Browse Drug Recalls
17,897 FDA drug safety recalls.
FDA Drug Recall Enforcement Database
Browse 17,897 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 17,897 FDA drug recalls.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| Feb 9, 2018 | Pentoxifylline USP for prescription compounding, packaged in a) 25g (NDC 585... | CGMP Deviations: Lack of stability data and controls to support the manufacturers assigned retest... | Class II | American Pharmaceutical Ingredients LLC |
| Feb 9, 2018 | Flurbiprofen USP for prescription compounding, packaged in a) 25g (NDC 58597-... | CGMP Deviations: Lack of stability data and controls to support the manufacturers assigned retest... | Class II | American Pharmaceutical Ingredients LLC |
| Feb 9, 2018 | Vancomycin HCl USP for prescription compounding, packaged in a) 25g (NDC 5859... | CGMP Deviations: Lack of stability data and controls to support the manufacturers assigned retest... | Class II | American Pharmaceutical Ingredients LLC |
| Feb 9, 2018 | Naltrexone HCl USP (Dihydrate) for prescription compounding, packaged in a) 1... | CGMP Deviations: Lack of stability data and controls to support the manufacturers assigned retest... | Class II | American Pharmaceutical Ingredients LLC |
| Feb 9, 2018 | Vardenafil HCl USP (trihydrate) for prescription compounding, packaged in a) ... | CGMP Deviations: Lack of stability data and controls to support the manufacturers assigned retest... | Class II | American Pharmaceutical Ingredients LLC |
| Feb 9, 2018 | Sumatriptan USP for prescription compounding, packaged in 10g (NDC 58597-8089... | CGMP Deviations: Lack of stability data and controls to support the manufacturers assigned retest... | Class II | American Pharmaceutical Ingredients LLC |
| Feb 9, 2018 | Levofloxacin Hemihydrate USP for prescription compounding, packaged in a) 100... | CGMP Deviations: Lack of stability data and controls to support the manufacturers assigned retest... | Class II | American Pharmaceutical Ingredients LLC |
| Feb 9, 2018 | Clindamycin Phosphate USP for prescription compounding, packaged in a) 10g (N... | CGMP Deviations: Lack of stability data and controls to support the manufacturers assigned retest... | Class II | American Pharmaceutical Ingredients LLC |
| Feb 9, 2018 | Testosterone (Soy) (Micronized) USP for prescription compounding, packaged in... | CGMP Deviations: Lack of stability data and controls to support the manufacturers assigned retest... | Class II | American Pharmaceutical Ingredients LLC |
| Feb 9, 2018 | Testosterone Enanthate USP for prescription compounding, packaged in a) 25g (... | CGMP Deviations: Lack of stability data and controls to support the manufacturers assigned retest... | Class II | American Pharmaceutical Ingredients LLC |
| Feb 9, 2018 | Estrone USP for prescription compounding, packaged in a) 5 g (NDC 58597-8049... | CGMP Deviations: Lack of stability data and controls to support the manufacturers assigned retest... | Class II | American Pharmaceutical Ingredients LLC |
| Feb 9, 2018 | Lincomycin HCl USP for prescription compounding, packaged in a)100g (NDC 585... | CGMP Deviations: Lack of stability data and controls to support the manufacturers assigned retest... | Class II | American Pharmaceutical Ingredients LLC |
| Feb 9, 2018 | Hydroxyprogesterone Caproate USP for prescription compounding, packaged in a)... | CGMP Deviations: Lack of stability data and controls to support the manufacturers assigned retest... | Class II | American Pharmaceutical Ingredients LLC |
| Feb 9, 2018 | Lidocaine USP for prescription compounding, packaged in a) 25g (NDC 58597-801... | CGMP Deviations: Lack of stability data and controls to support the manufacturers assigned retest... | Class II | American Pharmaceutical Ingredients LLC |
| Feb 9, 2018 | Ursodiol USP for prescription compounding, packaged in a) 100g (NDC 58597-80... | CGMP Deviations: Lack of stability data and controls to support the manufacturers assigned retest... | Class II | American Pharmaceutical Ingredients LLC |
| Feb 9, 2018 | Cyclosporine USP, for prescription compounding, packaged in a) 5g (NDC 58597-... | CGMP Deviations: Lack of stability data and controls to support the manufacturers assigned retest... | Class II | American Pharmaceutical Ingredients LLC |
