Gonadorelin Drug Vials Recalled Due to Sterility Assurance Failure
Tailor Made Compounding is recalling 294 vials of Gonadorelin 100mcg/mL distributed nationwide because the manufacturer cannot assure the product meets sterility standards.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: This is an FDA Class II recall for a sterility assurance failure on an injectable pharmaceutical product. No illnesses or injuries have been reported. The hazard represents a risk-of-harm product where injury has not yet been reported, meeting the criteria for High (3) severity.
Plain-English summary
Tailor Made Compounding is recalling 294 vials of Gonadorelin 100mcg/mL distributed nationwide, including Puerto Rico, because the manufacturer cannot provide sufficient assurance that the recalled vials meet required sterility standards.
The affected vials were distributed under the following batch numbers: 01062225B (Exp 4/6/2022), 01142207A1 (Exp 4/14/2022), 02012228A1 (Exp 5/2/2022), 02032203A1 (Exp 5/4/2022), 03012211A1 (Exp 5/30/2022), and 03082240A1 (Exp 6/6/2022). If you have received these vials, do not use them. Contact Tailor Made Compounding or your healthcare provider for further instructions.
The recalled product
- Product
- Gonadorelin 100mcg/mL, 10mL per vial, Refrigerate, Tailor Made Compounding
- Manufacturer
- TMC Acquisition LLC dba Tailor Made Compounding
- Category
- Drug — Compounded Injectable
- Affected units
- 294
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (12)
- Batch #: 01062225B
- Exp 4/6/2022
- 01142207A1
- Exp 4/14/2022
- 02012228A1
- Exp 5/2/2022
- 02032203A1
- Exp 5/4/2022
- 03012211A1
- Exp 5/30/2022
- 03082240A1
- Exp 6/6/2022.
Distribution
Part of a larger recall action
This product is one of 52 recalled by TMC Acquisition LLC dba Tailor Made Compounding under a single FDA (Drugs) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
See all 52 products in this recall →Related recalls
Same manufacturer · TMC Acquisition LLC dba Tailor Made Compounding
See all →- HighDexpanthenol Preservative Free Injectable Recalled Due to Sterility Assurance Failure
FDA (Drugs) · 2022-07-20
- HighHydroxocobalamin Compounded Injections Recalled for Lack of Sterility Assurance
FDA (Drugs) · 2022-07-20
- HighTailor Made Compounding Recalls Glycyrrhizic Acid Injectable for Lack of Sterility Assurance
FDA (Drugs) · 2022-07-20
- HighFDA Recalls Tailor Made Compounding GAC Injectable Vials for Lack of Sterility Assurance
FDA (Drugs) · 2022-07-20
- HighEstradiol Cypionate Injectable Recalled for Lack of Sterility Assurance
FDA (Drugs) · 2022-07-20
Same hazard · sterility failure
See all →- SevereROHTO DIGI-EYE Eye Drops Recalled Over Sterility Assurance Gap
FDA (Drugs) · 2026-07-29
- HighROHTO DRY-AID Eye Drops Recalled Due to Sterility Concerns
FDA (Drugs) · 2026-07-29
- SevereTransvenous Pacing Electrode Tray with Bipolar Balloon Pacing Electrode Recalled
FDA (Devices) · 2026-07-22
- SevereArterial Line Kit with Lidocaine HCL Injection Fails Sterility Testing
FDA (Devices) · 2026-07-22
- SevereOne-Piece Introducer Tray kits recalled for sterility failure
FDA (Devices) · 2026-07-22