Papaverine recalls
The FDA has published 64 recalls involving Papaverine since 2012. The latest was reported on 26 Aug 2026. Most were for sterility. Pharmacy Plus has the most recalls in this group. Recalls usually affect specific lots, not every bottle on the market. Check the lot number on each recall page before acting.
Total recalls 64 since 2012
Last 12 months 1 reported
Class I 1 2% of total
Ongoing 9 latest 26 Aug 2026
Recalls per month, last 24 months click a bar for that month Severity split
1 2%62 97%1 2%
Why papaverine is recalled
Ongoing papaverine recalls 9 active
All papaverine recalls, newest first 64 total Reported Class Recall Company Reason Where 26 Aug 2026 Drug CLASS I Papaverine HCl Injection, USP, 60 mg/ (30 mg/mL) recalled Papaverine Hydrochloride American Regent Particulate Matter Nationwide 1 Feb 2023 Drug CLASS II Papaverine/phentolamine 30mg/0.5mg/ML Vial) Injectable recalled Pharmacy Innovations Sterility Nationwide 9 Nov 2022 Drug CLASS II Papaverine / Phentolamine / Prostaglandin Inj recalled by Pharmacy Plus Pharmacy Plus Sterility 4 states 9 Nov 2022 Drug CLASS II Papaverine / Phentolamine / Prostaglandin 150MG / 2.5MG recalled Pharmacy Plus Sterility 4 states 9 Nov 2022 Drug CLASS II Papaverine/Phentolamine/Prostaglandin Inj 150/5/50MCG recalled Pharmacy Plus Sterility 4 states 9 Nov 2022 Drug CLASS II Papaverine / Phentolamine / Prostaglandin Inj recalled by Pharmacy Plus Pharmacy Plus Sterility 4 states 9 Nov 2022 Drug CLASS II Papaverine/Phentolamine/Prostaglandin Inj recalled by Pharmacy Plus Pharmacy Plus Sterility 4 states 9 Nov 2022 Drug CLASS II Papaverine / Phentolamine Injection 150MG / 5MG / Vial recalled Pharmacy Plus Sterility 4 states 9 Nov 2022 Drug CLASS II Papaverine / Phentolamine / Prostaglandin Inj recalled by Pharmacy Plus Pharmacy Plus Sterility 4 states 13 Apr 2022 Drug CLASS II Papaverine Hydrochloride Injection, USP, 60 mg/ (30 mg/mL) recalled Papaverine Hydrochloride Vitae Enim Vitae Scientific Sterility Nationwide 7 Aug 2019 Drug CLASS II Papaverine/Phentolamine 30 mg/1 mg/mL Injectable Vial recalled Wise Pharmacy Other CO, TX, WY 7 Aug 2019 Drug CLASS II Papaverine/Phentolamine/Alprostadil 30 mg/0.2 mg/10 mcg/mL recalled Wise Pharmacy Other CO, TX, WY 7 Aug 2019 Drug CLASS II Papaverine/Phentolamine/Alprostadil recalled by Wise Pharmacy Wise Pharmacy Other CO, TX, WY 7 Aug 2019 Drug CLASS II Papaverine/Phentolamine/Alprostadil/Atropine 30 mg/2 mg/50 recalled Wise Pharmacy Other CO, TX, WY 7 Aug 2019 Drug CLASS II Papaverine/Phentolamine/Alprostadil 30 mg/2 mg/50 mcg/mL recalled Wise Pharmacy Other CO, TX, WY 7 Aug 2019 Drug CLASS II Papaverine/Phentolamine/Alprostadil 30 mg/2 mg/30 mcg/mL recalled Wise Pharmacy Other CO, TX, WY 24 Apr 2019 Drug CLASS II Papaverine 30 mg/Phentolamine 0.5 mg/mL Vial recalled Anderson Compounding Pharmacy Sterility Nationwide 24 Apr 2019 Drug CLASS II Papaverine 30 mg/mL Injection Vial recalled Anderson Compounding Pharmacy Sterility Nationwide 16 May 2018 Drug CLASS II Papaverine 30mg/Phentolamine 2mg/Prostaglandin 20mcg/mL recalled Vitalab Pharmacy Sterility Nationwide 16 May 2018 Drug CLASS II Papaverine 9mg/Phentolamine 1mg/Atropine recalled by Vitalab Pharmacy Vitalab Pharmacy Sterility Nationwide 16 May 2018 Drug CLASS II Papaverine 30mg/Phentolamine 1.5mg/Prostaglandin 50mcg/mL recalled Vitalab Pharmacy Sterility Nationwide 24 May 2017 Drug CLASS II Papaverine/Phent Mdv 30/0.5MG/ML Inj, Injection, 30/0.5mg/mL recalled Key Pharmacy and Compounding Center Sterility Nationwide 24 May 2017 Drug CLASS II Papaverine/Phent Mdv 30/1MG/ML Inj, Injection, 30mg/1mg/mL recalled Key Pharmacy and Compounding Center Sterility Nationwide 5 Oct 2016 Drug CLASS II Papaverine 150 mg/Phentolamine 5 mg recalled by Pharmacy Plus Pharmacy Plus Sterility MS 5 Oct 2016 Drug CLASS II Papaverine 150 mg / Phentolamine 5 mg vials recalled by Pharmacy Plus Pharmacy Plus Sterility MS 28 Sep 2016 Drug CLASS II Papaverine 30 mg / Phentolamine 1 mg / mL -- Glass Vial recalled W & C Sterility MN 28 Sep 2016 Drug CLASS II Papaverine 75 mg / Phentolamine 2.5 mg / Prostaglandin recalled by W & C W & C Sterility MN 4 Nov 2015 Drug CLASS II Papaverine/Phentolamine/Prostaglandin, Injectable Solution recalled JD & SN Inc Sterility Nationwide 4 Nov 2015 Drug CLASS II Papaverine/Phentolamine/Atropine/Prostaglandin recalled by JD & SN Inc JD & SN Inc Sterility Nationwide 4 Nov 2015 Drug CLASS II Papaverine/Phentolamine/Atropine/Prostaglandin recalled by JD & SN Inc JD & SN Inc Sterility Nationwide
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Should you stop taking Papaverine?
Not on your own. Most recalls affect specific lots from one manufacturer, and stopping a prescription suddenly can be riskier than the defect. Check your lot number and NDC against the recall, then call the pharmacy that dispensed it for a replacement.