Recall of Ketamine Hydrochloride Injectable Solution by Wells Pharma

Source: FDA · United States

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Wells Pharma of Houston LLC is voluntarily recalling 4975 syringes of Ketamine Hydrochloride Injectable Solution due to cGMP deviations, affecting products distributed nationwide.

What this FDA recall tells you, and what most readers miss

This notice was issued by FDA on May 12, 2026 and geographically references United States. Its severity classification of "medium" signals how the issuing agency weighs the risk of harm if no action is taken - "critical" and "high" tier alerts typically carry direct consumer actions, while "medium" and "low" tend toward informational guidance or monitoring advisories. The category it belongs to - FDA Recalls - determines the consumer-protection framework behind it, which shapes what remedies (refunds, replacements, repairs, or the recall itself) are available to affected consumers and which agency holds statutory responsibility for enforcement.

Most readers skim a notice like this, check whether they are personally affected, and move on. The more useful lens is to read it as a data point about the issuing system: how quickly FDA detected the hazard, how precise the geographic or product-identifier scope is, and whether similar notices have clustered in the same category or region in the last 90 days. Cluster patterns frequently precede a broader regulatory action, a single localized FDA recall is isolated; three of them within a quarter often indicate a supply-chain, infrastructure, or seasonal driver that will keep producing notices until something structural changes.

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Recall of Ketamine Hydrochloride Injectable Solution

What Happened

Wells Pharma of Houston LLC is recalling Ketamine Hydrochloride Injectable Solution due to cGMP deviations, as part of a voluntary firm-initiated action.

Which Products Are Affected

The affected product is Ketamine Hydrochloride Injectable Solution, 50mg/ml (50 mg per mL), in 1 mL volume, with NDC 73702-302-31. A total of 4975 syringes are involved, distributed U.S. Nationwide. Specific codes include: 120925302312764 with expiration date 04/09/2026, 123125302312879 with expiration date 05/05/2026, 123125302312880 with expiration date 05/05/2026, 010226302310003 with expiration date 05/06/2026, 010626302310007 with expiration date 05/08/2026, 010626302310008 with expiration date 05/08/2026, and 020426302310243 with expiration date 06/06/2026. The recall number is D-0507-2026.

What You Should Do

The firm has initiated the recall via letter notification. Consumers who have the affected product should contact Wells Pharma of Houston LLC for further instructions regarding returns or refunds.

Why This Matters

This recall involves nearly 5000 syringes of a pharmaceutical drug distributed across the United States, underscoring potential manufacturing issues that could affect product safety and quality.

Source

FDA recall notice, recall number D-0507-2026.

Original source: FDA Official Notice ↗

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Frequently Asked Questions

Common questions about this FDA recall.

What is this FDA recall about?
Wells Pharma of Houston LLC is voluntarily recalling 4975 syringes of Ketamine Hydrochloride Injectable Solution due to cGMP deviations, affecting products distributed nationwide.
Which agency issued this alert?
This alert was issued by FDA. The original notice is available at the source link at the bottom of this article.
How severe is this alert?
This alert is classified as "medium" severity. Stay informed and follow agency guidance.
What area is affected?
This alert affects United States. Check with FDA for the most current geographic scope.
Where can I find more FDA Recalls updates?
Browse the full FDA Recalls feed on Areazine at areazine.com/recalls/fda/ for the latest updates from FDA and other agencies.