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-1265-2019 | 04-18-2019 | Losartan Potassium Tablets, USP, 50 mg, a) 90-count (NDC: 13668-409-90), b)1000-count (NDC: 13668-409-10) per bottle, Rx only, Manufactured by: Torrent Pharmaceuticals LTD, Indrad-382 721, Dist. Mehsana India | CGMP Deviations: FDA lab confirmed presence of an impurity, N-Methylnitrosobutyric acid (NMBA) in the finished product above the interim acceptable daily intake level. | Torrent Pharma Inc. / 164,424 bottles | Class II | Ongoing |
| D-1264-2019 | 04-18-2019 | Losartan Potassium Tablets, USP, 25 mg, a) 90-count (NDC: 13668-113-90), b)1000-count (NDC: 13668-113-10) per bottle, Rx only, Manufactured by: Torrent Pharmaceuticals LTD, Indrad-382 721, Dist. Mehsana India | CGMP Deviations: FDA lab confirmed presence of an impurity, N-Methylnitrosobutyric acid (NMBA) in the finished product above the interim acceptable daily intake level. | Torrent Pharma Inc. / 28,464 bottles | Class II | Ongoing |
| D-1267-2019 | 04-18-2019 | Losartan Potassium and Hydrochlorothiazide Tablets, USP, 50mg/12.5mg, a) 30-count (NDC: 13668-116-30), b) 90-count (NDC: 13668-116-90), c) 1000-count (NDC: 13668-116-10), per bottle, Rx only, Manufactured by: Torrent Pharmaceuticals LTD, Indrad-382 721, Dist. Mehsana India | CGMP Deviations: FDA lab confirmed presence of an impurity, N-Methylnitrosobutyric acid (NMBA) in the finished product above the interim acceptable daily intake level. | Torrent Pharma Inc. / 331,764 bottles | Class II | Ongoing |
| D-1269-2019 | 04-18-2019 | Losartan Potassium and Hydrochlorothiazide Tablets, USP, 100mg/25mg, a) 30-count (NDC: 13668-118-30) b) 90-count (NDC: 13668-118-90), c) 1000-count (NDC: 13668-118-10), per bottle, Rx only, Manufactured by: Torrent Pharmaceuticals LTD, Indrad-382 721, Dist. Mehsana India | CGMP Deviations: FDA lab confirmed presence of an impurity, N-Methylnitrosobutyric acid (NMBA) in the finished product above the interim acceptable daily intake level. | Torrent Pharma Inc. / 239,016 bottles | Class II | Ongoing |
| D-1268-2019 | 04-18-2019 | Losartan Potassium and Hydrochlorothiazide Tablets, USP, 100mg/12.5mg, a) 90-count (NDC: 13668-117-90), b) 1000-count (NDC: 13668-117-10), per bottle, Rx only, Manufactured by: Torrent Pharmaceuticals LTD, Indrad-382 721, Dist. Mehsana India | CGMP Deviations: FDA lab confirmed presence of an impurity, N-Methylnitrosobutyric acid (NMBA) in the finished product above the interim acceptable daily intake level. | Torrent Pharma Inc. / 54,084 bottles | Class II | Ongoing |
| D-1136-2019 | 04-15-2019 | Volumex (Iodinated I 131 Albumin) Injection USP, 25 uCi per 1 mL syringe, Rx Only, Manufactured for Daxor Corp., NY, NY; By: Iso-Tex Diagnostics, Inc.; NDC 50914-7720-8. Package NDCs: 50914-7720-8 | Lack of Assurance of Sterility: environmental monitoring report exceeds limits, therefore sterility cannot be assured. | Iso-Tex Diagnostics, Inc / 54 1ml syringes | Class II | Terminated |
| D-1211-2019 | 04-12-2019 | Diltiazem 250 mg in NS 250 mL bag, Made by: Enterprise Pharmacy, 4400 Golf Acres Drive, Bldg. J Suite E, Charlotte, NC, 28208. | Lack of sterility assurance. | CMC Enterprise Pharmacy / 1475 bags | Class II | Terminated |
| D-1215-2019 | 04-12-2019 | Magnesium Sulfate 4 GM in NS 50 mL bag, Made by: Enterprise Pharmacy, 4400 Golf Acres Drive, Bldg. J Suite E, Charlotte, NC, 28208. | Lack of sterility assurance. | CMC Enterprise Pharmacy / 3007 bags | Class II | Terminated |
| D-1233-2019 | 04-12-2019 | Sodium Bicarbonate 150 mEq in D5W 1000 mL bags, Made by: Enterprise Pharmacy, 4400 Golf Acres Drive, Bldg. J Suite E, Charlotte, NC, 28208. | Lack of sterility assurance. | CMC Enterprise Pharmacy / 100 bags | Class II | Terminated |
| D-1212-2019 | 04-12-2019 | Labetalol 20 mg/4 mL, 20 mg in 4 mL syringe, Made by: Enterprise Pharmacy, 4400 Golf Acres Drive, Bldg. J Suite E, Charlotte, NC, 28208. | Lack of sterility assurance. | CMC Enterprise Pharmacy / 6667 syringes | Class II | Terminated |
