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-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-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-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-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-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-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-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-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-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-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-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-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-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-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-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-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-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-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-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-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-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-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-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-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-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-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-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-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-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-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-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-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-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-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-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-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-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-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-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-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-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-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-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-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-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-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-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
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-0750-2022	03-04-2022	Sodium Acetate Injection, USP, 400 mEq / 100 mL (4 mEq / mL), packaged in 2 trays of 20 vials per shipper (NDC 63323-032-00), each vial: 100 mL fill in a 100 mL vial (NDC 63323-032-04), Rx Only, Fresenius Kabi, Lake Zurich, IL 60047 Package NDCs: 63323-032-04; 63323-032-00	Presence of particulate matter: particulates composed of carbon and oxygen with varying amounts of iron and trace amounts of sodium, silicon, chromium, aluminum and cellulose.	Fresenius Kabi USA, LLC / 118,040 vials	Class I	Terminated
D-0739-2022	03-03-2022	HAND SANITIZER Isopropyl Alcohol Antiseptic 75%, Net contents: 1 U.S. Gallon/3.785 Liters Tennessee Technical Coatings Corporation, 1421 Higgs Road (P.O. Box 1698) Lewisburg, TX 37091, NDC 76921-000-01	Chemical Contamination: FDA analysis found 1 lot of HAND SANITIZER Isopropyl Alcohol Antiseptic 75%, to contain methanol.	Tennessee Technical Coatings, Corp. / 169.2 gallons	Class I	Terminated
