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 August 07, 2026 and include a total of 17860 recall reports.
| Recall Number | Recall Initiation Date | Product Description | Recall Reason | Recall Firm / Quantity | Recall Classification | Status |
|---|---|---|---|---|---|---|
| D-1246-2019 | 04-10-2019 | Morphine Sulfate Extended-Release Tablets, 100 mg, 100-count bottles, Rx Only, Manufactured by: Novel Laboratories, Inc. Somerset, NJ 08873 Manufactured for: Lupin Pharmaceuticals, Inc. Baltimore, MD 21202 NDC 43386-543-01 Package NDCs: 43386-540-01; 43386-540-05; 43386-541-01; 43386-541-05; 43386-542-01; 43386-542-05; 43386-543-01; 43386-543-05; 43386-544-01; 43386-544-05 | Failed Impurities/Degradation Specifications | LUPIN SOMERSET / 3,444 bottles | Class III | Terminated |
| D-1244-2019 | 04-10-2019 | Morphine Sulfate Extended-Release Tablets, 30 mg, 100-count bottles, Rx Only, Manufactured by: Novel Laboratories, Inc. Somerset, NJ 08873 Manufactured for: Lupin Pharmaceuticals, Inc. Baltimore, MD 21202 NDC 43386-541-01 Package NDCs: 43386-540-01; 43386-540-05; 43386-541-01; 43386-541-05; 43386-542-01; 43386-542-05; 43386-543-01; 43386-543-05; 43386-544-01; 43386-544-05 | Failed Impurities/Degradation Specifications | LUPIN SOMERSET / 15,320 bottles | Class III | Terminated |
| D-1245-2019 | 04-10-2019 | Morphine Sulfate Extended-Release Tablets, 60 mg, 100-count bottles, Rx Only, Manufactured by: Novel Laboratories, Inc. Somerset, NJ 08873 Manufactured for: Lupin Pharmaceuticals, Inc. Baltimore, MD 21202 NDC 43386-542-01 Package NDCs: 43386-540-01; 43386-540-05; 43386-541-01; 43386-541-05; 43386-542-01; 43386-542-05; 43386-543-01; 43386-543-05; 43386-544-01; 43386-544-05 | Failed Impurities/Degradation Specifications | LUPIN SOMERSET / 10,284 bottles | Class III | Terminated |
| D-1344-2019 | 04-09-2019 | Aphrodisiac Platinum 40000, Proprietary Raw Material 6000 mg, 1 count blister card, 24 cards per box, Distributed by: APhrodisiac. UPC Code 644118128135 | Marketed without an approved NDA/ANDA: FDA analysis has found the product to be tainted with sildenafil | SELECT DISTRIBUTIONS LLC / 60 boxes | Class I | Terminated |
| D-1276-2019 | 04-08-2019 | GlipiZIDE Extended-release Tablets, 2.5 mg, 30 Tablets (3 x 10), Rx Only, Packaged and Distributed by: American Health Packaging, Columbus, Ohio 43217. NDC: 68084-295-21 | Failed Dissolution Specifications: dissolution failure at time zero of the repackaged lot. Drug release results were slightly above specification at time zero. | American Health Packaging / 2,203 cartons (cartons of 30 individual unit doses) | Class II | Terminated |
| D-1256-2019 | 04-08-2019 | HCG (CHORIONIC GONADOTROPIN 1000 IU/ML PEP 25 mg/mL) inj 5 mL multidose vial compounded. Customceutical Compounding 4611 E. Shea Blvd. Bldg 3 180, Phoenix, AZ 85028 Ph. 480 516 0272 | Lack of assurance of sterility for injectables and solutions intended to be sterile. | Customceutical Compounding / 12 vials | Class II | Terminated |
| D-1253-2019 | 04-08-2019 | BPlex (METHYLCOBALAMIN 1000 MCG/ML PYRIDOXAL 5 PHOSPHATE 20MG/ML DEXPANTHENOL 250MG/ML), 10 ML MULTIDOSE VIAL MDV INJ COMPOUNDED. Customceutical Compounding 4611 E. Shea Blvd. Bldg 3 180, Phoenix, AZ 85028 Ph. 480 516 0272 | Lack of assurance of sterility for injectables and solutions intended to be sterile. | Customceutical Compounding / 32 vials | Class II | Terminated |