| D-1213-2019 | 04-12-2019 | Magnesium Sulfate 1 GM in NS 50 mL bag, Made by: Enterprise Pharmacy, 4400 Golf Acres Drive, Bldg. J Suite E, Charlotte, NC, 28208. | Lack of sterility assurance. | CMC Enterprise Pharmacy / 2162 bags | Class II | Terminated |
| D-1238-2019 | 04-12-2019 | Vancomycin 1750 mg in 0.9% Sodium Chloride 500 mL bag, Made by: Enterprise Pharmacy, 4400 Golf Acres Drive, Bldg. J Suite E, Charlotte, NC, 28208. | Lack of sterility assurance. | CMC Enterprise Pharmacy / 118 bags | Class II | Terminated |
| D-1235-2019 | 04-12-2019 | Vancomycin 1000 mg in NS 250 mL bag, Made by: Enterprise Pharmacy, 4400 Golf Acres Drive, Bldg. J Suite E, Charlotte, NC, 28208. | Lack of sterility assurance. | CMC Enterprise Pharmacy / 532 bags | Class II | Terminated |
| D-1225-2019 | 04-12-2019 | CeFAZolin 2 GM a) in NS 100 mL bag; b) 100 mg/mL (20 mL) syringe, Made by: Enterprise Pharmacy, 4400 Golf Acres Drive, Bldg. J Suite E, Charlotte, NC, 28208. | Lack of sterility assurance. | CMC Enterprise Pharmacy / a) 1357 bags; b) 6895 syringes | Class II | Terminated |
| D-1205-2019 | 04-12-2019 | Amoxicillin for Oral Suspension USP, 125 mg per 5 mL, packaged in (a) 150 mL bottle (NDC 0093-4150-80) (b) 80 mL bottle (NDC 0093-4150-79), Rx Only, Manufactured in Canada By: Teva Canada Limited Toronto, Canada, M1B2K9, Manufactured For: Teva Pharmaceuticals USA, INC. North Wales, PA 19454. | Subpotent Product: assay results for Amoxicillin were below the specification limits. | Teva Pharmaceuticals USA / 171,488 150 mL and 80 mL bottles | Class II | Terminated |
| D-1227-2019 | 04-12-2019 | CefTRIAXone 1 GM, 100 mg/mL, 10 mL syringe, Made by: Enterprise Pharmacy, 4400 Golf Acres Drive, Bldg. J Suite E, Charlotte, NC, 28208. | Lack of sterility assurance. | CMC Enterprise Pharmacy / 15 syringes | Class II | Terminated |
| D-1224-2019 | 04-12-2019 | CeFAZolin 1 GM a) in NS 100 mL bag; b) 100 mg/mL (10 mL) syringe, Made by: Enterprise Pharmacy, 4400 Golf Acres Drive, Bldg. J Suite E, Charlotte, NC, 28208. | Lack of sterility assurance. | CMC Enterprise Pharmacy / a) 150 bags; b)1369 syringes | Class II | Terminated |
| D-1221-2019 | 04-12-2019 | Lidocaine Buffered with J-Tip 0.25 mL, 1 mL syringe, 10:1, For Intradermal Use Only, Made by: Enterprise Pharmacy, 4400 Golf Acres Drive, Bldg. J Suite E, Charlotte, NC, 28208. | Lack of sterility assurance. | CMC Enterprise Pharmacy / 705 syringes | Class II | Terminated |
| D-1240-2019 | 04-12-2019 | DelNido Cardioplegia (Normosol-R pH 7.4 or Plasma-Lyte A pH 7.4 1000 mL bag) Mannitol 20%-16.3 mL, Potassium Chloride 2 meq/mL-13 mL, Sodium Bicarbonate 8.4%-Lidocaine 1%-1:1 Dilution-26 mL, Magnesium Sulfate 500 mg/mL-4 mL, Cardiac Perfusion Only - Not for IV Use, Made by: Enterprise Pharmacy, 4400 Golf Acres Drive, Bldg. J Suite E, Charlotte, NC, 28208. | Lack of sterility assurance. | CMC Enterprise Pharmacy / 110 bags | Class II | Terminated |
| D-1234-2019 | 04-12-2019 | Sodium Citrate 4%, 40 mg/mL, 3 mL syringe, Flush Syringe, Made by: Enterprise Pharmacy, 4400 Golf Acres Drive, Bldg. J Suite E, Charlotte, NC, 28208. | Lack of sterility assurance. | CMC Enterprise Pharmacy / 40 syringes | Class II | Terminated |
| D-1219-2019 | 04-12-2019 | Oxytocin 30 units in NS 500 mL bag, Made by: Enterprise Pharmacy, 4400 Golf Acres Drive, Bldg. J Suite E, Charlotte, NC, 28208. | Lack of sterility assurance. | CMC Enterprise Pharmacy / 3690 bags | Class II | Terminated |
| D-1216-2019 | 04-12-2019 | Magnesium Sulfate 6 GM in NS 50 mL bag, Made by: Enterprise Pharmacy, 4400 Golf Acres Drive, Bldg. J Suite E, Charlotte, NC, 28208. | Lack of sterility assurance. | CMC Enterprise Pharmacy / 196 bags | Class II | Terminated |
| D-1236-2019 | 04-12-2019 | Vancomycin 1250 mg in NS 250 mL bag, Made by: Enterprise Pharmacy, 4400 Golf Acres Drive, Bldg. J Suite E, Charlotte, NC, 28208. | Lack of sterility assurance. | CMC Enterprise Pharmacy / 737 bags | Class II | Terminated |
