Recall of fentaNYL Citrate Injectable Solution by Wells Pharma
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 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, cpsc, Drugs.
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 ↗
Related FDA Recalls
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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 (1,067 characters here).
Similar severity timing
Same severity (medium) notices issued closest in time to May 13, 2026.
Frequently Asked Questions
Common questions about this FDA recall.