CLASS II Drug recall · Reported 13 Apr 2022 · FDA Enforcement Report

Papaverine Hydrochloride Injection, USP, 60 mg/ (30 mg/mL) recalled

Vitae Enim Vitae Scientific is recalling Papaverine Hydrochloride Injection, USP, 60 mg/ (30 mg/mL), packaged as a) 25 x Single, distributed nationwide in the US. The recall was initiated on 14 Mar 2022 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesLot #: a) 20VPHI037, 20VPHI038, 20VPHI039, Exp 12/31/2022; 21VPHI021, 21VPHI022, 21VPHI023, Exp 6/30/2023; 21VPHI047, 21VPHI048, Exp 10/31/2023; b) 21VPHI023, Exp 6/30/2023

NDC72516-024

Quantity recalleda) 2,098 boxes; b) 700 boxes

Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.

Recall details

Recall number: D-0742-2022
FDA event ID: 89803
Recalling firm: Vitae Enim Vitae Scientific, San Diego, CA
Brand: Papaverine Hydrochloride
Manufacturer: Oryza Pharmaceuticals Inc.
Classification: Class II
Status: Terminated
Recall initiated: 14 Mar 2022
FDA classified: 5 Apr 2022
Reported: 13 Apr 2022
Type: Voluntary: Firm initiated
Customers notified by: Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Reason category: Sterility
Drug class: Injectable & IV Drugs

Timeline

14 Mar 2022	Recall initiated by company
5 Apr 2022	Classified by FDA	+22 days
13 Apr 2022	Published in enforcement report	+8 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

Reason for recall

Lack of Assurance of Sterility: deviations from Current Good Manufacturing Practices (CGMP) that call into question the sterility of products intended to be sterile.

A sterility recall means a product that must be sterile, such as an injection or eye drop, may be contaminated. Using a non-sterile product can cause serious infection.

Product as listed by the FDA

PAPAVERINE HYDROCHLORIDE Injection, USP, 60 mg/2mL (30 mg/mL), packaged as a) 25 x 2mL Single Use Vials per box (NDC 72516-024-25) and b) 10 x 2mL Single Use Vials per box (NDC 72516-024-10); Manufactured for Oryza Pharmaceuticals, Inc.

Where it was distributed

Nationwide in the U.S.A

Nationwide

Questions about this recall

Why was it recalled?

Lack of Assurance of Sterility: deviations from Current Good Manufacturing Practices (CGMP) that call into question the sterility of products intended to be sterile.

Which lots are affected?

Lot #: a) 20VPHI037, 20VPHI038, 20VPHI039, Exp 12/31/2022; 21VPHI021, 21VPHI022, 21VPHI023, Exp 6/30/2023; 21VPHI047, 21VPHI048, Exp 10/31/2023; b) 21VPHI023, Exp 6/30/2023

Where was it sold?

Nationwide in the U.S.A

What should I do if I have it?

Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.

What does Class II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

Other products in this recall event

3 other products · FDA event 89803

This product is part of a recall event; the main page for the event is Tetracaine 1% Tetracaine HCI Injection, USP, 20mg recalled.

Reported	Class	Recall	Company	Reason	Where
13 Apr 2022	CLASS II	Tetracaine 1% Tetracaine HCI Injection, USP, 20mg recalled	Vitae Enim Vitae Scientific	Sterility	Nationwide
13 Apr 2022	CLASS II	Phenobarbital Sodium Injection, USP, 65mg/mL recalledPhenobarbital Sodium	Vitae Enim Vitae Scientific	Sterility	Nationwide
13 Apr 2022	CLASS II	Phenobarbital Sodium Injection, USP, 130 mg/mL recalledPhenobarbital Sodium	Vitae Enim Vitae Scientific	Sterility	Nationwide

More recalls from Vitae Enim Vitae Scientific

All 4

Reported	Class	Recall	Company	Reason	Where
13 Apr 2022Drug	CLASS II	Phenobarbital Sodium Injection, USP, 130 mg/mL recalledPhenobarbital Sodium	Vitae Enim Vitae Scientific	Sterility	Nationwide
13 Apr 2022Drug	CLASS II	Phenobarbital Sodium Injection, USP, 65mg/mL recalledPhenobarbital Sodium	Vitae Enim Vitae Scientific	Sterility	Nationwide
13 Apr 2022Drug	CLASS II	Tetracaine 1% Tetracaine HCI Injection, USP, 20mg recalled	Vitae Enim Vitae Scientific	Sterility	Nationwide

Other Papaverine recalls

All 64

Reported	Class	Recall	Company	Reason	Where
26 Aug 2026Drug	CLASS I	Papaverine HCl Injection, USP, 60 mg/ (30 mg/mL) recalledPapaverine Hydrochloride	American Regent	Particulate Matter	Nationwide
1 Feb 2023Drug	CLASS II	Papaverine/phentolamine 30mg/0.5mg/ML Vial) Injectable recalled	Pharmacy Innovations	Sterility	Nationwide
9 Nov 2022Drug	CLASS II	Papaverine / Phentolamine / Prostaglandin Inj recalled by Pharmacy Plus	Pharmacy Plus	Sterility	4 states
9 Nov 2022Drug	CLASS II	Papaverine / Phentolamine / Prostaglandin 150MG / 2.5MG recalled	Pharmacy Plus	Sterility	4 states
9 Nov 2022Drug	CLASS II	Papaverine/Phentolamine/Prostaglandin Inj 150/5/50MCG recalled	Pharmacy Plus	Sterility	4 states