Recall of Ketamine Hydrochloride Injectable Solution by Wells Pharma
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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 verify its scope, source, and timestamp, then compare related notices without assuming that one record proves a broader trend.
Areazine pairs this record with the original agency URL so you can check the primary source before acting. Its related labels are recall, product-safety, fda, Drugs.
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 ↗
Related FDA Recalls
All FDA Recalls →Nationwide notices with similar length or severity timing 8
Two Areazine-derived peer sets for this FDA recall: nearest notices by body length and by same severity near the same agency date. Peers come from other categories so they are not the same-feed Related list above.
Similar body length
Nearest notices by article body length (1,355 characters here).
Similar severity timing
Same severity (medium) notices issued closest in time to May 12, 2026.
Frequently Asked Questions
Common questions about this FDA recall.