| D-1257-2019 | 04-08-2019 | Lipoplex (METHIONINE 25 MG/ML INOSITOL 50 MG/ML CHOLINE CHLORIDE 50 MG/ML HYDROXOCOBALAMIN 500 MC/ML DEXPANTHENOL 50 MG/ML PYRIDOXINE HCL 50 MG/ML), 10 ML MULTIDOSE VIAL INJ COMPOUNDED. Customceutical Compounding 4611 E. Shea Blvd. Bldg 3 180, Phoenix, AZ 85028 Ph. 480 516 0272 | Lack of assurance of sterility for injectables and solutions intended to be sterile. | Customceutical Compounding / 16 vials | Class II | Terminated |
| D-1260-2019 | 04-08-2019 | Test PROCYP (TESTOSTERONE CYPIONATE 200MG/ML TESTOSTERONE PROPIONATE 20MG/ML), 5 ML MULTIDOSE VIAL INJ COMPOUNDED. Customceutical Compounding 4611 E. Shea Blvd. Bldg 3 180, Phoenix, AZ 85028 Ph. 480 516 0272 | Lack of assurance of sterility for injectables and solutions intended to be sterile. | Customceutical Compounding / 5 vials | Class II | Terminated |
| D-1262-2019 | 04-08-2019 | TriMix MEDIUM (Papaverine HCL 21 mg/mL Phentolamine Mesylate 0.7 mg/mL Alprostadil 7 mcg/mL), 2 mL multidose MDV Inj. Compounded. Customceutical Compounding 4611 E. Shea Blvd. Bldg 3 180, Phoenix, AZ 85028 Ph. 480 516 0272 | Lack of assurance of sterility for injectables and solutions intended to be sterile. | Customceutical Compounding / N/A | Class II | Terminated |
| D-1254-2019 | 04-08-2019 | BPlex (METHYLCOBALAMIN 1000 MCG/ML PYRIDOXAL 5 PHOSPHATE 20MG/ML DEXPANTHENOL 250MG/ML), 10 ML MULTIDOSE VIAL MDV INJ COMPOUNDED. Customceutical Compounding 4611 E. Shea Blvd. Bldg 3 180, Phoenix, AZ 85028 Ph. 480 516 0272 | Lack of assurance of sterility for injectables and solutions intended to be sterile. | Customceutical Compounding / 19 vials | Class II | Terminated |
| D-1255-2019 | 04-08-2019 | Glutathione 200mg/mL inj. a) 10 ML and b) 12 ML MULTIDOSE VIAL MDV Compounded. Customceutical Compounding 4611 E. Shea Blvd. Bldg 3 180, Phoenix, AZ 85028 Ph. 480 516 0272 | Lack of assurance of sterility for injectables and solutions intended to be sterile. | Customceutical Compounding / 4 vials | Class II | Terminated |
| D-1259-2019 | 04-08-2019 | Test D (TESTOSTERONE CYPIONATE 200MG/ML VITAMIN D3 5,000IU/ML), 5 ML MULTIDOSE VIAL COMPOUNDED. Customceutical Compounding 4611 E. Shea Blvd. Bldg 3 180, Phoenix, AZ 85028 Ph. 480 516 0272 | Lack of assurance of sterility for injectables and solutions intended to be sterile. | Customceutical Compounding / 2 vials | Class II | Terminated |
| D-1261-2019 | 04-08-2019 | Trimix HIGH (Papaverine HCl 30 mg/mL Phentolamine Mesylate 2 mg/mL Alprostadil 20 mcg/mL), 2 mL multidose vial MDV Inj. Compounded. Customceutical Compounding 4611 E. Shea Blvd. Bldg 3 180, Phoenix, AZ 85028 Ph. 480 516 0272 | Lack of assurance of sterility for injectables and solutions intended to be sterile. | Customceutical Compounding / 3 vials | Class II | Terminated |
| D-1258-2019 | 04-08-2019 | Test D (TESTOSTERONE CYPIONATE 200MG/ML VITAMIN D3 5,000IU/ML), 5 ML MULTIDOSE VIAL COMPOUNDED. Customceutical Compounding 4611 E. Shea Blvd. Bldg 3 180, Phoenix, AZ 85028 Ph. 480 516 0272 | Lack of assurance of sterility for injectables and solutions intended to be sterile. | Customceutical Compounding / 8 vials | Class II | Terminated |
| D-1206-2019 | 04-05-2019 | Kopi Jantan Tradisional Natural Herbs Coffee, 13g individual packages, Manufactured By: Fikrysz (M) Sdn. Bhd., Kedah, Malaysia, UPC 9 557205 060083. | Marketed Without An Approved NDA/ANDA: FDA analysis found this product to be tainted with undeclared sildenafil and tadalafil, two FDA approved drugs for the treatment of male erectile dysfunction, making this an unapproved drug for which safety and efficacy have not been established and, therefore, subject to recall. | Brian P. Richardson / 6000 packages | Class I | Terminated |
