Wise Pharmacy Recalls Papaverine/Phentolamine Injectable Due to Processing Controls
Wise Pharmacy is recalling 8 vials of Papaverine/Phentolamine Injectable due to lack of processing controls. The product was distributed in Colorado, Texas, and Wyoming.
What this means for you
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II due to a lack of processing controls, which fits the rubric for moderate severity involving potential but not confirmed serious harm or voluntary precautionary measures.
Plain-English summary
Wise Pharmacy, located in Littleton, Colorado, is recalling 8 vials of Papaverine/Phentolamine 30 mg/1 mg/mL Injectable. The recall is being conducted due to a lack of processing controls. The affected product is a prescription-only compounded medication available in 2.5 mL vials.
The recalled product includes two specific lots: Lot #5978N with an expiration date of 8/20/2019, and Lot #7266N with an expiration date of 11/5/2019. The product was distributed to locations in Colorado, Texas, and Wyoming.
Consumers and healthcare providers who have this product should stop using it and contact their pharmacist or Wise Pharmacy for further instructions. The FDA has classified this recall as Class II, indicating that use of, or exposure to, the violative product may cause temporary or medically reversible adverse health consequences.
The recalled product
- Product
- Papaverine/Phentolamine 30 mg/1 mg/mL Injectable, 2.5 mL Vial, Rx only, Compounded by Wise Pharmacy, Littleton, CO 80123.
- Manufacturer
- Wise Pharmacy
- Category
- Drug — Compounded Injectable
- Hazard
- Affected units
- 8
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (4)
- Lot #: 5978N
- Exp 8/20/2019
- 7266N
- Exp 11/5/2019
Distribution
Part of a larger recall action
This product is one of 11 recalled by Wise Pharmacy under a single FDA (Drugs) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
See all 11 products in this recall →Related recalls
Same manufacturer · Wise Pharmacy
See all →- ModerateWise Pharmacy Recalls Dexamethasone Sodium Phosphate Injection Due to Processing Controls
FDA (Drugs) · 2019-08-07
- SevereWise Pharmacy Recalls Compounded Papaverine Injectable Due to Processing Controls
FDA (Drugs) · 2019-08-07
- SevereWise Pharmacy Recalls Acetylcysteine Otic Drops Due to Processing Controls
FDA (Drugs) · 2019-08-07
- ModerateWise Pharmacy Recalls Gentamicin Irrigation Solution Due to Processing Controls
FDA (Drugs) · 2019-08-07
- ModerateWise Pharmacy Recalls Papaverine, Phentolamine, and Alprostadil Injectable Vials
FDA (Drugs) · 2019-08-07
Same hazard · processing controls
See all →- HighCompounded tirzepatide 8.8 mg vials recalled over lack of processing controls
FDA (Drugs) · 2025-08-13
- HighCompounded tirzepatide 11.24 mg vials recalled over lack of processing controls
FDA (Drugs) · 2025-08-13
- HighCompounded semaglutide 0.22 mg vials recalled over lack of processing controls
FDA (Drugs) · 2025-08-13
- HighCompounded semaglutide 0.44 mg vials recalled over lack of processing controls
FDA (Drugs) · 2025-08-13
- HighCompounded tirzepatide 4.4 mg vials recalled over lack of processing controls
FDA (Drugs) · 2025-08-13