Browse Drug Recalls

14,449 FDA drug safety recalls.

FDA Drug Recall Enforcement Database

Browse 14,449 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 14,449 FDA drug recalls, Class II.

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DateProductReasonClassFirm
Oct 24, 2024 JR WATKINS COOLING PAIN RELIEF PATCHES, Menthol 7.5%, 5 patches per box, Dist... cGMP Deviations Class II Unexo Life Sciences Private Limited
Oct 24, 2024 EQUATE MAXIMUM STRENGTH LIDOCAINE PAIN RELIEVING PATCH Lidocaine 4% Topical A... cGMP Deviations Class II Unexo Life Sciences Private Limited
Oct 24, 2024 PARCHE LEON PAIN RELIEVING HOT PATCH, Camphor 3%, Menthol 1.25%, Capsaicin 0.... cGMP Deviations Class II Unexo Life Sciences Private Limited
Oct 24, 2024 THERACARE Cold Hot Medicated Patch, Menthol 5%, 5 patches per box, Manufactur... cGMP Deviations Class II Unexo Life Sciences Private Limited
Oct 24, 2024 ABSORBINE JR PAIN RELIEVING KNEE PATCH, Camphor 7%, Menthol 7%, packaged in a... cGMP Deviations Class II Unexo Life Sciences Private Limited
Oct 24, 2024 CHEEKY BONSAI PAIN RELIEF PATCHES, Menthol 10%, 4 patches per box, Distribute... cGMP Deviations Class II Unexo Life Sciences Private Limited
Oct 24, 2024 ABSORBINE jr ULTRA STRENGTH PAIN PATCH, Menthol 6.5%, 1 patch per box, Distri... cGMP Deviations Class II Unexo Life Sciences Private Limited
Oct 24, 2024 HealthWise PERIOD PATCH Menstrual Pain Relief, Menthol 10%, 10 patches per bo... cGMP Deviations Class II Unexo Life Sciences Private Limited
Oct 23, 2024 Lanthanum Carbonate Chewable Tablets, 1000mg, 10-count bottle, Rx only, Manuf... Failed Tablet/Capsule Specifications: Complaints received of crushed and broken tablets. Class II Cipla USA, Inc.
Oct 23, 2024 Ramipril Capsules USP 5 mg, a) 90 count (NDC 68180-590-09), b) 100 count NDC ... CGMP Deviations: Active pharmaceutical ingredient was sourced from an unapproved vendor Class II Lupin Pharmaceuticals Inc.
Oct 23, 2024 Lanthanum Carbonate Chewable Tablets, 1000mg, 10-count bottle, Rx only, Manuf... Failed Tablet/Capsule Specifications: Complaints received of crushed and broken tablets. Class II Cipla USA, Inc.
Oct 23, 2024 Ramipril Capsules USP 2.5 mg, a) 90 count (NDC 68180-589-09), b) 100 count ND... CGMP Deviations: Active pharmaceutical ingredient was sourced from an unapproved vendor Class II Lupin Pharmaceuticals Inc.
Oct 23, 2024 Ramipril Capsules USP 10 mg, a) 90 count (NDC 68180-591-09), b) 100 count NDC... CGMP Deviations: Active pharmaceutical ingredient was sourced from an unapproved vendor Class II Lupin Pharmaceuticals Inc.
Oct 22, 2024 Morphine Sulfate Extended-Release Tablets 15 mg, 100-count per bottle, Rx On... Failed Impurities/Degradation Specification Class II Dr. Reddy's Laboratories, Inc.
Oct 22, 2024 Morphine Sulfate Extended-Release Tablets 30 mg, 100-count bottles, Rx Only,... Failed Impurities/Degradation Specification Class II Dr. Reddy's Laboratories, Inc.
