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-0672-2022 | 03-15-2022 | Clobetasol Propionate Lotion, 0.05%, packaged in a) 2 fl. oz. (59 mL) bottles, NDC 52565-055-02; b) 4 fl. oz. (118 mL) bottles, NDC 52565-055-04, Rx Only, Manufactured by: Teligent Pharma, Inc., Buena, New Jersey 08310. | cGMP deviations: all products within expiry are being recalled because the firm is discontinuing its stability study program. | Teligent Pharma, Inc. / 35,180 bottles | Class II | Terminated |
| D-0683-2022 | 03-15-2022 | Fluocinonide Cream USP, 0.1%, 120 grams tube, Rx Only, Manufactured by: Teligent Pharma, Inc., Buena, New Jersey 08310, NDC 52565-079-11. | cGMP deviations: all products within expiry are being recalled because the firm is discontinuing its stability study program. | Teligent Pharma, Inc. / 13,905 tubes | Class II | Terminated |
| D-0679-2022 | 03-15-2022 | Diclofenac Sodium Topical Solution USP, 1.5% w/w, 5 fl. oz. (150 mL) bottle, Rx only, Teligent Pharma, Inc., Buena, New Jersey 08310, NDC 52565-002-05. | cGMP deviations: all products within expiry are being recalled because the firm is discontinuing its stability study program. | Teligent Pharma, Inc. / 16,643 bottles | Class II | Terminated |
| D-0703-2022 | 03-15-2022 | Hydrocortisone Butyrate Lotion, 0.1%, 4 fl oz (118 mL) bottle, Rx only, Manufactured for: SOLA Pharmaceuticals, Baton Rouge, LA 70809, NDC 70512-032-04. | cGMP deviations: all products within expiry are being recalled because the firm is discontinuing its stability study program. | Teligent Pharma, Inc. / 6874 bottles | Class II | Terminated |
| D-0704-2022 | 03-15-2022 | Lidocaine Cream 4%, Net Wt. 30 grams tube, Distributed by: RUGBY LABORATORIES, 17177 N. Laurel Park Dr., Suite 233, Livonia, MI 48152, NDC 0536-1281-28. | cGMP deviations: all products within expiry are being recalled because the firm is discontinuing its stability study program. | Teligent Pharma, Inc. / 48,907 tubes | Class II | Terminated |
| D-0698-2022 | 03-15-2022 | Triamcinolone Acetonide Lotion USP, 0.025%, 60 mL (60 grams) bottle, Rx only, Teligent Pharma, Inc., Buena, New Jersey 08310, NDC 52565-010-59. | cGMP deviations: all products within expiry are being recalled because the firm is discontinuing its stability study program. | Teligent Pharma, Inc. / 112,769 bottles | Class II | Terminated |
| D-0671-2022 | 03-15-2022 | Clobetasol Propionate Cream USP, 0.05% (Emollient), packaged in a) 15 grams tube, NDC 52565-094-15; b) 30 grams tube, NDC 52565-094-30; c) 45 grams tube, NDC 52565-094-45; d) 60 grams tube, NDC 52565-094-60, Rx only, Manufactured by: Teligent Pharma, Inc., Buena, NJ 08310. | cGMP deviations: all products within expiry are being recalled because the firm is discontinuing its stability study program. | Teligent Pharma, Inc. / 105,200 tubes | Class II | Terminated |
| D-0684-2022 | 03-15-2022 | Fluocinonide Gel USP, 0.05%, packaged in a) 15 g tubes, NDC 52565-054-15; b) 60 g tubes, NDC 52565-054-60; c) 30 g tubes, NDC 52565-054-30, Rx Only, Teligent Pharma, Inc., Buena, NJ 08310. | cGMP deviations: all products within expiry are being recalled because the firm is discontinuing its stability study program. | Teligent Pharma, Inc. / 51,748 tubes | Class II | Terminated |
| D-0680-2022 | 03-15-2022 | Diclofenac Sodium Topical Solution USP, 1.5% w/w, 5 fl. oz. (150 mL) bottles, Rx Only, Manufactured for: SOLA Pharmaceuticals, Baton Rouge, LA 70810, NDC 70512-025-05. | cGMP deviations: all products within expiry are being recalled because the firm is discontinuing its stability study program. | Teligent Pharma, Inc. / 36,018 bottles | Class II | Terminated |
| D-0701-2022 | 03-15-2022 | Diflorasone Diacetate Ointment USP, 0.05%, Net Wt 60 g tubes, Rx only, Manufactured by: Teligent Pharm, Inc., Buena, New Jersey 08310, NDC 52565-063-60. | cGMP deviations: all products within expiry are being recalled because the firm is discontinuing its stability study program. | Teligent Pharma, Inc. / 4532 tubes | Class II | Terminated |
