Drug recall: Alpha Lipoic Acid 25mg/mL, 30mL-vial, Refrigerate, Tailor Made Compounding

Class II FDA enforcement event 89909. Recall start date: 7 Mar 2022. Status in the FDA record: Ongoing.

Reason for recall, in the words of FDA

Lack of Assurance of Sterility

Class II, in the words of FDA

a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote

TMC Acquisition LLC dba Tailor Made Compounding started this drug recall on 7 Mar 2022. The firm address in the FDA record is in Nicholasville, KY. FDA put the recall in Class II. FDA event 89909 has 52 product records. The first FDA enforcement report date is 20 Jul 2022. The record gives the status Ongoing.

FDA enforcement report The 52 product records

It is important to note that most of the time recall classifications are determined after the recalling firm provides all of the information needed to determine the risk posed to public health. The classification and posting in the FDA Enforcement Report should not be seen as an expansion or change to a firm’s voluntary public warning.
FDA publishes these words. Source: FDA, Enforcement Reports, Important Note, read on 1 Oct 2026. openFDA export of 28 Sep 2026.

Distribution

In the words of FDA.

Nationwide USA and Puerto Rico

Recalling firm

TMC Acquisition LLC dba Tailor Made Compounding, Nicholasville, KY.

Recalling firm: The firm that the FDA record names for a recall.

FDA records how the recall started: Voluntary: Firm initiated.

Products

52 product records in the event.

