The Recall Desk
Agency classClass IIOur severity:ModerateFDA (Drugs)·D-0507-2026·Announced 2026-05-06

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.

The agency’s classification

FDA (Drugs): Class II

Class II is 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.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 2/5 (Moderate).

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
Affected units
4,975

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.

Part of a larger recall action

This product is one of 7 recalled by Wells Pharma of Houston LLC 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 7 products in this recall →

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