D-0740-2022	03-03-2022	HAND SANITIZER Isopropyl Alcohol Antiseptic 75%, Net contents: 1 U.S. Gallon/3.785 Liters Tennessee Technical Coatings Corporation, 1421 Higgs Road (P.O. Box 1698) Lewisburg, TX 37091, NDC 76921-000-01	CGMP Deviations: lots and products of hand sanitizer are being recalled because they were manufactured under the same conditions as the product lot found to contain methanol.	Tennessee Technical Coatings, Corp. / N/A	Class II	Terminated
D-0654-2022	03-02-2022	Alprazolam Tablets, USP 1mg, 180-count bottles, Rx only, Manufactured by ULTRAlab Laboratories, Inc., NY; Packaged by GSMS, Inc., CA NDC 60429-504-18.	CGMP Deviation: Potential cross-contamination with other drug substance during the manufacturing process.	Golden State Medical Supply Inc. / 401 bottles	Class II	Terminated
D-0644-2022	03-02-2022	HEB 50% Isopropyl Alcohol First Aid Antiseptic, packaged in 16 FL OZ 91 PT) 473 mL brown bottles with brown colored closures. Distributed by HEB San Antonio, TX 78204. UPC 0 41220 25111 7	Labeling: Label Mix-Up-The primary label on the front of the bottles have 50% Isopropyl Alcohol affixed to the containers. However, the product inside the bottle is Hydrogen Peroxide, Topical Solution USP with active ingredient Hydrogen Peroxide (stabilized) 3%, 32 FL Ounces. The back label is correct. Product is packaged in dark bottles.	Vi-Jon, Inc. / 11,580 bottles	Class II	Terminated
D-0649-2022	02-28-2022	PALIPERIDONE EXTENDED-RELEASE TABLETS, 9 mg, 100 Tablets per carton (10 x 10 blister packs), Rx only, Manufactured by: Sun Pharmaceutical Industries Ltd., Survey No. 259/15, Dadra-396 191, India. Distributed by: MAJOR PHARMACEUTICALS, 17177 N. Laurel Park Dr., Suite 233, Livonia, MI 48152. NDC: 0904-6937-61 Package NDCs: 0904-6935-61; 0904-6936-61; 0904-6937-61	Failed Dissolution Specifications	The Harvard Drug Group / 174 cartons	Class II	Terminated
D-0727-2022	02-25-2022	Clotrimazole and Betamethasone Dipropionate Cream USP, 1%/0.05%,15 g tubes, Rx only, Manufactured by: Taro Pharmaceuticals Industries Ltd. Haifa Bay, Israel 2624761, Distributed by: Taro Pharmaceuticals U.S.A., Inc. Hawthorne, NY 10532, NDC 51672-4048-1 Package NDCs: 51672-4048-1; 51672-4048-6	Failed Content Uniformity Specifications: Out-of-specification result for the Betamethasone Dipropionate assay of a stability sample	Taro Pharmaceuticals U.S.A., Inc. / 768 tubes	Class III	Terminated
D-0655-2022	02-25-2022	0.9% Sodium Chloride Injection USP, 250 mL Excel Container, Rx only, B. Braun Medical Inc., Bethlehem, PA, NDC 0264-7800-20 Package NDCs: 0264-7800-00; 0264-7800-10; 0264-7800-20; 0264-7802-00; 0264-7802-10	Lack of sterility assurance: leaking bags	B. Braun Medical, Inc. / 33,742 bags	Class II	Terminated
D-0653-2022	02-24-2022	hydrALAZINE HCl Tablets, USP, 10 mg, 100 Tablets per carton (10x10 blister packs), Rx only, Distributed by: MAJOR PHARMACEUTICALS, Livonia, MI 48152 USA. NDC # 0904-6440-61	Failed Impurities/Degradation Specifications: Out of specification result obtained during routine stability testing for Impurities.	The Harvard Drug Group / 5,953 cartons	Class II	Terminated
D-0652-2022	02-22-2022	Oxycodone Hydrochloride Oral Solution, USP (C-II), 5 mg/5 mL, Delivers 5 mL per Cup, 1 Tray of 10 Cups, Rx Only, For Institutional Use Only, American Health Packaging, Columbus, OH 43217. UPC (01) 003 60687 406 40 4; Case NDC#: 60687-406-77, Unit Dose NDC#: 60687-406-40 Package NDCs: 60687-406-40; 60687-406-46; 60687-406-77; 60687-406-67	Impurity failure at 0-time of the repackaged lot.	American Health Packaging / 89,880 unit-dose cups	Class II	Terminated