| D-1122-2019 | 04-03-2019 | Telmisartan and Amlodipine Tablets 80 mg/5 mg, 30 tablets, Rx Only, Manufactured for: AvKARE, Inc. Pulaski, TN 38478 --- NDC 42291-795-30 | Failed Impurities/Degradation Specifications; 18 month long term stability study (manufacturer) | AVKARE Inc. / 397 bottles | Class III | Terminated |
| D-1200-2019 | 04-02-2019 | Prostaglandin Tri-Mix 5:15:0.5 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 / N/A | Class II | Terminated |
| D-1198-2019 | 04-02-2019 | Papaverine 30 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 / N/A | Class II | Terminated |
| D-1188-2019 | 04-02-2019 | Lidocaine 1%/Dextrose 12.5% (PF) 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 / N/A | Class II | Terminated |
| D-1184-2019 | 04-02-2019 | Serum Tears 50% Ophthalmic Drops, 1 mL Dropper, Anderson Compounding Pharmacy 310 Bluff City Hwy, Bristol, TN. | Lack of sterility assurance. | Anderson Compounding Pharmacy, Inc. DBA Anderson Compounding Pharmacy / N/A | Class II | Terminated |
| D-1183-2019 | 04-02-2019 | Methylcobalamin 3000 mcg/mL Injection Solution, 2 mL Vial, Anderson Compounding Pharmacy 310 Bluff City Hwy, Bristol, TN. | Lack of sterility assurance. | Anderson Compounding Pharmacy, Inc. DBA Anderson Compounding Pharmacy / N/A | Class II | Terminated |
| D-1192-2019 | 04-02-2019 | Gentamicin 160 mg/1000 mL Sterile Water for Irrigation,1000 mL Bottle, Anderson Compounding Pharmacy 310 Bluff City Hwy, Bristol, TN. | Lack of sterility assurance. | Anderson Compounding Pharmacy, Inc. DBA Anderson Compounding Pharmacy / N/A | Class II | Terminated |
| D-1203-2019 | 04-02-2019 | Prostaglandin Tri-Mix 20:25:1 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 / N/A | Class II | Terminated |
| D-1140-2019 | 04-02-2019 | Vancomycin 125 mg/3mL Inhalation, 3 mL Vial, Anderson Compounding Pharmacy 310 Bluff City Hwy, Bristol, TN. | Lack of sterility assurance. | Anderson Compounding Pharmacy, Inc. DBA Anderson Compounding Pharmacy / N/A | Class II | Terminated |
| D-1189-2019 | 04-02-2019 | EDTA 1% Sterile Injection (Preservative Free), Anderson Compounding Pharmacy 310 Bluff City Hwy, Bristol, TN. | Lack of sterility assurance. | Anderson Compounding Pharmacy, Inc. DBA Anderson Compounding Pharmacy / N/A | Class II | Terminated |
| D-1185-2019 | 04-02-2019 | Interferon 1 Million IU/mL Eye 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 / N/A | Class II | Terminated |
| D-1202-2019 | 04-02-2019 | Prostaglandin Tri-Mix 8.33:22.5:0.833 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 / N/A | Class II | Terminated |
| D-1252-2019 | 04-02-2019 | Remifentanil HCl active pharmaceutical ingredient (API) for manufacturing, processing or repackaging, 416.95 g glass container, Rx ONLY, Johnson Matthey Pharmaceutical Materials, 2003 Nolte Drive, West Deptford, NJ 08066-1742. | Failed Impurities/Degradation Specifications: Unknown impurity above specification limits. | Johnson Matthey Inc. / 416.95 g glass container | Class III | Terminated |
| D-1196-2019 | 04-02-2019 | HCG 11,00Units/B 12 11,000 mcg 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 / N/A | Class II | Terminated |
| D-1201-2019 | 04-02-2019 | Prostaglandin Tri-Mix 2.5:7.5:0.25 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 / N/A | Class II | Terminated |
| D-1194-2019 | 04-02-2019 | Heparin 10 mL/Marcaine 0.25% 20 mL/Sodium Bicarbonate 40 mL/Normal Saline 5 mL per 75 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 / N/A | Class II | Terminated |
| D-1195-2019 | 04-02-2019 | Estrone 5mg/mL Oil 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 / N/A | Class II | Terminated |
