Browse Drug Recalls
1,788 FDA drug safety recalls.
FDA Drug Recall Enforcement Database
Browse 1,788 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 1,788 FDA drug recalls in 2019.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| Apr 1, 2019 | Tootsie Roll POP GRAPE SCENTED ANTIBACTERIAL HAND GEL (Ethyl Alcohol 62%), 1.... | CGMP deviations: Stability testing was not conducted on manufactured sunscreen and hand sanitizer... | Class III | NingBo Huize Commodity Co.,Ltd. |
| Apr 1, 2019 | Telmisartan and Amlodipine Tablets 80 mg/5 mg, 30 tablet bottle, Rx only, Man... | Failed Impurities/Degradation Specifications; 18 month long term stability study. | Class III | Lupin Pharmaceuticals Inc. |
| Apr 1, 2019 | CHARMS BLOW POP CHERRY SCENTED ANTIBACTERIAL HAND GEL (Ethyl Alcohol 62%), 1.... | CGMP deviations: Stability testing was not conducted on manufactured sunscreen and hand sanitizer... | Class III | NingBo Huize Commodity Co.,Ltd. |
| Apr 1, 2019 | SPF 30 SUNSCREEN LOTION Active Ingredients Octinoxate 7.5%, Octisalate 2.0%, ... | 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 POP ORANGE SCENTED ANTIBACTERIAL HAND GEL (Ethyl Alcohol 62%), 1... | 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 POP CHOCOLATE 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. |
| Apr 1, 2019 | Tootsie Roll POP RASPBERRY 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. |
| Apr 1, 2019 | AIR HEADS PINK LEMONADE SCENTED ANTIBACTERIAL HAND GEL (Ethyl Alcohol 62%), 1... | CGMP deviations: Stability testing was not conducted on manufactured sunscreen and hand sanitizer... | Class III | NingBo Huize Commodity Co.,Ltd. |
| Apr 1, 2019 | AMERICA'S ORIGINAL DUBBLE BUBBLE Pink Lemonade SCENTED ANTIBACTERIAL HAND GEL... | CGMP deviations: Stability testing was not conducted on manufactured sunscreen and hand sanitizer... | Class III | NingBo Huize Commodity Co.,Ltd. |
| Apr 1, 2019 | AMERICA'S ORIGINAL DUBBLE BUBBLE SCENTED ANTIBACTERIAL HAND GEL (Ethyl Alcoho... | 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 ORANGE (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 | Accent Care of New York Home Care Nursing Personal Care Hand Sanitizer (Ethyl... | 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. |
| 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 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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. |
| Mar 29, 2019 | Pantoprazole Sodium Delayed-Release Tablets, USP, 40 mg*, 90-count bottle, Rx... | Discoloration: Expansion of an earlier recall due to the presence of dark brown discoloration on ... | Class II | Jubilant Cadista Pharmaceuticals, Inc. |
| Mar 29, 2019 | Clonidine HCL Injection, 1000 mcg/10mL (100 mcg/mL), 10 ML Single Dose Vial, ... | Labeling: Label Error on Declared Strength: Side carton panel incorrectly lists the concentration... | Class III | X-Gen Pharmaceuticals Inc. |
| Mar 28, 2019 | Lidocaine HCl Injection, USP 1 % 50 mg/5 mL (10 mg/mL), 5mL vial, Rx only, M... | Presence of Particulate Matter: One vial was found to contain a hair. | Class I | Aurobindo Pharma USA Inc. |
| Mar 28, 2019 | Nystatin Oral Suspension, USP, 100,000 units per mL, 473 mL per bottle, Rx on... | Failed Impurities/Degradation Specifications: Out of Specification for an unknown impurity was ob... | Class III | Akorn, Inc. |
| Mar 26, 2019 | Thallous Chloride TI 201 Injection, Specific Concentration: 37 MBq/mL (1 mCi/... | Chemical Contamination: Trace amounts of an impurity was detected in the reagent used to manufact... | Class III | Medi-Physics Inc. dba GE Healthcare |
| Mar 25, 2019 | Bismuth Subsalicylate Oral Suspension 262mg/15mL, unit dose cups, OTC, Rpkg. ... | Labeling: Incorrect or Missing Lot and/or Exp Date - the label contains an incorrect Exp Date. | Class II | Lohxa LLC |
| Mar 25, 2019 | Phenobarbital Oral Solution, USP 20 mg/5mL, unit dose cup, Rx Only, Rpkg. By.... | Labeling: Incorrect or Missing Lot and/or Exp Date - the label contains an incorrect Exp Date. | Class II | Lohxa LLC |