| D-0670-2022 | 03-15-2022 | Clobetasol Propionate Cream USP, 0.05%, packaged in a) 15 grams tube, NDC 52565-051-15; b) 30 grams tube, NDC 52565-051-30; c) 45 grams tube, NDC 52565-051-45; d) 60 grams tube, NDC 52565-051-60; Rx only, Manufactured by: Teligent Pharma, Inc., Buena, NJ 08310. | cGMP deviations: all products within expiry are being recalled because the firm is discontinuing its stability study program. | Teligent Pharma, Inc. / 207,933 tubes | Class II | Terminated |
| D-0699-2022 | 03-15-2022 | Triamcinolone Acetonide Ointment USP, 0.1%, packaged in a) 15 grams tubes, NDC 52565-014-15; b) 80 grams tubes, NDC 52565-014-80; c) 1 lb (454 g) jars, NDC 52565-014-26; Rx only, Teligent Pharma, Inc., Buena, New Jersey 08310. | cGMP deviations: all products within expiry are being recalled because the firm is discontinuing its stability study program. | Teligent Pharma, Inc. / 482,003 tubes; 45,583 jars | Class II | Terminated |
| D-0705-2022 | 03-15-2022 | Lidocaine Ointment USP, 5%, Net Wt 35.44 g (1 1/4 Oz) tube, Rx Only, Manufactured for: Hi-Tech Pharmacal Co., Inc., Amityville, NY 11701, NDC 50383-341-35. | cGMP deviations: all products within expiry are being recalled because the firm is discontinuing its stability study program. | Teligent Pharma, Inc. / 49,081 tubes | Class II | Terminated |
| D-0674-2022 | 03-15-2022 | Clobetasol Propionate Gel, 0.05%, packaged in a) 15 grams tube, NDC 52565-082-15; b) 30 grams tube, NDC 52565-082-30; c) 60 grams tube, NDC 52565-082-60, Rx Only, Teligent Pharma, Inc., Buena, NJ 08310. | cGMP deviations: all products within expiry are being recalled because the firm is discontinuing its stability study program. | Teligent Pharma, Inc. / 81,883 tubes | Class II | Terminated |
| D-0687-2022 | 03-15-2022 | Gentamicin Sulfate Ointment USP 0.1%, packaged as a) 15 grams tube, NDC 52565-090-15; b) 30 grams tube, NDC 52565-090-30, Rx Only, Manufactured by: Teligent Pharma, Inc., Buena, NJ 08310. | cGMP deviations: all products within expiry are being recalled because the firm is discontinuing its stability study program. | Teligent Pharma, Inc. / 43,956 tubes | Class II | Terminated |
| D-0691-2022 | 03-15-2022 | Halobetasol Propionate Ointment, 0.05%, Net Wt. 50 grams tube, Rx Only, Manufactured by: Teligent Pharma, Inc., Buena, NJ 08310, Distributed by: McKesson Corporation, dba Sky Packaging, 4971 Southridge Blvd., Suite 101, Memphis, TN 38141, NDC 63739-998-67. | cGMP deviations: all products within expiry are being recalled because the firm is discontinuing its stability study program. | Teligent Pharma, Inc. / 21,323 tubes | Class II | Terminated |
| D-0700-2022 | 03-15-2022 | Clobetasol Propionate Cream USP, 0.05%, packaged in 60 grams tube, Rx only, Manufactured for SOLA Pharmaceuticals, Baton Rouge, LA 70809; NDC 70512-028-60. | cGMP deviations: all products within expiry are being recalled because the firm is discontinuing its stability study program. | Teligent Pharma, Inc. / 26,326 tubes | Class II | Terminated |
| D-0685-2022 | 03-15-2022 | Fluocinonide Topical Solution USP, 0.05%, packaged in a) 20 mL bottles, NDC 52565-025-20; b) 60 mL bottles, NDC 52565-025-59, Rx only, Teligent Pharma, Inc., Buena, New Jersey 08310. | cGMP deviations: all products within expiry are being recalled because the firm is discontinuing its stability study program. | Teligent Pharma, Inc. / 7169 bottles | Class II | Terminated |
| D-0706-2022 | 03-14-2022 | Norepinephrine Bitartrate Injection 4mg per 250 mL in 0.9% Sodium Chloride, 4 mg, 250 mL excel bag, Rx only, Athenex Pharma Solutions, LLC, Clarence, NY, 14031, NDC 76154-474-15 | Defective container | Athenex Pharma Solutions, LLC / 4,270 bags | Class II | Terminated |
| D-0708-2022 | 03-14-2022 | Norepinephrine Bitartrate Injection 8 mg per 250 mL in 0.9% Sodium Chloride, 8 mg, 250 mL excel bag, Rx only, Athenex Pharma Solutions, LLC, Clarence, NY, 14031, NDC 76154-475-15 | Defective container | Athenex Pharma Solutions, LLC / 9,800 bags | Class II | Terminated |
