CLASS II ONGOING Drug recall · Reported 20 Jul 2022 · FDA Enforcement Report
Estradiol Cypionate 10mg/mL, a)-vial, b)-vial recalled
TMC Acquisition is recalling Estradiol Cypionate 10mg/mL, a)-vial, b)-vial, Room Temperature, Tailor Made Compounding, distributed nationwide in the US. The recall was initiated on 7 Mar 2022 and the FDA has classified it as Class II.
Check your package
Lot, batch or date codes Batch #: a) 01052210A1, Exp 4/5/2022; 10202101A1, Exp 4/18/2022; 01052210A1 7/4/2022; b)10202102A1, Exp 4/18/2022; 12022126A1, Exp 5/31/2022; 01052210A1, Exp 7/4/2022.
Quantity recalled 349 vials
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
Recall details
Recall number D-1201-2022
FDA event ID 89909
Classification Class II
Status Ongoing
Recall initiated 7 Mar 2022
FDA classified 14 Jul 2022
Reported 20 Jul 2022
Type Voluntary: Firm initiated
Customers notified by Letter
Timeline
7 Mar 2022 Recall initiated by company 14 Jul 2022 Classified by FDA +129 days 20 Jul 2022 Published in enforcement report +6 days
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Lack of Assurance of Sterility
A sterility recall means a product that must be sterile, such as an injection or eye drop, may be contaminated. Using a non-sterile product can cause serious infection.
Product as listed by the FDA
Estradiol Cypionate 10mg/mL, a) 1mL-vial, b) 2 mL-vial, Room Temperature, Tailor Made Compounding
Questions about this recall
Why was it recalled? Lack of Assurance of Sterility
Which lots are affected? Batch #: a) 01052210A1, Exp 4/5/2022; 10202101A1, Exp 4/18/2022; 01052210A1 7/4/2022; b)10202102A1, Exp 4/18/2022; 12022126A1, Exp 5/31/2022; 01052210A1, Exp 7/4/2022.
Where was it sold? Nationwide USA and Puerto Rico
What should I do if I have it? Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
What does Class II mean? Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
Other products in this recall event 51 other products · FDA event 89909 This product is part of a recall event; the main page for the event is GAC (Glutamine/Arginine/L-Carnitine) recalled by TMC Acquisition .
Reported Class Recall Company Reason Where 20 Jul 2022 CLASS II GAC (Glutamine/Arginine/L-Carnitine) recalled by TMC Acquisition TMC Acquisition Sterility Nationwide 20 Jul 2022 CLASS II Semaglutide/Cyanocobalamin 5mg/0.2mg/ml-vial, Refrigerate recalled TMC Acquisition Sterility Nationwide 20 Jul 2022 CLASS II Procaine HCL 2% (20mg/mL)-vial, Refrigerate, Tailor Made Compounding recalled TMC Acquisition Sterility Nationwide 20 Jul 2022 CLASS II Pentosan Polysulfate Sodium 250mg/mL-vial, Room Temperature recalled TMC Acquisition Sterility Nationwide 20 Jul 2022 CLASS II Alprostadil/Papaverine/Phentolamine 60mcg/30mg/3mg/mL-vial recalled TMC Acquisition Sterility Nationwide 20 Jul 2022 CLASS II Methionine/Inositol/Choline B12 + Carnitine recalled by TMC Acquisition TMC Acquisition Sterility Nationwide 20 Jul 2022 CLASS II Alpha Lipoic Acid 25mg/mL-vial, Refrigerate, Tailor Made Compounding recalled TMC Acquisition Sterility Nationwide 20 Jul 2022 CLASS II Inositol/Choline B12 + Carnitine recalled by TMC Acquisition TMC Acquisition Sterility Nationwide 20 Jul 2022 CLASS II Folic Acid 5mg/mL-vial, Refrigerate, Tailor Made Compounding recalled TMC Acquisition Sterility Nationwide 20 Jul 2022 CLASS II PT-141 10mg/mL a)-vial, b)-vial, Refrigerate recalled by TMC Acquisition TMC Acquisition Sterility Nationwide 20 Jul 2022 CLASS II Methylcobalamin 10mg/mL, a)-vial, b)-vial, c)-vial recalled TMC Acquisition Sterility Nationwide 20 Jul 2022 CLASS II Nandrolone Decanoate 200mg/mL, a)-vial, b)-vial recalled TMC Acquisition Sterility Nationwide 20 Jul 2022 CLASS II Gonadorelin 100mcg/mL per vial, Refrigerate, Tailor Made Compounding recalled TMC Acquisition Sterility Nationwide 20 Jul 2022 CLASS II Testosterone Cypionate (GSO) 200mg/ml a)-vial, b)-vial recalled TMC Acquisition Sterility Nationwide 20 Jul 2022 CLASS II Glutathione 200mg/mL Preservative Free, Injectable-vial recalled TMC Acquisition Sterility Nationwide 20 Jul 2022 CLASS II Vitamin D3 50,000IU/mL-vial, Room Temperature recalled TMC Acquisition Sterility Nationwide 20 Jul 2022 CLASS II Testosterone Enanthate (GSO) 100mg/ml-vial recalled by TMC Acquisition TMC Acquisition