| D-1214-2019 | 04-12-2019 | Magnesium Sulfate 2 GM in NS 50 mL bag, Made by: Enterprise Pharmacy, 4400 Golf Acres Drive, Bldg. J Suite E, Charlotte, NC, 28208. | Lack of sterility assurance. | CMC Enterprise Pharmacy / 6746 bags | Class II | Terminated |
| D-1210-2019 | 04-12-2019 | Clindamycin 900 mg in NS 50 mL bag, Made by: Enterprise Pharmacy, 4400 Golf Acres Drive, Bldg. J Suite E, Charlotte, NC, 28208. | Lack of sterility assurance. | CMC Enterprise Pharmacy / 1233 bags | Class II | Terminated |
| D-1223-2019 | 04-12-2019 | Lidocaine 1% - Sodium Bicarbonate 8.4% 1:1, 1 mL syringe, For Intradermal Use Only, Made by: Enterprise Pharmacy, 4400 Golf Acres Drive, Bldg. J Suite E, Charlotte, NC, 28208. | Lack of sterility assurance. | CMC Enterprise Pharmacy / 1135 syringes | Class II | Terminated |
| D-1217-2019 | 04-12-2019 | NICARdipine 25 mg in NS 250 mL EXCEL bag, Made by: Enterprise Pharmacy, 4400 Golf Acres Drive, Bldg. J Suite E, Charlotte, NC, 28208. | Lack of sterility assurance. | CMC Enterprise Pharmacy / 1783 bags | Class II | Terminated |
| D-1229-2019 | 04-12-2019 | Heparin Pork 30,000 Units in NS 1000 mL bag, Made by: Enterprise Pharmacy, 4400 Golf Acres Drive, Bldg. J Suite E, Charlotte, NC, 28208. | Lack of sterility assurance. | CMC Enterprise Pharmacy / 87 bags | Class II | Terminated |
| D-1218-2019 | 04-12-2019 | Norepinephrine 16 mg in NS 250 mL bag, Made by: Enterprise Pharmacy, 4400 Golf Acres Drive, Bldg. J Suite E, Charlotte, NC, 28208. | Lack of sterility assurance. | CMC Enterprise Pharmacy / 2567 bags | Class II | Terminated |
| D-1231-2019 | 04-12-2019 | Phenylephrine 20 mg NS 250 mL bag, Made by: Enterprise Pharmacy, 4400 Golf Acres Drive, Bldg. J Suite E, Charlotte, NC, 28208. | Lack of sterility assurance. | CMC Enterprise Pharmacy / 390 bags | Class II | Terminated |
| D-1237-2019 | 04-12-2019 | Vancomycin 1500 mg in NS 250 mL bag, Made by: Enterprise Pharmacy, 4400 Golf Acres Drive, Bldg. J Suite E, Charlotte, NC, 28208. | Lack of sterility assurance. | CMC Enterprise Pharmacy / 715 bags | Class II | Terminated |
| D-1222-2019 | 04-12-2019 | Lidocaine 1% - Sodium Bicarb 8.4% 10:1, 10 mL syringe, For Intradermal Use Only, Made by: Enterprise Pharmacy, 4400 Golf Acres Drive, Bldg. J Suite E, Charlotte, NC, 28208. | Lack of sterility assurance. | CMC Enterprise Pharmacy / 40 syringes | Class II | Terminated |
| D-1232-2019 | 04-12-2019 | Phenylephrine 40 mg in 0.9% Sodium Chloride 250 mL bag, 160 mcg/mL, Made by: Enterprise Pharmacy, 4400 Golf Acres Drive, Bldg. J Suite E, Charlotte, NC, 28208. | Lack of sterility assurance. | CMC Enterprise Pharmacy / 215 bags | Class II | Terminated |
| D-1230-2019 | 04-12-2019 | Phenylephrine 0.8 mg/10 mL NS (0.08 mg/mL), (80 mcg/mL) syringe, Made by: Enterprise Pharmacy, 4400 Golf Acres Drive, Bldg. J Suite E, Charlotte, NC, 28208. | Lack of sterility assurance. | CMC Enterprise Pharmacy / 1310 syringes | Class II | Terminated |
| D-1209-2019 | 04-12-2019 | Dexmedetomidine 400 mcg in NS 100 mL bag, Made by: Enterprise Pharmacy, 4400 Golf Acres Drive, Bldg. J Suite E, Charlotte, NC, 28208. | Lack of sterility assurance. | CMC Enterprise Pharmacy / 5678 bags | Class II | Terminated |
| D-1239-2019 | 04-12-2019 | Vancomycin 2000 mg in 0.9% Sodium Chloride 500 mL bag, Made by: Enterprise Pharmacy, 4400 Golf Acres Drive, Bldg. J Suite E, Charlotte, NC, 28208. | Lack of sterility assurance. | CMC Enterprise Pharmacy / 532 bags | Class II | Terminated |
| D-1226-2019 | 04-12-2019 | CeFAZolin 3 gm 100 mg/mL, 30 mL syringe, Made by: Enterprise Pharmacy, 4400 Golf Acres Drive, Bldg. J Suite E, Charlotte, NC, 28208. | Lack of sterility assurance. | CMC Enterprise Pharmacy / 475 syringes | Class II | Terminated |
| D-1220-2019 | 04-12-2019 | Alteplase 1 mg/mL 1 mL in 10 mL syringe, Made by: Enterprise Pharmacy, 4400 Golf Acres Drive, Bldg. J Suite E, Charlotte, NC, 28208. | Lack of sterility assurance. | CMC Enterprise Pharmacy / 97 syringes | Class II | Terminated |
