Drug Recall Enforcement Reports
What are the Drug Enforcement Reports?
All drug recalls are monitored by the Food and Drug Administration (FDA) and are included in the Enforcement Report once they are properly classified. The FDA will determine if a firm's removal or correction actions of a marked product meet the requirements to be considered a "recall". The FDA will also determine the public hazard assessment and a recall classification will be published in the Enforcement Report.
The Drug Enforcement Reports included in this listing was last updated on October 09, 2026 and include a total of 18002 recall reports.
| Recall Number | Recall Initiation Date | Product Description | Recall Reason | Recall Firm / Quantity | Recall Classification | Status |
|---|---|---|---|---|---|---|
| D-1166-2019 | 04-02-2019 | Phenylephrine 1 mg/mL Injection, 10 mL Vial, Anderson Compounding Pharmacy 310 Bluff City Hwy, Bristol, TN. | Lack of sterility assurance. | Anderson Compounding Pharmacy, Inc. DBA Anderson Compounding Pharmacy / 1 vial | Class II | Terminated |
| D-1182-2019 | 04-02-2019 | Vitamin D3 200,000 IU/mL Injection, 2 mL Vial, Anderson Compounding Pharmacy 310 Bluff City Hwy, Bristol, TN. | Lack of sterility assurance. | Anderson Compounding Pharmacy, Inc. DBA Anderson Compounding Pharmacy / 4 vials | Class II | Terminated |
| D-1145-2019 | 04-02-2019 | Gentamicin 250 mg/1000 mL Irrigation, 1000 mL, Anderson Compounding Pharmacy 310 Bluff City Hwy, Bristol, TN. | Lack of sterility assurance. | Anderson Compounding Pharmacy, Inc. DBA Anderson Compounding Pharmacy / 4 bottles | Class II | Terminated |
| D-1143-2019 | 04-02-2019 | Estradiol Cypionate 10 mg/mL, 5 mL Vial, Anderson Compounding Pharmacy 310 Bluff City Hwy, Bristol, TN. | Lack of sterility assurance. | Anderson Compounding Pharmacy, Inc. DBA Anderson Compounding Pharmacy / 35 vials | Class II | Terminated |
| D-1162-2019 | 04-02-2019 | Methylcobalamin 1 mg/mL Injection, 2 mL Vial, Anderson Compounding Pharmacy 310 Bluff City Hwy, Bristol, TN. | Lack of sterility assurance. | Anderson Compounding Pharmacy, Inc. DBA Anderson Compounding Pharmacy / 5 vials | Class II | Terminated |
| D-1164-2019 | 04-02-2019 | Morphine Sulfate 5 mg/3mL Inhalation, 3 mL Vials, Anderson Compounding Pharmacy 310 Bluff City Hwy, Bristol, TN. | Lack of sterility assurance. | Anderson Compounding Pharmacy, Inc. DBA Anderson Compounding Pharmacy / 60 vials | Class II | Terminated |
| D-1169-2019 | 04-02-2019 | Prostaglandin 40 mcg/mL, Vial, Anderson Compounding Pharmacy 310 Bluff City Hwy, Bristol, TN. | Lack of sterility assurance. | Anderson Compounding Pharmacy, Inc. DBA Anderson Compounding Pharmacy / 6 vials | Class II | Terminated |
| D-1171-2019 | 04-02-2019 | Prostaglandin Quad-Mix 20:30:1:0.15 Injection, 10 mL Vial, Anderson Compounding Pharmacy 310 Bluff City Hwy, Bristol, TN. | Lack of sterility assurance. | Anderson Compounding Pharmacy, Inc. DBA Anderson Compounding Pharmacy / 40 vials | Class II | Terminated |
| D-1157-2019 | 04-02-2019 | Heparin 10 mL/ Marcain 0.25% 20 mL/Sodium Bicarbonate 8.4%-40 mL/ Normal Saline 5 mL, 60 mL Syringe, Anderson Compounding Pharmacy 310 Bluff City Hwy, Bristol, TN. | Lack of sterility assurance. | Anderson Compounding Pharmacy, Inc. DBA Anderson Compounding Pharmacy / 1 syringe | Class II | Terminated |
| D-1142-2019 | 04-02-2019 | DMSO 50% 60 mL/Heparin 1 mL/ Sodium Bicarbonate 60 mL/ Solu-Cortef 100 mg, 41 mL syringe, Anderson Compounding Pharmacy 310 Bluff City Hwy, Bristol, TN. | Lack of sterility assurance. | Anderson Compounding Pharmacy, Inc. DBA Anderson Compounding Pharmacy / 1 syringe | Class II | Terminated |
| D-1175-2019 | 04-02-2019 | Sermorelin 0.3 mg/0.5 mL, 10 mL Vial, Anderson Compounding Pharmacy 310 Bluff City Hwy, Bristol, TN. | Lack of sterility assurance. | Anderson Compounding Pharmacy, Inc. DBA Anderson Compounding Pharmacy / 22 vials | Class II | Terminated |
| D-1176-2019 | 04-02-2019 | Sermorelin 0.4 mg/0.5 mL, 10 mL Vial, Anderson Compounding Pharmacy 310 Bluff City Hwy, Bristol, TN. | Lack of sterility assurance. | Anderson Compounding Pharmacy, Inc. DBA Anderson Compounding Pharmacy / 6 vials | Class II | Terminated |
| D-1161-2019 | 04-02-2019 | Methionine 15mg/Choline 100mg/ Inositol 50mg/ Methylcobalamin 1mg/ Lidocoaine 10 mg, benzyl alcohol/ water, Anderson Compounding Pharmacy 310 Bluff City Hwy, Bristol, TN. | Lack of sterility assurance. | Anderson Compounding Pharmacy, Inc. DBA Anderson Compounding Pharmacy / 276 vails | Class II | Terminated |
| D-1170-2019 | 04-02-2019 | Prostaglandin 60 mcg/mL, Vial, Anderson Compounding Pharmacy 310 Bluff City Hwy, Bristol, TN. | Lack of sterility assurance. | Anderson Compounding Pharmacy, Inc. DBA Anderson Compounding Pharmacy / 5 vials | Class II | Terminated |
