Injectable Papaverine/Phentolamine Recalled Due to Sterility Assurance Failure
Pharmacy Plus, Inc. is recalling 242 vials of papaverine/phentolamine injection because FDA inspection found the products were produced in conditions that cannot guarantee sterility. The affected lots were distributed to AL, LA, MS, and TN.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: This is an FDA Class II recall involving a high-risk injectable medication with documented sterility assurance failures, presenting a significant risk of microbial contamination and infection. No illnesses or injuries have been reported to date, limiting the score to 3 per the rubric criterion for 'risk-of-harm products where injury has not yet been reported.'
Plain-English summary
Pharmacy Plus, Inc. dba Vital Care Compounder is recalling 242 vials of Papaverine/Phentolamine Injection (150mg/5mg per 10 mL vial). The affected lots are: 55092 (BUD 10/22/2022), 59100 (BUD 10/30/2022), 62038 (BUD 04/08/2023), and 66533 (BUD 04/08/2023).
The recall was initiated after an FDA inspection found that these products were manufactured in a manner that cannot guarantee their sterility. Sterile injectable medications must be produced under strict conditions to prevent bacterial, fungal, or other microbial contamination.
The affected products were distributed to healthcare facilities and pharmacies in Alabama, Louisiana, Mississippi, and Tennessee.
Patients who have received this medication or healthcare providers who have doses of these lots should contact Pharmacy Plus, Inc. or consult their healthcare provider. Do not use any remaining product from the affected lots.
The recalled product
- Product
- PAPAVERINE / PHENTOLAMINE INJECTION 150MG / 5MG / VIAL SOLUTION, 10 mL vials, Rx only, Vital Care Compounder, 115 S. 40th Ave., Hattiesburg, MS 39402
- Manufacturer
- Pharmacy Plus, Inc. dba Vital Care Compounder
- Category
- Drug — Injectable Solution
- Hazard
- sterility-failure
- contamination
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 (7)
- Lots: 55092
- BUD: 10/22/2022
- 59100
- BUD: 10/30/2022
- 62038
- BUD: 04/08/2023
- 66533
Distribution
Distributed in 4 states:
- AL
- LA
- MS
- TN
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