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Recall data is sourced from official U.S. government agencies (CPSC, FDA, NHTSA, USDA) and processed using AI to improve readability. This site is not affiliated with or endorsed by any government agency. Always refer to the original agency notice for authoritative information.

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Medium RiskFDA Drug
Medications & Supplements/Prescription Drugs

Wells Pharma Injectable Solutions Recalled for Quality Standard Deviations

Agency Publication Date: April 28, 2026
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Summary

Wells Pharma of Houston LLC has recalled approximately 25,265 units of several injectable drug products, including Phenylephrine, Fentanyl Citrate, and Ketamine Hydrochloride. The recall was initiated due to deviations from Current Good Manufacturing Practice (cGMP) quality standards, which may affect the safety and effectiveness of the sterile solutions. These products were distributed nationwide to hospitals, infusion centers, and wholesalers between April 2026 and June 2026.

Risk

Sterile injectable solutions manufactured under substandard conditions may pose a risk of infection or unpredictable drug performance. While no injuries have been reported to date, these quality deviations mean the products may not meet safety and purity requirements.

What You Should Do

  1. Identify if you have the recalled injectable solutions by checking the product names, NDC numbers, lot numbers, and expiration dates on the packaging.
  2. Specific products include Phenylephrine Hydrochloride (NDC 73702-122-03), Fentanyl Citrate (NDCs 73702-202-02, 73702-202-03, 73702-204-25, 73702-203-65, 73702-202-15), and Ketamine Hydrochloride (NDC 73702-302-31). See the Affected Products section below for the full list of affected codes.
  3. Stop using the recalled product. Contact the manufacturer or your distributor to arrange return.
  4. Call the FDA Consumer Complaint hotline at 1-888-723-3332 (1-888-SAFEFDA) for additional questions.

Your Remedy Options

๐Ÿ“‹Other Action
How to: Stop using the recalled product. Contact the manufacturer or your distributor to arrange return.

Affected Products

Product: Phenylephrine Hydrochloride Injectable Solution, 40mg (250 mL Bag)
Variants: 40mg, 250 mL Bag
Lot Numbers:
120325122032719 (Exp 04/03/2026)
120425122032734 (Exp 04/04/2026)
120425122032735 (Exp 04/04/2026)
120925122032781 (Exp 04/10/2026)
010626122030010 (Exp 05/08/2026)
010626122030009 (Exp 05/08/2026)
010826122030031 (Exp 05/13/2026)
010826122030032 (Exp 05/13/2026)
011326122030072 (Exp 05/15/2026)
011326122030071 (Exp 05/15/2026)
011626122030107 (Exp 05/20/2026)
011626122030106 (Exp 05/20/2026)
011926122030118 (Exp 05/21/2026)
011926122030119 (Exp 05/21/2026)
012726122030171 (Exp 05/29/2026)
012726122030170 (Exp 05/29/2026)
012826122030181 (Exp 05/30/2026)
012826122030182 (Exp 05/30/2026)
020226122030201 (Exp 06/04/2026)
020326122030217 (Exp 06/05/2026)
020426122030235 (Exp 06/06/2026)
020426122030242 (Exp 06/06/2026)
020426122030241 (Exp 06/06/2026)
020626122030260 (Exp 06/09/2026)
020626122030256 (Exp 06/09/2026)
020926122030303 (Exp 06/11/2026)
021026122030308 (Exp 06/12/2026)
021126122030321 (Exp 06/13/2026)
021126122030316 (Exp 06/13/2026)
021226122030326 (Exp 06/16/2026)
021326122030341 (Exp 06/17/2026)
021726122030366 (Exp 06/19/2026)
021726122030369 (Exp 06/19/2026)
021826122030388 (Exp 06/20/2026)
022026122030421 (Exp 06/24/2026)
022026122030420 (Exp 06/24/2026)
022326122030435 (Exp 06/25/2026)
031026122030552 (Exp 07/10/2026)
031026122030553 (Exp 07/10/2026)
NDC:
73702-122-03

