Browse Drug Recalls
17,874 FDA drug safety recalls.
FDA Drug Recall Enforcement Database
Browse 17,874 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 17,874 FDA drug recalls.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| Mar 11, 2025 | Ciprofloxacin Ophthalmic Solution USP, 0.3% as base, package in 5 mL bottles,... | Defective container: Unable to get the solution out of the bottle as the spike of the cap was lod... | Class II | FDC Limited |
| Mar 11, 2025 | CVS Health Concealing Acne Treatment Cream, CVS, 10% benzoyl peroxide, 1 oz (... | Chemical contamination: presence of benzene | Class II | Fruit Of The Earth, Inc. |
| Mar 11, 2025 | chlorproMAZINE Hydrochloride Tablets, USP 100 mg, Rx Only, 100 Tablets per bo... | CGMP deviations: presence of N-Nitroso-Desmethyl Chlorpromazine impurity above the recommended in... | Class II | Glenmark Pharmaceuticals Inc., USA |
| Mar 11, 2025 | Walgreens Maximum Strength Tinted Acne Treatment Cream 10% Benzoyl Peroxide/A... | Chemical contamination: presence of benzene | Class II | Fruit Of The Earth, Inc. |
| Mar 7, 2025 | Levothyroxine Sodium Tablets, USP, 150 mcg (0.15 mg), Rx Only, 100 Unit Dose ... | Super-Potent Drug: Out of specification potency results were obtained. | Class II | Mylan Institutional, Inc. |
| Mar 7, 2025 | Cinacalcet Hydrochloride Tablets 30 mg, 30-count bottle, Rx only, Distr. by: ... | CGMP deviations: The presence of nitrosamine impurity above the acceptable daily intake limits. | Class II | Slate Run Pharmaceuticals |
| Mar 7, 2025 | Duloxetine D/R, 30 mg, 30 Caps, RX Only, Packaged as a) 30-count bottle NDC 6... | CGMP Deviations: Presence of Nitrosamine Drug Substance Related Impurity above the proposed inter... | Class II | Direct Rx |
| Mar 7, 2025 | 8.4% Sodium Bicarbonate Injection, USP, 50 mEq/50 mL (1 mEq/mL), 25 x 50 mL S... | Lack of Assurance of Sterility | Class II | Exela Pharma Sciences LLC |
| Mar 7, 2025 | [CORRECT FRONT PANEL] Hydrogen Peroxide Topical Solution, USP, 32 FL OZ (1 QT... | Labeling; Label Mixup; some bottles have an incorrect back label indicating 91% Isopropyl Alcohol | Class II | Consumer Product Partners, LLC |
| Mar 7, 2025 | Duloxetine D/R, 20 mg, 30 Caps, 30-count bottle, RX Only, Packaged & Distribu... | CGMP Deviations: Presence of Nitrosamine Drug Substance Related Impurity above the proposed inter... | Class II | Direct Rx |
| Mar 7, 2025 | Levothyroxine Sodium Tablets, USP, 125 mcg (0.125 mg), Rx Only, 100 Unit Dose... | Super-Potent Drug: Out of specification potency results were obtained. | Class II | Mylan Institutional, Inc. |
| Mar 7, 2025 | Cinacalcet Hydrochloride Tablets 60 mg, 30-count bottle, Rx only, Distr. by: ... | CGMP deviations: The presence of nitrosamine impurity above the acceptable daily intake limits. | Class II | Slate Run Pharmaceuticals |
| Mar 7, 2025 | Sofosbuvir and Velpatasvir, 400 mg/100 mg tablets, 28 tablets: 2x14 blister c... | Defective Container: blister packs not properly sealed resulting in tablets being loose in the ca... | Class II | ASEGUA THERAPEUTICS LLC |
| Mar 6, 2025 | fentaNYL Citrate PF 200 mcg/100 mL (2 mcg/ml) /0.125% Bupivacaine HCl 125 mg/... | Lack of Assurance of Sterility | Class II | QuVa Pharma, Inc. |
| Mar 6, 2025 | fentaNYL Citrate PF 200 mcg/100 mL (2 mcg/ml) /0.2% ROPivacaine HCl 200 mg/10... | Lack of Assurance of Sterility | Class II | QuVa Pharma, Inc. |
| Mar 6, 2025 | fentaNYL Citrate PF 200 mcg/100 mL (2 mcg/ml) /0.1% Bupivacaine HCl 100 mg/10... | Lack of Assurance of Sterility | Class II | QuVa Pharma, Inc. |
| Mar 5, 2025 | La Roche-Posay Laboratoire Dermatologique Effaclar Duo Dual Action Acne Treat... | Chemical Contamination: This recall has been initiated due to detected trace levels of benzene. | Class II | L'Oreal USA |