| D-1168-2019 | 04-02-2019 | Prostaglandin 20 mcg/mL, 10 mL Vial, Anderson Compounding Pharmacy 310 Bluff City Hwy, Bristol, TN. | Lack of sterility assurance. | Anderson Compounding Pharmacy, Inc. DBA Anderson Compounding Pharmacy / 23 vials | Class II | Terminated |
| D-1150-2019 | 04-02-2019 | HCG 30 Day, 3750 Units/6 mL, 10 mL Vial, Anderson Compounding Pharmacy 310 Bluff City Hwy, Bristol, TN 1-800-263-8890 | Lack of sterility assurance. | Anderson Compounding Pharmacy, Inc. DBA Anderson Compounding Pharmacy / 57 vials | Class II | Terminated |
| D-1178-2019 | 04-02-2019 | Serum Tears 30% Drops, 1 mL Droptainer, Anderson Compounding Pharmacy 310 Bluff City Hwy, Bristol, TN. | Lack of sterility assurance. | Anderson Compounding Pharmacy, Inc. DBA Anderson Compounding Pharmacy / 60 drop containers | Class II | Terminated |
| D-1154-2019 | 04-02-2019 | HCG 4,100 Units/vial Injection, Anderson Compounding Pharmacy 310 Bluff City Hwy, Bristol, TN. | Lack of sterility assurance. | Anderson Compounding Pharmacy, Inc. DBA Anderson Compounding Pharmacy / 1 vial | Class II | Terminated |
| D-1147-2019 | 04-02-2019 | HCG 11,000 Units, 30 mL Vial, Anderson Compounding Pharmacy 310 Bluff City Hwy, Bristol, TN. | Lack of sterility assurance. | Anderson Compounding Pharmacy, Inc. DBA Anderson Compounding Pharmacy / 9 vials | Class II | Terminated |
| D-1152-2019 | 04-02-2019 | HCG 20,000 units/vial, Anderson Compounding Pharmacy 310 Bluff City Hwy, Bristol, TN. | Lack of sterility assurance. | Anderson Compounding Pharmacy, Inc. DBA Anderson Compounding Pharmacy / 1 vial | Class II | Terminated |
| D-1156-2019 | 04-02-2019 | Heparin 20,000 U/Lidocaine 2% 10 mL/Sodium Bicarbonate 8.4% 10 mL/Sterile Water 5 mL, 27 mL Syringe, Anderson Compounding Pharmacy 310 Bluff City Hwy, Bristol, TN. | Lack of sterility assurance. | Anderson Compounding Pharmacy, Inc. DBA Anderson Compounding Pharmacy / 2 syringes | Class II | Terminated |
| D-1179-2019 | 04-02-2019 | Streptomycin 24 mg/Dexamethasone 10 mg/mL Otic Injection, 1 mL Syringe, Anderson Compounding Pharmacy 310 Bluff City Hwy, Bristol, TN. | Lack of sterility assurance. | Anderson Compounding Pharmacy, Inc. DBA Anderson Compounding Pharmacy / 10 syringes | Class II | Terminated |
| D-1146-2019 | 04-02-2019 | HCG 1,000 U/mL Injection, 30 mL, Vial Anderson Compounding Pharmacy 310 Bluff City Hwy, Bristol, TN. | Lack of sterility assurance. | Anderson Compounding Pharmacy, Inc. DBA Anderson Compounding Pharmacy / 1 vial | Class II | Terminated |
| D-1167-2019 | 04-02-2019 | Polyhexamethylene Biguanide 0.02% Ophthalmic Drops, 2 mL Dropper, Anderson Compounding Pharmacy 310 Bluff City Hwy, Bristol, TN. | Lack of sterility assurance. | Anderson Compounding Pharmacy, Inc. DBA Anderson Compounding Pharmacy / 5 drop containers | Class II | Terminated |
| D-1148-2019 | 04-02-2019 | HCG 20 Day Injection, 2625 Units/4 mL, Anderson Compounding Pharmacy 310 Bluff City Hwy, Bristol, TN. | Lack of sterility assurance. | Anderson Compounding Pharmacy, Inc. DBA Anderson Compounding Pharmacy / 217 vials | Class II | Terminated |
| D-1163-2019 | 04-02-2019 | Methylprednisolone 1% PF Ophthalmic, 3 mL Droppers, Anderson Compounding Pharmacy 310 Bluff City Hwy, Bristol, TN. | Lack of sterility assurance. | Anderson Compounding Pharmacy, Inc. DBA Anderson Compounding Pharmacy / 5 drop containers | Class II | Terminated |
| D-1158-2019 | 04-02-2019 | Heparin 10,000 U/Bupivacaine 0.5% 10 mL, Sodium Bicarbonate 8.4% 50 mL, 61 mL Syringe, Anderson Compounding Pharmacy 310 Bluff City Hwy, Bristol, TN. | Lack of sterility assurance. | Anderson Compounding Pharmacy, Inc. DBA Anderson Compounding Pharmacy / 1 syringe | Class II | Terminated |
| D-1177-2019 | 04-02-2019 | Serum Tears 20% Drops, 1 mL Droptainer, Anderson Compounding Pharmacy 310 Bluff City Hwy, Bristol, TN. | Lack of sterility assurance. | Anderson Compounding Pharmacy, Inc. DBA Anderson Compounding Pharmacy / 40 drop containers | Class II | Terminated |
| D-1562-2019 | 04-01-2019 | DIPPIN' DOTS SCENTED COOKIES 'N CREAM ANTIBACTERIAL HAND GEL (Ethyl Alcohol 62%), 1.35 fl oz / 40 mL, OTC, Distributed by: JFL Enterprises, Inc. Cleveland, Ohio 44102. | CGMP deviations: Stability testing was not conducted on manufactured sunscreen and hand sanitizer OTC products. | NingBo Huize Commodity Co.,Ltd. / 13,068 | Class III | Terminated |
| D-1561-2019 | 04-01-2019 | DIPPIN' DOTS SCENTED BIRTHDAY CAKE ANTIBACTERIAL HAND GEL (Ethyl Alcohol 62%), 1.35 fl oz / 40 mL, OTC, Distributed by: JFL Enterprises, Inc. Cleveland, Ohio 44102. | CGMP deviations: Stability testing was not conducted on manufactured sunscreen and hand sanitizer OTC products. | NingBo Huize Commodity Co.,Ltd. / 13,068 | Class III | Terminated |
