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 |
|---|---|---|---|---|
| Jan 18, 2017 | Nystatin Oral Suspension, USP 100,000 units per mL, a) 2 fl. oz. (60 mL), 24 ... | CGMP Deviations: Purified water used to manufacture the drug products may have been contaminated ... | Class II | VistaPharm, Inc. |
| Dec 15, 2016 | Gentell Hydrogel Wound Dressing REGULAR, 4 oz. tube, Manufactured by: Gentell... | CGMP Deviations | Class II | Gentell, Inc |
| Dec 15, 2016 | Gentell Hydrogel Ag Saturated Gauze, 2"x2"(NDC 61551-112-20), 4x4(NDC 61554-... | CGMP Deviations | Class II | Gentell, Inc |
| Dec 14, 2016 | Torsemide Tablets, 5 mg 100-count bottle, Rx only ,Manufactured by: Apotex In... | CGMP Deviations | Class II | Apotex Corp. |
| Dec 14, 2016 | Torsemide Tablets, 20 mg 100-count bottle, Rx only, Manufactured by: Apotex I... | CGMP Deviations | Class II | Apotex Corp. |
| Dec 12, 2016 | Virt-Select Prenatal/Postnatal Softgels, Prescription Multivitamin/Mineral Di... | cGMP Deviations: Active Pharmaceutical Ingredient (API) manufacturer is on FDA Import Alert. | Class III | VIRTUS PHARMACEUTICALS OPCO II L |
| Dec 12, 2016 | Extra-Virt Plus DHA Prenatal/Postnatal Softgel, Prescription Multivitamin/Min... | cGMP Deviations: Active Pharmaceutical Ingredient (API) manufacturer is on FDA Import Alert. | Class III | VIRTUS PHARMACEUTICALS OPCO II L |
| Dec 12, 2016 | Virt-Advance Prenatal/Postnatal Softgels, Prescription Folic Acid Containing ... | cGMP Deviations: Active Pharmaceutical Ingredient (API) manufacturer is on FDA Import Alert. | Class III | VIRTUS PHARMACEUTICALS OPCO II L |
| Dec 12, 2016 | VirtPrex Prenatal/Postnatal Tablets, Prescription Supplement Containing Folic... | cGMP Deviations: Active Pharmaceutical Ingredient (API) manufacturer is on FDA Import Alert. | Class III | VIRTUS PHARMACEUTICALS OPCO II L |
| Nov 18, 2016 | Kids' Relief Ear Relief Oral Liquid 0.85 fl oz. (25 mL) 3025 de'l Assomption... | CGMP Deviations | Class II | Raritan Pharmaceuticals, Inc. |
| Nov 18, 2016 | CVS pharmacy Kids' Ear Relief Oral Liquid 0.85 oz (25 mL) Distributed by: CVS... | CGMP Deviations | Class II | Raritan Pharmaceuticals, Inc. |
| Nov 18, 2016 | CVS Health Homeopathic Infants Teething Tablets 135 count bottle Distributed... | CGMP Deviations | Class II | Raritan Pharmaceuticals, Inc. |
| Oct 28, 2016 | Phenazopyridine Hydrochloride Tablets, USP, 200 mg, 100 count bottles, Rx onl... | CGMP Deviations: manufactured under practices which may result in assay or content uniformity fai... | Class II | Nationwide Laboratories, LLC |
| Oct 28, 2016 | Phenazopyridine Hydrochloride Tablets, USP, 100 mg, 100 count bottles, Rx onl... | CGMP Deviations: manufactured under practices which may result in assay or content uniformity fai... | Class II | Nationwide Laboratories, LLC |
| Oct 28, 2016 | Salsalate Tablets, USP, 500 mg, packaged in a) 500 count bottles (NDC 42937-7... | CGMP Deviations: manufactured under practices which may result in assay or content uniformity fai... | Class II | Nationwide Laboratories, LLC |
| Oct 28, 2016 | Salsalate Tablets, USP, 750 mg, packaged in a) 100 count bottles (NDC 42937-7... | CGMP Deviations: manufactured under practices which may result in assay or content uniformity fai... | Class II | Nationwide Laboratories, LLC |