FDA event 89909: product records
Recall number	Product	Quantity	Class	Status	Report date
D-1192-2022	Alpha Lipoic Acid 25mg/mL, 30mL-vial, Refrigerate, Tailor Made Compounding	29 vials	Class II	Ongoing	20 Jul 2022
D-1193-2022	Alprostadil/Papaverine/Phentolamine 60mcg/30mg/3mg/mL, 3mL-vial, Refrigerate, Tailor Made Compounding	32 vials	Class II	Ongoing	20 Jul 2022
D-1194-2022	Anastrozole/Testosterone Cypionate/Propionate 1mg/160mg/40mg/mL, 10 mL-vial, Room Temperature, Tailor Made Compounding	39	Class II	Ongoing	20 Jul 2022
D-1195-2022	Ascorbic Acid 500mg/mL, a) 25 ml-vial, b) 50 ml-vial, Refrigerate, Tailor Made Compounding	657 vials	Class II	Ongoing	20 Jul 2022
D-1196-2022	BCAAs (Leucine/Iso-Leucine/Valine) 10mg/10mg/5mg/mL, 30mL-vial, Refrigerate, Tailor Made Compounding	180 vials	Class II	Ongoing	20 Jul 2022
D-1197-2022	Biotin 5mg/mL, 5mL-vial, Refrigerate, Tailor Made Compounding	39	Class II	Ongoing	20 Jul 2022
D-1198-2022	Calcium Chloride Preservative Free, 100mg/mL, a) 5 mL-vial, b) 30 ml-vial, Room Temperature, Tailor Made Compounding	138 vials	Class II	Ongoing	20 Jul 2022
D-1199-2022	Dexpanthenol 250mg/mL, 30mL-vial, Room Temperature, Tailor Made Compounding	19 vials	Class II	Ongoing	20 Jul 2022
D-1200-2022	Dexpanthenol Preservative Free 250mg/mL, 2mL-vial, Room Temperature, Tailor Made Compounding	84 vials	Class II	Ongoing	20 Jul 2022
D-1201-2022	Estradiol Cypionate 10mg/mL, a) 1mL-vial, b) 2 mL-vial, Room Temperature, Tailor Made Compounding	349 vials	Class II	Ongoing	20 Jul 2022
D-1202-2022	Folic Acid 5mg/mL, 30mL-vial, Refrigerate, Tailor Made Compounding	45	Class II	Ongoing	20 Jul 2022
D-1203-2022	GAC (Glutamine/Arginine/L-Carnitine) 25mg/100mg/250mg/mL, 30mL-vial, Refrigerate, Tailor Made Compounding	90 vials	Class II	Ongoing	20 Jul 2022
D-1204-2022	GOAL (Glutamine/Ornithine/Arginine/Lysine 25mg/75mg/150mg/250mg/ml) 30 ml-vial, Refrigerate, Tailor Made Compounding	60 Vials	Class II	Ongoing	20 Jul 2022
D-1205-2022	Glutathione 200mg/mL Preservative Free, Injectable, 30mL-vial, Refrigerate, Tailor Made Compounding	40 vials	Class II	Ongoing	20 Jul 2022
D-1206-2022	Glycyrrhizic Acid 8mg/mL, 10mL-vial, Refrigerate, Tailor Made Compounding	101 vials	Class II	Ongoing	20 Jul 2022
D-1207-2022	Gonadorelin 100mcg/mL, 10mL per vial, Refrigerate, Tailor Made Compounding	294 vials	Class II	Ongoing	20 Jul 2022
D-1208-2022	Hydroxocobalamin 25mg/mL, 10mL-vial, Room Temperature, Tailor Made Compounding	63 vials	Class II	Ongoing	20 Jul 2022
D-1209-2022	Hydroxocobalamin Preservative Free 5mg/mL, 1mL-vial, Refrigerate, Tailor Made Compounding	26 vials	Class II	Ongoing	20 Jul 2022
D-1210-2022	Inositol/Choline B12 + Carnitine 40mg/40mg/1mg/100mg/mL, 30mL-vial, Refrigerate, Tailor Made Compounding	25 vials	Class II	Ongoing	20 Jul 2022
D-1211-2022	Levocarnitine 500mg/mL, 30mL-vial, Refrigerate, Tailor Made Compounding	12 vials	Class II	Ongoing	20 Jul 2022
D-1212-2022	Melanotan I 200mcg/mL (2mg/ml), a) 1.5mL-vial, b) 5 mL-vial, Refrigerate, Tailor Made Compounding	182 vials	Class II	Ongoing	20 Jul 2022
D-1213-2022	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	924 vials	Class II	Ongoing	20 Jul 2022
D-1214-2022	Methionine/Inositol/Choline B12 25mg/50mg/50mg/1mg/mL, a)10 mL-vial, b) 30 mL-vial, Room Temperature, Tailor Made Compounding	232 vials	Class II	Ongoing	20 Jul 2022
D-1215-2022	Methylcobalamin 10mg/mL, a) 1 mL-vial, b) 10mL-vial, c) 30 mL-vial, Room Temperature, Tailor Made Compounding	652 vials	Class II	Ongoing	20 Jul 2022
D-1216-2022	Methylcobalamin 1mg/mL, a) 10 mL-vial, b) 30 ml-vial, Room Temperature, Tailor Made Compounding	191 vials	Class II	Ongoing	20 Jul 2022
D-1217-2022	Methylcobalamin Preservative Free, 10mg/mL, 1mL-vial, Room Temperature, Tailor Made Compounding	4 vials	Class II	Ongoing	20 Jul 2022
D-1218-2022	Methylene Blue Hypotonic Solution, 10mg/mL, a) 2 mL-vial, b) 10mL-vial, Refrigerate, Tailor Made Compounding	464 vials	Class II	Ongoing	20 Jul 2022
D-1219-2022	NAD+ 200mg/mL, 10mL-vial, Refrigerate, Tailor Made Compounding	1,856 vials	Class II	Ongoing	20 Jul 2022
D-1220-2022	Nandrolone Decanoate 200mg/mL, a) 5 mL-vial, b) 10mL-vial, Refrigerate, Tailor Made Compounding	243 vials	Class II	Ongoing	20 Jul 2022
D-1221-2022	Pentosan Polysulfate Sodium 250mg/mL, 5mL-vial, Room Temperature, Tailor Made Compounding	220 vials	Class II	Ongoing	20 Jul 2022
D-1222-2022	Procaine HCL 2% (20mg/mL), 30 ml-vial, Refrigerate, Tailor Made Compounding	58 vials	Class II	Ongoing	20 Jul 2022
D-1223-2022	PT-141 10mg/mL a) 1mL-vial, b) 2 mL-vial, Refrigerate, Tailor Made Compounding	392 vials	Class II	Ongoing	20 Jul 2022
D-1224-2022	Semaglutide/Cyanocobalamin 2mg/0.4mg/ml, 1mL-vial, Refrigerate, Tailor Made Compounding	5,842 vials	Class II	Ongoing	20 Jul 2022
D-1225-2022	Semaglutide/Cyanocobalamin 5mg/0.2mg/ml, 2ml-vial, Refrigerate, Tailor Made Compounding	9,993 vials	Class II	Ongoing	20 Jul 2022
D-1226-2022	Sermorelin 2000mcg/mL, 7.5mL-vial, Refrigerate, Tailor Made Compounding	1,208 vials	Class II	Ongoing	20 Jul 2022
D-1227-2022	Sermorelin/Glycine 2000mcg/5mg/mL, 4mL-vial, Refrigerate, Tailor Made Compounding	1,562 vials	Class II	Ongoing	20 Jul 2022
D-1228-2022	Sermorelin/Glycine 2000mcg/5mg/mL, 7.5mL-vial, Refrigerate, Tailor Made Compounding	2,870 vials	Class II	Ongoing	20 Jul 2022
D-1229-2022	Teriparatide 226mcg/ml Injectable, 4 Pre-filled Syringes, 0.25 mL-Syringe, Refrigerate, Tailor Made Compounding	12 syringes	Class II	Ongoing	20 Jul 2022
D-1230-2022	Testosterone Cypionate (GSO) 100mg/ml a)1mL-vial , b) 2mL-vial, Room temperature, Tailor Made Compounding	273 vials	Class II	Ongoing	20 Jul 2022
D-1231-2022	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	4,219 vials	Class II	Ongoing	20 Jul 2022
D-1232-2022	Testosterone Cypionate/Anastrozole 200mg/0.5mg/mL, 10mL-vial, Room temperature, Tailor Made Compounding	41 vials	Class II	Ongoing	20 Jul 2022
D-1233-2022	Testosterone Cypionate/Anastrozole 200mg/1mg/mL, a) 4 mL-vial, b)10mL-vial, Room temperature, Tailor Made Compounding	106 vials	Class II	Ongoing	20 Jul 2022
D-1234-2022	Testosterone Cypionate/Enanthate 100/100mg/ml, a) 2 mL-vial, b) 4 mL-vial c) 10 mL-vial, Room temperature, Tailor Made Compounding	58 vials	Class II	Ongoing	20 Jul 2022
D-1235-2022	Testosterone Cypionate/Enanthate/Propionate 80/80/40mg, a) 5 mL-vial, b) 10 ml-vial, Room temperature, Tailor Made Compounding	246 vials	Class II	Ongoing	20 Jul 2022
D-1236-2022	Testosterone Cypionate/Propionate 180/20mg/ml, a) 5 mL-vial, b) 10 mL-vial, Room temperature, Tailor Made Compounding	176 vials	Class II	Ongoing	20 Jul 2022
D-1237-2022	Testosterone Enanthate (GSO) 100mg/ml, 2 mL-vial, Room temperature, Tailor Made Compounding	93 vials	Class II	Ongoing	20 Jul 2022
D-1238-2022	Testosterone Enanthate (GSO) 200mg/ml, a) 5 mL-vial, b) 10 mL-vial, Room temperature, Tailor Made Compounding	414 vials	Class II	Ongoing	20 Jul 2022
D-1239-2022	Testosterone Propionate 100mg/ml, 10mL-vial, Room temperature, Tailor Made Compounding	64 vials	Class II	Ongoing	20 Jul 2022
D-1240-2022	Vitamin B-Complex, a) 10 mL-vial, b) 30 mL-vial, Refrigerate, Tailor Made Compounding	75 vials	Class II	Ongoing	20 Jul 2022
D-1241-2022	Vitamin B-Complex Preservative Free, 3ml-vial, Refrigerate, Tailor Made Compounding	6 vials	Class II	Ongoing	20 Jul 2022
D-1242-2022	Vitamin D3 50,000IU/mL, 10mL-vial, Room Temperature, Tailor Made Compounding	15 vials	Class II	Ongoing	20 Jul 2022
D-1243-2022	Glutathione 200mg/ml, a) 10ml-vial, b) 30ml-vial, Refrigerate, Tailor Made Compounding	485 Vials	Class II	Ongoing	20 Jul 2022