| D-1532-2019 | 04-01-2019 | SPF 30 SUNSCREEN LOTION Active Ingredients Octinoxate 7.5%, Octisalate 2.0%, Oxybenzone 4.0% Titanium Dioxide 2.5% Sunscreen, 53mL/1.8fl.oz., OTC, Distributed by: EVANS, Made in China | CGMP deviations: Stability testing was not conducted on manufactured sunscreen and hand sanitizer OTC products. | NingBo Huize Commodity Co.,Ltd. / 10, 000 | Class III | Terminated |
| D-1529-2019 | 04-01-2019 | Accent Care of New York Home Care Nursing Personal Care Hand Sanitizer (Ethyl Alcohol 62%), 0.33 oz/10 mL, OTC, Made in China | CGMP deviations: Stability testing was not conducted on manufactured sunscreen and hand sanitizer OTC products. | NingBo Huize Commodity Co.,Ltd. / 35,500 | Class III | Terminated |
| D-1547-2019 | 04-01-2019 | AMERICA'S ORIGINAL DUBBLE BUBBLE Pink Lemonade SCENTED ANTIBACTERIAL HAND GEL (Ethyl Alcohol 62%), 1.35 fl oz / 40 mL, OTC, Distributed by: JFL Enterprises, Inc. Cleveland, Ohio 44102. | CGMP deviations: Stability testing was not conducted on manufactured sunscreen and hand sanitizer OTC products. | NingBo Huize Commodity Co.,Ltd. / 20,160 | Class III | Terminated |
| D-1539-2019 | 04-01-2019 | DOTS SCENTED ANTIBACTERIAL HAND GEL LIME (Ethyl Alcohol 62%), 1.35 fl oz / 40 mL, OTC, Distributed by: JFL Enterprises, Inc. Cleveland, Ohio 44102. | CGMP deviations: Stability testing was not conducted on manufactured sunscreen and hand sanitizer OTC products. | NingBo Huize Commodity Co.,Ltd. / 3852 | Class III | Terminated |
| D-1563-2019 | 04-01-2019 | DIPPIN' DOTS SCENTED COTTON CANDY ANTIBACTERIAL HAND GEL (Ethyl Alcohol 62%), 1.35 fl oz / 40 mL, OTC, Distributed by: JFL Enterprises, Inc. Cleveland, Ohio 44102. | CGMP deviations: Stability testing was not conducted on manufactured sunscreen and hand sanitizer OTC products. | NingBo Huize Commodity Co.,Ltd. / 13,068 | Class III | Terminated |
| D-1564-2019 | 04-01-2019 | Lemon Hand Sanitizer (Alcohol 62%), 30 mL / 1.0 fl.oz, OTC, Made in China. | CGMP deviations: Stability testing was not conducted on manufactured sunscreen and hand sanitizer OTC products. | NingBo Huize Commodity Co.,Ltd. / 126,500 | Class III | Terminated |
| D-1558-2019 | 04-01-2019 | ICEE CHERRY SCENTED ANTIBACTERIAL HAND GEL (Ethyl Alcohol 62%), 1.35 fl oz / 40 mL, OTC, Distributed by: JFL Enterprises, Inc. Cleveland, Ohio 44102. | CGMP deviations: Stability testing was not conducted on manufactured sunscreen and hand sanitizer OTC products. | NingBo Huize Commodity Co.,Ltd. / 13,068 | Class III | Terminated |
| D-1551-2019 | 04-01-2019 | TOOTSIE ROLL SCENTED ANTIBACTERIAL HAND GEL (Ethyl Alcohol 62%), 1.35 fl oz / 40 mL, OTC, Distributed by: JFL Enterprises, Inc. Cleveland, Ohio 44102. | CGMP deviations: Stability testing was not conducted on manufactured sunscreen and hand sanitizer OTC products. | NingBo Huize Commodity Co.,Ltd. / 8,856 | Class III | Terminated |
| D-1560-2019 | 04-01-2019 | DIPPIN' DOTS SCENTED BANANA SPLIT ANTIBACTERIAL HAND GEL (Ethyl Alcohol 62%), 1.35 fl oz / 40 mL, OTC, Distributed by: JFL Enterprises, Inc. Cleveland, Ohio 44102. | CGMP deviations: Stability testing was not conducted on manufactured sunscreen and hand sanitizer OTC products. | NingBo Huize Commodity Co.,Ltd. / 13,068 | Class III | Terminated |
| D-1535-2019 | 04-01-2019 | Tootsie Roll POP ORANGE SCENTED ANTIBACTERIAL HAND GEL (Ethyl Alcohol 62%), 1.35 fl oz / 40 mL, OTC, Distributed by: JFL Enterprises, Inc. Cleveland, Ohio 44102. | CGMP deviations: Stability testing was not conducted on manufactured sunscreen and hand sanitizer OTC products. | NingBo Huize Commodity Co.,Ltd. / 5112 | Class III | Terminated |
| D-1553-2019 | 04-01-2019 | AIR HEADS BLUE RASPBERRY SCENTED ANTIBACTERIAL HAND GEL (Ethyl Alcohol 62%), 1.35 fl oz / 40 mL, OTC, Distributed by: JFL Enterprises, Inc. Cleveland, Ohio 44102. | CGMP deviations: Stability testing was not conducted on manufactured sunscreen and hand sanitizer OTC products. | NingBo Huize Commodity Co.,Ltd. / 13,068 | Class III | Terminated |
| D-1557-2019 | 04-01-2019 | ICEE PEACH SCENTED ANTIBACTERIAL HAND GEL (Ethyl Alcohol 62%), 1.35 fl oz / 40 mL, OTC, Distributed by: JFL Enterprises, Inc. Cleveland, Ohio 44102. | CGMP deviations: Stability testing was not conducted on manufactured sunscreen and hand sanitizer OTC products. | NingBo Huize Commodity Co.,Ltd. / 13,068 | Class III | Terminated |
| D-1550-2019 | 04-01-2019 | TOOTSIE ROLL FRUIT CHEWS LIME SCENTED ANTIBACTERIAL HAND GEL (Ethyl Alcohol 62%), 1.35 fl oz / 40 mL, OTC, Distributed by: JFL Enterprises, Inc. Cleveland, Ohio 44102. | CGMP deviations: Stability testing was not conducted on manufactured sunscreen and hand sanitizer OTC products. | NingBo Huize Commodity Co.,Ltd. / 8,856 | Class III | Terminated |
