FDA Recall of fentaNYL Citrate Injectable Solution by Wells Pharma

Source: FDA · United States

Areazine synthesizes this FDA recall directly from FDA's official public data feed. See our methodology for full source attribution and refresh cadence.

Wells Pharma of Houston LLC is voluntarily recalling 150 syringes of fentaNYL Citrate Injectable Solution due to cGMP deviations, affecting products distributed nationwide in the U.S.

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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What Happened

Wells Pharma of Houston LLC is recalling their fentaNYL Citrate Injectable Solution due to cGMP deviations, as announced in a voluntary firm-initiated recall.

Which Products Are Affected

The affected product is fentaNYL Citrate Injectable Solution in 0.9% Sodium Chloride, 1000 mcg/50mL (20 mcg per mL), manufactured by Wells Pharma of Houston, with NDC 73702-203-65. The recall involves 150 syringes from Lot 022326203650432, with an expiration date of 06/25/2026. This recall is for products distributed nationwide in the United States.

What You Should Do

Consumers should stop using the affected product immediately and contact Wells Pharma of Houston LLC for further instructions. For returns or refunds, reach out to the firm at their address: 9265 Kirby Dr, Houston, TX 77054-2520, as initially notified via letter.

Why This Matters

This recall highlights potential quality issues in pharmaceutical manufacturing that could affect drug safety and efficacy for users. It is classified as a Class II recall, indicating a situation where use may cause temporary or reversible health consequences.

Source

This information is from the FDA recall notice, recall number D-0506-2026. Attribution: FDA (U.S. Food and Drug Administration).

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 150 syringes of fentaNYL Citrate Injectable Solution due to cGMP deviations, affecting products distributed nationwide in the U.S.
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.