openFDA, about the status: FDA does not update the status of a recall after the recall has been classified according to its level of hazard. As such, the status of a recall (open, completed, or terminated) will remain unchanged after published in the Enforcement Reports. Source: openFDA, Drug Recall Enforcement Reports, Disclaimer.

Enforcement report: The FDA publication that lists recalls. It has one record for each product of a recall.

Enforcement event: All the product records that have one FDA event number. This site shows one event on one page.

Class II: The middle of the three FDA recall classes.

The event in context

Drug events that started in 2022: 325
Share of these events in Class II: 65%
Product records in this event: 52
Events of the firm on the register: 1

Official channels

FDA enforcement report D-1192-2022The FDA record of the first product of this event.
FDA: recalls, market withdrawals and safety alertsThe recall notices on the FDA site.
FDA MedWatchThe FDA safety reporting program for drugs and medical devices.

Follow by RSS:Food, drug and device recallsFDA Class I recalls

Cite this page

Recall Register. FDA enforcement event 89909. https://recallregister.com/fda/ii/89909/. Source: openFDA enforcement reports. Data through 28 Sep 2026.

Sources

Source: openFDA drug enforcement reports
Licence: CC0 1.0
Export date: 28 Sep 2026
Newest FDA report date on the register: 23 Sep 2026

FDA has one record for each product. This site puts the records with the same event number on one page. The class of the event is the highest class of its records. How the register is made. Report an error.

Questions

Where was the product distributed?: The FDA record gives this distribution: Nationwide USA and Puerto Rico
What quantity of product is in FDA event 89909?: The event has 52 product records. The first record gives this quantity: 29 vials
How did the recall start?: The FDA record says: Voluntary: Firm initiated
How many drug recalls of 2022 have the same class?: 65% of the 325 drug events that started in 2022 are in Class II.