Browse Drug Recalls
1,020 FDA drug safety recalls.
FDA Drug Recall Enforcement Database
Browse 1,020 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 1,020 FDA drug recalls.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| Apr 15, 2020 | Cefixime for Oral Suspension USP, 100mg/5mL, Rx Only, Manufactured for: Lupin... | Subpotent Drug: low out of specification (OOS) test result observed in long term stability study. | Class II | Lupin Pharmaceuticals Inc. |
| Mar 19, 2020 | DRAXIMAGE DTPA (KIT FOR THE PREPARATION OF TECHNETIUM TC 99M PENTETATE INJECT... | Failed Stability Specifications | Class II | Jubilant Draximage Inc |
| Feb 24, 2020 | Zoledronic Acid Injection 5 mg/100 mL (0.05 mg/mL), Solution for Intravenous ... | Failed Impurities/Degradation Specifications: Out-of-specification results obtained for impuritie... | Class III | Breckenridge Pharmaceutical, Inc |
| Feb 20, 2020 | Mesalamine Delayed-Release Tablets, USP, 1.2 gram, 120-count bottle, Rx Only,... | Failed Dissolution Specifications: Low out of specification dissolution result observed during st... | Class II | Teva Pharmaceuticals USA |
| Feb 12, 2020 | Memantine Hydrochloride Extended Release Capsules, 21 mg, 30-count bottles, R... | Failed Dissolution Specifications: Low out of specification results observed in dissolution test ... | Class II | Lupin Pharmaceuticals Inc. |
| Dec 13, 2019 | Memantine Hydrochloride Extended-release Capsules, 28mg, packaged in 100-coun... | Failed Dissolution Specifications: High out of specification result observed at stability studies. | Class III | The Harvard Drug Group |
| Dec 10, 2019 | Memantine Hydrochloride Extended-release Capsules, 28mg, packaged in a) 90-co... | Failed Dissolution Specifications: High out of specification result observed at stability studies. | Class III | Lupin Pharmaceuticals Inc. |
| Dec 4, 2019 | Raloxifene Hydrochloride Tablets, USP, 60 mg, 30 Tablets (3 x 10 blister card... | Failed Dissolution Specifications: Low out of specification results obtained during stability tes... | Class II | American Health Packaging |
| Nov 4, 2019 | Valganciclovir Hydrochloride for Oral Solution, 50 mg/mL, 100 mL (3.4 fl. oz.... | Presence of foreign substance: Brown/black particles found during stability testing. | Class II | Teva Pharmaceuticals USA, Inc. |
| Oct 30, 2019 | Potassium Phosphate, Monobasic, Crystal, NF, Multi-Compendial, Bulk Pharmaceu... | Failed Stability Specifications: Product exceeds compendia and firm's specifications for iron con... | Class II | Avantor Performance Materials Inc |
| Sep 6, 2019 | Anagrelide Capsules, USP, 0.5 mg, 100-count bottle, Rx only, Manufactured in... | Failed Impurities/Degradation Specifications: High Out Of Specification results for impurities de... | Class II | Torrent Pharma Inc. |
| Aug 28, 2019 | AVKARE Fexofenadine Hydrochloride Tablets USP Antihistamine 180 mg, 500 Table... | Failed Stability Specifications. | Class II | AVKARE Inc. |
| Aug 21, 2019 | Pramipexole Dihydrochloride Tablets 0.125 mg,90-count bottle, Rx Only, Manufa... | Subpotent Drug: Out of specification result during stability study in Pramipexole Dihydrochloride... | Class III | Macleods Pharma Usa Inc |
| Jul 17, 2019 | Nystatin and Triamcinolone Acetonide Cream USP100,000 units/g, 0.1%, 15 g tub... | Failed Content Uniformity Specifications: Out-of-specification result observed in uniformity of c... | Class III | Lupin Pharmaceuticals Inc. |
| Jul 11, 2019 | Hydrocodone Polistirex and Chlorpheniramine Polistirex Extended-Release Suspe... | Superpotent Drug and Failed Stability Specifications: High out-of-specification results for the a... | Class II | Tris Pharma Inc. |
| Jul 9, 2019 | Drospirenone and Ethinyl Estradiol Tablets, USP, 3 mg/0.02 mg, packaged into ... | Failed dissolution specifications : failed results at the 3-month stability time point. | Class I | Jubilant Cadista Pharmaceuticals, Inc. |