| D-0707-2022 | 03-14-2022 | Norepinephrine Bitartrate Injection 16 mg per 250 mL added to 0.9% Sodium Chloride, 16 mg, 250 mL excel bag, Rx only, Athenex Pharma Solutions, LLC, Clarence, NY, 14031, NDC 76154-476-15 | Defective container | Athenex Pharma Solutions, LLC / 5,320 bags | Class II | Terminated |
| D-0711-2022 | 03-14-2022 | Phenylephrine HCl Injection in 0.9% Sodium Chloride, 20 mg, 250 mL excel bag, Rx only, Athenex Pharma Solutions, LLC, Clarence, NY, 14031, NDC 76154-491-15 | Defective container | Athenex Pharma Solutions, LLC / 1,980 bags | Class II | Terminated |
| D-0712-2022 | 03-14-2022 | Epinephrine Injection 8 mg per 250 mL in 0.9% Sodium Chloride, 8mg, 250 mL excel bag, Rx only, Athenex Pharma Solutions, LLC, Clarence, NY, 14031, NDC 76154-814-15 | Defective container | Athenex Pharma Solutions, LLC / N/A | Class II | Terminated |
| D-0709-2022 | 03-14-2022 | Phenylephrine HCl Injection 40 mg per 250 mL in 0.9% Sodium Chloride, 40 mg, 250 mL excel bag, Rx only, Athenex Pharma Solutions, LLC, Clarence, NY, 14031, NDC 76154-493-15 | Defective container | Athenex Pharma Solutions, LLC / 670 bags | Class II | Terminated |
| D-0710-2022 | 03-14-2022 | Phenylephrine HCl Injection 50 mg per 250 mL in 0.9% Sodium Chloride, 50 mg, 250 mL excel bag, Rx only, Athenex Pharma Solutions, LLC, Clarence, NY, 14031, NDC 76154-494-15 | Defective container | Athenex Pharma Solutions, LLC / 1,800 bags | Class II | Terminated |
| D-0744-2022 | 03-14-2022 | PHENOBARBITAL Sodium Injection, USP, 130 mg/mL, packaged as a) 25 x 1 mL Vials per box (NDC 42494-416-25) and b) 3 x 1mL Vials per box (NDC 42494-416-03), Rx only, Manufactured for Cameron Pharmaceuticals, LLC. Package NDCs: 42494-416-25; 42494-416-03; 42494-415-25; 42494-415-03 | Lack of Assurance of Sterility: deviations from Current Good Manufacturing Practices (CGMP) that call into question the sterility of products intended to be sterile. | Vitae Enim Vitae Scientific, Inc. / a) 18,531 boxes; b) 4,492 boxes | Class II | Terminated |
| D-0743-2022 | 03-14-2022 | PHENOBARBITAL Sodium Injection, USP, 65mg/mL, packaged as a) 25 x 1 mL Vials per box (NDC 42494-415-25) and b) 3 x 1 mL Vials per box (NDC 42494-415-03), Rx only, Manufactured for Cameron Pharmaceuticals, LLC. Package NDCs: 42494-416-25; 42494-416-03; 42494-415-25; 42494-415-03 | Lack of Assurance of Sterility: deviations from Current Good Manufacturing Practices (CGMP) that call into question the sterility of products intended to be sterile. | Vitae Enim Vitae Scientific, Inc. / a) 21,501 boxes; b) 4,846 boxes | Class II | Terminated |
| D-0742-2022 | 03-14-2022 | PAPAVERINE HYDROCHLORIDE Injection, USP, 60 mg/2mL (30 mg/mL), packaged as a) 25 x 2mL Single Use Vials per box (NDC 72516-024-25) and b) 10 x 2mL Single Use Vials per box (NDC 72516-024-10); Manufactured for Oryza Pharmaceuticals, Inc. Package NDCs: 72516-024-25; 72516-024-10 | Lack of Assurance of Sterility: deviations from Current Good Manufacturing Practices (CGMP) that call into question the sterility of products intended to be sterile. | Vitae Enim Vitae Scientific, Inc. / a) 2,098 boxes; b) 700 boxes | Class II | Terminated |
| D-0741-2022 | 03-14-2022 | TETRACAINE 1% Tetracaine HCI Injection, USP, 20mg/2mL (10mg/mL), 10 x 2ml Single Use Vials per box, Rx only, Manufactured for Cameron Pharmaceuticals, LLC., NDC 42494-437-10. | Lack of Assurance of Sterility: deviations from Current Good Manufacturing Practices (CGMP) that call into question the sterility of products intended to be sterile. | Vitae Enim Vitae Scientific, Inc. / 722 boxes | Class II | Terminated |
| D-0749-2022 | 03-11-2022 | Sucralfate Oral Suspension, USP 1g/10mL, packaged in a) 40 case of 10 mL unit Dose Cups (NDC 69339-148-17) and b) 100 case of 10 mL Unit Dose Cups (NDC 69339-148-19) Rx Only, Dash Pharmaceuticals, Upper Saddle River, NJ 07458. | Labeling: Label Mix-Up | DASH Pharmaceuticals LLC / 45,940 Unit Dose Cups | Class II | Terminated |