Sterility Nationwide 20 Jul 2022 CLASS II Levocarnitine 500mg/mL-vial, Refrigerate, Tailor Made Compounding recalled TMC Acquisition Sterility Nationwide 20 Jul 2022 CLASS II Dexpanthenol Preservative Free 250mg/mL-vial recalled by TMC Acquisition TMC Acquisition Sterility Nationwide 20 Jul 2022 CLASS II BCAAs (Leucine/Iso-Leucine/Valine) 10mg/10mg/5mg/mL-vial recalled TMC Acquisition Sterility Nationwide 20 Jul 2022 CLASS II Sermorelin 2000mcg/mL-vial, Refrigerate, Tailor Made Compounding recalled TMC Acquisition Sterility Nationwide 20 Jul 2022 CLASS II Methylcobalamin 1mg/mL, a)-vial, b)-vial, Room Temperature recalled TMC Acquisition Sterility Nationwide 20 Jul 2022 CLASS II Testosterone Cypionate/Propionate 180/20mg/ml, a)-vial recalled TMC Acquisition Sterility Nationwide 20 Jul 2022 CLASS II Glycyrrhizic Acid 8mg/mL-vial, Refrigerate, Tailor Made Compounding recalled TMC Acquisition Sterility Nationwide 20 Jul 2022 CLASS II NAD+ 200mg/mL-vial, Refrigerate, Tailor Made Compounding recalled TMC Acquisition Sterility Nationwide 20 Jul 2022 CLASS II Testosterone Enanthate (GSO) 200mg/ml, a)-vial, b)-vial recalled TMC Acquisition Sterility Nationwide 20 Jul 2022 CLASS II Anastrozole/Testosterone Cypionate/Propionate recalled TMC Acquisition Sterility Nationwide 20 Jul 2022 CLASS II Melanotan I 200mcg/mL (2mg/ml), a)-vial, b)-vial recalled TMC Acquisition Sterility Nationwide 20 Jul 2022 CLASS II Semaglutide/Cyanocobalamin 2mg/0.4mg/ml-vial, Refrigerate recalled TMC Acquisition Sterility Nationwide 20 Jul 2022 CLASS II Teriparatide 226mcg/ml Injectable recalled by TMC Acquisition TMC Acquisition Sterility Nationwide 20 Jul 2022 CLASS II Dexpanthenol 250mg/mL-vial, Room Temperature recalled by TMC Acquisition TMC Acquisition Sterility Nationwide 20 Jul 2022 CLASS II Testosterone Propionate 100mg/ml-vial, Room temperature recalled TMC Acquisition Sterility Nationwide 20 Jul 2022 CLASS II Ascorbic Acid 500mg/mL, a)-vial, b)-vial, Refrigerate recalled TMC Acquisition Sterility Nationwide 20 Jul 2022 CLASS II Calcium Chloride Preservative Free, 100mg/mL, a)-vial recalled TMC Acquisition Sterility Nationwide 20 Jul 2022 CLASS II GOAL (Glutamine/Ornithine/Arginine/Lysine recalled by TMC Acquisition TMC Acquisition Sterility Nationwide 20 Jul 2022 CLASS II Testosterone Cypionate/Enanthate/Propionate 80/80/40mg recalled TMC Acquisition Sterility Nationwide 20 Jul 2022 CLASS II Methylcobalamin Preservative Free, 10mg/mL-vial recalled TMC Acquisition Sterility Nationwide 20 Jul 2022 CLASS II Sermorelin/Glycine 2000mcg/5mg/mL-vial, Refrigerate recalled TMC Acquisition Sterility Nationwide 20 Jul 2022 CLASS II Glutathione 200mg/ml, a)-vial, b)-vial, Refrigerate recalled TMC Acquisition Sterility Nationwide 20 Jul 2022 CLASS II Vitamin B-Complex, a)-vial, b)-vial, Refrigerate recalled TMC Acquisition Sterility Nationwide 20 Jul 2022 CLASS II Methionine/Inositol/Choline B12 25mg/50mg/50mg/1mg/mL recalled TMC Acquisition Sterility Nationwide 20 Jul 2022 CLASS II Testosterone Cypionate (GSO) 100mg/ml a)-vial , b)-vial recalled TMC Acquisition Sterility Nationwide 20 Jul 2022 CLASS II Testosterone Cypionate/Anastrozole 200mg/0.5mg/mL-vial recalled TMC Acquisition Sterility Nationwide 20 Jul 2022 CLASS II Vitamin B-Complex Preservative Free-vial, Refrigerate recalled TMC Acquisition Sterility Nationwide 20 Jul 2022 CLASS II Testosterone Cypionate/Anastrozole 200mg/1mg/mL, a)-vial recalled TMC Acquisition Sterility Nationwide 20 Jul 2022 CLASS II Hydroxocobalamin 25mg/mL-vial, Room Temperature recalled TMC Acquisition Sterility Nationwide 20 Jul 2022 CLASS II Hydroxocobalamin Preservative Free 5mg/mL-vial, Refrigerate recalled TMC Acquisition Sterility Nationwide 20 Jul 2022 CLASS II Biotin 5mg/mL-vial, Refrigerate, Tailor Made Compounding recalled TMC Acquisition Sterility Nationwide 20 Jul 2022 CLASS II Sermorelin/Glycine 2000mcg/5mg/mL-vial, Refrigerate recalled TMC Acquisition Sterility Nationwide 20 Jul 2022 CLASS II Testosterone Cypionate/Enanthate 100/100mg/ml, a)-vial recalled TMC Acquisition Sterility Nationwide 20 Jul 2022 CLASS II Methylene Blue Hypotonic Solution, 10mg/mL, a)-vial recalled TMC Acquisition Sterility Nationwide
More recalls from TMC Acquisition All 52
Other Estradiol Cypionate recalls All 9