Oct 21, 2024 Chlorpheniramine Maleate 4 mg tablets, 24-count bottle, Manufactured For: Ath... Superpotent Drug: Stability failure for assay at 6 months test time-point. Class II BLI International, Inc.
Oct 18, 2024 Sunitinib Malate Capsules, 12.5 mg, 28-count bottles, Rx Only, Manufactured f... Labeling: Label Mix-Up Class II AvKARE
Oct 18, 2024 Sunitinib Malate Capsules, 25 mg, 28-count bottles, Rx Only, Manufactured for... Labeling: Label Mix-Up Class II AvKARE
Oct 17, 2024 Perio Maintenance Rinse 0.63% Stannous Fluoride Concentrated Solution, Rx Onl... Subpotent Drug Class II Keystone Industries
Oct 15, 2024 OneLAX Docusate Sodium Liquid (docusate sodium 50 mg/5 mL) Stool Softener Lax... CGMP Deviations Class II Akron Pharma, Inc.
Oct 10, 2024 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
Oct 10, 2024 Cinacalcet Tablets, 90 mg, Rx Only, a) 30 Tablets per bottle, NDC: 16729-442-... CGMP Deviations: the presence of a nitrosamine impurity, N-nitroso-cinacalcet, above the acceptab... Class II ACCORD HEALTHCARE, INC.
Oct 10, 2024 Cinacalcet Tablets, 60 mg, Rx Only, a) 30 Tablets per bottle, NDC: 16729-441-... CGMP Deviations: the presence of a nitrosamine impurity, N-nitroso-cinacalcet, above the acceptab... Class II ACCORD HEALTHCARE, INC.
Oct 10, 2024 Cinacalcet Tablets 30 mg, Rx Only, a) 30 Tablets per bottle, NDC: 16729-440-1... CGMP Deviations: the presence of a nitrosamine impurity, N-nitroso-cinacalcet, above the acceptab... Class II ACCORD HEALTHCARE, INC.
Oct 9, 2024 Cinacalcet Tablets, 30 mg, 30-count bottle, Rx Only, Dr. Reddy's Laboratories... CGMP Deviations: Presence of N-nitroso Cinacalcet impurity above FDA recommended interim limit Class II Dr. Reddy's Laboratories, Inc.
Oct 9, 2024 Cinacalcet Tablets, 60 mg, 30-count bottles, Rx Only, Dr. Reddy's Laboratorie... CGMP Deviations: Presence of N-nitroso Cinacalcet impurity above FDA recommended interim limit Class II Dr. Reddy's Laboratories, Inc.
Oct 9, 2024 Cinacalcet Tablets, 90 mg, 30-count bottle, Rx Only, Dr. Reddy's Laboratories... CGMP Deviations: Presence of N-nitroso Cinacalcet impurity above FDA recommended interim limit Class II Dr. Reddy's Laboratories, Inc.
Oct 8, 2024 LICEOUT, Liquid Lice Treatment for Human Use, Contents: 1 FL. OZ. (29.6 mL) p... CGMP violations. Class II Neogen Corporation
Oct 8, 2024 AK Forte Ortiga y Omega 3 Cont. Neto 100 Tabletas, 400 mg, Marketed without an Approved NDA/ANDA: FDA analysis found the product to be tainted with undeclar... Class II C & A Naturistics
Oct 8, 2024 LICEOUT, Liquid Lice Treatment for Human Use, Contents: 128 FL OZ. (3785.4 mL... CGMP violations. Class II Neogen Corporation
Oct 1, 2024 Cisplatin Injection, 100mg/100mL (1mg/mL), For Intravenous Use, 100 mL Multip... Failed Impurities/Degradation Specifications. Class II ACCORD HEALTHCARE, INC.
Sep 25, 2024 NORepinephrine Bitartrate 0.9% Sodium Chloride Injection USP, 8 mg per 250 mL... cGMP violations Class II Fresenius Kabi Compounding, LLC
Sep 25, 2024 Phenylephrine HCl 0.9% Sodium Chloride Injection USP, 10 mg per 250 mL, Singl... cGMP violations Class II Fresenius Kabi Compounding, LLC