| D-1549-2019 | 04-01-2019 | TOOTSIE ROLL FRUIT CHEWS VANILLA SCENTED ANTIBACTERIAL HAND GEL (Ethyl Alcohol 62%), 1.35 fl oz / 40 mL, OTC, Distributed by: JFL Enterprises, Inc. Cleveland, Ohio 44102. | CGMP deviations: Stability testing was not conducted on manufactured sunscreen and hand sanitizer OTC products. | NingBo Huize Commodity Co.,Ltd. / 8,856 | Class III | Terminated |
| D-1559-2019 | 04-01-2019 | ICEE BLUE RASPBERRY SCENTED ANTIBACTERIAL HAND GEL (Ethyl Alcohol 62%), 1.35 fl oz / 40 mL, OTC, Distributed by: JFL Enterprises, Inc. Cleveland, Ohio 44102. | CGMP deviations: Stability testing was not conducted on manufactured sunscreen and hand sanitizer OTC products. | NingBo Huize Commodity Co.,Ltd. / 13,068 | Class III | Terminated |
| D-1542-2019 | 04-01-2019 | CHARMS BLOW POP CHERRY SCENTED ANTIBACTERIAL HAND GEL (Ethyl Alcohol 62%), 1.35 fl oz / 40 mL, OTC, Distributed by: JFL Enterprises, Inc. Cleveland, Ohio 44102. | CGMP deviations: Stability testing was not conducted on manufactured sunscreen and hand sanitizer OTC products. | NingBo Huize Commodity Co.,Ltd. / 18036 | Class III | Terminated |
| D-1545-2019 | 04-01-2019 | CHARMS BLOW POP SOUR APPLE SCENTED ANTIBACTERIAL HAND GEL (Ethyl Alcohol 62%), 1.35 fl oz / 40 mL, OTC, Distributed by: JFL Enterprises, Inc. Cleveland, Ohio 44102. | CGMP deviations: Stability testing was not conducted on manufactured sunscreen and hand sanitizer OTC products. | NingBo Huize Commodity Co.,Ltd. / 18036 | Class III | Terminated |
| D-1556-2019 | 04-01-2019 | ICEE LEMON LIME SCENTED ANTIBACTERIAL HAND GEL (Ethyl Alcohol 62%), 1.35 fl oz / 40 mL, OTC, Distributed by: JFL Enterprises, Inc. Cleveland, Ohio 44102. | CGMP deviations: Stability testing was not conducted on manufactured sunscreen and hand sanitizer OTC products. | NingBo Huize Commodity Co.,Ltd. / 13,068 | Class III | Terminated |
| D-1544-2019 | 04-01-2019 | CHARMS BLOW POP BLUE RAZZ BERRY SCENTED ANTIBACTERIAL HAND GEL (Ethyl Alcohol 62%), 1.35 fl oz / 40 mL, OTC, Distributed by: JFL Enterprises, Inc. Cleveland, Ohio 44102. | CGMP deviations: Stability testing was not conducted on manufactured sunscreen and hand sanitizer OTC products. | NingBo Huize Commodity Co.,Ltd. / 18036 | Class III | Terminated |
| D-1555-2019 | 04-01-2019 | AIR HEADS ORANGE SCENTED ANTIBACTERIAL HAND GEL (Ethyl Alcohol 62%), 1.35 fl oz / 40 mL, OTC, Distributed by: JFL Enterprises, Inc. Cleveland, Ohio 44102. | CGMP deviations: Stability testing was not conducted on manufactured sunscreen and hand sanitizer OTC products. | NingBo Huize Commodity Co.,Ltd. / 13,068 | Class III | Terminated |
| D-1552-2019 | 04-01-2019 | AIR HEADS STRAWBERRY SCENTED ANTIBACTERIAL HAND GEL (Ethyl Alcohol 62%), 1.35 fl oz / 40 mL, OTC, Distributed by: JFL Enterprises, Inc. Cleveland, Ohio 44102. | CGMP deviations: Stability testing was not conducted on manufactured sunscreen and hand sanitizer OTC products. | NingBo Huize Commodity Co.,Ltd. / 13,068 | Class III | Terminated |
| D-1543-2019 | 04-01-2019 | CHARMS BLOW POP WATERMELON SCENTED ANTIBACTERIAL HAND GEL (Ethyl Alcohol 62%), 1.35 fl oz / 40 mL, OTC, Distributed by: JFL Enterprises, Inc. Cleveland, Ohio 44102. | CGMP deviations: Stability testing was not conducted on manufactured sunscreen and hand sanitizer OTC products. | NingBo Huize Commodity Co.,Ltd. / 18036 | Class III | Terminated |
| D-1534-2019 | 04-01-2019 | Texas Home Health Home Care Hospice Personal Care Hand Sanitizer (Ethyl Alcohol 62%), 0.33 oz/10 mL, OTC, Made in China | CGMP deviations: Stability testing was not conducted on manufactured sunscreen and hand sanitizer OTC products. | NingBo Huize Commodity Co.,Ltd. / 50,000 | Class III | Terminated |
| D-1536-2019 | 04-01-2019 | Tootsie Roll POP CHOCOLATE SCENTED ANTIBACTERIAL HAND GEL (Ethyl Alcohol 62%), 1.35 fl oz / 40 mL, OTC, Distributed by: JFL Enterprises, Inc. Cleveland, Ohio 44102. | CGMP deviations: Stability testing was not conducted on manufactured sunscreen and hand sanitizer OTC products. | NingBo Huize Commodity Co.,Ltd. / 5112 | Class III | Terminated |
| D-1533-2019 | 04-01-2019 | festpak clearly fun SPF30 sunscreen lotion SPF 30 SUNSCREEN LOTION Active Ingredients Octinoxate 7.5%, Octisalate 2.0%, Oxybenzone 4.0% Titanium Dioxide 2.5% Sunscreen Distributed by: festpak - Austin, TX 78732 Made in China | CGMP deviations: Stability testing was not conducted on manufactured sunscreen and hand sanitizer OTC products. | NingBo Huize Commodity Co.,Ltd. / 20, 000 | Class III | Terminated |
| D-1538-2019 | 04-01-2019 | DOTS SCENTED ANTIBACTERIAL HAND GEL ORANGE (Ethyl Alcohol 62%), 1.35 fl oz / 40 mL, OTC, Distributed by: JFL Enterprises, Inc. Cleveland, Ohio 44102. | CGMP deviations: Stability testing was not conducted on manufactured sunscreen and hand sanitizer OTC products. | NingBo Huize Commodity Co.,Ltd. / 3852 | Class III | Terminated |
