Class IIOngoing

Phenylephrine Hydrochloride Injectable Solution recall

FDA recall D-0502-2026 · initiated Apr 1, 2026

By the pharmaranks editorial teamReviewed against the FDA (openFDA) sourcesUpdated May 6, 2026How we research

Wells Pharma of Houston LLC recalled Phenylephrine Hydrochloride Injectable Solution in Apr 2026 — an FDA Class II recall (D-0502-2026) because cGMP deviations.

May cause temporary or medically reversible harm; low probability of serious harm.

Why it was recalled

cGMP deviations.

The manufacturing process itself

The FDA found the process itself out of compliance, usually before any defective product was identified.

This is a manufacturing or quality failure, not a finding that the medicine is unsafe to take — across every recall we hold, none was issued for that reason. It does not mean the batch was harmless.

Is your product affected? Check the lot number

A recall covers only specific lots. Find the lot number and expiration date on your package and compare them to the affected codes below — if yours is not listed, it was not part of this recall.

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, 031026122030553, Exp Date 07/10/2026

Quantity recalled: 13,070 IV Bags

Details

Product: Phenylephrine Hydrochloride Injectable Solution, 40mg, 250*mL Bag, wells pharma of Houston, NDC 73702-122-03
Recalling company: Wells Pharma of Houston LLC
Classification: Class II
Status: Ongoing
Type: Voluntary: Firm initiated
Distribution: U.S. Nationwide.
Initiated: Apr 1, 2026
FDA report date: May 6, 2026

What to do.If you have a recalled product, don't throw away questions — check the FDA notice for the affected lot numbers and expiration dates, and ask your pharmacist or doctor before stopping a prescribed medicine. This page reproduces public FDA data and is not medical advice.

Frequently asked

Was Phenylephrine Hydrochloride Injectable Solution recalled?: Wells Pharma of Houston LLC recalled Phenylephrine Hydrochloride Injectable Solution in Apr 2026 — an FDA Class II recall (D-0502-2026) because cGMP deviations. May cause temporary or medically reversible harm; low probability of serious harm.
Why was Phenylephrine Hydrochloride Injectable Solution recalled?: Per the FDA enforcement record, the reason for recall D-0502-2026 was: cGMP deviations.
Is a recalled Phenylephrine Hydrochloride Injectable Solution dangerous to take?: An FDA recall removes specific lots from the market for a defined reason and does not by itself mean the medicine is unsafe for everyone — your specific lot may never have been affected. May cause temporary or medically reversible harm; low probability of serious harm. Check the FDA notice for the affected lot numbers and expiration dates, and ask your pharmacist or doctor before stopping a prescribed medicine. This reproduces public FDA data and is not medical advice.
Which lots of Phenylephrine Hydrochloride Injectable Solution are affected?: Distributed: U.S. Nationwide.. The recall covers these lots — 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,…. Check the lot number and expiration date on your package against this list; if yours is not listed, it was not part of recall D-0502-2026.

Source: openFDA Drug Enforcement record D-0502-2026 ↗

← All drug recalls