Baclofen Injectable Recalled Due to Sterility Concerns
The Compounding Shop is recalling Baclofen 1,000 mcg/mL Injectable vials due to FDA inspection findings regarding quality control and sterility assurance.
What this means for you
Illness, injury, or structural failure has been reported. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The agency classification is FDA Class II, and the hazard involves a lack of assurance of sterility in an injectable drug, which poses a significant risk of serious injury or infection.
Plain-English summary
The Compounding Shop, Inc. is recalling Baclofen 1,000 mcg/mL Injectable, 20 mL and 40 mL vials. The recall was initiated following FDA inspection findings that raised concerns regarding the quality control processes used to ensure the sterility of the product.
The affected product was distributed in Florida, California, Minnesota, and Maine. All lots of the product are included in this recall.
Consumers who have this product should stop using it and contact their healthcare provider or pharmacist for further instructions.
The recalled product
- Product
- Baclofen 1,000 mcg/mL Injectable, 20 mL and 40 mL vial, Compounded by The Compounding Shop, St. Petersburg, FL
- Manufacturer
- THE COMPOUNDING SHOP, INC.
- Category
- Drug — Injectable
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 (1)
- All Lots
Distribution
Part of a larger recall action
This product is one of 25 recalled by THE COMPOUNDING SHOP, INC. 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 25 products in this recall →Related recalls
Same manufacturer · THE COMPOUNDING SHOP, INC.
See all →- SevereMitomycin Injectable Recalled Due to Sterility Assurance Concerns
FDA (Drugs) · 2013-06-12
- SevereFDA Recalls Glutathione Injectable Due to Sterility Concerns
FDA (Drugs) · 2013-06-12
- SevereTestosterone Cypionate Injectable Recalled Due to Sterility Concerns
FDA (Drugs) · 2013-06-12
- SevereCompounded Injectable MIC Plus B12 Recalled Due to Sterility Concerns
FDA (Drugs) · 2013-06-12
- SevereFDA Recalls Hydroxyprogesterone Injectable Due to Sterility Concerns
FDA (Drugs) · 2013-06-12
Same hazard · sterility
See all →- SevereRegeneron Recalls Libtayo Injection Due to Sterility Assurance Concerns
FDA (Drugs) · 2026-08-26
- SeverePrestige Recalls Clear Eyes Maximum Itchy Eye Relief Due to Sterility Concerns
FDA (Drugs) · 2026-08-19
- SevereROHTO Cooling Eye Drops Recalled Over Sterility Assurance Concerns
FDA (Drugs) · 2026-07-29
- HighROHTO Cooling Eye Drops Recalled Over Sterility Assurance Concerns
FDA (Drugs) · 2026-07-29
- SevereFDA Recalls ROHTO OPTIC GLOW Eye Drops Over Sterility Concerns
FDA (Drugs) · 2026-07-29