| D-1186-2019 | 04-02-2019 | Prostaglandin Tri-Mix 60:30:1 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 / N/A | Class II | Terminated |
| D-1191-2019 | 04-02-2019 | Heparin 20,000U/Marcaine 0.25%, 10 mL, Sodium Bicarbonate 8.4% 48 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 / N/A | Class II | Terminated |
| D-1197-2019 | 04-02-2019 | Papaverine 30 mg/Phentolamine 0.5 mg/mL, 2 mL Vial, Anderson Compounding Pharmacy 310 Bluff City Hwy, Bristol, TN. | Lack of sterility assurance. | Anderson Compounding Pharmacy, Inc. DBA Anderson Compounding Pharmacy / N/A | Class II | Terminated |
| D-1204-2019 | 04-02-2019 | Prostaglandin Tri-Mix 30:30:1 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 / N/A | Class II | Terminated |
| D-1187-2019 | 04-02-2019 | Neomycin 40 mg/Polymixin B 200,000 Bladder Irrigation Solution, 1000 mL bottle, Anderson Compounding Pharmacy 310 Bluff City Hwy, Bristol, TN. | Lack of sterility assurance. | Anderson Compounding Pharmacy, Inc. DBA Anderson Compounding Pharmacy / N/A | Class II | Terminated |
| D-1190-2019 | 04-02-2019 | Sodium Bicarbonate 8.4% 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 / N/A | Class II | Terminated |
| D-1199-2019 | 04-02-2019 | Phenol 10% Injection, 5 mL Vial, Anderson Compounding Pharmacy 310 Bluff City Hwy, Bristol, TN. | Lack of sterility assurance. | Anderson Compounding Pharmacy, Inc. DBA Anderson Compounding Pharmacy / N/A | Class II | Terminated |
| D-1193-2019 | 04-02-2019 | Gentamicin 240 mg/500 mL Sterile Water for Irrigation,60 mL Syringe, Anderson Compounding Pharmacy 310 Bluff City Hwy, Bristol, TN. | Lack of sterility assurance. | Anderson Compounding Pharmacy, Inc. DBA Anderson Compounding Pharmacy / N/A | 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-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-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-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-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-1155-2019 | 04-02-2019 | HCG 40 Day Injection Extra Strength, vials, Anderson Compounding Pharmacy 310 Bluff City Hwy, Bristol, TN. | Lack of sterility assurance. | Anderson Compounding Pharmacy, Inc. DBA Anderson Compounding Pharmacy / 2 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-1181-2019 | 04-02-2019 | Testosterone Cypionate 250 mg/mL Sterile Injection, 5 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-1153-2019 | 04-02-2019 | HCG 23 Day Injection Extra Strength, vials, 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 / 14 vials | Class II | Terminated |
| D-1160-2019 | 04-02-2019 | Heparin 2 mL/Lidocaine 2%-10 mL/Sodium Bicarbonate 8.4%-5mL/ Sterile Water 10 mL, Anderson Compounding Pharmacy 310 Bluff City Hwy, Bristol, TN. | Lack of sterility assurance. | Anderson Compounding Pharmacy, Inc. DBA Anderson Compounding Pharmacy / 6 syringes | Class II | Terminated |
| D-1159-2019 | 04-02-2019 | Heparin 10 mL/Marcain 0.25% 20 mL/Sodium Bicarbonate 8.4%-40 mL/per 70 mL, Anderson Compounding Pharmacy 310 Bluff City Hwy, Bristol, TN. | Lack of sterility assurance. | Anderson Compounding Pharmacy, Inc. DBA Anderson Compounding Pharmacy / 12 syringes | Class II | Terminated |
| D-1180-2019 | 04-02-2019 | Bacitracin 3000U/30 mL Irrigation, 30 mL Syringe, Anderson Compounding Pharmacy 310 Bluff City Hwy, Bristol, TN. | Lack of sterility assurance. | Anderson Compounding Pharmacy, Inc. DBA Anderson Compounding Pharmacy / 2 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-1173-2019 | 04-02-2019 | Prostaglandin Tri-Mix 20:30:1, 10 mL Vial, Anderson Compounding Pharmacy 310 Bluff City Hwy, Bristol, TN. | Lack of sterility assurance. | Anderson Compounding Pharmacy, Inc. DBA Anderson Compounding Pharmacy / 58 vials | Class II | Terminated |