D-0642-2022	02-22-2022	Alprazolam Tablets, USP 1mg, Generic for Xanax, Pkg Size: a) 30 tablets per bottle, NDC: 68788-6381-03, b) 60 tablets per bottle, NDC: 68788-6381-06, c) 90 tablets per bottle, NDC: 68788-6381-09, Mfg: Par Pharmaceutical.	CGMP deviations	Preferred Pharmaceuticals, Inc. / 276 bottles	Class II	Terminated
D-0713-2022	02-21-2022	Dexamethasone Elixir, USP 0.5 mg/5 mL, Net: 8 fl oz (237 mL) bottle, Rx only, Manufactured By: Morton Grove Pharmaceuticals, Inc., Morton Grove, IL 60053, NDC 60432-466-08.	Failed Impurities/Degradation Specifications: higher than permissible levels of unknown impurities were found in the drug product.	Morton Grove Pharmaceuticals, Inc. /	Class II	Terminated
D-0641-2022	02-18-2022	All Over-The-Counter (OTC) drug products sold by Family Dollar retail stores located in Alabama, Arkansas, Louisiana, Mississippi, Missouri and Tennessee.	CGMP Deviations: Potential exposure to rodents and rodent activity in the distribution center.	Dollar Tree Distribution, Inc. / Unknown	Class II	Ongoing
D-0637-2022	02-17-2022	Moxifloxacin Ophthalmic Solution USP 0.5%, 3 mL, Packaged and Distributed By: Direct Rx Dawsonville, GA 30534 Dist. By Aurobindo Pharma USA, Inc. East Windsor, NJ 08520, NDC 72189-076-05	Failed impurities/degradation specifications	Direct Rx / 44 bottles	Class II	Terminated
D-0640-2022	02-17-2022	Sapropterin Dihydrochloride Powder for Oral Solution, 100 mg, 30 individual packets per carton, Rx Only, Dr. Reddy's, Distributor: Dr. Reddy's Laboratories Inc., Princeton, NJ 08540, Made in India, NDC: 43598-477-11 (packet), 43598-477-30 (carton).	Subpotent Drug: Out-of-specification results observed in Assay in sapropterin dihydrochloride powder 100mg.	Dr. Reddy's Laboratories, Inc. / 340 packets	Class III	Terminated
D-0209-2024	02-16-2022	Sure Regular Antiperspirant Deodorant Aerosol (Aluminum Chlorohydrate 10%), packaged in 6 oz (170 g) aerosol cans, Distributed by Idelle Labs, Ltd., El Paso, TX 79912, NDC 41595-5518-06	Chemical contamination: Presence of benzene	TCP HRB ACQUISITON LLC / 5.4 million	Class I	Ongoing
D-0208-2024	02-16-2022	Sure Unscented Anti-perspirant Deodorant Aerosol (Aluminum Chlorohydrate 10%), packaged in 6 oz (170 g) aerosol cans, Distributed by Idelle Labs, Ltd., El Paso, TX 79912, NDC 41595-5517-06	Chemical contamination: Presence of benzene	TCP HRB ACQUISITON LLC / 0.5 million	Class I	Ongoing
D-0207-2024	02-16-2022	Brut Classic Antiperspirant & Deodorant (aluminum chlorohydrate 20.9%) packaged in a) 4 oz. (113g) aerosol cans (UPC 00827755070085, NDC 41595-7103-1) and b) 6 oz. (170g) aerosol cans (UPC 00827755070108, NDC 41595-7103-2), Distributed by Idelle Labs, Ltd. El Paso, TX 79912 USA	Chemical contamination: Presence of benzene	TCP HRB ACQUISITON LLC / a) 0.4 million cans, b) 3.4 million cans	Class I	Ongoing
D-0639-2022	02-16-2022	Olanzapine Tablets, USP 10 mg, 30-count bottles, Rx only, Manufactured for: Macleods Pharma USA , Inc. Plainsboro, NJ 08536, Manufactured by: Macleods Pharmaceuticals Ltd., Baddi, HImachal Pradesh, India, NDC 33342-070-07. Package NDCs: 33342-067-07; 33342-067-44; 33342-067-12; 33342-067-11; 33342-068-07; 33342-068-44; 33342-068-12; 33342-068-11; 33342-069-07; 33342-069-44; 33342-069-12; 33342-069-11; 33342-070-07; 33342-070-15; 33342-070-12; 33342-070-44; 33342-070-11; 33342-071-07; 33342-071-15; 33342-071-12; 33342-071-44; 33342-071-11; 33342-072-07; 33342-072-15; 33342-072-12; 33342-072-44; 33342-072-11	cGmp Deviations	Macleods Pharma Usa Inc / 3672 bottles	Class II	Terminated