| D-0715-2022 | 03-10-2022 | ROCK TOWN - DISTILLERY - HAND SANITIZER, Alcohol Antiseptic 70%, Topical Solution packaged in a) 375 mL (12.7 fl. oz.), NDC 74492-0002-1; b) 3785 mL/1 gallon NDC 74492-0002-2; c) 236 mL/8 oz. NDC 74492-0002-3; d) 473 mL/16 oz. NDC 74492-0002-4; Made in USA Rock Town Distillery, 1201 Main Street Little Rock, Arkansas 72202 | CGMP Deviations: FDA analysis found product to contain acetal and acetaldehyde above specification limits. | Rock Town Distillery, Inc. / 35,468 containers | Class II | Terminated |
| D-0762-2022 | 03-10-2022 | Risedronate Sodium Tablets, USP, 5 mg, Rx Only, 30-count bottle, Manufactured for: Macleods Pharma USA, Plainsboro, NJ 08536, Manufactured by: Macleods Pharmaceuticals Ltd., BAddi, HImchal Pradesh, INDIA, NDC 33342-107-07. Package NDCs: 33342-107-07; 33342-107-49; 33342-107-06; 33342-108-07; 33342-108-15; 33342-108-06; 33342-109-37; 33342-109-50 | FAILED CONTENT UNIFORMITY SPECIFICATIONS | Macleods Pharma Usa Inc / 4872 bottles | Class III | Terminated |
| D-0767-2022 | 03-08-2022 | Meclizine Hydrochloride Tablets USP, 12.5 mg, packaged in a case of 24 bottles (100-count bottle), Rx only, Manufactured by: Jubilant Cadista Pharmaceuticals, Inc., Salisbury, MD, 21801, NDC 59746-122-06 Package NDCs: 59746-122-06; 59746-122-10; 59746-121-06; 59746-121-10 | Labeling: Label mix-up: Incorrect label placed on product. Shipper cases labeled Meclizine Hydrochloride Tablets contain bottles incorrectly labeled as PredniSONE Tablets. The tablets in the bottles are Meclizine Hydrochloride | Jubilant Cadista Pharmaceuticals, Inc. / 12,174 bottles | Class I | Terminated |
| D-0721-2022 | 03-08-2022 | T-105, Papaverine 30 mg/mL Phentolamine 1 mg/mL PGE 10 mcg/mL packaged as a) 5 mL Multi-dose NDC 73198-0005-05; b) 10 mL Multi-dose NDC 73198-0005-10; Each ML contains: 0.5% Chlorobutanol NF, 0.0005% Edetate Disodium Dihydrate USP, 1.84% Benzyl Alcohol NF, 5% Mannitol USP, 1% Sodium Metabisulfite NF, 0.5% Ethyl Alcohol USP, Sterile Water for Injection USP, Rx Only, Olympia Pharmaceuticals, 6700 Conroy Rd., Ste. 155, Orlando, FL 32835. | Super Potent | Olympia Compounding Pharmacy dba Olympia Pharmacy / 1093 vials | Class III | Terminated |
| D-0724-2022 | 03-08-2022 | Sincalide Lyophilized powder for reconstitution Each ML contains: Mannitol 170mg, Arginine 30mg, Lysine 15mg, Potassium Phosphate 9mg, Methionine 4mg, Edetate Disodium Dihydrate 2mg, Polysorbate mcg, Water for Injection, Multiple Dose Injection 5 mcg Vial, Rx Only, Olympia Compounding Pharmacy Compounded by: Olympia Pharmacy Conroy Rd., Ste. 155, Orlando, FL 32835, NDC 73198-0082-00 Revised Label: Sincalide Lyophilized powder for reconstitution, 5mcg per multi dose vial, Each ML contains: 16.7% Mannitol, 3% Arginine, 1.5% Lysine, 0.9% Potassium Phosphate, 0.4% Methionine, 0.2% Edetate Disodium Dihydrate, 0.004% Sodium Metabisulfate, 0.0005% Polysorbate. Water for injection. Rx only, Olympia Pharmaceuticals NDC 73198-0082-00 | Super Potent and Failed Reconstitution Time | Olympia Compounding Pharmacy dba Olympia Pharmacy / 836 vials | Class II | Terminated |
| D-0720-2022 | 03-08-2022 | Formula F9, Papaverine 0.9 mg/mL, Phentolamine 0.1 mg/mL, PGE 20 mcg/mL, Atropine 0.01 mg/mL, Multi-Dose 10 mL vial, Each ML contains: 0.5% Chlorobutanol NF, 0.005% Edetate Disodium Dihydrate USP, 2.74% Benzyl Alcohol NF, 5% Mannitol USP, 1% Sodium Metabisulfite NF, 1% Ethyl Alcohol USP, Sterile Water for Injection USP, Rx Only, Olympia Pharmaceuticals, 6700 Conroy Rd., Ste. 155, Orlando, FL 32835. NDC 73198-0004-10 | Sub Potent | Olympia Compounding Pharmacy dba Olympia Pharmacy / 493 vials. | Class III | Terminated |
| D-0718-2022 | 03-08-2022 | Sermorelin Acetate Lyophilized powder for reconstitution, Multi-Dose 9 mg per vial, Each ML contains: 5% Mannitol USP, Sterile Water for Injection USP, Rx Only, Olympia Pharmaceuticals, 6700 Conroy Rd., Ste. 155, Orlando, FL 32835. NDC 73198-0059-00 | Sub Potent | Olympia Compounding Pharmacy dba Olympia Pharmacy / 2283 vials | Class II | Terminated |
| D-0723-2022 | 03-08-2022 | Hydroxocobalamin B12 1mg/mL, Multi-Dose 30 mL vial, Each ML contains: 0.82% Sodium Chloride USP, 0.9% Benzyl Alcohol NF, Sterile Water for Injection USP, Rx Only, Olympia Pharmaceuticals Conroy Rd., Ste. 155, Orlando, FL 32835 NDC 73198-0080-30 | Sub Potent | Olympia Compounding Pharmacy dba Olympia Pharmacy / 1613 vials | Class III | Terminated |