| D-1137-2019 | 04-02-2019 | Acetylcysteine 10% Ophthalmic Eye Drop 2 mL droptainer, Anderson Compounding Pharmacy 310 Bluff City Hwy Bristol, TN. | Lack of sterility assurance. | Anderson Compounding Pharmacy, Inc. DBA Anderson Compounding Pharmacy / 10 drop containers | Class II | Terminated |
| D-1165-2019 | 04-02-2019 | Penicillin G 100,000/mL 10 mL Syringe, 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-1151-2019 | 04-02-2019 | HCG 20 Day Extra Strength, 3500 Units/4 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 / 99 vials | Class II | Terminated |
| D-1174-2019 | 04-02-2019 | Prostaglandin Tri-Mix 50:30:1, 10 mL Vial, Anderson Compounding Pharmacy 310 Bluff City Hwy, Bristol, TN. | Lack of sterility assurance. | Anderson Compounding Pharmacy, Inc. DBA Anderson Compounding Pharmacy / 31 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-1144-2019 | 04-02-2019 | Gentamicin 120 mg/250 mL 0.9% Sodium Chloride for Irrigation, 30 mL Syringe, Anderson Compounding Pharmacy 310 Bluff City Hwy, Bristol, TN. | Lack of sterility assurance. | Anderson Compounding Pharmacy, Inc. DBA Anderson Compounding Pharmacy / 6 syringes | Class II | Terminated |
| D-1141-2019 | 04-02-2019 | Dexamethasone 24 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 / 3 vials | Class II | Terminated |
| D-1149-2019 | 04-02-2019 | HCG 23 Day, 2876 Units/4.6 mL Vial, Anderson Compounding Pharmacy 310 Bluff City Hwy, Bristol, TN. | Lack of sterility assurance. | Anderson Compounding Pharmacy, Inc. DBA Anderson Compounding Pharmacy / 31 vials | Class II | Terminated |
| 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-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-1172-2019 | 04-02-2019 | Prostaglandin Quad with Atropine 10:30:1:0.15, 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-1139-2019 | 04-02-2019 | Amphotericin B 0.15% Eye Drops, 2 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-1138-2019 | 04-02-2019 | Atropine 0.01% Eye Drops, 1 mL and 2 mL Dropper, Anderson Compounding Pharmacy 310 Bluff City Hwy, Bristol, TN. | Lack of sterility assurance. | Anderson Compounding Pharmacy, Inc. DBA Anderson Compounding Pharmacy / Unknown | 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-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-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-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-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-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-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-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-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-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-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-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-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-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-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-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-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-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-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-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-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-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 |