D-0632-2022	02-15-2022	Amlodipine and Olmesartan Medoxomil Tablets, 10 mg /20 mg, 30-count bottles, Rx only, Manufactured for: Macleods Pharma USA, Inc., Plainsboro, NJ 08536, Manufactured by: Macleods Pharmaceuticals, Ltd, Baddi, Himachal Pradesh, INDIA, NDC 33342-192-07. Package NDCs: 33342-190-07; 33342-190-10; 33342-190-12; 33342-190-44; 33342-191-07; 33342-191-10; 33342-191-12; 33342-191-44; 33342-192-07; 33342-192-10; 33342-192-12; 33342-192-44; 33342-193-07; 33342-193-10; 33342-193-12; 33342-193-44	cGMP deviations	Macleods Pharma Usa Inc / 3,672 bottles	Class II	Terminated
D-0564-2022	02-15-2022	Alprazolam Tablets, USP 0.25 mg, packaged in a) 100-count bottles (NDC 67253-900-10), b) 500-count bottles (NDC 67253-900-50), and c) 1000-count bottles (NDC 67253-900-11), Rx only, Distributed by: Par Pharmaceutical Chestnut Ridge, NY 10977	cGMP Deviations	ANI Pharmaceuticals, Inc. / 73,920 bottles	Class II	Terminated
D-0566-2022	02-15-2022	Alprazolam Tablets, USP 1.0 mg, packaged in a) 100-count bottles (NDC 67253-902-10), b) 500-count bottles (NDC 67253-902-50), and c) 1000-count bottles (NDC 67253-902-11), Rx only, Distributed by: Par Pharmaceutical Chestnut Ridge, NY 10977	cGMP Deviations	ANI Pharmaceuticals, Inc. / 173,499 bottles	Class II	Terminated
D-0567-2022	02-15-2022	Alprazolam Tablets, USP 2.0 mg, packaged in a) 100-count bottles (NDC 67253-903-10), b) 500-count bottles (NDC 67253-903-50), Rx only, Distributed by: Par Pharmaceutical Chestnut Ridge, NY 10977	cGMP Deviations	ANI Pharmaceuticals, Inc. / 70,788 bottles	Class II	Terminated
D-0568-2022	02-15-2022	Pyrazinamide Tablets, USP 500 mg, 100-count bottles, Rx only, Manufactured by: ULTRAtab Laboratories, Inc. Highland, NY 12528, Distributed by Par Pharmaceuticals, Chestnut Ridge, NY 10977, NDC 67253-660-10.	cGMP Deviations	ANI Pharmaceuticals, Inc. / 5,477 bottles	Class II	Terminated
D-0565-2022	02-15-2022	Alprazolam Tablets, USP 0.5 mg, packaged in a) 100-count bottles (NDC 67253-901-10), b) 500-count bottles (NDC 67253-901-50), and c) 1000-count bottles (NDC 67253-901-11), Rx only, Distributed by: Par Pharmaceutical Chestnut Ridge, NY 10977	cGMP Deviations	ANI Pharmaceuticals, Inc. / 205,662 bottles	Class II	Terminated
D-0569-2022	02-14-2022	Norepinephrine bitartrate 16 mg in 250 mL NaCl 0.9%, packaged in IV bags, Rx only, BayCare Central Pharmacy 7802 E. Telecom Parkway Temple Terrace, FL 33637 (813) 901-6392	Subpotent drug	BayCare Integrated Service Center, LLC /dba BayCare Central Pharmacy / 1157 bags	Class III	Terminated
D-0648-2022	02-11-2022	HCG 6,000iu (lyo) Human Chorionic Gonadotropin Inj., For Sub-Q or IM Use Only, Not For IV Use, Vial, Rx Only, Compounded By: Revive Rx 3831 Golf Dr., Houston, TX 77018, NDC: 88888-1739-01.	Non-sterility; bacterial contamination identified as Paenibacillus lautus.	Revive Rx LLC dba Revive Rx Pharmacy / 115 vials	Class I	Terminated
D-0645-2022	02-10-2022	RISE UP RED EDITION Capsules, 650 mg, 10-count blisters packaged in a carton, ASIN B08JCWG84D, barcode X002NI8PE1.	Marketed Without An Approved NDA/ANDA: Product was found to contain undeclared tadalafil, an ingredient found in FDA approved products for the treatment of male sexual enhancement, making this an unapproved drug.	Positive Health / 5,500 cartons	Class I	Terminated
