Elevated risk U.S. Food and Drug Administration

Caps Phenylephrine 40 mg added to 0.9% Sodium Chloride 250 mL in 250 mL recall: Due to visible black particulate matter

Recall published 1+ years ago

Due to visible black particulate matter

Caps Prescription & OTC drugs — recalled prescription & otc drugs
Photo published by U.S. Food and Drug Administration with the recall notice.

The hazard: Foreign material — foreign objects

The company found foreign objects in the product, or a customer did. Either way the recall covers every pack from the runs listed, because contamination of this kind is rarely confined to one unit.

What the notice says: Risk Statement: Administration of an injectable product containing particulate matter may cause local irritation or swelling as a response to the foreign material.

Why it matters: Pieces of foreign objects may be inside the product. The risk here is physical rather than microbial: cuts to the mouth or throat, a broken tooth, or an injury further down if a fragment is swallowed.

Symptoms and when to call a doctor

If someone has swallowed a fragment and has mouth or throat pain, trouble swallowing, chest or stomach pain, vomiting, or blood in saliva or stool, they should be seen the same day. A fragment swallowed without symptoms usually passes on its own, but tell the clinician exactly what the product was: whether it shows up on imaging depends entirely on the material, so describe the product and the notice to them.

This page is general information, not medical advice. If you feel unwell, a clinician who can see you is the only person able to judge your case.

Recall details

Published
February 24, 2025
Risk level
Elevated risk
Issued by
U.S. Food and Drug Administration
Brand
Caps
Product type
Prescription & OTC drugs

Products covered by this recall

Phenylephrine 40 mg added to 0.9% Sodium Chloride 250 mL in 250 mL Excel Bag

What the company announced

FOR IMMEDIATE RELEASE – February 24, 2025 – Bethlehem, PA. Central Admixture Pharmacy is recalling three lots of Phenylephrine 40 mg added to 0.9% Sodium Chloride 250 mL in 250 mL Excel Bags (NDC: 71285-6092-1) to the hospital level. The product is being recalled because CAPS was notified by their raw material supplier of the detection of visible black particulate matter in a single sealed vial of Phenylephrine Hydrochloride.

Risk Statement: Administration of an injectable product containing particulate matter may cause local irritation or swelling as a response to the foreign material. If the particulate matter enters the blood vessels, it can travel to various organs and potentially blocking blood vessels in the heart, lungs or brain, leading to serious complications such as stroke or even death. To date, CAPS has not received any reports of adverse events or injuries associated with this recall.

Affected Product:

  • NDC: 71285-6092-1 · Product Description: Phenylephrine 40 mg added to 0.9% Sodium Chloride 250 mL in 250 mL Excel Bag · Lot #: 37-928390 · Expiration Date: 03MAR2025 · Distribution Dates: 17 Dec 2024 · Region Distributed: United States
  • NDC: 71285-6092-1 · Product Description: Phenylephrine 40 mg added to 0.9% Sodium Chloride 250 mL in 250 mL Excel Bag · Lot #: 37-928796 · Expiration Date: 09MAR2025 · Distribution Dates: 26 Dec 2024 · Region Distributed: United States
  • NDC: 71285-6092-1 · Product Description: Phenylephrine 40 mg added to 0.9% Sodium Chloride 250 mL in 250 mL Excel Bag · Lot #: 37-928839 · Expiration Date: 10MAR2025 · Distribution Dates: 03 Jan 2025 – 08 Jan 2025 · Region Distributed: United States

CAPS drug product is packaged in 0.9% Sodium Chloride 250 mL in 250 mL Excel Bag. The product can be identified by the sample label below, the NDC format for products compounded at Lehigh Valley is “71285-XXXX-X.” The lot number format is “37-XXXXXX.”

CAPS is notifying its distributors and customers by USPS certified mail and is arranging for return. By completing a “Urgent Pharmaceutical Recall Response Form” and either faxing the form to (610) 849-1197 or e-mail to r [email protected] within two (2) weeks of receipt, even if the total inventory in the customer’s possession is zero (0).

Consumers with questions regarding this recall can contact CAPS by calling 1-844-903-6417. Consumers should contact their physician or healthcare provider if they have experienced any problems that may be related to taking or using this drug product.

Adverse reactions or quality problems experienced with the use of this product may be reported to the FDA's MedWatch Adverse Event Reporting program either online, by regular mail or by fax.

Complete and submit the report Online : www.fda.gov/medwatch/report.htm

Regular Mail or Fax: Download form www.fda.gov/MedWatch/getforms.htm or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178

This recall is being conducted with the knowledge of the U.S. Food and Drug Administration.

Reproduced from the company announcement posted on fda.gov. Links and contact forms in the original are not repeated here; the official notice below has them.

Check your product

The notice names 10 codes you can read straight off the package. Type the one printed on yours and the list below narrows to it.

Lot or batch code

Usually ink-stamped near the seam, the cap or the bottom of the pack.

  • 37-928390
  • 37-928796
  • 37-928839

Best-by / use-by date

Printed beside the lot code, not on the price sticker.

  • 03MAR2025
  • 09MAR2025
  • 10MAR2025

NDC number

On the carton and again on the bottle or blister label.

  • 71285-6092-1

Model or item number

On the rating label, the box or the instruction sheet.

  • NDC 71285-6092-1

Package size

Match the net weight or the piece count on the front of the pack.

  • 40 mg
  • 250 mL

Codes are lifted verbatim from the FDA — Company recall announcements notice. A code that is missing here may still be covered — the official notice is the complete list.

What to do about Foreign material

Caps — The company found foreign objects in the product, or a customer did. Either way the recall covers every pack from the runs listed, because contamination of this kind is rarely confined to one unit.

  1. Stop eating it, and do not pick through it to find the fragment — sorting it by hand is how people get cut.
  2. Check the freezer and the pantry for other packs carrying the same codes before you consider the matter closed.
  3. If someone has already bitten into something hard, have them stop, spit out what is in their mouth and rinse rather than swallow.
  4. Keep the pack if you can. If anyone was hurt, the fragment and the packaging together are the evidence that matters.

Refunds, and what else you can claim

The purchase price is the floor, not the ceiling. Where a recall caused you a real cost, say so.

  • Claim the refund at the store first; it is the fastest route and needs the least paperwork.
  • If you bought several packs over time, list them. Firms routinely settle for more than a single unit when a customer asks.
  • Medical costs, lost earnings or a spoiled event are not handled at the service desk. Write to the company contact on this page instead, with dates and documents.
  • Keep copies of everything you send. If a recall caused harm, that file is what any later claim rests on.

Company contact: CAPS — Consumers: CAPS, 1-844-903-6417 — Media: Allison Longenhagen, 484-523-6801

The official notice

This page summarises a notice published by U.S. Food and Drug Administration. The agency notice is the authoritative version — read it before you act, and treat it as the final word if anything here looks different.

Open the FDA — Company recall announcements record U.S. Food and Drug Administration recalls

Questions people ask about this recall

Why was Caps prescription & otc drugs recalled?

Due to visible black particulate matter Risk Statement: Administration of an injectable product containing particulate matter may cause local irritation or swelling as a response to the foreign material.

How do I know if I have the recalled product?

Match the codes printed on your package against the notice: lot code 37-928390, 37-928796, 37-928839; best-by date 03MAR2025 or 09MAR2025; model number NDC 71285-6092-1. If the code on your package is not on that list, your unit is outside the recall.

What should I do with it right now?

Stop eating it, and do not pick through it to find the fragment — sorting it by hand is how people get cut.

Can I get my money back?

Claim the refund at the store first; it is the fastest route and needs the least paperwork.

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