| D-1537-2019 | 04-01-2019 | Tootsie Roll POP RASPBERRY SCENTED ANTIBACTERIAL HAND GEL (Ethyl Alcohol 62%), 1.35 fl oz / 40 mL, OTC, Distributed by: JFL Enterprises, Inc. Cleveland, Ohio 44102. | CGMP deviations: Stability testing was not conducted on manufactured sunscreen and hand sanitizer OTC products. | NingBo Huize Commodity Co.,Ltd. / 5112 | Class III | Terminated |
| D-1530-2019 | 04-01-2019 | Good to Go Hand Sanitizer (Ethyl Alcohol 62%), 1 FL OZ (30 mL), OTC, Made in China for Cashco Distributors Inc. 6430 N. E. Columbia Blvd Portland OR 97218 | CGMP deviations: Stability testing was not conducted on manufactured sunscreen and hand sanitizer OTC products. | NingBo Huize Commodity Co.,Ltd. / 52,160 | Class III | Terminated |
| D-1531-2019 | 04-01-2019 | Tootsie Roll POP GRAPE SCENTED ANTIBACTERIAL HAND GEL (Ethyl Alcohol 62%), 1.35 fl oz / 40 mL, OTC, Distributed By: JFL Enterprises, Inc. Cleveland, Ohio 44102, Made in China | CGMP deviations: Stability testing was not conducted on manufactured sunscreen and hand sanitizer OTC products. | NingBo Huize Commodity Co.,Ltd. / 5112 | Class III | Terminated |
| D-1554-2019 | 04-01-2019 | AIR HEADS PINK LEMONADE SCENTED ANTIBACTERIAL HAND GEL (Ethyl Alcohol 62%), 1.35 fl oz / 40 mL, OTC, Distributed by: JFL Enterprises, Inc. Cleveland, Ohio 44102. | CGMP deviations: Stability testing was not conducted on manufactured sunscreen and hand sanitizer OTC products. | NingBo Huize Commodity Co.,Ltd. / 13,068 | Class III | Terminated |
| D-1546-2019 | 04-01-2019 | AMERICA'S ORIGINAL DUBBLE BUBBLE SCENTED ANTIBACTERIAL HAND GEL (Ethyl Alcohol 62%), 1.35 fl oz / 40 mL, OTC, Distributed by: JFL Enterprises, Inc. Cleveland, Ohio 44102. | CGMP deviations: Stability testing was not conducted on manufactured sunscreen and hand sanitizer OTC products. | NingBo Huize Commodity Co.,Ltd. / 20160 | Class III | Terminated |
| D-1548-2019 | 04-01-2019 | TOOTSIE ROLL FRUIT CHEWS LEMON SCENTED ANTIBACTERIAL HAND GEL (Ethyl Alcohol 62%), 1.35 fl oz / 40 mL, OTC, Distributed by: JFL Enterprises, Inc. Cleveland, Ohio 44102. | CGMP deviations: Stability testing was not conducted on manufactured sunscreen and hand sanitizer OTC products. | NingBo Huize Commodity Co.,Ltd. / 8,856 | Class III | Terminated |
| D-1540-2019 | 04-01-2019 | DOTS SCENTED ANTIBACTERIAL HAND GEL STRAWBRRY (Ethyl Alcohol 62%), 1.35 fl oz / 40 mL, OTC, Distributed by: JFL Enterprises, Inc. Cleveland, Ohio 44102. | CGMP deviations: Stability testing was not conducted on manufactured sunscreen and hand sanitizer OTC products. | NingBo Huize Commodity Co.,Ltd. / 3852 | Class III | Terminated |
| D-1541-2019 | 04-01-2019 | DOTS SCENTED ANTIBACTERIAL HAND GEL LEMON (Ethyl Alcohol 62%), 1.35 fl oz / 40 mL, OTC, Distributed by: JFL Enterprises, Inc. Cleveland, Ohio 44102. | CGMP deviations: Stability testing was not conducted on manufactured sunscreen and hand sanitizer OTC products. | NingBo Huize Commodity Co.,Ltd. / 3852 | Class III | Terminated |
| D-1121-2019 | 04-01-2019 | Telmisartan and Amlodipine Tablets 80 mg/5 mg, 30 tablet bottle, Rx only, Manufactured for: Lupin Pharmaceuticals, Inc., Baltimore, MD, Manufactured by : Lupin Limited, Goa, INDIA -- NDC 68180-198-06 Package NDCs: 68180-196-06; 68180-196-09; 68180-196-12; 68180-197-06; 68180-197-09; 68180-197-12; 68180-197-07; 68180-198-06; 68180-198-09; 68180-198-12; 68180-199-06; 68180-199-09; 68180-199-12 | Failed Impurities/Degradation Specifications; 18 month long term stability study. | Lupin Pharmaceuticals Inc. / 12,504 bottles | Class III | Terminated |
| D-1074-2019 | 03-29-2019 | Pantoprazole Sodium Delayed-Release Tablets, USP, 40 mg*, 90-count bottle, Rx Only, Manufactured by: Jubilant Generics Ltd., Roorkee - 247661, India; Marketed by: Jubilant Cadista Pharmaceuticals Inc., Salisbury, MD 21801; NDC 59746-284-90. | Discoloration: Expansion of an earlier recall due to the presence of dark brown discoloration on the edges of the tablets. | Jubilant Cadista Pharmaceuticals, Inc. / 12,960 bottles | Class II | Terminated |
| D-1084-2019 | 03-29-2019 | Clonidine HCL Injection, 1000 mcg/10mL (100 mcg/mL), 10 ML Single Dose Vial, Rx only, Manufactured for: X-Gen Pharmaceuticals, Big Flats, NY 14814, NDC 39822-2000-1. Package NDCs: 39822-2000-1; 39822-2010-1 | Labeling: Label Error on Declared Strength: Side carton panel incorrectly lists the concentration as "500 mcg Clonidine Hydrochloride" rather than the correct concentration of "100 mcg Clonidine Hydrochloride" per mL. | X-Gen Pharmaceuticals Inc. / 24,966 vials | Class III | Terminated |