| D-0719-2022 | 03-08-2022 | NAD+ Nicotinamide Adenine Dinucleotide, Lyophilized powder for reconstitution, Multi-Dose 500 mg per vial, Each ML contains: 0.288% Sodium Phosphate Monobasic USP, 0.42% Sodium Phosphate Dibasic USP, 5% Mannitol USP, Sterile Water for Injection USP, Rx Only, Olympia Pharmaceuticals 6700 Conroy Rd., Ste. 155, Orlando, FL 32835 NDC: 73198-0083-00 | Product found to be Sub Potent or Exceeded reconstitution time | Olympia Compounding Pharmacy dba Olympia Pharmacy / 2634 vials | Class II | Terminated |
| D-0722-2022 | 03-08-2022 | SB-4, Papaverine 30mg/mL, Phentolamine 3mg/mL, Alprostadil 40mcg/mL, packaged in a) 5 mL Multi-dose vial NDC 73198-0023-05; b) 10 mL Multi-dose vial NDC 73198-0023-10, Each ML contains: 0.5% Chlorobutanol NF, 0.0005% Edetate Disodium Dihydrate USP, 1.84% Benzyl Alcohol NF, 5% Mannitol USP, 1% Sodium Metabisulfite NF, 2% Ethyl Alcohol USP, Sterile Water for Injection USP, Rx Only, Olympia Pharmaceuticals, Conroy Rd., Ste. 155, Orlando, FL 32835 | Sub Potent | Olympia Compounding Pharmacy dba Olympia Pharmacy / 1032 vials | Class III | Terminated |
| D-1199-2022 | 03-07-2022 | Dexpanthenol 250mg/mL, 30mL-vial, Room Temperature, Tailor Made Compounding | Lack of Assurance of Sterility | TMC Acquisition LLC dba Tailor Made Compounding / 19 vials | Class II | Ongoing |
| D-1209-2022 | 03-07-2022 | Hydroxocobalamin Preservative Free 5mg/mL, 1mL-vial, Refrigerate, Tailor Made Compounding | Lack of Assurance of Sterility | TMC Acquisition LLC dba Tailor Made Compounding / 26 vials | Class II | Ongoing |
| D-1225-2022 | 03-07-2022 | Semaglutide/Cyanocobalamin 5mg/0.2mg/ml, 2ml-vial, Refrigerate, Tailor Made Compounding | Lack of Assurance of Sterility | TMC Acquisition LLC dba Tailor Made Compounding / 9,993 vials | Class II | Ongoing |
| D-1193-2022 | 03-07-2022 | Alprostadil/Papaverine/Phentolamine 60mcg/30mg/3mg/mL, 3mL-vial, Refrigerate, Tailor Made Compounding | Lack of Assurance of Sterility | TMC Acquisition LLC dba Tailor Made Compounding / 32 vials | Class II | Ongoing |
| D-1220-2022 | 03-07-2022 | Nandrolone Decanoate 200mg/mL, a) 5 mL-vial, b) 10mL-vial, Refrigerate, Tailor Made Compounding | Lack of Assurance of Sterility | TMC Acquisition LLC dba Tailor Made Compounding / 243 vials | Class II | Ongoing |
| D-1231-2022 | 03-07-2022 | Testosterone Cypionate (GSO) 200mg/ml a) 2 mL-vial, b) 4 mL-vial, c) 5 mL-vial, d) 10 mL-vial, Room temperature, Tailor Made Compounding | Lack of Assurance of Sterility | TMC Acquisition LLC dba Tailor Made Compounding / 4,219 vials | Class II | Ongoing |
| D-1226-2022 | 03-07-2022 | Sermorelin 2000mcg/mL, 7.5mL-vial, Refrigerate, Tailor Made Compounding | Lack of Assurance of Sterility | TMC Acquisition LLC dba Tailor Made Compounding / 1,208 vials | Class II | Ongoing |
| D-1212-2022 | 03-07-2022 | Melanotan I 200mcg/mL (2mg/ml), a) 1.5mL-vial, b) 5 mL-vial, Refrigerate, Tailor Made Compounding | Lack of Assurance of Sterility | TMC Acquisition LLC dba Tailor Made Compounding / 182 vials | Class II | Ongoing |
| D-1205-2022 | 03-07-2022 | Glutathione 200mg/mL Preservative Free, Injectable, 30mL-vial, Refrigerate, Tailor Made Compounding | Lack of Assurance of Sterility | TMC Acquisition LLC dba Tailor Made Compounding / 40 vials | Class II | Ongoing |
| D-1222-2022 | 03-07-2022 | Procaine HCL 2% (20mg/mL), 30 ml-vial, Refrigerate, Tailor Made Compounding | Lack of Assurance of Sterility | TMC Acquisition LLC dba Tailor Made Compounding / 58 vials | Class II | Ongoing |
| D-1228-2022 | 03-07-2022 | Sermorelin/Glycine 2000mcg/5mg/mL, 7.5mL-vial, Refrigerate, Tailor Made Compounding | Lack of Assurance of Sterility | TMC Acquisition LLC dba Tailor Made Compounding / 2,870 vials | Class II | Ongoing |
| D-1233-2022 | 03-07-2022 | Testosterone Cypionate/Anastrozole 200mg/1mg/mL, a) 4 mL-vial, b)10mL-vial, Room temperature, Tailor Made Compounding | Lack of Assurance of Sterility | TMC Acquisition LLC dba Tailor Made Compounding / 106 vials | Class II | Ongoing |