| D-1228-2019 | 04-12-2019 | Chlorothiazide 100 mg, 3.57 mL syringe, Made by: Enterprise Pharmacy, 4400 Golf Acres Drive, Bldg. J Suite E, Charlotte, NC, 28208. | Lack of sterility assurance. | CMC Enterprise Pharmacy / 60 syringes | Class II | Terminated |
| D-1133-2019 | 04-11-2019 | Divalproex Sodium Extended-Release Tablets, USP, 250 mg a) 100-count bottle (NDC 55111-0533-01), b) 500-count bottle (NDC 55111-0533-05), Rx only, Mfd. By: Dr. Reddy's Laboratories Limited, Bachupally, - 500 090 INDIA | cGMP deviations: Product was exposed above 50% relative humidity levels during packaging operations. | Dr. Reddy's Laboratories, Inc. / 33,958 bottles | Class II | 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-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-1247-2019 | 04-10-2019 | Morphine Sulfate Extended-Release Tablets, 200 mg Rx Only 100 Tablets Manufactured by: Novel Laboratories, Inc. Somerset, NJ 08873 Manufactured for: Lupin Pharmaceuticals, Inc. Baltimore, MD 21202 NDC 43386-544-01 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 / 324 bottles | Class III | Terminated |
| 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-1243-2019 | 04-10-2019 | Morphine Sulfate Extended-Release Tablets, 15 mg, 100-count bottles, Rx Only, Manufactured by: Novel Laboratories, Inc. Somerset, NJ 08873 Manufactured for: Lupin Pharmaceuticals, Inc. Baltimore, MD 21202, NDC 43386-540-01 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 / 17,328 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-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-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-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-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-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-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-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-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-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-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-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-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-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-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-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-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-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-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-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-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-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-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-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-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-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-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-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-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-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-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-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-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-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-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-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-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-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-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-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-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-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-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-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-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 |
