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 50 syringes of fentaNYL Citrate Injectable Solution due to cGMP deviations, affecting products distributed nationwide in the United States.

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

This notice was issued by FDA on May 13, 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 fentaNYL Citrate Injectable Solution

What Happened

Wells Pharma of Houston LLC is voluntarily recalling fentaNYL Citrate Injectable Solution due to cGMP deviations.

Which Products Are Affected

The affected product is fentaNYL Citrate Injectable Solution in 0.9% Sodium Chloride, 50 mcg/5mL (10 mcg per mL), wells pharma, NDC 73702-202-15. This recall involves 50 syringes with Lot 020226202150202 and expiration date of 05/05/2026. The recall number is D-0508-2026, and it was initiated on 20260401 with distribution across the U.S. nationwide.

What You Should Do

Consumers should follow the initial firm notification, which was a letter, and contact Wells Pharma of Houston LLC at their address: 9265 Kirby Dr, Houston, TX 77054-2520 for information on returns or refunds.

Why This Matters

This recall highlights potential issues in pharmaceutical manufacturing that could impact product safety. It is classified as a Class II recall by the FDA, indicating a moderate risk to health.

Source

Attribution: FDA Recall Number D-0508-2026.

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 50 syringes of fentaNYL Citrate Injectable Solution due to cGMP deviations, affecting products distributed nationwide in the United States.
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.