Browse Drug Recalls
3,368 FDA drug safety recalls.
FDA Drug Recall Enforcement Database
Browse 3,368 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 3,368 FDA drug recalls.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| 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 |
| Jun 20, 2024 | Little Moon Essentials, Clear Breeze Plus, Hand Sanitizer (Alcohol 65% v/v) P... | CGMP deviations | Class II | Little Moon Essentials LLC |
| Jun 20, 2024 | Little Moon Essentials, Vital Vapor Balm, (Camphor 0.6%, Menthol 5.2%) Packag... | CGMP deviations | Class II | Little Moon Essentials LLC |
| Jun 20, 2024 | Little Moon Essentials, Ass Kisser, Packaged as a) 0.5 OZ (14G) metal tin, UP... | CGMP deviations | Class II | Little Moon Essentials LLC |
| Jun 20, 2024 | Little Moon Essentials, Crampy Belly Rub (Camphor 1.1%), Packaged as a) 4 FL ... | CGMP deviations | Class II | Little Moon Essentials LLC |
| May 30, 2024 | Potassium Chloride Extended-Release Capsules, USP, (750 mg) 10 mEq K, 500-cou... | CGMP Deviations | Class II | Glenmark Pharmaceuticals Inc., USA |
| May 30, 2024 | Potassium Chloride Extended-Release Capsules, USP, (750 mg) 10 mEq K, 100-cou... | CGMP Deviations | Class II | Glenmark Pharmaceuticals Inc., USA |
| May 28, 2024 | Little Remedies Gas Relief Drops (Simethicone/Antigas), packaged in 1 fl. oz.... | cGMP deviations: Test results confirmed aypical Burkholderia Cepacia were a result of personnel e... | Class II | Denison Pharmaceuticals, LLC |
| May 24, 2024 | suntegrity, (Zinc Oxide 15%) IMPECCABLE SKIN sunscreen foundation, Multiple S... | CGMP Deviations | Class II | SYNCHRONICITY SPA INC, DBA SUNTE |
| May 17, 2024 | Duloxetine Delayed-Release Capsules, USP, 60mg, 90-count bottle, Rx Only, Mf... | CGMP Deviations: Presence of N-nitroso-duloxetine impurity above FDA recommended interim limit | Class II | Breckenridge Pharmaceutical, Inc |
| May 13, 2024 | Duloxetine Delayed-Release Capsules, USP, 30mg, Rx Only, a) 30 capsules bottl... | CGMP Deviations: Presence of Nitrosamine Drug Substance Related Impurity (NDSRI), N-nitroso-dulox... | Class II | Golden State Medical Supply Inc. |
| May 13, 2024 | Rizatriptan Benzoate Orally Disintegrating Tablets, USP 5mg, 18 (3 x 6) Unit-... | CGMP Deviations: N-Nitroso Desmethyl Rizatriptan Impurity results that are above the FDA acceptab... | Class II | Glenmark Pharmaceuticals Inc., USA |
| May 13, 2024 | Rizatriptan Benzoate Orally Disintegrating Tablets, USP 10mg, 18 (3 x 6) Unit... | CGMP Deviations: N-Nitroso Desmethyl Rizatriptan Impurity results that are above the FDA acceptab... | 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.