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.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| Sep 23, 2019 | DrKids Children's Natural Cough Syrup English Ivy Leaf, packaged in Pre-measu... | CGMP Deviations: Recall as a precautionary measure due to potential risk of product contamination... | Class II | Unipharma, Llc. |
| Sep 19, 2019 | Losartan Potassium/ Hydrochlorothiazide Tablets, USP 100mg/25mg, 90 tablets p... | CGMP Deviations: FDA lab confirmed presence of an impurity, N-Methylnitrosobutyric acid (NMBA) in... | Class II | Torrent Pharma Inc. |
| Sep 19, 2019 | Losartan Potassium /Hydrochlorothiazide Tablets, USP 50mg/12.5mg, 90 tablets ... | CGMP Deviations: FDA lab confirmed presence of an impurity, N-Methylnitrosobutyric acid (NMBA) in... | Class II | Torrent Pharma Inc. |
| Sep 19, 2019 | Losartan Potassium Tablets, USP 50mg, 1000 tablets per bottle, Rx Only, Manuf... | CGMP Deviations: FDA lab confirmed presence of an impurity, N-Methylnitrosobutyric acid (NMBA) in... | Class II | Torrent Pharma Inc. |
| Sep 19, 2019 | Losartan Potassium Tablets, USP 100 mg, [90 or 1000] tablets per bottle, Rx O... | CGMP Deviations: FDA lab confirmed presence of an impurity, N-Methylnitrosobutyric acid (NMBA) in... | Class II | Torrent Pharma Inc. |
| Sep 17, 2019 | Lidocaine Hydroclhoride Jelly USP, 2%, 30 mL tubes, Rx Only, Sterile, Manufac... | cGMP Deviations: firm reported finding metal particulate matter in the filling room near the tub... | Class II | Akorn, Inc. |
| Sep 12, 2019 | Fentanyl Citrate USP, Active Pharmaceutical Ingredient, Spectrum Chemical MFG... | CGMP Deviations: Received notice from supplier that there is potential glass contamination. | Class II | Spectrum Laboratory Products |
| Sep 4, 2019 | Pantoprazole Sodium Delayed Release Tablets, USP, 40 mg, packaged in 90-count... | CGMP Deviation: Presence of dark brown discoloration on edges of tablets. | Class II | Jubilant Cadista Pharmaceuticals, Inc. |
| Aug 29, 2019 | Fentanyl Citrate Active Pharmaceutical Ingredient, Johnson Matthey Pharmaceut... | cGMP Deviations: Potential glass contamination | Class II | Johnson Matthey Inc. |
| Aug 29, 2019 | Cisplatin Active Pharmaceutical Ingredient, Johnson Matthey Pharmaceutical Ma... | cGMP Deviations: Potential glass contamination | Class II | Johnson Matthey Inc. |
| Aug 29, 2019 | Oxaliplatin Active Pharmaceutical Ingredient, Johnson Matthey Pharmaceutical ... | cGMP Deviations: Potential glass contamination | Class II | Johnson Matthey Inc. |
| Jul 26, 2019 | Clear Eyes Assorted IRC Display; each display contains 6 each of a) Clear eye... | CGMP Deviations: concerns regarding the sufficiency of Quality Assurance controls over critical s... | Class II | Medtech Products, Inc. |
| Jul 26, 2019 | Clear Eyes Assorted Sidekick Floor Stand Display; each display contains 6 eac... | CGMP Deviations: concerns regarding the sufficiency of Quality Assurance controls over critical s... | Class II | Medtech Products, Inc. |
| Jul 26, 2019 | Clear Eyes Maximum Itchy Eye Relief Sidekick Floor Stand Display; each displa... | CGMP Deviations: concerns regarding the sufficiency of Quality Assurance controls over critical s... | Class II | Medtech Products, Inc. |
| Jul 26, 2019 | Clear Eyes Redness Relief Handy Pocket Pal Club Pak Display; each display (ca... | CGMP Deviations: concerns regarding the sufficiency of Quality Assurance controls over critical s... | Class II | Medtech Products, Inc. |
| Jul 26, 2019 | Clear eyes REDNESS RELIEF (Glycerin 0.25%, Naphazoline hydrochloride 0.012%) ... | CGMP Deviations: concerns regarding the sufficiency of Quality Assurance controls over critical s... | Class II | Medtech Products, Inc. |
| Jul 26, 2019 | Clear Eyes Redness Relief Club Pack Display; each display contains 18 3-Pack ... | CGMP Deviations: concerns regarding the sufficiency of Quality Assurance controls over critical s... | Class II | Medtech Products, Inc. |
