July 2026 Papaverine Injection Recall: NDC, Lot, and Particulate Matter Case Study

Key Takeaways

What To Remember

• FDA posted American Regent's July 24 company announcement on July 27, 2026.
• The voluntary consumer-level recall covers one lot: NDC 0517-4002-25, lot 25202, expiration 11/30/2026.
• The reason was visible particulate matter identified as glass and/or paraformaldehyde; the company reported no related adverse events received at announcement time.
• Match product plus NDC plus lot plus expiration, then quarantine, document, and escalate.
• Consumer level is recall depth, not an automatic Class I, II, or III designation, and FDA posting does not make the action mandatory.

The Direct Answer: One Product, One NDC, One Lot, One Expiration

FDA published American Regent's company announcement on July 27, 2026; the company announcement itself is dated July 24, 2026. American Regent voluntarily recalled one lot of Papaverine Hydrochloride Injection, USP 60 mg/2 mL single-dose vials nationwide to the consumer level because of visible particulate matter identified as glass and/or paraformaldehyde. The affected package is NDC 0517-4002-25, lot 25202, expiration 11/30/2026.

Those four product fields define the operational case. The recall does not automatically cover every papaverine product, every strength, every package, or every American Regent injectable. A technician should use the current notice and pharmacy procedure to match stock precisely. If the item is a confirmed match, or if an identifier cannot be resolved, prevent use, preserve the package, quarantine it, document what was found, and notify the pharmacist or responsible supervisor. This article is educational and does not give instructions to an individual patient.

• FDA publish date: July 27, 2026; company announcement date: July 24, 2026.
• Product: Papaverine Hydrochloride Injection, USP 60 mg/2 mL single-dose vial.
• NDC: 0517-4002-25.
• Lot: 25202; expiration: 11/30/2026.
• Scope: voluntary nationwide recall of one lot to the consumer level.

Run the Four-Field Match in the Same Order Every Time

Start with the product and strength: Papaverine Hydrochloride Injection, USP 60 mg/2 mL. Next compare NDC 0517-4002-25. Then compare lot 25202. Finally compare expiration 11/30/2026. Using the same sequence reduces the chance that a familiar drug name or matching package color ends the check too early. Package size, dosage form, manufacturer, and single-dose-vial presentation provide useful supporting confirmation.

A four-field match also handles near misses correctly. Papaverine with a different NDC is not automatically part of this announcement. The same NDC with a different lot is not one of the listed affected units. A matching lot printed unclearly should not be guessed. Separate an unresolved vial or carton from routine stock and ask the pharmacist, inventory lead, supplier, or manufacturer contact specified by procedure to resolve it. Precision protects patients without unnecessarily treating unrelated inventory as recalled.

• 1. Product and strength: papaverine hydrochloride injection 60 mg/2 mL.
• 2. NDC: 0517-4002-25.
• 3. Lot: 25202.
• 4. Expiration: 11/30/2026.

Treat Visible Particulate Matter as a Stop Signal

The announcement identifies visible particulate matter as glass and/or paraformaldehyde. It also provides a risk statement about administering injectable product containing particulate matter. A technician does not need to inspect a vial to determine which material is present, decide that a particle is harmless, or reproduce the investigation. The recall notice already establishes the reason for the affected lot, and any unexplained particulate or product-integrity concern in another injectable should be handled under the pharmacy's separate product-quality procedure.

Do not open, shake, filter, transfer, or otherwise manipulate a recalled vial to make it appear usable. Keep the container and labeling intact unless current official instructions and authorized pharmacy procedure direct otherwise. If a technician notices particulate matter before seeing a notice, stop the preparation or dispensing process, protect the product from use, and alert the pharmacist. Visual inspection is a detection step; clinical risk assessment, reporting decisions, and final disposition are not independent technician decisions.

Keep Recall Depth Separate From Recall Classification

The company announcement says the action extends to the consumer level. That phrase describes recall depth: how far through the distribution chain the recall strategy reaches. FDA separately classifies recalls as Class I, II, or III based on the degree of health risk. FDA's general recall resource explains those classes and maintains recall information that can include a classification. Depth and classification answer different questions and should not be substituted for one another.

The cited papaverine announcement page does not display Class I, Class II, or Class III. Therefore, this article does not assign one. The risk statement is important, but a reader should not convert its wording into an unofficial class. Likewise, the fact that FDA hosts the company announcement does not mean FDA forced the recall. The page explicitly identifies a company announcement, says the recall is voluntary, and explains that FDA posts company announcements as a public service. Use the exact official status available at the time of work.