| D-1214-2022 | 03-07-2022 | Methionine/Inositol/Choline B12 25mg/50mg/50mg/1mg/mL, a)10 mL-vial, b) 30 mL-vial, Room Temperature, Tailor Made Compounding | Lack of Assurance of Sterility | TMC Acquisition LLC dba Tailor Made Compounding / 232 vials | Class II | Ongoing |
| D-1195-2022 | 03-07-2022 | Ascorbic Acid 500mg/mL, a) 25 ml-vial, b) 50 ml-vial, Refrigerate, Tailor Made Compounding | Lack of Assurance of Sterility | TMC Acquisition LLC dba Tailor Made Compounding / 657 vials | Class II | Ongoing |
| D-1210-2022 | 03-07-2022 | Inositol/Choline B12 + Carnitine 40mg/40mg/1mg/100mg/mL, 30mL-vial, Refrigerate, Tailor Made Compounding | Lack of Assurance of Sterility | TMC Acquisition LLC dba Tailor Made Compounding / 25 vials | Class II | Ongoing |
| D-1204-2022 | 03-07-2022 | GOAL (Glutamine/Ornithine/Arginine/Lysine 25mg/75mg/150mg/250mg/ml) 30 ml-vial, Refrigerate, Tailor Made Compounding | Lack of Assurance of Sterility | TMC Acquisition LLC dba Tailor Made Compounding / 60 Vials | Class II | Ongoing |
| D-1223-2022 | 03-07-2022 | PT-141 10mg/mL a) 1mL-vial, b) 2 mL-vial, Refrigerate, Tailor Made Compounding | Lack of Assurance of Sterility | TMC Acquisition LLC dba Tailor Made Compounding / 392 vials | Class II | Ongoing |
| D-1235-2022 | 03-07-2022 | Testosterone Cypionate/Enanthate/Propionate 80/80/40mg, a) 5 mL-vial, b) 10 ml-vial, Room temperature, Tailor Made Compounding | Lack of Assurance of Sterility | TMC Acquisition LLC dba Tailor Made Compounding / 246 vials | Class II | Ongoing |
| D-1196-2022 | 03-07-2022 | BCAAs (Leucine/Iso-Leucine/Valine) 10mg/10mg/5mg/mL, 30mL-vial, Refrigerate, Tailor Made Compounding | Lack of Assurance of Sterility | TMC Acquisition LLC dba Tailor Made Compounding / 180 vials | Class II | Ongoing |
| D-1243-2022 | 03-07-2022 | Glutathione 200mg/ml, a) 10ml-vial, b) 30ml-vial, Refrigerate, Tailor Made Compounding | Lack of Assurance of Sterility | TMC Acquisition LLC dba Tailor Made Compounding / 485 Vials | Class II | Ongoing |
| D-1219-2022 | 03-07-2022 | NAD+ 200mg/mL, 10mL-vial, Refrigerate, Tailor Made Compounding | Lack of Assurance of Sterility | TMC Acquisition LLC dba Tailor Made Compounding / 1,856 vials | Class II | Ongoing |
| D-1240-2022 | 03-07-2022 | Vitamin B-Complex, a) 10 mL-vial, b) 30 mL-vial, Refrigerate, Tailor Made Compounding | Lack of Assurance of Sterility | TMC Acquisition LLC dba Tailor Made Compounding / 75 vials | Class II | Ongoing |
| D-1200-2022 | 03-07-2022 | Dexpanthenol Preservative Free 250mg/mL, 2mL-vial, Room Temperature, Tailor Made Compounding | Lack of Assurance of Sterility | TMC Acquisition LLC dba Tailor Made Compounding / 84 vials | Class II | Ongoing |
| D-1218-2022 | 03-07-2022 | Methylene Blue Hypotonic Solution, 10mg/mL, a) 2 mL-vial, b) 10mL-vial, Refrigerate, Tailor Made Compounding | Lack of Assurance of Sterility | TMC Acquisition LLC dba Tailor Made Compounding / 464 vials | Class II | Ongoing |
| D-1238-2022 | 03-07-2022 | Testosterone Enanthate (GSO) 200mg/ml, a) 5 mL-vial, b) 10 mL-vial, Room temperature, Tailor Made Compounding | Lack of Assurance of Sterility | TMC Acquisition LLC dba Tailor Made Compounding / 414 vials | Class II | Ongoing |
| D-1217-2022 | 03-07-2022 | Methylcobalamin Preservative Free, 10mg/mL, 1mL-vial, Room Temperature, Tailor Made Compounding | Lack of Assurance of Sterility | TMC Acquisition LLC dba Tailor Made Compounding / 4 vials | Class II | Ongoing |
| D-1224-2022 | 03-07-2022 | Semaglutide/Cyanocobalamin 2mg/0.4mg/ml, 1mL-vial, Refrigerate, Tailor Made Compounding | Lack of Assurance of Sterility | TMC Acquisition LLC dba Tailor Made Compounding / 5,842 vials | Class II | Ongoing |
| D-1197-2022 | 03-07-2022 | Biotin 5mg/mL, 5mL-vial, Refrigerate, Tailor Made Compounding | Lack of Assurance of Sterility | TMC Acquisition LLC dba Tailor Made Compounding / 39 | Class II | Ongoing |
| D-1194-2022 | 03-07-2022 | Anastrozole/Testosterone Cypionate/Propionate 1mg/160mg/40mg/mL, 10 mL-vial, Room Temperature, Tailor Made Compounding | Lack of Assurance of Sterility | TMC Acquisition LLC dba Tailor Made Compounding / 39 | Class II | Ongoing |