| Feb 9, 2018 | Celecoxib USP for prescription compounding, packaged in a) 25g (NDC 58597-863... | CGMP Deviations: Lack of stability data and controls to support the manufacturers assigned retest... | Class II | American Pharmaceutical Ingredients LLC |
| Feb 9, 2018 | Lidocaine HCl USP for prescription compounding, packaged in a) 100g (NDC 5859... | CGMP Deviations: Lack of stability data and controls to support the manufacturers assigned retest... | Class II | American Pharmaceutical Ingredients LLC |
| Feb 9, 2018 | Testosterone USP (Micronized) (Yam) for prescription compounding, packaged in... | CGMP Deviations: Lack of stability data and controls to support the manufacturers assigned retest... | Class II | American Pharmaceutical Ingredients LLC |
| Feb 9, 2018 | Amitriptyline HCl USP for prescription compounding , packaged in a) 25 g (NDC... | CGMP Deviations: Lack of stability data and controls to support the manufacturers assigned retest... | Class II | American Pharmaceutical Ingredients LLC |
| Feb 9, 2018 | Estriol USP (Micronized) (Yam) for prescription compounding, packaged in a) ... | CGMP Deviations: Lack of stability data and controls to support the manufacturers assigned retest... | Class II | American Pharmaceutical Ingredients LLC |
| Feb 9, 2018 | Imiquimod USP for prescription compounding, packaged in a) 1g (NDC 58597-8317... | CGMP Deviations: Lack of stability data and controls to support the manufacturers assigned retest... | Class II | American Pharmaceutical Ingredients LLC |
| Feb 9, 2018 | Fluticasone propionate USP (Micronized) for prescription compounding, package... | CGMP Deviations: Lack of stability data and controls to support the manufacturers assigned retest... | Class II | American Pharmaceutical Ingredients LLC |
| Feb 9, 2018 | Anastrozole USP for prescription compounding, packaged in a) 1g ( NDC 58597-8... | CGMP Deviations: Lack of stability data and controls to support the manufacturers assigned retest... | Class II | American Pharmaceutical Ingredients LLC |
| Feb 9, 2018 | Ketoprofen USP (Micronized) for prescription compounding, packaged in a) 25g ... | CGMP Deviations: Lack of stability data and controls to support the manufacturers assigned retest... | Class II | American Pharmaceutical Ingredients LLC |
| Feb 9, 2018 | Diphenhydramine HCl USP f (or prescription compounding , packaged in a) 25g (... | CGMP Deviations: Lack of stability data and controls to support the manufacturers assigned retest... | Class II | American Pharmaceutical Ingredients LLC |
| Feb 9, 2018 | Progesterone USP (Micronized) (Yam) for prescription compounding, packaged i... | CGMP Deviations: Lack of stability data and controls to support the manufacturers assigned retest... | Class II | American Pharmaceutical Ingredients LLC |
| Feb 9, 2018 | Fluconazole USP for prescription compounding, packaged in a) 25g (NDC 58597-8... | CGMP Deviations: Lack of stability data and controls to support the manufacturers assigned retest... | Class II | American Pharmaceutical Ingredients LLC |
| Feb 9, 2018 | Ascorbic Acid USP, for prescription compounding, packaged in a) 100g (NDC 585... | CGMP Deviations: Lack of stability data and controls to support the manufacturers assigned retest... | Class II | American Pharmaceutical Ingredients LLC |
| Feb 9, 2018 | Itraconazole USP (Micronized) for prescription compounding, packaged in a) 1... | CGMP Deviations: Lack of stability data and controls to support the manufacturers assigned retest... | Class II | American Pharmaceutical Ingredients LLC |
| Feb 9, 2018 | Levocetirizine Dihydrochloride for prescription compounding, packaged in a) 2... | CGMP Deviations: Lack of stability data and controls to support the manufacturers assigned retest... | Class II | American Pharmaceutical Ingredients LLC |
| Feb 7, 2018 | Hydromorphone, Hydrochloride, Injection, USP CII, 10 mg/mL, Rx Only, 1 mL Sin... | Non-Sterility: Confirmed customer complaints of glass product container vials that may be empty o... | Class I | Pfizer Inc. |