| Mar 5, 2025 | Testosterone Gel 1%, 5 grams, 30 Unit-dose Packets in a carton, Rx only, Dist... | Presence of foreign substance: Presence of Benzene. | Class II | Strides Pharma, Inc. |
| Mar 5, 2025 | PRASUGREL TABLETS, 5 mg, 30 tablet bottles, Rx only, packaged by GSMS, Incorp... | Failed Dissolution Specifications | Class II | Golden State Medical Supply Inc. |
| Mar 5, 2025 | Testosterone Gel 1%, 2.5 grams, 30 Unit-dose packets in a carton, Rx only, D... | Presence of foreign substance: Presence of Benzene. | Class II | Strides Pharma, Inc. |
| Mar 5, 2025 | Duloxetine Delayed-Release Capsules, USP, 30 mg, 1,000-count bottle, Rx only,... | CGMP Deviations: Presence of N-nitroso-duloxetine impurity above recommended interim limit. | Class II | Rising Pharma Holding, Inc. |
| Mar 5, 2025 | La Roche-Posay Laboratoire Dermatologique Effaclar Dermatological Acne System... | cGMP Deviations: The recall was initiated due to detected trace levels of benzene in a specific l... | Class II | L'Oreal USA |
| Mar 5, 2025 | La Roche-Posay Laboratoire Dermatologique Effaclar Duo Dual Action Acne Treat... | cGMP Deviations: The recall was initiated due to detected trace levels of benzene in a specific l... | Class II | L'Oreal USA |
| Mar 4, 2025 | Tolterodine Tartrate Extended-Release Capsules, 2 mg, 30 Capsules (3 x 10) Un... | Failed Dissolution Specifications: Out of specification results obtained during routine stability... | Class III | The Harvard Drug Group LLC dba Major Pharmaceut... |
| Mar 4, 2025 | Gabapentin Capsules, USP 400 mg, Rx Only, Packaged in a) 500-count bottles, N... | Cross Contamination | Class III | SUN PHARMACEUTICAL INDUSTRIES INC |
| Mar 4, 2025 | Unisom, SleepMelts, Diphenhydramine HCl tablets, 25 mg, Nighttime Sleep-Aid, ... | CGMP Deviations: Nitrosamine Drug Substance Related Issue impurity above the daily acceptable int... | Class II | Chattem Inc |
| Mar 4, 2025 | Gabapentin Capsules, USP 300 mg, Rx Only, Packaged in a) 500-count bottles, ... | Cross Contamination | Class III | SUN PHARMACEUTICAL INDUSTRIES INC |
| Feb 28, 2025 | Walgreens, Acne Control Cleanser, 10% Benzoyl Peroxide/Acne Treatment, NET WT... | Chemical Contamination: Presence of benzene | Class II | Sigan Industries Group Inc. |
| Feb 28, 2025 | Duloxetine Delayed-Release Capsules, USP, 60mg, Rx Only, 1000-count bottles, ... | CGMP Deviations: Presence of N-nitroso-duloxetine impurity above FDA recommended interim limit. | Class II | Breckenridge Pharmaceutical, Inc. |
| Feb 28, 2025 | Duloxetine Delayed-Release Capsules, USP, 30mg, Rx Only, 1000-count bottles, ... | CGMP Deviations: Presence of N-nitroso-duloxetine impurity above FDA recommended interim limit. | Class II | Breckenridge Pharmaceutical, Inc. |
| Feb 28, 2025 | Duloxetine Delayed-Release Capsules, USP, 20mg, Rx Only, 500-count bottles, M... | CGMP Deviations: Presence of N-nitroso-duloxetine impurity above FDA recommended interim limit. | Class II | Breckenridge Pharmaceutical, Inc. |
| Feb 28, 2025 | Carvedilol Tablets USP 12.5 mg, 500-Count bottle, Rx Only, Manufactured by: G... | CGMP Deviations; presence 'N-Nitroso Carvedilol I' Impurity above the recommended acceptable inta... | Class II | Glenmark Pharmaceuticals Inc., USA |
| Feb 28, 2025 | Carvedilol Tablets USP 3.125mg Tablets a.)100-count bottle (NDC 68462-162-01... | CGMP Deviations; presence 'N-Nitroso Carvedilol I' Impurity above the recommended acceptable inta... | Class II | Glenmark Pharmaceuticals Inc., USA |