| D-1080-2019 | 03-28-2019 | Nystatin Oral Suspension, USP, 100,000 units per mL, 473 mL per bottle, Rx only, HI-TECH Pharmacal Co., Inc., Amityville, NY 11701, NDC 50383-587-16 | Failed Impurities/Degradation Specifications: Out of Specification for an unknown impurity was observed during the 18 month stability testing. | Akorn, Inc. / 2,796 bottles | Class III | Terminated |
| D-1248-2019 | 03-28-2019 | Lidocaine HCl Injection, USP 1 % 50 mg/5 mL (10 mg/mL), 5mL vial, Rx only, Mrd. in India for: AuroMedics Pharna LLC. E Windsor, NJ 08520 NDC 55150-162-05 Package NDCs: 76420-782-01; 0517-0720-01; 55150-162-05; 0409-1159-18; 67777-419-02 | Presence of Particulate Matter: One vial was found to contain a hair. | Aurobindo Pharma USA Inc. / 88600 vials | Class I | Terminated |
| D-1134-2019 | 03-26-2019 | Thallous Chloride TI 201 Injection, Specific Concentration: 37 MBq/mL (1 mCi/mL), Total Activity: 325.6 MBq (8.8 mCi) Volume: 8.8 mL vial, Rx Only, Mfg. by GE Healthcare, Medi-physics, Inc., Arlington Heights, IL 60004. NDC: 17156-299-18 | Chemical Contamination: Trace amounts of an impurity was detected in the reagent used to manufacture finished product. | Medi-Physics Inc. dba GE Healthcare / 110 10 ml vials | Class III | Terminated |
| D-1130-2019 | 03-25-2019 | Bismuth Subsalicylate Oral Suspension 262mg/15mL, unit dose cups, OTC, Rpkg. By.: Lohxa Worcester, MA, NDC 70166-059-01 | Labeling: Incorrect or Missing Lot and/or Exp Date - the label contains an incorrect Exp Date. | Lohxa LLC / 5 boxes - 250 unit dose cups. | Class II | Terminated |
| D-1131-2019 | 03-25-2019 | Phenobarbital Oral Solution, USP 20 mg/5mL, unit dose cup, Rx Only, Rpkg. By.Lohxa Worcester, MA 01608 NDC 70166-536-02 | Labeling: Incorrect or Missing Lot and/or Exp Date - the label contains an incorrect Exp Date. | Lohxa LLC / 46 boxes - 1380 unit dose cups | Class II | Terminated |
| D-1120-2019 | 03-25-2019 | Pravastatin Sodium Tablets USP, 20 mg, 500-count bottle, Rx Only, Manufactured by: Glenmark Pharmaceuticals Ltd. Plot No. 2, Phase-2, Pharma zone SEZ, Pithampur, Dist-Dhar, Madhya Pradesh 454 775, India. Manufactured for: Glenmark Pharmaceuticals Inc., USA Mahwah, NJ 07430. NDC 68462-196-05 Package NDCs: 68462-195-90; 68462-195-05; 68462-196-90; 68462-196-05; 68462-197-90; 68462-197-05; 68462-198-90; 68462-198-05 | Presence Of Foreign Tablet: in a bottle of Pravastatin Sodium Tablets 20 mg. | Glenmark Pharmaceuticals Inc., USA / 2076 500-count Bottles | Class II | Terminated |
| D-1057-2019 | 03-22-2019 | Fayosim (levonorgestrel and ethinyl estradiol) tablets USP, (0.15 mg/0.02 mg, 0.15 mg/0.025 mg, 0.15 mg/0.03 mg) and ethinyl estradiol tablets USP, (0.01 mg), packaged in 1 Extended-Cycle Wallet of 91 Tablets packed in a pouch(NDC 68180-860-11); one pouch per carton (NDC 68180-860-12), Rx only, Distributed by: Lupin Pharmaceuticals, Inc., Baltimore, Maryland 21202; Manufactured by: Lupin Limited, Pithampur (M.P.) - 454775, INDIA. | Failed Impurities/Degradation Specifications: Out-of-specification results observed in related substance test (Any Other Individual Impurity and Total impurities) in Ethinyl Estradiol Tablets USP 0.01mg at 12 month long term stability study. | Lupin Pharmaceuticals Inc. / 12,464 cartons | Class II | Terminated |
| D-1082-2019 | 03-22-2019 | Biotin 10 mg/mL Injection, 30 mL vial, Rx only, 511 S. Harbor Blvd., Building. F, La Habra, CA 90631, 562-352-9630. | Failed pH Specification: product does not meet pH label claim. | Auro Pharmacies Inc. DBA Central Drugs / 167 vials | Class III | Terminated |
| D-1123-2019 | 03-22-2019 | Testosterone Cypionate Injection, USP, 2000 mg/10 mL (200 mg/mL), For intramuscular use only, 10 mL Vial, Multiple-Dose, Rx Only, Manufactured by: Cipla Ltd., Verna Goa, India, Manufactured for: Cipla USA, Inc., 1560 Sawgrass Corporate Parkway, Suite 130, Sunrise, FL 33323, NDC 69097-537-37. Package NDCs: 69097-536-37; 69097-537-37; 69097-537-31 | Presence of Particulate Matter. | InvaGen Pharmaceuticals, Inc. / 12234 vials | Class II | Terminated |
| D-1124-2019 | 03-22-2019 | Testosterone Cypionate Injection, USP, 200 mg/mL, For IM use only, 1 mL Vial, Single Dose, Rx Only, Manufactured by: Cipla Ltd., Verna Goa, India, Manufactured for: Cipla USA, Inc., 1560 Sawgrass Corporate Parkway, Suite 130, Sunrise, FL 33323, NDC 69097-537-31. Package NDCs: 69097-536-37; 69097-537-37; 69097-537-31 | Presence of Particulate Matter. | InvaGen Pharmaceuticals, Inc. / 692538 vials | Class II | Terminated |
| D-1125-2019 | 03-22-2019 | Testosterone Cypionate Injection, USP, 1000 mg/10 mL (100 mg/mL), For intramuscular use only, 10 mL Vial, Multiple-Dose, Rx Only, Manufactured by: Cipla Ltd., Verna Goa, India, Manufactured for: Cipla USA, Inc., 1560 Sawgrass Corporate Parkway, Suite 130, Sunrise, FL 33323, NDC 69097-536-37. Package NDCs: 69097-536-37; 69097-537-37; 69097-537-31 | Presence of Particulate Matter. | InvaGen Pharmaceuticals, Inc. / 75968 vials | Class II | Terminated |