D-0558-2022	02-09-2022	Diazepam Oral Solution (Concentrate), 25 mg per 5 mL (5 mg/mL), 30 mL BOTTLE and DROPPER, Rx Only, Distributed by: Lannett Company, Inc., Philadelphia, PA 19136, NDC 0527-1768-36.	Failed Impurities/Degradation Specifications: Out of specification results for related substances.	Lannett Company, Inc. / 23,598 bottles	Class II	Terminated
D-0725-2022	02-09-2022	Avaphinal Maximum Male Enhancement Sexual Pills, 2000 MG*, packaged in 10 Capsules per carton.	Marketed Without An Approved NDA/ANDA: Product was found to contain undeclared sildenafil, an ingredient found in FDA approved products for the treatment of male sexual enhancement, making this an unapproved drug.	Walmart Stores / unknown	Class I	Terminated
D-0638-2022	02-08-2022	RED MAMMOTH capsules, 400 mg, packaged in 10-count blisters per carton, ASIN B00KA8FBNI, barcode X001ANE0I5.	Marketed Without An Approved NDA/ANDA: Product was found to contain undeclared sildenafil and tadalafil, ingredients found in FDA approved products for the treatment of male sexual enhancement, making this an unapproved drug.	Celebrate Today / 500 cartons	Class I	Terminated
D-0563-2022	02-08-2022	MAC DADDY PURPLE Capsules, packaged in 10-count blisters per carton, ASIN B08Z63Z4QK, UPC 742137 605764.	Marketed Without An Approved NDA/ANDA: product was found to contain undeclared tadalafil and/or sildenafil, ingredients found in FDA approved products for the treatment of male sexual enhancement, making these unapproved drugs.	ABC Sales 1 Inc / 336 cartons	Class I	Terminated
D-0562-2022	02-08-2022	MAC DADDY RED Capsules, packaged in 10-count blisters per carton, ASIN B07TLDZLY2, UPC 742137 605191.	Marketed Without An Approved NDA/ANDA: product was found to contain undeclared tadalafil and/or sildenafil, ingredients found in FDA approved products for the treatment of male sexual enhancement, making these unapproved drugs.	ABC Sales 1 Inc / 565 cartons	Class I	Terminated
D-0630-2022	02-08-2022	THE RED PILL, EXTRA STRENGTH capsules, 800 mg, packaged in 10-count blisters packaged in a carton, ASIN B0847BSQQ5, Barcode X002G5GMJ1.	Marketed Without An Approved NDA/ANDA: Product was found to contain undeclared tadalafil, an ingredient found in FDA approved products for the treatment of male sexual enhancement, making this an unapproved drug.	Your Favorite Shop / 12,500 cartons	Class I	Terminated
D-0578-2022	02-07-2022	Chlorthalidone Tablets USP 25 mg, Rx Only, 100 Tablets, Sun Pharma, Mfg. by: Fontida Bio Pharm Inc., 1100 Orthodox St. Philadephia, PA 19124, Dist. by: Sun Pharmaceutical Industries, Inc., Cranbury, NJ 08512, NDC 57664-648-88. Package NDCs: 57664-648-88; 57664-648-18; 57664-649-88; 57664-649-18	Foreign Matter identified as stainless steel microscopic wear particles mixed with punch lubricant oil and silicone particles from the dust cup	SUN PHARMACEUTICAL INDUSTRIES INC / 59,232 bottles	Class II	Terminated
D-0716-2022	02-07-2022	Erythromycin Topical Gel USP, 2%, Net Wt 30 g 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 63739-053-66.	Failed Impurities/Degradation Specifications: Lot not meeting specification for Unknown Max Related Compounds.	Teligent Pharma, Inc. / 11040 tubes	Class II	Terminated