| Feb 28, 2025 | Carvedilol Tablets USP 6.25 mg, a.)100-count bottle (NDC 68462-163-01), b.) 5... | CGMP Deviations; presence 'N-Nitroso Carvedilol I' Impurity above the recommended acceptable inta... | Class II | Glenmark Pharmaceuticals Inc., USA |
| Feb 28, 2025 | Carvedilol Tablets USP 25 mg, 500 -Count bottle, Rx Only, Manufactured by: Gl... | CGMP Deviations; presence 'N-Nitroso Carvedilol I' Impurity above the recommended acceptable inta... | Class II | Glenmark Pharmaceuticals Inc., USA |
| Feb 27, 2025 | Neupogen (filgrastim) For Injection, 300mcg/1 mL, 1 mL Single Dose Vials, Rx ... | Stability data does not support expiry: the products have the potential to be out of specificatio... | Class II | Amgen, Inc. |
| Feb 27, 2025 | Neupogen (filgrastim) For Injection, 480 mcg/1.6 mL (300 mcg/1 mL), 1.6 mL si... | Stability data does not support expiry: the products have the potential to be out of specificatio... | Class II | Amgen, Inc. |
| Feb 25, 2025 | Prasugrel Tablets, USP, 5 mg, 30-count bottle, Rx only, Manufactured for: Myl... | Failed Dissolution Specifications - low dissolution results | Class II | MYLAN PHARMACEUTICALS INC |
| Feb 25, 2025 | METFORMIN HYDROCHLORIDE EXTENDED- RELEASE 500MG, 180 TABLETS, Packaged BY: A-... | Presence of Foreign Tablets/Capsules. | Class II | A-S Medication Solutions LLC |
| Feb 24, 2025 | Livalo (pitavatstatin) tablets, 4 mg, 90-count bottles, Rx only, Manufactured... | Presence of foreign tablets/capsules | Class III | Kowa Pharmaceuticals America |
| Feb 24, 2025 | Zapzyt, Acne Treatment Gel, 10% benzoyl peroxide Gel, packaged in 1 oz (28.35... | Chemical Contamination: Presence of benzene. | Class II | Denison Pharmaceuticals, LLC |
| Feb 24, 2025 | Tropicamide - Proparacaine - Phenylephrine - Ketorolac Sterile Ophthalmic Sol... | Sub-Potent Drug: The stability batch showed a subpotent result, which does not meet the product s... | Class III | Imprimis NJOF, LLC |
| Feb 20, 2025 | Vitality, Fast Acting Male Enhancement Product, Dietary Supplement, a) One Ca... | Marketed without an approved NDA/ANDA: Product found to be tainted with undeclared sildenafil and... | Class I | One Source Nutrition, Inc, |
| Feb 20, 2025 | PHENYLephrine added to 0.9% sodium chloride, 40 mg/250 mL* (160 mcg/mL), Rx O... | Presence of Particulate Matter | Class I | Central Admixture Pharmacy Services, Inc. |
| Feb 18, 2025 | Avastin 1.25 mg/0.05 mL in 0.25 mL Syringe, For Intravitreal Injection Only, ... | Lack of Assurance of Sterility: due to a quality control process deviation. During an internal qu... | Class II | Turbare Manufacturing |
| Feb 17, 2025 | Lorazepam 0.5 mg per 0.25 mL Oral Syringe, Delivers: 0.25 mL, Oral Concentrat... | Defective Delivery System: Leakage observed after oral solution was repackaged into unit-dose syr... | Class II | Safecor Health, LLC |
| Feb 17, 2025 | CURAD Alcohol Prep Pads, Sterile, Medium, 2-Ply, Contents: 5 boxes per Carton... | Subpotent Drug | Class II | MEDLINE INDUSTRIES, LP - Northfield |
| Feb 17, 2025 | Ergocalciferol - Vitamin D Supplement - 10 mcg (400 Units) per 0.05 mL Oral S... | Defective Delivery System: Leakage observed after oral solution was repackaged into unit-dose syr... | Class II | Safecor Health, LLC |
| Feb 17, 2025 | Ferrous Sulfate 7.5 mg Iron/0.5 mL Oral Syringe, Delivers: 0.5 mL, Iron Suppl... | Defective Delivery System: Leakage observed after oral solution was repackaged into unit-dose syr... | Class II | Safecor Health, LLC |
| Feb 17, 2025 | Morphine Sulfate 5 mg per 0.25 mL Oral Syringe, Delivers: 0.25 mL, Oral Solut... | Defective Delivery System: Leakage observed after oral solution was repackaged into unit-dose syr... | Class II | Safecor Health, LLC |
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.