| Jul 2, 2019 | Kaitlib Fe norethindrone and ethinyl estradiol chewable tablets (0.8 mg/0.025... | Failed Impurities/Degradation Specifications: Kaitlib Fe Tablets has an out of specification resu... | Class II | Lupin Pharmaceuticals Inc. |
| Jun 21, 2019 | ARMY HEALTH With CURCUMIN (Menthol 3.00%) Pain Reliever Roll-On, 2.5 FL OZ (7... | CGMP Deviations: products were manufactured with lack of process validation, cleaning validation,... | Class II | Pharma-Natural Inc. |
| Jun 21, 2019 | Oliver's Harvest CBD+Capsaicin 0.2% Pain Relief (Capsaicin 0.2%) Topical Anal... | CGMP Deviations: products were manufactured with lack of process validation, cleaning validation,... | Class II | Pharma-Natural Inc. |
| Jun 21, 2019 | Dermanak original crema blanqueador (Hydroquinone 2%) Skin Fade Cream, 2 OZ. ... | CGMP Deviations: products were manufactured with lack of process validation, cleaning validation,... | Class II | Pharma-Natural Inc. |
| Jun 21, 2019 | NEOGEN-D (Dextromethorphan HBr, 30 mg; Guaifenesin, 200 mg; Phenylephrine HCl... | CGMP Deviations: products were manufactured with lack of process validation, cleaning validation,... | Class II | Pharma-Natural Inc. |
| Jun 21, 2019 | Lido E.R. (Lidocaine HCL 4%) Pain Relieving Topical Analgesic Cream, 4 oz (11... | CGMP Deviations: products were manufactured with lack of process validation, cleaning validation,... | Class II | Pharma-Natural Inc. |
| Jun 21, 2019 | TUSSLIN (Dextromethorphan HBr, 28 mg; Guaifenesin, 388 mg; Phenylephrine HCl,... | CGMP Deviations: products were manufactured with lack of process validation, cleaning validation,... | Class II | Pharma-Natural Inc. |
| Jun 21, 2019 | Lid O Creme (Lidocaine HCL 4% and Menthol 1%) Topical Analgesic Cream, 2.5 Oz... | CGMP Deviations: products were manufactured with lack of process validation, cleaning validation,... | Class II | Pharma-Natural Inc. |
| Jun 21, 2019 | Oliver's Harvest CBD+Lidocaine HCL 4% Pain Relief (Lidocaine HCL 4%) Topical ... | CGMP Deviations: products were manufactured with lack of process validation, cleaning validation,... | Class II | Pharma-Natural Inc. |
| Jun 21, 2019 | LidoAID (Lidocaine HCL 4%) portable pain relieving TOPICAL ANALGESIC GEL, 0.1... | CGMP Deviations: products were manufactured with lack of process validation, cleaning validation,... | Class II | Pharma-Natural Inc. |
| Jun 21, 2019 | SORBUGEN NR (Dextromethorphan HBr, 15 mg; Glyceryl Guaiacolate (Guaifenesin),... | CGMP Deviations: products were manufactured with lack of process validation, cleaning validation,... | Class II | Pharma-Natural Inc. |
| Jun 21, 2019 | Workvie Instant Pain Relieving Roll On (Lidocaine HCL 4% + Menthol 1% & Arnic... | CGMP Deviations: products were manufactured with lack of process validation, cleaning validation,... | Class II | Pharma-Natural Inc. |
| Jun 21, 2019 | AbeeMed cream (Menthol 1.48% and Histamine DHCL 0.05%), 2 OZ jar, Manufacture... | CGMP Deviations: products were manufactured with lack of process validation, cleaning validation,... | Class II | Pharma-Natural Inc. |
| Jun 21, 2019 | ARMY HEALTH Pain Reliever Gel With CURCUMIN (Menthol 3.00%), 0.5 OZ jar, Manu... | CGMP Deviations: products were manufactured with lack of process validation, cleaning validation,... | Class II | Pharma-Natural Inc. |
| Jun 21, 2019 | DOUBLE TUSSIN DM (Dextromethorphan Hbr 20 mg, Guaifenesin 300 mg) in each 5ml... | CGMP Deviations: products were manufactured with lack of process validation, cleaning validation,... | Class II | Pharma-Natural Inc. |
| Jun 21, 2019 | Dayma SUPER FORTE XL10 (Camphor 0.5%, Menthol 2%, Methyl Salicylate 2%) Pain ... | CGMP Deviations: products were manufactured with lack of process validation, cleaning validation,... | Class II | Pharma-Natural Inc. |
| Jun 21, 2019 | GENCONTUSS (Chlorpheniramine Maleate, 2mg; Dextromethorphan HBr, 10 mg; Pheny... | CGMP Deviations: products were manufactured with lack of process validation, cleaning validation,... | Class II | Pharma-Natural Inc. |