| Oct 24, 2016 | Phenazopyridine Hydrochloride Tablets, USP, 200 mg, 100 count bottles, Rx onl... | CGMP Deviations; deficiencies at the manufacturer may result in assay or content uniformity fail... | Class II | Burel Pharmaceuticals Inc |
| Oct 24, 2016 | AZUPHEN MB URINARY ANTISEPTIC Capsules, Each capsule contains: Methenamine 1... | CGMP Deviations; deficiencies at the manufacturer may result in assay or content uniformity fail... | Class II | Burel Pharmaceuticals Inc |
| Oct 24, 2016 | Phenazopyridine Hydrochloride Tablets, USP, 100 mg, 100 count bottles, Rx onl... | CGMP Deviations; deficiencies at the manufacturer may result in assay or content uniformity fail... | Class II | Burel Pharmaceuticals Inc |
| Oct 24, 2016 | URAMIT MB URINARY ANTISEPTIC Capsules, Each capsule contains: Methenamine 11... | CGMP Deviations; deficiencies at the manufacturer may result in assay or content uniformity fail... | Class II | Burel Pharmaceuticals Inc |
| Oct 24, 2016 | Hyolev MB URINARY ANTISEPTIC Tablets, Each tablet for oral administration con... | CGMP Deviations; deficiencies at the manufacturer may result in assay or content uniformity fail... | Class II | Burel Pharmaceuticals Inc |
| Oct 24, 2016 | Indiomin MB URINARY ANTISEPTIC, ANTISPASMODIC Capsules, Each capsule contains... | CGMP Deviations; deficiencies at the manufacturer may result in assay or content uniformity fail... | Class II | Burel Pharmaceuticals Inc |
| Oct 24, 2016 | UROPHEN MB URINARY ANTISEPTIC Tablets, Each tablet contains: Methenamine 81.... | CGMP Deviations; deficiencies at the manufacturer may result in assay or content uniformity fail... | Class II | Burel Pharmaceuticals Inc |
| Oct 24, 2016 | UROLET MB URINARY ANTISEPTIC, ANTISPASMODIC Tablets, Each tablet contains: M... | CGMP Deviations; deficiencies at the manufacturer may result in assay or content uniformity fail... | Class II | Burel Pharmaceuticals Inc |
| Aug 8, 2016 | Diocto Syrup (docusate sodium), 60 mg/15 mL, One Pint (473 mL) bottle, Dist. ... | CGMP Deviations: Recall initiated as a precautionary measure due to a potential risk of product c... | Class II | Pharmatech LLC |
| Aug 8, 2016 | Sennazon (sennosides) Syrup, 8.8 mg, 8 fl. oz. (237 mL) bottle, Mfd. for: Bay... | CGMP Deviations: Recall initiated as a precautionary measure due to a potential risk of product c... | Class II | Pharmatech LLC |
| Aug 8, 2016 | Aller-Chlor (chlorpheniramine maleate) Syrup, USP, 2 mg in each 5 mL, 4 fl oz... | CGMP Deviations: Recall initiated as a precautionary measure due to a potential risk of product c... | Class II | Pharmatech LLC |
| Aug 8, 2016 | Ninjacof (chlophedianol HCl and pyrilamine maleate) Liquid, 12.5 mg/12.5 mg i... | CGMP Deviations: Recall initiated as a precautionary measure due to a potential risk of product c... | Class II | Pharmatech LLC |
| Aug 8, 2016 | Senexon Liquid (sennosides) 8.8 mg, 8 fl oz. (237 mL) bottle, Distributed by:... | CGMP Deviations: Recall initiated as a precautionary measure due to a potential risk of product c... | Class II | Pharmatech LLC |
| Aug 8, 2016 | Ninjacof-A (acetaminophen, chlophedianol HCl, pyrilamine maleate) Liquid, 160... | CGMP Deviations: Recall initiated as a precautionary measure due to a potential risk of product c... | Class II | Pharmatech LLC |
