FDA Recall of Phenylephrine Hydrochloride Injectable Solution by Wells Pharma
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Wells Pharma of Houston LLC is voluntarily recalling 13,070 IV bags of Phenylephrine Hydrochloride 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 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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What Happened
Wells Pharma of Houston LLC is recalling Phenylephrine Hydrochloride Injectable Solution due to cGMP deviations, as initiated voluntarily on April 1, 2026.
Which Products Are Affected
The affected product is Phenylephrine Hydrochloride Injectable Solution, 40mg, 250mL Bag, with NDC 73702-122-03. A total of 13,070 IV bags are involved, distributed U.S. nationwide. The specific codes include: 120325122032719 (Exp Date 04/03/2026), 120425122032734 (Exp Date 04/04/2026), 120425122032735 (Exp Date 04/04/2026), 120925122032781 (Exp Date 04/10/2026), 010626122030010 (Exp Date 05/08/2026), 010626122030009 (Exp Date 05/08/2026), 010826122030031 (Exp Date 05/13/2026), 010826122030032 (Exp Date 05/13/2026), 011326122030072 (Exp Date 05/15/2026), 011326122030071 (Exp Date 05/15/2026), 011626122030107 (Exp Date 05/20/2026), 011626122030106 (Exp Date 05/20/2026), 011926122030118 (Exp Date 05/21/2026), 011926122030119 (Exp Date 05/21/2026), 012726122030171 (Exp Date 05/29/2026), 012726122030170 (Exp Date 05/29/2026), 012826122030181 (Exp Date 05/30/2026), 012826122030182 (Exp Date 05/30/2026), 020226122030201 (Exp Date 06/04/2026), 020326122030217 (Exp Date 06/05/2026), 020426122030235 (Exp Date 06/06/2026), 020426122030242 (Exp Date 06/06/2026), 020426122030241 (Exp Date 06/06/2026), 020626122030260 (Exp Date 06/09/2026), 020626122030256 (Exp Date 06/09/2026), 020926122030303 (Exp Date 06/11/2026), 021026122030308 (Exp Date 06/12/2026), 021126122030321 (Exp Date 06/13/2026), 021126122030316 (Exp Date 06/13/2026), 021226122030326 (Exp Date 06/16/2026), 021326122030341 (Exp Date 06/17/2026), 021726122030366 (Exp Date 06/19/2026), 021726122030369 (Exp Date 06/19/2026), 021826122030388 (Exp Date 06/20/2026), 022026122030421 (Exp Date 06/24/2026), 022026122030420 (Exp Date 06/24/2026), 022326122030435 (Exp Date 06/25/2026), 031026122030552 (Exp Date 07/10/2026), and 031026122030553 (Exp Date 07/10/2026).
What You Should Do
Consumers should check if they have the affected products and follow the initial firm notification, which was issued via letter, by contacting Wells Pharma of Houston LLC for further instructions on returns or refunds.
Why This Matters
This recall involves a Class II classification, indicating potential for temporary or reversible health consequences, and affects over 13,000 IV bags distributed nationwide, highlighting concerns in drug manufacturing standards.
Source
Attribution: FDA Recall Number D-0502-2026. For more information, visit the FDA website.
Original source: FDA Official Notice ↗
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