| D-1216-2022 | 03-07-2022 | Methylcobalamin 1mg/mL, a) 10 mL-vial, b) 30 ml-vial, Room Temperature, Tailor Made Compounding | Lack of Assurance of Sterility | TMC Acquisition LLC dba Tailor Made Compounding / 191 vials | Class II | Ongoing |
| D-1206-2022 | 03-07-2022 | Glycyrrhizic Acid 8mg/mL, 10mL-vial, Refrigerate, Tailor Made Compounding | Lack of Assurance of Sterility | TMC Acquisition LLC dba Tailor Made Compounding / 101 vials | Class II | Ongoing |
| D-1229-2022 | 03-07-2022 | Teriparatide 226mcg/ml Injectable, 4 Pre-filled Syringes, 0.25 mL-Syringe, Refrigerate, Tailor Made Compounding | Lack of Assurance of Sterility | TMC Acquisition LLC dba Tailor Made Compounding / 12 syringes | Class II | Ongoing |
| D-1215-2022 | 03-07-2022 | Methylcobalamin 10mg/mL, a) 1 mL-vial, b) 10mL-vial, c) 30 mL-vial, Room Temperature, Tailor Made Compounding | Lack of Assurance of Sterility | TMC Acquisition LLC dba Tailor Made Compounding / 652 vials | Class II | Ongoing |
| D-1211-2022 | 03-07-2022 | Levocarnitine 500mg/mL, 30mL-vial, Refrigerate, Tailor Made Compounding | Lack of Assurance of Sterility | TMC Acquisition LLC dba Tailor Made Compounding / 12 vials | Class II | Ongoing |
| D-1192-2022 | 03-07-2022 | Alpha Lipoic Acid 25mg/mL, 30mL-vial, Refrigerate, Tailor Made Compounding | Lack of Assurance of Sterility | TMC Acquisition LLC dba Tailor Made Compounding / 29 vials | Class II | Ongoing |
| D-1207-2022 | 03-07-2022 | Gonadorelin 100mcg/mL, 10mL per vial, Refrigerate, Tailor Made Compounding | Lack of Assurance of Sterility | TMC Acquisition LLC dba Tailor Made Compounding / 294 vials | Class II | Ongoing |
| D-1221-2022 | 03-07-2022 | Pentosan Polysulfate Sodium 250mg/mL, 5mL-vial, Room Temperature, Tailor Made Compounding | Lack of Assurance of Sterility | TMC Acquisition LLC dba Tailor Made Compounding / 220 vials | Class II | Ongoing |
| D-1203-2022 | 03-07-2022 | GAC (Glutamine/Arginine/L-Carnitine) 25mg/100mg/250mg/mL, 30mL-vial, Refrigerate, Tailor Made Compounding | Lack of Assurance of Sterility | TMC Acquisition LLC dba Tailor Made Compounding / 90 vials | Class II | Ongoing |
| D-1208-2022 | 03-07-2022 | Hydroxocobalamin 25mg/mL, 10mL-vial, Room Temperature, Tailor Made Compounding | Lack of Assurance of Sterility | TMC Acquisition LLC dba Tailor Made Compounding / 63 vials | Class II | Ongoing |
| D-1234-2022 | 03-07-2022 | Testosterone Cypionate/Enanthate 100/100mg/ml, a) 2 mL-vial, b) 4 mL-vial c) 10 mL-vial, Room temperature, Tailor Made Compounding | Lack of Assurance of Sterility | TMC Acquisition LLC dba Tailor Made Compounding / 58 vials | Class II | Ongoing |
| D-1201-2022 | 03-07-2022 | Estradiol Cypionate 10mg/mL, a) 1mL-vial, b) 2 mL-vial, Room Temperature, Tailor Made Compounding | Lack of Assurance of Sterility | TMC Acquisition LLC dba Tailor Made Compounding / 349 vials | Class II | Ongoing |
| D-1213-2022 | 03-07-2022 | Methionine/Inositol/Choline B12 + Carnitine 10mg/40mg/40mg/1mg/100mg/mL, a) 4mL-vial, b) 10 mL-vial, c) 30mL- vial, Refrigerate, Tailor Made Compounding | Lack of Assurance of Sterility | TMC Acquisition LLC dba Tailor Made Compounding / 924 vials | Class II | Ongoing |
| D-1202-2022 | 03-07-2022 | Folic Acid 5mg/mL, 30mL-vial, Refrigerate, Tailor Made Compounding | Lack of Assurance of Sterility | TMC Acquisition LLC dba Tailor Made Compounding / 45 | Class II | Ongoing |
| D-1242-2022 | 03-07-2022 | Vitamin D3 50,000IU/mL, 10mL-vial, Room Temperature, Tailor Made Compounding | Lack of Assurance of Sterility | TMC Acquisition LLC dba Tailor Made Compounding / 15 vials | Class II | Ongoing |
| D-1236-2022 | 03-07-2022 | Testosterone Cypionate/Propionate 180/20mg/ml, a) 5 mL-vial, b) 10 mL-vial, Room temperature, Tailor Made Compounding | Lack of Assurance of Sterility | TMC Acquisition LLC dba Tailor Made Compounding / 176 vials | Class II | Ongoing |
| D-1239-2022 | 03-07-2022 | Testosterone Propionate 100mg/ml, 10mL-vial, Room temperature, Tailor Made Compounding | Lack of Assurance of Sterility | TMC Acquisition LLC dba Tailor Made Compounding / 64 vials | Class II | Ongoing |