| Mar 25, 2019 | Pravastatin Sodium Tablets USP, 20 mg, 500-count bottle, Rx Only, Manufacture... | Presence Of Foreign Tablet: in a bottle of Pravastatin Sodium Tablets 20 mg. | Class II | Glenmark Pharmaceuticals Inc., USA |
| Mar 22, 2019 | Fayosim (levonorgestrel and ethinyl estradiol) tablets USP, (0.15 mg/0.02 mg,... | Failed Impurities/Degradation Specifications: Out-of-specification results observed in related su... | Class II | Lupin Pharmaceuticals Inc. |
| Mar 22, 2019 | Testosterone Cypionate Injection, USP, 1000 mg/10 mL (100 mg/mL), For intramu... | Presence of Particulate Matter. | Class II | InvaGen Pharmaceuticals, Inc. |
| Mar 22, 2019 | Testosterone Cypionate Injection, USP, 2000 mg/10 mL (200 mg/mL), For intramu... | Presence of Particulate Matter. | Class II | InvaGen Pharmaceuticals, Inc. |
| Mar 22, 2019 | Testosterone Cypionate Injection, USP, 200 mg/mL, For IM use only, 1 mL Vial,... | Presence of Particulate Matter. | Class II | InvaGen Pharmaceuticals, Inc. |
| Mar 22, 2019 | Biotin 10 mg/mL Injection, 30 mL vial, Rx only, 511 S. Harbor Blvd., Building... | Failed pH Specification: product does not meet pH label claim. | Class III | Auro Pharmacies Inc. DBA Central Drugs |
| Mar 19, 2019 | Gavilyte-N, PEG-3350, Sodium chloride, Sodium Bicarbonate and Potassium Chlor... | Labeling Not Elsewhere Classified; orange and cherry flavor packets incorrect list "natural lemon... | Class II | LUPIN SOMERSET |
| Mar 19, 2019 | Combigan (brimonidine tartrate/timolol maleate ophthalmic solution) 0.2%/0.5%... | cGMP Deviations | Class II | Allergan Sales, LLC |
| Mar 18, 2019 | Diclofenac Sodium Topical Solution, 1.5% w/w, 5 FL. OZ. (150 mL) bottle, Rx O... | Defective Container: firm discovered samples stored horizontally as well as product quality compl... | Class III | Ingenus Pharmaceuticals Llc |
| Mar 15, 2019 | Cleocin Phosphate, clindamycin injection, USP, 900 mg/ 6 mL (150 mg/mL), 6 mL... | Failed Impurities/Degradation Specifications: High out-of-specification (OOS) results were demons... | Class III | Pfizer Inc. |
| Mar 15, 2019 | 8.4% Sodium Bicarbonate Injection, USP 50 mEq (1 mEq/mL) 4.2 grams (84 mg/mL)... | Presence of Particulate Matter; glass particulates | Class I | Pfizer Inc. |
| Mar 15, 2019 | Clindamycin Injection, USP, 600 mg/ 4 mL (150 mg/mL), 4 mL vials, Rx only, Di... | Failed Impurities/Degradation Specifications: High out-of-specification (OOS) results were demons... | Class III | Pfizer Inc. |
| Mar 15, 2019 | Repairwear Laser Focus Line Smoothing Cream Broad Spectrum SPF 15, packaged i... | Defective container: Ineffective seal between the cap and jar of the affected product. | Class III | Estee Lauder Inc |
| Mar 15, 2019 | Clindamycin Injection, USP, 900 mg/6 mL (150 mg/mL), 6 mL vial, Rx only, Dist... | Failed Impurities/Degradation Specifications: High out-of-specification (OOS) results were demons... | Class III | Pfizer Inc. |
| Mar 15, 2019 | Clindamycin Injection, USP, 300 mg/ 2 mL (150 mg/mL), 2 mL vials, Rx only, Di... | Failed Impurities/Degradation Specifications: High out-of-specification (OOS) results were demons... | Class III | Pfizer Inc. |
| Mar 15, 2019 | Cleocin Phosphate, clindamycin injection, USP, 600 mg/ 4 mL (150 mg/mL), 4 mL... | Failed Impurities/Degradation Specifications: High out-of-specification (OOS) results were demons... | Class III | Pfizer Inc. |
| Mar 15, 2019 | Cleocin Phosphate (clindamycin injection), USP, 300 mg/ 2 mL (150 mg/mL), 2 m... | Failed Impurities/Degradation Specifications: High out-of-specification (OOS) results were demons... | Class III | Pfizer Inc. |
| Mar 14, 2019 | Losartan 50mg Tablet, 30 count each blister card. | CGMP Deviations; Detection of trace amounts of an unexpected impurity found in an active pharmace... | Class II | RemedyRepack Inc. |
| Mar 14, 2019 | Blue Fusion Capsules, 1- count blister pack, Distributed by: DNS Distribution... | Marketed Without An Approved NDA/ANDA: FDA analysis found this product to contain undeclared ingr... | Class I | Ata International 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.