| Feb 7, 2018 | Hydromorphone, Hydrochloride, Injection, USP CII, 10 mg/mL, Rx Only, 1 mL Sin... | Non-Sterility: Confirmed customer complaints of glass product container vials that may be empty o... | Class I | Pfizer Inc. |
| Feb 7, 2018 | BonaDur For Men (lidocaine) spray, 10 mg per spray, Net Contents .25 fl. oz. ... | CGMP Deviations: not manufactured according to current good manufacturing practices. | Class III | Webrx dba RxPalace.com |
| Feb 5, 2018 | Klonopin (clonazepam) 0.5 mg Tablets,100-count bottle, Rx only. Made in Canad... | Labeling: Not Elsewhere Classified: Schedule IV controlled substance indicator of CIV being omitt... | Class III | Genentech, Inc. |
| Feb 5, 2018 | Azelastine HCl Nasal Solution (Nasal Spray) 0.1% (137 mcg per spray), 30 mL, ... | Sun Pharmaceutical is recalling Azelastine HCl Nasal Solution, 0.1% (30 mL Bottle) following a fa... | Class III | Sun Pharmaceutical Industries, Inc. |
| Feb 5, 2018 | 0.2% Ropivacaine HCI (Preservative Free) in 0.9 Sodium Chloride, Epidural, 25... | Lack of assurance of sterility: Three lots were released where there was a failure to follow prop... | Class II | PharMEDium Services, LLC |
| Feb 5, 2018 | Fluoxetine Tablets USP, 10 mg, 30-count bottle, Rx only, Manufactured in Isra... | Failed impurities/ degradation specifications: Teva Pharmaceuticals USA, Inc. is voluntarily reca... | Class III | Teva Pharmaceuticals USA |
| Feb 5, 2018 | 100 mcg / mL Phenylephrine HCl (Preservative Free) Injection, 10 mL syringe,... | Lack of assurance of sterility: Three lots were released where there was a failure to follow prop... | Class II | PharMEDium Services, LLC |
| Feb 5, 2018 | 15 units Oxytocin added to 0.9% Sodium Chloride Injection, 250 mL Viaflex Bag... | Lack of assurance of sterility: Three lots were released where there was a failure to follow prop... | Class II | PharMEDium Services, LLC |
| Feb 2, 2018 | NORCO (Hydrocodone Bitartrate and Acetaminophen) Tablets, USP, 10 mg/325 mg, ... | Labeling: Not Elsewhere Classified: does not have the required "CII" controlled drug classificati... | Class III | ALLERGAN |
| Feb 2, 2018 | Metformin Hydrochloride Tablets, USP 1000 mg, 500-count bottles, Rx Only, M... | Presence of Foreign Tablet: Metformin BP 1000mg was found in bottle of Metformin HCl 1000mg | Class III | Aurobindo Pharma Ltd. |
| Jan 30, 2018 | VELCADE (bortezomib) for injection, 3.5 mg/vial, Reconstitution Information, ... | Defective Container: Confirmed reports of loose vial crimps. | Class II | Millennium Pharmaceuticals Inc. |
| Jan 29, 2018 | Atorvastatin Calcium Tablets 10 mg, a) 90 count and b) 500 count bottles, Rx ... | Failed Impurities/Degradations Specifications; out-of-specification results observed for Total De... | Class III | Dr. Reddy's Laboratories, Inc. |
| Jan 29, 2018 | Atorvastatin Calcium Tablets 40 mg, 90 count bottles, Rx only, Mfd by: Dr. Re... | Failed Impurities/Degradations Specifications; out-of-specification results observed for Total De... | Class III | Dr. Reddy's Laboratories, Inc. |
| Jan 29, 2018 | Fentanyl Transdermal System. 25 mcg/h, packaged in 5 pouch system cartons (ND... | Failed Impurities/Degradation Specifications: Fentanyl-n-Oxide (FNO) degradant exceeding the spec... | Class III | Teva Pharmaceuticals USA |
| Jan 29, 2018 | Fentanyl Transdermal System, 100 mcg/h, packaged in 5 pouch system (NDC 0591-... | Failed Impurities/Degradation Specifications: Fentanyl-n-Oxide (FNO) degradant exceeding the spec... | Class III | Teva Pharmaceuticals USA |
| Jan 29, 2018 | Fentanyl Transdermal System, 50 mcg/h, packaged in 5 pouch system cartons (ND... | Failed Impurities/Degradation Specifications: Fentanyl-n-Oxide (FNO) degradant exceeding the spec... | Class III | Teva Pharmaceuticals USA |
| Jan 29, 2018 | Megestrol Acetate Oral Suspension, USP 400 mg/ 10mL (10 mL UD cups in boxes o... | Subpotent Drug: Out of specification for assay (stability testing) | Class III | Mckesson Packaging Services |
| Jan 29, 2018 | Atorvastatin Calcium Tablets 20 mg, a) 90 count and b) 500 count bottles, Rx ... | Failed Impurities/Degradations Specifications; out-of-specification results observed for Total De... | Class III | Dr. Reddy's Laboratories, Inc. |
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.