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.

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DateProductReasonClassFirm
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.