| D-1113-2019 | 03-19-2019 | Gavilyte-N, PEG-3350, Sodium chloride, Sodium Bicarbonate and Potassium Chloride for Oral Solution, Rx only, Manufactured by Novel Laboratories, Inc. Somerset, NJ 08873 Manufactured for Lupin Pharmaceuticals, Inc. Baltimore, MD NDC 43386-050-19 UPC 343386050192 a) Lemon Flavor Pack net wt. 2 g UPC 343386200023 b) Orange Flavor Pack net wt. 2 g UPC 343386202027 c) Cherry Flavor Pack net wt. 2 g UPC 3433862034 Package NDCs: 43386-050-19; 3433860501; 3433862000; 3433862020; 3433862034 | Labeling Not Elsewhere Classified; orange and cherry flavor packets incorrect list "natural lemon flavor" as an ingredient | LUPIN SOMERSET / 76422 bottles | Class II | Terminated |
| D-1056-2019 | 03-19-2019 | Combigan (brimonidine tartrate/timolol maleate ophthalmic solution) 0.2%/0.5% 5 mL bottles, Rx only, Allergan, Inc. Irvine, CA 92612 U.S.A. NDC 0023-9211-05 Package NDCs: 0023-9211-03; 0023-9211-05; 0023-9211-10; 0023-9211-15 | cGMP Deviations | Allergan Sales, LLC / 72 bottles | Class II | Terminated |
| D-1058-2019 | 03-18-2019 | Diclofenac Sodium Topical Solution, 1.5% w/w, 5 FL. OZ. (150 mL) bottle, Rx Only, Manufactured for: Ingenus Pharmaceuticals, LLC, Orlando, FL 32839-6408, NDC 50742-308-05. | Defective Container: firm discovered samples stored horizontally as well as product quality complaints from customers for bottles leaking. | Ingenus Pharmaceuticals Llc / 29,435 bottles | Class III | Terminated |
| D-1073-2019 | 03-15-2019 | 8.4% Sodium Bicarbonate Injection, USP 50 mEq (1 mEq/mL) 4.2 grams (84 mg/mL) 50 mL Single-dose fliptop vial, 25 vials per carton, Rx only Hospira, Inc. Lake Forest, IL 60045 USA ---- NDC 0409-6625-02 | Presence of Particulate Matter; glass particulates | Pfizer Inc. / 283,400 vials | Class I | Terminated |
| D-1071-2019 | 03-15-2019 | Clindamycin Injection, USP, 600 mg/ 4 mL (150 mg/mL), 4 mL vials, Rx only, Distributed by: Alvogen, Inc., Pine Brook, NJ 07058 USA, NDC 47781-620-94 | Failed Impurities/Degradation Specifications: High out-of-specification (OOS) results were demonstrated for several specified impurities at the 24-month time point | Pfizer Inc. / 8,878 cartons (25 vials per carton) | Class III | Terminated |
| D-1070-2019 | 03-15-2019 | Clindamycin Injection, USP, 300 mg/ 2 mL (150 mg/mL), 2 mL vials, Rx only, Distributed by: Alvogen, Inc., Pine Brook, NJ 07058 USA.,NDC 47781-619-94 | Failed Impurities/Degradation Specifications: High out-of-specification (OOS) results were demonstrated for several specified impurities at the 24-month time point | Pfizer Inc. / 701 cartons (25 vials per carton) | Class III | Terminated |
| D-1072-2019 | 03-15-2019 | Clindamycin Injection, USP, 900 mg/6 mL (150 mg/mL), 6 mL vial, Rx only, Distributed by: Alvogen, Inc., Pine Brook, NJ 07058 USA. NDC 47781-621-94 | Failed Impurities/Degradation Specifications: High out-of-specification (OOS) results were demonstrated for several specified impurities at the 24-month time point | Pfizer Inc. / 8,320 cartons (25 vials per carton) | Class III | Terminated |
| D-1067-2019 | 03-15-2019 | Cleocin Phosphate (clindamycin injection), USP, 300 mg/ 2 mL (150 mg/mL), 2 mL-vial, Rx only, Distributed by Pharmacia & Upjohn Co, Division of Pfizer, Inc, New York, NY 10017, NDC 0009-6582-02 Package NDCs: 0009-0870-21; 0009-0870-26; 0009-0775-20; 0009-0775-26; 0009-0902-11; 0009-0902-18; 0009-0728-05; 0009-0728-09; 0009-3124-01; 0009-3124-03; 0009-3447-01; 0009-3447-03; 0009-3381-01; 0009-3381-02; 0009-3375-01; 0009-3375-02; 0009-3382-01; 0009-3382-02; 0009-6582-02; 0009-6582-01 | Failed Impurities/Degradation Specifications: High out-of-specification (OOS) results were demonstrated for several specified impurities at the 24-month time point | Pfizer Inc. / 67 cartons (25 vials per carton) | Class III | Terminated |
| D-1069-2019 | 03-15-2019 | Cleocin Phosphate, clindamycin injection, USP, 900 mg/ 6 mL (150 mg/mL), 6 mL vial, Rx only, Distributed by Pharmacia & Upjohn Co, Division of Pfizer, Inc, New York, NY 10017. NDC 0009-3447-01 Package NDCs: 0009-0870-21; 0009-0870-26; 0009-0775-20; 0009-0775-26; 0009-0902-11; 0009-0902-18; 0009-0728-05; 0009-0728-09; 0009-3124-01; 0009-3124-03; 0009-3447-01; 0009-3447-03; 0009-3381-01; 0009-3381-02; 0009-3375-01; 0009-3375-02; 0009-3382-01; 0009-3382-02; 0009-6582-02; 0009-6582-01 | Failed Impurities/Degradation Specifications: High out-of-specification (OOS) results were demonstrated for several specified impurities at the 24-month time point | Pfizer Inc. / 500 cartons (25 vials per carton) | Class III | Terminated |