Quantity Distributed: 13,070 IV Bags

Product: Fentanyl Citrate Injectable Solution, Narcotic, CII, 1000 mcg/100 mL (100 mL bag)
Variants: 1000 mcg/100 mL, 10 mcg per mL, 100 mL bag
Lot Numbers:
120925202022769 (Exp 04/09/2026)
123125202022883 (Exp 05/05/2026)
123125202022884 (Exp 05/05/2026)
011226202020057 (Exp 05/14/2026)
011226202020058 (Exp 05/14/2026)
011626202020110 (Exp 05/20/2026)
012726202020156 (Exp 05/28/2026)
012726202020161 (Exp 05/28/2026)
020226202020195 (Exp 06/04/2026)
021826202020386 (Exp 06/20/2026)
022026202020417 (Exp 06/24/2026)
022026202020424 (Exp 06/24/2026)
NDC:
73702-202-02

Quantity Distributed: 4,030 IV Bags

Product: Fentanyl Citrate Injectable Solution in 0.9% Sodium Chloride, Narcotic, (2500 mcg/ 250 mL) (250 mL bag)
Variants: 2500 mcg/ 250 mL, 10 mcg per mL, 250 mL bag
Lot Numbers:
120125202032701 (Exp 04/01/2026)
122625202032857 (Exp 04/25/2026)
122625202032862 (Exp 04/28/2026)
122625202032863 (Exp 04/28/2026)
122625202032864 (Exp 04/28/2026)
122625202032865 (Exp 04/28/2026)
011226202030062 (Exp 05/14/2026)
011326202030776 (Exp 05/15/2026)
011326202030077 (Exp 05/15/2026)
011626202030111 (Exp 05/20/2026)
011926202030122 (Exp 05/21/2026)
011926202030123 (Exp 05/21/2026)
012726202030159 (Exp 05/28/2026)
020226202030200 (Exp 06/04/2026)
020326202030216 (Exp 06/05/2026)
020426202030234 (Exp 06/06/2026)
02182202030398 (Exp 06/20/2026)
NDC:
73702-202-03

Quantity Distributed: 2,940 IV Bags

Product: Fentanyl Citrate Injectable Solution, Narcotic, CII, 1250 mcg/25mL (25 mL)
Variants: 1250 mcg/25mL, 50 mcg per mL, 25 mL
Lot Numbers:
011226204250063 (Exp 05/14/2026)
NDC:
73702-204-25

Quantity Distributed: 50 syringes

Product: Fentanyl Citrate Injectable Solution in 0.9% Sodium Chloride, 1000 mcg/50mL
Variants: 1000 mcg/50mL, 20 mcg per mL
Lot Numbers:
022326203650432 (Exp 06/25/2026)
NDC:
73702-203-65

Quantity Distributed: 150 syringes

Product: Ketamine Hydrochloride Injectable Solution, 50mg/ml
Variants: 50mg/ml, 50 mg per mL, 1 mL
Lot Numbers:
120925302312764 (Exp 04/09/2026)
123125302312879 (Exp 05/05/2026)
123125302312880 (Exp 05/05/2026)
010226302310003 (Exp 05/06/2026)
010626302310007 (Exp 05/08/2026)
010626302310008 (Exp 05/08/2026)
020426302310243 (Exp 06/06/2026)
NDC:
73702-302-31

Quantity Distributed: 4,975 syringes

Product: Fentanyl Citrate Injectable Solution in 0.9% Sodium Chloride, 50 mcg/5mL
Variants: 50 mcg/5mL, 10 mcg per mL
Lot Numbers:
020226202150202 (Exp 05/05/2026)
NDC:
73702-202-15

Quantity Distributed: 50 syringes

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 98694
Status: Active
Manufacturer: Wells Pharma of Houston LLC
Sold By: Hospitals; Infusion centers; Wholesalers
Manufactured In: United States
Units Affected: 25,265
Distributed To: Nationwide

Were You Affected by This Recall?

If you or a family member were harmed by this recalled product, you may have legal rights. Consider consulting a consumer protection attorney to understand your options for compensation.

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AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.

Sources: FDA iRES ยท Raw API Response

openFDA Disclaimer: This recall information is sourced from the openFDA API. Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Refer to the openFDA terms of service for more information.