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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

Wise Pharmacy: Various Compounded Injectable and Topical Drugs Recalled for Processing Issues

Agency Publication Date: July 31, 2019
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Summary

Wise Pharmacy is recalling approximately 313 units of various compounded medications, including injectable vials, ear drops, and irrigation solutions, due to a lack of processing controls during manufacturing. This recall affects various prescription medications such as Acetylcysteine otic drops, Alprostadil, Dexamethasone, Gentamicin, Tobramycin, and several Papaverine/Phentolamine/Alprostadil combinations. These products were distributed in Colorado, Texas, and Wyoming and may not meet safety or sterility standards. Consumers should check their medicine cabinets for these specific compounded products and consult their doctor or pharmacist immediately.

Risk

A lack of processing controls means the pharmacy cannot guarantee the sterility or proper strength of these medications. Using medications that have not been manufactured under strict controls poses a risk of infection or receiving an incorrect dose, which is especially dangerous for injectable drugs and those used in sensitive areas like the eyes, ears, or for internal irrigation.

What You Should Do

  1. Identify if you have any of the affected products by checking for these specific lot numbers and expiration dates: Acetylcysteine 2% Otic Drop (Lot 7131N, Exp 7/11/19), Alprostadil 100 mcg/mL Injectable (Lot 6981N, Exp 10/17/2019), Dexamethasone Sodium Phosphate (Lots 5506N, Exp 9/21/2019; 7180N, Exp 12/29/2019), Gentamicin Irrigation (Lot 7179N, Exp 7/16/2019), Tobramycin Irrigation (Lot 7270N, Exp 7/22/2019), and various Papaverine/Phentolamine/Alprostadil injectable combinations (Lots 5978N, 7266N, 6054N, 4796N, 7049N, 5333N, 7000N, 5620N, 6221N, 6952N, 6176N, 7162N, 6153N).
  2. Stop using any affected medications immediately to prevent potential health risks.
  3. Contact your healthcare provider or pharmacist for guidance regarding your treatment and to find a suitable replacement for the recalled medication.
  4. Return any unused product to Wise Pharmacy or your place of purchase for a refund and contact Wise Pharmacy for further instructions regarding the disposal or return of the medication.
  5. For additional questions or to report a problem, contact the FDA Consumer Complaint hotline at 1-888-723-3332 (1-888-SAFEFDA) or visit www.fda.gov/safety/recalls.

Your Remedy Options

๐Ÿ’ฐFull Refund

Contact healthcare provider and return product for refund.

How to: Contact your healthcare provider or pharmacist for guidance. Return any unused product to the pharmacy for a refund

Affected Products

Product: Acetylcysteine 2% Otic Drop (15 mL bottle)
Model:
D-1567-2019
Lot Numbers:
7131N (Exp 7/11/19)
Date Ranges: 7/11/19
Product: Alprostadil 100 mcg/mL Injectable (2.5 mL vial)
Model:
D-1568-2019
Lot Numbers:
6981N (Exp 10/17/2019)
Date Ranges: 10/17/2019
Product: Dexamethasone Sodium Phosphate PF 24 mg/mL Injection (1 mL vial)
Model:
D-1569-2019
Lot Numbers:
5506N (Exp 9/21/2019)
7180N (Exp 12/29/2019)
Date Ranges: 9/21/2019, 12/29/2019
Product: Gentamicin (GU) Irrigation 240 mg/500 mL Solution (250 mL Container)
Model:
D-1570-2019
Lot Numbers:
7179N (Exp 7/16/2019)
Date Ranges: 7/16/2019
Product: Tobramycin Irrigation 80 mg/1000 mL Solution (1000 mL Container)
Model:
D-1571-2019
Lot Numbers:
7270N (Exp 7/22/2019)
Date Ranges: 7/22/2019
Product: Papaverine/Phentolamine 30 mg/1 mg/mL Injectable (2.5 mL Vial)
Model:
D-1572-2019
Lot Numbers:
5978N (Exp 8/20/2019)
7266N (Exp 11/5/2019)
Date Ranges: 8/20/2019, 11/5/2019
Product: Papaverine/Phentolamine/Alprostadil 30 mg/0.2 mg/10 mcg/mL Injectable (2.5 mL Vial)
Model:
D-1573-2019
Lot Numbers:
6054N
4796N (Exp 7/16/2019)
7049N (Exp 11/24/2019)
Date Ranges: 7/16/2019, 11/24/2019
Product: Papaverine/Phentolamine/Alprostadil - 30 mg/1 mg/10 mcg/mL Injectable (2.5 mL Vial)
Model:
D-1574-2019
Lot Numbers:
5333N (Exp 7/12/2019)
7000N (Exp 10/18/2019)
Date Ranges: 7/12/2019, 10/18/2019
Product: Papaverine/Phentolamine/Alprostadil 30 mg/2 mg/30 mcg/mL Injectable (2.5 mL Vial)
Model:
D-1575-2019
Lot Numbers:
5620N (Exp 7/16/2019)
6221N (Exp 8/31/2019)
6952N (Exp 10/16/2019)
Date Ranges: 7/16/2019, 8/31/2019, 10/16/2019
Product: Papaverine/Phentolamine/Alprostadil 30 mg/2 mg/50 mcg/mL Injectable (2.5 mL Vial)
Model:
D-1576-2019
Lot Numbers:
6176N (Exp 8/30/2019)
7162N (Exp 10/20/2019)
Date Ranges: 8/30/2019, 10/20/2019
Product: Papaverine/Phentolamine/Alprostadil/Atropine 30 mg/2 mg/50 mcg/0.15 mg/mL Injectable (2.5 mL Vial)
Model:
D-1577-2019
Lot Numbers:
6153N (Exp 8/29/2019)
Date Ranges: 8/29/2019

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 83397
Status: Resolved
Manufacturer: Wise Pharmacy
Sold By: Wise Pharmacy
Manufactured In: United States
Units Affected: 11 products (1 bottle; 4 vials; 27 vials; 1 container; 1 container; 8 vials; 84 vials; 44 vials; 97 vials; 32 vials; 14 vials)
Distributed To: Colorado, Texas, Wyoming

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.

Find an Attorney

This is general information, not legal advice. Go Backs is not a law firm and does not provide legal services.

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.