• Consumer level answers: how far does the recall extend?
• Recall class answers: how does FDA classify the degree of risk?
• Voluntary answers: who initiated the action described in the announcement?
• FDA publish date answers: when did FDA post the company announcement?

Create a Quarantine Chain That Can Be Audited

After a confirmed or unresolved match, stop use and move the product to the designated quarantine area. Mark its status clearly, maintain any required security or storage conditions, and prevent it from being selected for dispensing or administration. Check all locations named by procedure: active inventory, refrigerator or specialty storage if applicable, will-call or prepared areas, return bins, emergency stock, satellite locations, and recent receipts. The exact locations depend on the practice setting.

Document enough detail for another trained person to reconstruct the response: notice date, product, strength, NDC, lot, expiration, quantity, storage locations checked, quarantine location, people notified, inventory-system action, and return or disposition reference. American Regent's announcement says the company was notifying distributors and customers and arranging return or replacement, and it directs affected distributors, retailers, and facilities to stop using the product and return it to the place of purchase or discard it. The pharmacy should choose among those actions through its authorized procedure, not through an improvised technician decision.

Escalate Patient, Adverse-Event, and Disposition Questions

At the time of the July 24 announcement, American Regent said it had not received reports of adverse events related to the recall. That dated statement must not be rewritten as 'the product caused no harm' or assumed to remain current forever. If a patient, caregiver, prescriber, or facility reports possible exposure, symptoms, or an adverse event, capture the contact and information according to policy and immediately route the matter to the pharmacist or appropriate clinical and safety channel.

The same boundary applies to disposition and communication. A technician may locate stock, document identifiers, process an approved return, or support outreach under supervision. The technician should not tell an individual to stop or continue treatment, interpret symptoms, assign causality, announce an FDA recall class, or decide which patients require intervention. Current company instructions, FDA information, pharmacy policy, and pharmacist judgment guide those actions.

Make the Case Useful for PTCE Review Without Memorizing a Headline

The PTCE Content Outline effective January 6, 2026 includes FDA requirements for medication recalls, product-integrity event reporting, issues that require pharmacist intervention, lot and expiration numbers, NDC numbers, and procedures for identifying and returning non-dispensable products. This case integrates those published areas. The outline does not identify this papaverine lot, so this article is not a prediction that the recall will appear on the examination.

The transferable pattern is four-field identification followed by controlled action. When a question gives an NDC, lot, and expiration, use every identifier. When it describes particulate matter, stop normal use rather than attempting a repair. When it says consumer level, do not invent a recall class. When it asks what the technician should do, choose precise matching, quarantine, documentation, and escalation. Those habits apply to many product-quality events while keeping the response within technician scope.

Exam Signals

What This Looks Like on the PTCE

• A recall notice lists product and strength, NDC, lot, and expiration, and an answer choice matches only the drug name.
• A vial contains visible particulate matter or has another product-integrity concern during inspection.
• The prompt uses 'consumer level' and offers an unsupported Class I, II, or III conclusion.
• The FDA page is labeled company announcement and the action is described as voluntary.
• A technician is asked to decide clinical risk, patient instructions, adverse-event causality, or final disposition independently.

Method

Step-by-Step Approach

1. Read the current FDA-posted company announcement and the pharmacy's recall procedure.
2. Match product and strength, NDC, lot, and expiration in that order, using package and manufacturer details as supporting checks.
3. Stop use of confirmed or unresolved matches and preserve the vial, carton, and identifying information.
4. Place the product in the designated quarantine area and prevent selection for dispensing or administration.
5. Document quantity, locations checked, quarantine status, system actions, and notifications.
6. Escalate clinical questions, patient communication, adverse-event handling, recall classification, and return or disposal authorization.

Mistakes

Common Traps and Fixes

Mini Practice

PTCE-Style Practice Questions

Official References

Sources To Verify High-Risk Topics

• FDA-Posted American Regent Papaverine Recall Announcement
• FDA: Understanding Drug Recalls and Recall Classification
• PTCB PTCE Content Outline effective January 2026

Editorial Notes

How To Use This Page

This article is written for PTCE study practice and focuses on repeatable exam-prep reasoning, not patient-specific professional advice. AI tools may assist with explanations, but official references and human editorial review define the content boundaries.

For the content process, see the editorial process. For review standards, see the content review policy. For AI boundaries, see AI usage transparency. To report an issue, use contact and corrections.