Injection, USP 3.375 gram/vial* 10-count Sing... | Subpotent Drug: High Levels of Impurities Resulting in Decrease Potency | Class I | Apotex Inc. |
| May 8, 2018 | Piperacillin and Tazobactam for Injection, USP 4.5 gram/vial* 10-count Single... | Subpotent Drug: High Levels of Impurities Resulting in Decrease Potency | Class I | Apotex Inc. |
| Feb 7, 2018 | Hydromorphone, Hydrochloride, Injection, USP CII, 10 mg/mL, Rx Only, 1 mL Sin... | Non-Sterility: Confirmed customer complaints of glass product container vials that may be empty o... | Class I | Pfizer Inc. |
| Feb 7, 2018 | Hydromorphone, Hydrochloride, Injection, USP CII, 10 mg/mL, Rx Only, 1 mL Sin... | Non-Sterility: Confirmed customer complaints of glass product container vials that may be empty o... | Class I | Pfizer 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.