| D-1068-2019 | 03-15-2019 | Cleocin Phosphate, clindamycin injection, USP, 600 mg/ 4 mL (150 mg/mL), 4 mL vial, Rx only, Distributed by Pharmacia & Upjohn Co, Division of Pfizer, Inc, New York, NY 10017, NDC 0009-3124-01 Package NDCs: 0009-0870-21; 0009-0870-26; 0009-0775-20; 0009-0775-26; 0009-0902-11; 0009-0902-18; 0009-0728-05; 0009-0728-09; 0009-3124-01; 0009-3124-03; 0009-3447-01; 0009-3447-03; 0009-3381-01; 0009-3381-02; 0009-3375-01; 0009-3375-02; 0009-3382-01; 0009-3382-02; 0009-6582-02; 0009-6582-01 | Failed Impurities/Degradation Specifications: High out-of-specification (OOS) results were demonstrated for several specified impurities at the 24-month time point | Pfizer Inc. / 820 cartons (25 vials per carton) | Class III | Terminated |
| D-1132-2019 | 03-15-2019 | Repairwear Laser Focus Line Smoothing Cream Broad Spectrum SPF 15, packaged in a light green folding carton containing a 50 mL silver jar with a silver cap, Clinique Laboratories, Dist. New York, NY 10022 | Defective container: Ineffective seal between the cap and jar of the affected product. | Estee Lauder Inc / 14490 jars | Class III | Terminated |
| D-1081-2019 | 03-14-2019 | Losartan 50mg Tablet, 30 count each blister card. | CGMP Deviations; Detection of trace amounts of an unexpected impurity found in an active pharmaceutical ingredient (API) - N-Methylnitrosobutyric acid (NMBA). | RemedyRepack Inc. / 33 blister cards of 30 = 990 tablets | Class II | Terminated |
| D-1085-2019 | 03-14-2019 | Blue Fusion Capsules, 1- count blister pack, Distributed by: DNS Distribution 5225 Canyon Crest Dr. Ste 71-640, Riverside, CA 92507, UPC 7 48252 66460 0 | Marketed Without An Approved NDA/ANDA: FDA analysis found this product to contain undeclared ingredients: Sildenafil, Tadalafil, desmethyl carbodenafil, dithiodesmethyl carbodenafil, scutellarin, and daidzein. | Ata International Inc / Unknown | Class I | Terminated |
| D-1024-2019 | 03-13-2019 | Neostigmine Methylsulfate Injection Solution 5 mg/5mL (1 mg per mL), 5mL Sterile single use syringe, For IV use only, NDC: 42852-829-67 Avella of Houston 9265 Kirby Dr., Houston, TX 77054 (877) 794-0404 | Lack of Assurance of Sterility | Advanced Pharma Inc. / 5700 syringes | Class II | Terminated |
| D-1025-2019 | 03-13-2019 | Glycopyrrolate 0.6 mg/3 mL (0.2 mg per mL) Injectable Solution, 3 mL Sterile single use syringe, For IV or IM use, NDC: 42852-828-22 Avella of Houston 9265 Kirby Dr., Houston, TX 77054 (877) 794-0404 | Lack of Assurance of Sterility | Advanced Pharma Inc. / 140 syringes | Class II | Terminated |
| D-1026-2019 | 03-13-2019 | 2% Lidocaine HCl Injectable Solution, 60 mg/3 mL (20 mg per mL), 3mL Sterile single use syringe, NDC: 42852-011-22 Avella of Houston 9265 Kirby Dr., Houston, TX 77054 (877) 794-0404 | Lack of Assurance of Sterility | Advanced Pharma Inc. / 1540 syringes | Class II | Terminated |
| D-1034-2019 | 03-13-2019 | Phenylephrine HCl, 1,200 mcg in 0.9% Sodium Chloride, QS 10 mL Injectable Solution 1,200 mcg/10 mL (120 mcg per mL), Sterile single use syringe, NDC: 42852-882-61 Avella of Houston 9265 Kirby Dr., Houston, TX 77054 (877) 794-0404 | Lack of Assurance of Sterility | Advanced Pharma Inc. / 975 | Class II | Terminated |
| D-1020-2019 | 03-13-2019 | Phenylephrine HCl, 500 mcg in 0.9% Sodium Chloride, QS 5 mL Injectable Solution 500 mcg/5 mL (100 mcg per mL), 5mL Sterile single use syringe, NDC: 42852-830-67 Avella of Houston 9265 Kirby Dr., Houston, TX 77054 (877) 794-0404 | Lack of Assurance of Sterility | Advanced Pharma Inc. / 16075 syringes | Class II | Terminated |
| D-1033-2019 | 03-13-2019 | Morphine Sulfate 30 mg/30 mL (1 mg/mL) Injectable Solution Morphine Sulfate 30 mg 0.9% Sodium Chloride QS 30 mL Sterile singe use syringe, NDC: 42852-241-63 Avella of Houston 9265 Kirby Dr., Houston, TX 77054 (877) 794-0404 | Lack of Assurance of Sterility | Advanced Pharma Inc. / 2325 syringes | Class II | Terminated |
| D-1030-2019 | 03-13-2019 | Heparin 10 Units/10 mL 10 Units in 0.45% Sodium Chloride, QS 10 mL, Injectable Solution, Dwell, 10mL Sterile single use syringe, NDC: 42852-725-61 Avella of Houston 9265 Kirby Dr., Houston, TX 77054 (877) 794-0404 | Lack of Assurance of Sterility | Advanced Pharma Inc. / 500 syringes | Class II | Terminated |
| D-1022-2019 | 03-13-2019 | Phenylephrine HCl, 400 mcg in 0.9% Sodium Chloride, QS 10 mL Injectable Solution 400 mcg/10 mL (40 mcg per mL), Sterile single use syringe, NDC: 42852-876-61 Avella of Houston 9265 Kirby Dr., Houston, TX 77054 (877) 794-0404 | Lack of Assurance of Sterility | Advanced Pharma Inc. / 1575 syringes | Class II | Terminated |
| D-1021-2019 | 03-13-2019 | Glycopyrrolate Injectable Solution 1 mg/5 mL (0.2 mg per mL), Sterile single use syringe, NDC: 42852-828-67 Avella of Houston 9265 Kirby Dr., Houston, TX 77054 (877) 794-0404 | Lack of Assurance of Sterility | Advanced Pharma Inc. / 2580 syringes | Class II | Terminated |
