CLASS II ONGOING Drug recall · Reported 6 May 2026 · FDA Enforcement Report
Phenylephrine Hydrochloride Injectable Solution, 40mg recalled
Wells Pharma of Houston is recalling Phenylephrine Hydrochloride Injectable Solution, 40mg, 250*mL, wells pharma of Houston, distributed nationwide in the US. The recall was initiated on 1 Apr 2026 and the FDA has classified it as Class II.
Check your package
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
Recall details
- Recall number
- D-0502-2026
- FDA event ID
- 98694
- Recalling firm
- Wells Pharma of Houston, Houston, TX
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 1 Apr 2026
- FDA classified
- 28 Apr 2026
- Reported
- 6 May 2026
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Manufacturing (CGMP) Deviations
- Drug class
- Cold & Cough Medicine
Timeline
| 1 Apr 2026 | Recall initiated by company | |
| 28 Apr 2026 | Classified by FDA | +27 days |
| 6 May 2026 | Published in enforcement report | +8 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
cGMP deviations.
Product as listed by the FDA
Phenylephrine Hydrochloride Injectable Solution, 40mg, 250*mL Bag, wells pharma of Houston, NDC 73702-122-03
Where it was distributed
U.S. Nationwide.
Questions about this recall
Is Phenylephrine Hydrochloride Injectable Solution, 40mg, 250*mL, wells pharma of Houston recalled?
Yes. Wells Pharma of Houston recalled Phenylephrine Hydrochloride Injectable Solution, 40mg, 250*mL, wells pharma of Houston on 1 Apr 2026. The recall is Class II and its status is Ongoing. Recall number D-0502-2026.
Why was it recalled?
cGMP deviations.
Which lots are affected?
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
Where was it sold?
U.S. Nationwide.
What should I do if I have it?
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.