| Jul 26, 2019 | Clear Eyes Maximum Redness Relief Club Pack Display; each display contains 18... | CGMP Deviations: concerns regarding the sufficiency of Quality Assurance controls over critical s... | Class II | Medtech Products, Inc. |
| Jul 26, 2019 | Clear Eyes Maximum Itchy Eye Relief Sidekick Floor Stand Display; each displa... | CGMP Deviations: concerns regarding the sufficiency of Quality Assurance controls over critical s... | Class II | Medtech Products, Inc. |
| Jul 26, 2019 | Clear eyes REDNESS RELIEF (Glycerin 0.25%, Naphazoline hydrochloride 0.012%) ... | CGMP Deviations: concerns regarding the sufficiency of Quality Assurance controls over critical s... | Class II | Medtech Products, Inc. |
| Jul 26, 2019 | Clear eyes REDNESS RELIEF (Glycerin 0.25%, Naphazoline hydrochloride 0.012%) ... | CGMP Deviations: concerns regarding the sufficiency of Quality Assurance controls over critical s... | Class II | Medtech Products, Inc. |
| Jul 26, 2019 | Clear eyes MAXIMUM REDNESS RELIEF (Glycerin 0.5%, Naphazoline hydrochloride 0... | CGMP Deviations: concerns regarding the sufficiency of Quality Assurance controls over critical s... | Class II | Medtech Products, Inc. |
| Jul 26, 2019 | Clear Eyes Redness Relief Hand Pocket Pal Tray Display; each display (UPC 6 7... | CGMP Deviations: concerns regarding the sufficiency of Quality Assurance controls over critical s... | Class II | Medtech Products, Inc. |
| Jul 26, 2019 | Clear eyes MAXIMUM ITCHY EYE RELIEF (Glycerin 0.25%, Naphazoline hydrochlorid... | CGMP Deviations: concerns regarding the sufficiency of Quality Assurance controls over critical s... | Class II | Medtech Products, Inc. |
| Jul 26, 2019 | Clear Eyes Maximum Redness and Itchy Eye Relief Sidekick Display; each displa... | CGMP Deviations: concerns regarding the sufficiency of Quality Assurance controls over critical s... | Class II | Medtech Products, Inc. |
| Jul 18, 2019 | Neomycin Sulfate 3.5 mg/Polymyxin B Sulfate 10,000 units/Dexamethasone 1 mg ... | CGMPs Deviations: Insufficient Quality Assurance controls over critical systems in the manufactur... | Class II | Preferred Pharmaceuticals, Inc |
| Jul 16, 2019 | Temozolomide Capsules, 180 mg, packaged in a) 5-count bottle (NDC 67877-541-0... | CGMP Deviations: product was manufactured that did not prevent possible cross contamination with ... | Class II | Deva Holding AS - Cerkezkoy Subesi |
| Jul 16, 2019 | Temozolomide Capsules, 100 mg, packaged in a) 5-count bottle (NDC 67877-539-0... | CGMP Deviations: product was manufactured that did not prevent possible cross contamination with ... | Class II | Deva Holding AS - Cerkezkoy Subesi |
| Jul 16, 2019 | Temozolomide Capsules, 20 mg, packaged in a) 5-count bottle (NDC 67877-538-07... | CGMP Deviations: product was manufactured that did not prevent possible cross contamination with ... | Class II | Deva Holding AS - Cerkezkoy Subesi |
| Jul 16, 2019 | Temozolomide Capsules, 250 mg, 5-count bottle, Rx only, Manufactured by: Deva... | CGMP Deviations: product was manufactured that did not prevent possible cross contamination with ... | Class II | Deva Holding AS - Cerkezkoy Subesi |
| Jul 16, 2019 | Temozolomide Capsules, 140 mg, packaged in a) 5-count bottle (NDC 67877-540-0... | CGMP Deviations: product was manufactured that did not prevent possible cross contamination with ... | Class II | Deva Holding AS - Cerkezkoy Subesi |
| Jul 16, 2019 | Temozolomide Capsules, 5 mg, packaged in a) 5-count bottle (NDC 67877-537-07)... | CGMP Deviations: product was manufactured that did not prevent possible cross contamination with ... | Class II | Deva Holding AS - Cerkezkoy Subesi |
| Jul 15, 2019 | DrKids Children's Allergy Relief Diphenhydramine HCl 12.5 mg/5 mL Antihistami... | CGMP Deviations: Recall as a precautionary measure due to potential risk of product contamination... | Class II | Unipharma, Llc. |
| Jul 15, 2019 | CVS Health Children's Allergy Relief Liquid Medication Diphenhydramine HCl 12... | CGMP Deviations: Recall as a precautionary measure due to potential risk of product contamination... | Class II | Unipharma, Llc. |