| Aug 8, 2016 | Senna Syrup (sennosides) 8.8 mg, 8 fl. oz. (237 mL) bottle, Distributed by: M... | CGMP Deviations: Recall initiated as a precautionary measure due to a potential risk of product c... | Class II | Pharmatech LLC |
| Jul 29, 2016 | 2% Chlorhexidine Gluconate* Cloth, 2 disposable cloths per package, further p... | CGMP Deviations: potential contamination of products manufactured on the same equipment and lines... | Class II | Sage Products LLC |
| Jul 29, 2016 | Amikacin Sulfate Injection, USP, 500 mg/2 mL (250 mg/mL) Rx Only, Manufacture... | CGMP Deviations | Class II | Teva Pharmaceuticals USA |
| Jul 29, 2016 | COMFORT SHIELD (dimethicone) Barrier Cream Cloths, 3%, packaged as impregnate... | CGMP Deviations: potential contamination of products manufactured on the same equipment and lines... | Class II | Sage Products LLC |
| Jul 29, 2016 | Amikacin Sulfate Injection, USP, 1 gm/4 mL (250 mg/mL) Rx Only, Manufactured ... | CGMP Deviations | Class II | Teva Pharmaceuticals USA |
| Jul 7, 2016 | Calcium Carbonate 600mg/Vitamin D3 400 International Units tablets, 60-count ... | CGMP Deviations | Class II | Safecor Health, LLC |
| Jul 7, 2016 | Acetaminophen 325mg tablets, 120-count bottles, Pk By Safecor Health Woburn, ... | CGMP Deviations | Class II | Safecor Health, LLC |
| Jul 7, 2016 | Atorvastatin Calcium 40mg Tablet, 30-count bottles, Rx only, Pk By Safecor He... | CGMP Deviations | Class II | Safecor Health, LLC |
| Jul 7, 2016 | Doxycycline100mg Tablets, 14-count bottles, Rx only, Packaged By Safecor Heal... | CGMP Deviations | Class II | Safecor Health, LLC |
| Jul 7, 2016 | Acyclovir 400mg Tablet, 15-count bottles, Rx only, Packaged by Safecor Health... | CGMP Deviations | Class II | Safecor Health, LLC |
| Jul 7, 2016 | Metronidazole 500mg Tablet, 50-count bottles, Rx only, Packaged By Safecor He... | CGMP Deviations | Class II | Safecor Health, LLC |
| Jun 17, 2016 | ARGATROBAN Injection in 0.9% Sodium Chloride 250 mg/250 mL (1 mg/mL) , Rx Onl... | CGMP Deviations | Class II | Teva North America |
| Jun 17, 2016 | Linezolid Injection 600 mg/300 mL Rx Only, Manufactured in Hungary for TEVA P... | CGMP Deviations | Class II | Teva North America |
| Jun 17, 2016 | Eptifibatide Injection 75 mg/100 mL (0.75 mg/mL) single use vial, For Intrave... | CGMP Deviations | Class II | Teva North America |
| Jun 17, 2016 | Ondansetron Injection USP 40 mg/20 mL (2 mg/mL), Rx Only, Manufactured in Hun... | CGMP Deviations | Class II | Teva North America |
| Jun 1, 2016 | CEFTRIAXONE for Injection USP, 250mg/vial, Rx only, MFG: LUPIN LIMITED INDIA,... | CGMP Deviations: Out of specification (OOS) intermediate in the subsequent processes to manufactu... | Class III | Aidarex Pharmaceuticals LLC |
| May 18, 2016 | Mycophenolate Mofetil, Bulk Powder, Quantity 1000 g, For prescription compoun... | cGMP deviation; manufacturer is Not Registered with the Food and Drug Administration | Class III | Attix Pharmaceuticals Inc |
| May 11, 2016 | 1% Clotrimazol cream, 30 mg tube, UPC 501318644335 | CGMP Deviations | Class II | Profarma Distributors LLC |
| May 11, 2016 | VERMOX Tablets 500 mg, 1-count box, UPC 501109900596 | CGMP Deviations | Class II | Profarma Distributors LLC |
| May 11, 2016 | tabcin ACTIVE M.R. Capsules, 12-count box , UPC 7501008485057 | CGMP Deviations | Class II | Profarma Distributors 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.