| Jun 17, 2019 | Lotemax (loteprednol etabonate ophthalmic gel 0.5%), Sterile, Rx Only, 5 g bo... | Failed Stability Specifications: Out of specification for viscosity. | Class III | Bausch & Lomb |
| Jun 13, 2019 | Sevoflurane, USP Inhalation Anesthetic 250 mL bottles, Rx only, Manufactured ... | Failed Stability Specifications | Class II | Baxter Healthcare Corporation |
| Apr 25, 2019 | Revonto (dantrolene sodium for injection), 20 mg/vial, For treatment of malig... | Presence of Precipitate: Appearance is Out of Specification for the reconstituted solution during... | Class II | US Worldmeds LLC |
| Apr 23, 2019 | Fentanyl Citrate Injection, USP, 100 mcg/2 mL (50 mcg/mL), 25 Ampules per car... | Failed impurities/degradation specification: Out of Specification result for total impurity at 4.... | Class III | Akorn Inc |
| Apr 3, 2019 | Telmisartan and Amlodipine Tablets 80 mg/5 mg, 30 tablets, Rx Only, Manufact... | Failed Impurities/Degradation Specifications; 18 month long term stability study (manufacturer) | Class III | AVKARE Inc. |
| Apr 1, 2019 | ICEE PEACH SCENTED ANTIBACTERIAL HAND GEL (Ethyl Alcohol 62%), 1.35 fl oz / 4... | CGMP deviations: Stability testing was not conducted on manufactured sunscreen and hand sanitizer... | Class III | NingBo Huize Commodity Co.,Ltd. |
| Apr 1, 2019 | DOTS SCENTED ANTIBACTERIAL HAND GEL LIME (Ethyl Alcohol 62%), 1.35 fl oz / 40... | CGMP deviations: Stability testing was not conducted on manufactured sunscreen and hand sanitizer... | Class III | NingBo Huize Commodity Co.,Ltd. |
| Apr 1, 2019 | festpak clearly fun SPF30 sunscreen lotion SPF 30 SUNSCREEN LOTION Active Ing... | CGMP deviations: Stability testing was not conducted on manufactured sunscreen and hand sanitizer... | Class III | NingBo Huize Commodity Co.,Ltd. |
| Apr 1, 2019 | ICEE LEMON LIME SCENTED ANTIBACTERIAL HAND GEL (Ethyl Alcohol 62%), 1.35 fl o... | CGMP deviations: Stability testing was not conducted on manufactured sunscreen and hand sanitizer... | Class III | NingBo Huize Commodity Co.,Ltd. |
| Apr 1, 2019 | AIR HEADS ORANGE SCENTED ANTIBACTERIAL HAND GEL (Ethyl Alcohol 62%), 1.35 fl ... | CGMP deviations: Stability testing was not conducted on manufactured sunscreen and hand sanitizer... | Class III | NingBo Huize Commodity Co.,Ltd. |
| Apr 1, 2019 | DIPPIN' DOTS SCENTED BANANA SPLIT ANTIBACTERIAL HAND GEL (Ethyl Alcohol 62%),... | CGMP deviations: Stability testing was not conducted on manufactured sunscreen and hand sanitizer... | Class III | NingBo Huize Commodity Co.,Ltd. |
| Apr 1, 2019 | DIPPIN' DOTS SCENTED BIRTHDAY CAKE ANTIBACTERIAL HAND GEL (Ethyl Alcohol 62%)... | CGMP deviations: Stability testing was not conducted on manufactured sunscreen and hand sanitizer... | Class III | NingBo Huize Commodity Co.,Ltd. |
| Apr 1, 2019 | DOTS SCENTED ANTIBACTERIAL HAND GEL STRAWBRRY (Ethyl Alcohol 62%), 1.35 fl oz... | CGMP deviations: Stability testing was not conducted on manufactured sunscreen and hand sanitizer... | Class III | NingBo Huize Commodity Co.,Ltd. |
| Apr 1, 2019 | TOOTSIE ROLL SCENTED ANTIBACTERIAL HAND GEL (Ethyl Alcohol 62%), 1.35 fl oz /... | CGMP deviations: Stability testing was not conducted on manufactured sunscreen and hand sanitizer... | Class III | NingBo Huize Commodity Co.,Ltd. |
| Apr 1, 2019 | CHARMS BLOW POP BLUE RAZZ BERRY SCENTED ANTIBACTERIAL HAND GEL (Ethyl Alcohol... | CGMP deviations: Stability testing was not conducted on manufactured sunscreen and hand sanitizer... | Class III | NingBo Huize Commodity Co.,Ltd. |
| Apr 1, 2019 | Texas Home Health Home Care Hospice Personal Care Hand Sanitizer (Ethyl Alcoh... | CGMP deviations: Stability testing was not conducted on manufactured sunscreen and hand sanitizer... | Class III | NingBo Huize Commodity Co.,Ltd. |
| Apr 1, 2019 | CHARMS BLOW POP SOUR APPLE SCENTED ANTIBACTERIAL HAND GEL (Ethyl Alcohol 62%)... | CGMP deviations: Stability testing was not conducted on manufactured sunscreen and hand sanitizer... | Class III | NingBo Huize Commodity Co.,Ltd. |
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.