| Jul 15, 2019 | CVS Health Children's Nasal Saline Drops with Himalayan Salt Saline Nasal Moi... | CGMP Deviations: Recall as a precautionary measure due to potential risk of product contamination... | Class II | Unipharma, Llc. |
| Jul 12, 2019 | Prostatin Capsules, Distributed by Herbal Doctor Remedies Alhambra, CA 91801-... | CGMP Deviations: Products were manufactured outside of the controls required by current Good Manu... | Class II | Herbal Doctor Remedies |
| Jul 12, 2019 | Edema Off Capsules, Distributed by Herbal Doctor Remedies Alhambra, CA 91801-... | CGMP Deviations: Products were manufactured outside of the controls required by current Good Manu... | Class II | Herbal Doctor Remedies |
| Jul 12, 2019 | Fungo Off Capsules, Distributed by Herbal Doctor Remedies, Alhambra, CA 91801... | CGMP Deviations: Products were manufactured outside of the controls required by current Good Manu... | Class II | Herbal Doctor Remedies |
| Jul 12, 2019 | Lung Tonic EX Capsules, Distributed by Herbal Doctor Remedies Alhambra, CA 91... | CGMP Deviations: Products were manufactured outside of the controls required by current Good Manu... | Class II | Herbal Doctor Remedies |
| Jul 12, 2019 | Detensin, 500 mg Capsules, 90-count bottles, Herbal Doctor Remedies Alhambra,... | CGMP Deviations: Products were manufactured outside of the controls required by current Good Manu... | Class II | Herbal Doctor Remedies |
| Jul 12, 2019 | Smoke End Capsules,Distributed Herbal Doctor Remedies Alhambra, CA 91801-7081... | CGMP Deviations: Products were manufactured outside of the controls required by current Good Manu... | Class II | Herbal Doctor Remedies |
| Jul 12, 2019 | Stomach Flu Capsules, Distributed by Herbal Doctor Remedies Alhambra, CA 9180... | CGMP Deviations: Products were manufactured outside of the controls required by current Good Manu... | Class II | Herbal Doctor Remedies |
| Jul 12, 2019 | Herpes-V Balm, Distributed by Herbal Doctor Remedies Alhambra, CA 91801-7081 ... | CGMP Deviations: Products were manufactured outside of the controls required by current Good Manu... | Class II | Herbal Doctor Remedies |
| Jul 12, 2019 | Worm Off, 500 mg Capsules, 90-count bottles, Herbal Doctor Remedies Alhambra,... | CGMP Deviations: Products were manufactured outside of the controls required by current Good Manu... | Class II | Herbal Doctor Remedies |
| Jul 12, 2019 | Dragon Pain Oil, Distributed by Herbal Doctor Remedies Alhambra, CA 91801-708... | CGMP Deviations: Products were manufactured outside of the controls required by current Good Manu... | Class II | Herbal Doctor Remedies |
| Jul 12, 2019 | Herpes-S, 500 mg Capsules, 90-count bottles, Herbal Doctor Remedies Alhambra,... | CGMP Deviations: Products were manufactured outside of the controls required by current Good Manu... | Class II | Herbal Doctor Remedies |
| Jul 12, 2019 | Baby Saver Capsules, Distributed by Herbal Doctor Remedies Alhambra, CA 91801... | CGMP Deviations: Products were manufactured outside of the controls required by current Good Manu... | Class II | Herbal Doctor Remedies |
| Jul 12, 2019 | Asma Stopper Capsules, Distributed by Herbal Doctor Remedies, Alhambra, CA 91... | CGMP Deviations: Products were manufactured outside of the controls required by current Good Manu... | Class II | Herbal Doctor Remedies |
| Jul 12, 2019 | Anemia Off, Distributed by Herbal Doctor Remedies, Alhambra, CA 91801-7081 US... | CGMP Deviations: Products were manufactured outside of the controls required by current Good Manu... | Class II | Herbal Doctor Remedies |
| Jul 12, 2019 | Lung Fixer Capsules, Distributed by Herbal Doctor Remedies Alhambra, CA 91801... | CGMP Deviations: Products were manufactured outside of the controls required by current Good Manu... | Class II | Herbal Doctor Remedies |
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.