Browse Drug Recalls

3,430 FDA drug safety recalls.

FDA Drug Recall Enforcement Database

Browse 3,430 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 3,430 FDA drug recalls.

Clear
DateProductReasonClassFirm
Nov 1, 2024 Diltiazem Hydrochloride Extended-Release Capsules, USP 120 mg, Rx Only, 100 C... cGMP Deviations: Presence of N-nitroso-Desmethyl-Diltiazem impurity above FDA recommended interim... Class II Glenmark Pharmaceuticals Inc., USA
Nov 1, 2024 Diltiazem Hydrochloride Extended-Release Capsules, USP 90mg, Twice-a-Day Dosa... cGMP Deviations: Presence of N-nitroso-Desmethyl-Diltiazem impurity above FDA recommended interim... Class II Glenmark Pharmaceuticals Inc., USA
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 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 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 LILAS Feminine Pain Relief Patch, Menthol 10%, a) 5 patches per box (UPC 7 87... cGMP Deviations Class II Unexo Life Sciences Private Limited
Oct 24, 2024 THERACARE MAXIMUM STRENGTH PAIN RELIEF 4% LIDOCAINE PATCH, a) 1 patch (NDC 71... 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 ABSORBINE jr. Extra Large BACK PATCH, Menthol 5%, 1 extra large patch per box... 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 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 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 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 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 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 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 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: 128 FL OZ. (3785.4 mL... CGMP violations. Class II Neogen Corporation
Oct 8, 2024 LICEOUT, Liquid Lice Treatment for Human Use, Contents: 1 FL. OZ. (29.6 mL) p... CGMP violations. Class II Neogen Corporation
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 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 Thiamine HCl 0.9% Sodium Chloride Injection USP, 500 mg per 100 mL, Single Do... 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 NORepinephrine Bitartrate 0.9% Sodium Chloride Injection USP, 4 mg per 250 mL... 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 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 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 NORepinephrine Bitartrate 0.9% Sodium Chloride Injection USP, 8 mg per 250 mL... cGMP violations Class II Fresenius Kabi Compounding, LLC
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 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
Aug 5, 2024 HAND-I-SAN, No-Rinse Hand Sanitizer (75% Isopropyl Alcohol), packaged in a) ... CGMP Deviations: sterile water not used for production Class II Zeco LLC
Aug 5, 2024 Rubbing Alcohol (70% Isopropyl Alcohol), First-Aid Antiseptic, packaged in a)... CGMP Deviations: sterile water not used for production Class II Zeco LLC
Jul 22, 2024 Glenmark, Azelaic Acid Gel, 15 %, 50 grams, Rx only, Manufactured by: Glenmar... CGMP Deviations Class II Glenmark Pharmaceuticals Inc., USA
Jul 2, 2024 Decitabine for Injection 50mg per vial, For intravenous infusion only Cytotox... CGMP Deviations: Out of Specification for Total Aerobic Microbial Count (TAMC) test for unfiltere... Class II SUN PHARMACEUTICAL INDUSTRIES INC
Jun 26, 2024 Blemfree All Day Lotion (salicylic acid 0.5% w/w), packaged in a) 1 oz. 29 ML... CGMP Deviations: Manufactured without following Current Good Manufacturing Practises. Class II Equibal Inc
Jun 26, 2024 Budesonide, USP (Micronized), 500 mg, White to off-white odorless, crystallin... CGMP Deviations and Presence of Particulate Matter: Glass Class II Medisca Inc.
Jun 26, 2024 Potassium Chloride Micro 10mEq K (750 mg) Extended Release Capsules, 30-count... CGMP Deviations: Out of specification for dissolution Class II RemedyRepack Inc.
Jun 20, 2024 Little Moon Essentials, Aching Head Rub (Camphor 3.09%, Menthol 2.55%) , a) 0... CGMP deviations Class II Little Moon Essentials LLC
Jun 20, 2024 Little Moon Essentials, Magical Muscle Oil, (Camphor 1.95%, Menthol 3.75%) pa... CGMP deviations Class II Little Moon Essentials LLC
Jun 20, 2024 Little Moon Essentials, Dream Cream (Camphor 0.45%, Menthol 5%), Packaged as ... CGMP deviations Class II Little Moon Essentials LLC
Jun 20, 2024 Little Moon Essentials, Asana Kisser, (Camphor 1.35%, Menthol 2.86%), Package... CGMP deviations Class II Little Moon Essentials 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.