D-0573-2022	02-07-2022	Methylphenidate Hydrochloride Chewable Tablets, 2.5 mg, 100-count bottle, Rx Only, Manufactured for: Rising Pharmaceuticals Inc., Saddle Brook, NJ 07863, NDC 64980-221-01 Package NDCs: 64980-221-01; 64980-222-01; 64980-223-01	Failed Tablet Specifications: Recall of this drug product was voluntarily initiated by the manufacturer due to a market complaint, which stated that a tablet in the sealed bottle was twice larger in size when compared to the remaining tablets. This complaint is second of its kind.	RISING PHARMACEUTICALS / 2220 100-count bottles	Class II	Ongoing
D-0636-2022	02-07-2022	Luxury 70% Isopropyl Alcohol, 16 FL. OZ. (1PT) 473 ML bottle, Distributed by: TSM Brands LLC, 540 Equinox Ln, Manalapan, NJ 07726, UPC 868275965734.	Labeling - product contains undeclared ethyl alcohol	Tsm Brands LLC / 135.444 bottles	Class II	Ongoing
D-0635-2022	02-07-2022	70% Isopropyl Alcohol First Aid Antiseptic with Wintergreen, 12 FL. OZ. 355 ML bottle, Distributed By: TSM Brands LLC, 540 Equinox LN, Manalapan, NJ 07726, www.tsmbrands.com, Made in Turkey, UPC 868275965765	Labeling - product contains undeclared ethyl alcohol	Tsm Brands LLC / 1.186.800 bottles	Class II	Ongoing
D-0571-2022	02-04-2022	Prevantics (chlorhexidine gluconate and isopropyl alcohol) Swab, 3.15% w/v and 70% v/v, packaged as a) One Swab, 0.034 fl. Oz. (1 mL) Each in a pouch, 100 Individual Swabs per carton, 10 boxes of 100 Individual Swabs per case, REORDER NO. B10800, NDC 10819-1080-1; b) One Swab, 0.034 fl. oz. (1 mL) Each in a pouch, 3000 Individual Swabs per case, REORDER NO. B11400, NDC 10819-1080-2; Professional Disposables International, Inc., Orangeburg, NY 10962-1376. Package NDCs: 10819-1080-1; 10819-1080-2	cGMP deviations: uncertainty of the adequacy of the validation of the test methods used to manufacture the products.	Professional Disposables International, Inc. / a) 160531 cases; b) 16123 cases	Class II	Terminated
D-0570-2022	02-04-2022	Prevantics (chlorhexidine gluconate and isopropyl alcohol) Maxi Swabstick, 3.15% w/v and 70% v/v, packaged as a) One Maxi Swabstick, 0.172 fl. Oz. (5.1 mL) Each in a pouch, 30 Individual Maxi Swabsticks per carton, 10 boxes of 30 Individual Swabsticks per case, NDC 10819-4076-4, REORDER NO. S41950; b) One Maxi Swabstick, 0.172 fl. Oz. (5.1 mL) Each in a pouch, 300 Individual Swabsticks per case, NDC 10819-4076-3, REORDER NO. S27350; Professional Disposables International, Inc., Orangeburg, NY 10962-1376. Package NDCs: 10819-4076-4; 10819-4076-3	cGMP deviations: uncertainty of the adequacy of the validation of the test methods used to manufacture the products.	Professional Disposables International, Inc. / a) 9518 cases; b) 3347 cases	Class II	Terminated
D-0572-2022	02-04-2022	Prevantics (chlorhexidine gluconate and isopropyl alcohol) Swabstick, 3.15% w/v and 70% v/v, packaged as a) One Swabstick, 0.054 fl. oz. (1.6 mL) Each in a pouch, NDC 10819-4077-1; 50 Individual Swabsticks per carton, 10 boxes of 50 Individual Swabsticks per case, REORDER NO. S40750, NDC 10819-4077-4; b) One Swabstick, 0.054 fl. Oz. (1.6 mL) Each in a pouch, 500 Individual Swabsticks per case, REORDER NO. S32450, NDC 10819-4077-2; c) One Swabstick, 0.054 fl. Oz. (1.6 mL) Each in a pouch, 500 Individual Swabsticks per case, REORDER NO. S42850, NDC 10819-4077-3; Professional Disposables International, Inc., Orangeburg, NY 10962-1376. Package NDCs: 10819-4077-1; 10819-4077-4; 10819-4077-2; 10819-4077-3	cGMP deviations: uncertainty of the adequacy of the validation of the test methods used to manufacture the products.	Professional Disposables International, Inc. / a) 28201 cases; b) 7579 cases; c) 8882 cases	Class II	Terminated