Browse Drug Recalls
777 FDA drug safety recalls.
FDA Drug Recall Enforcement Database
Browse 777 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 777 FDA drug recalls in 2025.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| Mar 13, 2025 | Gabapentin Tablets 600mg, 500-count bottles, Rx Only, Manufactured by: Glenma... | CGMP Deviations | Class II | Glenmark Pharmaceuticals Inc., USA |
| Mar 13, 2025 | Solifenacin Succinate Tablets 5mg, a.) 30-count bottle (NDC# 68462-386-30) b.... | CGMP Deviations | Class II | Glenmark Pharmaceuticals Inc., USA |
| Mar 13, 2025 | Metformin Hydrochloride Extended-Release Tablets 1000mg, 90-count bottle. Man... | CGMP Deviations | Class II | Glenmark Pharmaceuticals Inc., USA |
| Mar 13, 2025 | Pravastatin Sodium Tablets, 20mg, a).500-count bottle (NDC# 68462-196-05), b)... | CGMP Deviations | Class II | Glenmark Pharmaceuticals Inc., USA |
| Mar 13, 2025 | Naproxen Sodium Tablets, USP, 550mg, 100-count bottles, Rx Only, Manufactured... | CGMP Deviations | Class II | Glenmark Pharmaceuticals Inc., USA |
| Mar 13, 2025 | Frovatriptan Succinate Tablets 2.5mg, 9-count bottle, Rx Only, Manufactured b... | CGMP Deviations | Class II | Glenmark Pharmaceuticals Inc., USA |
| Mar 13, 2025 | Fenofibrate Capsules 67 mg, USP, 100-count bottle, Rx Only, Manufactured by: ... | CGMP Deviations | Class II | Glenmark Pharmaceuticals Inc., USA |
| Mar 13, 2025 | Pravastatin Sodium Tablets, USP, 80mg, a).90-count bottle (16714-570-01), b).... | CGMP Deviations | Class II | Glenmark Pharmaceuticals Inc., USA |
| Mar 13, 2025 | Ranolazine Extended-Release Tablets 1000mg, 60-count bottle, Rx Only, Manuf... | CGMP Deviations | Class II | Glenmark Pharmaceuticals Inc., USA |
| Mar 13, 2025 | Cetirizine Hydrochloride Tablets, USP, 10mg, 365-count packs, Rx Only, Manufa... | CGMP Deviations | Class II | Glenmark Pharmaceuticals Inc., USA |
| Mar 12, 2025 | In Your Face Mineral Tint SPF 31, Zinc Oxide 25%, Tinted Sunscreen Broad Spec... | cGMP deviations | Class II | KABANA SKIN CARE |
| Mar 12, 2025 | Proactiv Emergency Blemish Relief (Benzoyl Peroxide 5%), 0.33 oz. (9.45 g), D... | Chemical contamination: Presence of benzene | Class II | Alchemee, LLC |
| Mar 12, 2025 | B Natural Organics, Organic Sunscreen, Broad Spectrum, SPF 30, 25% non-nano Z... | cGMP deviations | Class II | KABANA SKIN CARE |
| Mar 12, 2025 | Proactiv Skin Smoothing Exfoliator (Benzoyl Peroxide 2.5%), Packaged as a) 6 ... | Chemical contamination: Presence of benzene | Class II | Alchemee, LLC |
| Mar 12, 2025 | Erin's Faces, Mineral SPF 32, UVA/UVB Sunscreen, Broad Spectrum SPF 32, 25% Z... | cGMP deviations | Class II | KABANA SKIN CARE |
| Mar 12, 2025 | GreenScreen, kabana organic skincare, Bread Spectrum UVA & UVB, Zinc Oxide Su... | cGMP deviations | Class II | KABANA SKIN CARE |
| 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 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 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 | 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 | 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 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 | 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 | 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 | 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) /0.2% 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 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 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 | 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%, 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 | 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 | 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 | Gabapentin Capsules, USP 300 mg, Rx Only, Packaged in a) 500-count bottles, ... | Cross Contamination | Class III | SUN PHARMACEUTICAL INDUSTRIES INC |
| 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 |
| 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 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 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 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 |
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.