| D-1198-2022 | 03-07-2022 | Calcium Chloride Preservative Free, 100mg/mL, a) 5 mL-vial, b) 30 ml-vial, Room Temperature, Tailor Made Compounding | Lack of Assurance of Sterility | TMC Acquisition LLC dba Tailor Made Compounding / 138 vials | Class II | Ongoing |
| D-1241-2022 | 03-07-2022 | Vitamin B-Complex Preservative Free, 3ml-vial, Refrigerate, Tailor Made Compounding | Lack of Assurance of Sterility | TMC Acquisition LLC dba Tailor Made Compounding / 6 vials | Class II | Ongoing |
| D-1237-2022 | 03-07-2022 | Testosterone Enanthate (GSO) 100mg/ml, 2 mL-vial, Room temperature, Tailor Made Compounding | Lack of Assurance of Sterility | TMC Acquisition LLC dba Tailor Made Compounding / 93 vials | Class II | Ongoing |
| D-1227-2022 | 03-07-2022 | Sermorelin/Glycine 2000mcg/5mg/mL, 4mL-vial, Refrigerate, Tailor Made Compounding | Lack of Assurance of Sterility | TMC Acquisition LLC dba Tailor Made Compounding / 1,562 vials | Class II | Ongoing |
| D-1230-2022 | 03-07-2022 | Testosterone Cypionate (GSO) 100mg/ml a)1mL-vial , b) 2mL-vial, Room temperature, Tailor Made Compounding | Lack of Assurance of Sterility | TMC Acquisition LLC dba Tailor Made Compounding / 273 vials | Class II | Ongoing |
| D-1232-2022 | 03-07-2022 | Testosterone Cypionate/Anastrozole 200mg/0.5mg/mL, 10mL-vial, Room temperature, Tailor Made Compounding | Lack of Assurance of Sterility | TMC Acquisition LLC dba Tailor Made Compounding / 41 vials | Class II | Ongoing |
| D-0856-2022 | 03-04-2022 | SyrSpend SF Suspending Base, Cherry Flavored, packaged in a) 500mL bottles (NDC 51552-1123-5) and b) 4L bottles (NDC 51552-1123-9), Rx Only, Manufactured for Fagron, Inc., St. Paul, MN 55120. | Microbial Contamination of Non-Sterile Product: Product is contaminated with Burkholderia gladioli. | Fagron, Inc / a) 559 bottles and b) 243 bottles | Class I | Completed |
| D-0650-2022 | 03-04-2022 | Alprazolam C-IV 1 mg 60-count bottles, Rx Only, Dist. By: Par Pharmaceutical Chestnut Ridge, NY 10977 Packaged and Distributed By: Direct Rx Dawsonville, GA 30534, NDC 61919-836-60 | CGMP Deviations: The Recall is due to the potential cross-contamination at the contract manufacturer (Ultra Tab Laboratories Inc.) | Direct Rx / 16 bottles | Class II | Terminated |
| D-0651-2022 | 03-04-2022 | Alprazolam C-IV 2 mg, 60-count bottles, Rx Only, Dist. By: Par Pharmaceutical Chestnut Ridge, NY 10977 Packaged and Distributed By: Direct Rx Dawsonville, GA 30534, NDC 72189-0058-60 | CGMP Deviations: The Recall is due to the potential cross-contamination at the contract manufacturer (Ultra Tab Laboratories Inc.) | Direct Rx / 8 bottles | Class II | Terminated |
| D-0866-2022 | 03-04-2022 | Nandrolone Decanoate, USP, 1 kg per plastic container, Rx Only, For Prescription Compounding, Distributed by: Humco, 7400 Alumax Road, Texarkana, TX 75501. NDC 0395-8212-43 | Subpotent Drug | Fagron, Inc / 1 containers | Class III | Terminated |
| D-0863-2022 | 03-04-2022 | Nandrolone Decanoate, USP, 500 g per plastic container, Rx Only, For Prescription Compounding, Fagron, Inc. 2400 Pilot Knob Rd., St Paul, MN 55120. NDC 51552-1564-05 | Subpotent Drug | Fagron, Inc / 53 containers | Class III | Terminated |
| D-0865-2022 | 03-04-2022 | Nandrolone Decanoate, USP, 500 g per plastic container, Rx Only, For Prescription Compounding, Distributed by: Humco, 7400 Alumax Road, Texarkana, TX 75501. NDC 0395-8212-56 | Subpotent Drug | Fagron, Inc / 2 containers | Class III | Terminated |
| D-0864-2022 | 03-04-2022 | Nandrolone Decanoate, USP, 1 kg per plastic container, Rx Only, For Prescription Compounding, Fagron, Inc. 2400 Pilot Knob Rd., St Paul, MN 55120. NDC 51552-1564-07 | Subpotent Drug | Fagron, Inc / 68 containers | Class III | Terminated |
| D-0862-2022 | 03-04-2022 | Nandrolone Decanoate, USP, 100 g per plastic container, Rx Only, For Prescription Compounding, Fagron, Inc. 2400 Pilot Knob Rd., St Paul, MN 55120. NDC 51552-1564-04 | Subpotent Drug | Fagron, Inc / 58 containers | Class III | Terminated |
