Ketamine Hydrochloride Injectable Solution Recalled for cGMP Deviations
Wells Pharma of Houston LLC is recalling 4,975 syringes of Ketamine Hydrochloride Injectable Solution (50 mg/mL) distributed nationwide due to current Good Manufacturing Practice (cGMP) deviations.
What this means for you
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: This is an FDA Class II recall for cGMP deviations without any reported illnesses or injuries. The hazard is manufacturing-process related rather than an acute safety threat, and there is no indication of harm. cGMP violations constitute a precautionary recall category.
Plain-English summary
Wells Pharma of Houston LLC is recalling Ketamine Hydrochloride Injectable Solution, 50 mg per mL in 1 mL syringes (NDC 73702-302-31), due to current Good Manufacturing Practice (cGMP) deviations. The affected product consists of 4,975 syringes that were distributed nationwide across the United States.
Specific lot/serial numbers and expiration dates subject to recall include: 120925302312764 (Exp. 04/09/2026), 123125302312879 (Exp. 05/05/2026), 123125302312880 (Exp. 05/05/2026), 010226302310003 (Exp. 05/06/2026), 010626302310007 (Exp. 05/08/2026), 010626302310008 (Exp. 05/08/2026), and 020426302310243 (Exp. 06/06/2026).
This is a voluntary recall initiated by the manufacturer. Healthcare providers and facilities that have received this product should stop distribution and contact their supplier or Wells Pharma of Houston LLC for instructions on how to handle the affected syringes.
The recalled product
- Product
- Ketamine Hydrochloride Injectable Solution, 50mg/ml, (50 mg per mL) Volume: 1 mL, 5265 Kitty Drive, Houston, TX 77054, NDC 73702-302-31.
- Manufacturer
- Wells Pharma of Houston LLC
- Category
- Drug — Injectable / Anesthetic
- Hazard
- cgmp-deviation
- manufacturing-defect
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 (13)
- 120925302312764
- Exp Date 04/09/2026
- 123125302312879 Exp Date
- 05/05/2026
- 123125302312880
- Exp Date 05/05/2026
- 010226302310003
- Exp Date 05/06/2026
- 010626302310007
- Exp Date 05/08/2026
- 010626302310008
- Exp Date 05/08/2026 020426302310243
- Exp Date 06/06/2026.
Distribution
Distributed nationwide across the United States.