Sep 25, 2024 Phenylephrine HCl 0.9% Sodium Chloride Injection USP, 20 mg per 250 mL, Singl... cGMP violations Class II Fresenius Kabi Compounding, LLC
Sep 25, 2024 EPINEPHrine 0.9% Sodium Chloride Injection USP, 8 mg per 250 mL Single Dose B... cGMP violations Class II Fresenius Kabi Compounding, LLC
Sep 25, 2024 Oxytocin 0.9% Sodium Chloride Injection USP, 30 units per 500 mL Single Dose ... cGMP violations Class II Fresenius Kabi Compounding, LLC
Sep 25, 2024 NORepinephrine Bitartrate 0.9% Sodium Chloride Injection USP, 4 mg per 250 mL... cGMP violations Class II Fresenius Kabi Compounding, LLC
Sep 25, 2024 Vancomycin HCl 750 mg per 250 mL 0.9% Sodium Chloride Injection USP, Single D... cGMP violations Class II Fresenius Kabi Compounding, LLC
Sep 25, 2024 Phenylephrine HCl 0.9% Sodium Chloride Injection USP, 20 mg per 250 mL, Singl... CGMP violations Class II Fresenius Kabi Compounding, LLC
Sep 25, 2024 Phenylephrine HCl 0.9% Sodium Chloride Injection USP, 10 mg per 250 mL, Singl... cGMP violations Class II Fresenius Kabi Compounding, LLC
Sep 25, 2024 Thiamine HCl 0.9% Sodium Chloride Injection USP, 500 mg per 100 mL, Single Do... cGMP violations Class II Fresenius Kabi Compounding, LLC
Sep 24, 2024 Ryaltris (olopatadine hydrochloride and mometasone fluorate) Nasal Spray, 665... Defective Delivery System: The dip tube is clogged causing the spray not to work. Class II Glenmark Pharmaceuticals Inc., USA
Sep 24, 2024 Atorvastatin Calcium Tablets, USP, 40mg, Rx only, 1000 Tablets per bottle, Ma... Presence of Foreign Tablets/Capsules: A Carbamazepine Extended-Release 400 mg tablet was found in... Class II Nivagen Pharmaceuticals Inc
Sep 24, 2024 Dapsone Gel 7.5%, 60 gram pump, Rx Only, Manufactured by: Zydus Lifesciences ... Crystallization Class II VIONA PHARMACEUTICALS INC
Sep 23, 2024 Pluvicto, 1000 MBq/mL (27 mCi/mL), lutetium, LU 177, vipivotide tetraxetan in... CGMP deviations Class II Advanced Accelerator Applications USA, Inc.
Sep 18, 2024 EnviroClean Hand Sanitizer Gel (isopropyl alcohol 70% v/v), 473 mL (16 fl. oz... CGMP deviations Class II EnviroServe Chemicals Inc.
Sep 16, 2024 Refresh P.M., (Mineral Oil 42.5%, White Petrolatum 57.3%) Lubricant Eye Ointm... Lack of Assurance of Sterility: The impacted lots may contain a breach in the tube seal. Class II AbbVie Inc.
Sep 16, 2024 Refresh LACRI-LUBE, (42.5% Mineral Oil, 57.3% White Petrolatum) Lubricant Eye... Lack of Assurance of Sterility: The impacted lots may contain a breach in the tube seal. Class II AbbVie Inc.
Sep 11, 2024 Proparacaine Hydrochloride Ophthalmic Solution, USP 0.5% (sterile), 15 mL bot... Temperature abuse: Products exposed to improper temperature above drug label specifications. Class II Mckesson Medical-Surgical Inc. Corporate Office
Sep 11, 2024 Hylenex recombinant (hyaluronidase) injection, 150 USP units/mL, 4x1 mL Singl... cGMP Deviations: Temperature excursion Class II Mckesson Medical-Surgical Inc. Corporate Office

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.