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FDA announces nationwide recall of epinephrine injections after reports of cracked vials. A nationwide voluntary recall of three lots of Epinephrine Injection has been issued due to the "presence of particulate matter and lack of sterility assurance," according to the U.S. Food and Drug Administration. The FDA on Thursday shared a recall notice from Ohio-based American Regent stating that some Epinephrine Injection, USP 30 mg/ 30 mL (1 mg/mL) multi-dose vials were being recalled after the company received customer complaints "for leaking and cracked vials, resulting in lack of assurance of sterility." Related video above: How to stay ahead of recalls The firm's investigation also revealed "the presence of particulate matter identified as nylon, cellulosic, acrylic, polyethylene, and glass" in the product, the recall announcement states. The epinephrine injections are meant to be used for "the emergency treatment of allergic reactions (Type I), including anaphylaxis, which may result from insect stings or bites, foods, drugs, sera, diagnostic testing substances, and other allergens, as well as idiopathic anaphylaxis or exercise-induced anaphylaxis," the company said in a risk statement attached to the recall notice. The notice goes on to state that "Epinephrine Injection, USP is also indicated to increase mean arterial blood pressure in adult patients with hypotension associated with septic shock." The affected Epinephrine Injection, USP products were distributed nationwide in the United States and carry an NDC number of 0517-3030-01. Lot Numbers 25128L1C0, 25280L1C0, and 26108L1C0 were distributed nationwide in the United States. Here are the specific lot numbers, expiration dates, and distribution dates: * Lot: 25128L1C0 * Expiry: August 2026 * Distribution date range: Sept. 04, 2025 to Dec. 18, 2025 * Lot: 25280L1C0 * Expiry: October 2026 * Distribution date range: Dec. 16, 2025 to April 17, 2026 * Lot: 26108L1C0 * Expiry: July 2027 * Distribution date range: June 15, 2026 to July 31, 2026 American Regent said that as of Sept. 3, it had not received any reports of adverse events related to this recall. In its risk statement, American Regent said that intravenous administration of a product containing particulate matter can lead to "serious adverse health consequences." "Particulate matter can cause blockage and clotting in blood vessels, which can cut off blood flow to vital organs, lead to a life-threatening blood clot in the lungs (pulmonary embolism), and cause permanent organ damage or death," the company wrote, adding that the particles "may cause local vein irritation, inflammatory reaction, aggravation of preexisting infections, and allergic reactions." The company said cracked vials can "compromise the integrity of the container, resulting in loss of sterility and potential contamination, which can pose a serious risk for patients." What to do if you have an impacted product. American Regent said it is notifying distributors and customers by letter and is arranging for the return or replacement of all recalled products. Patients who use the product being recalled should stop using it and contact their doctor or health care provider, the company said in the notice. Consumers and healthcare professionals with questions regarding the recall can contact American Regent. The contact information can be found below: | Contact Center | Contact Information | Area of Support | | American Regent, Inc. Customer Service | Phone: 800-645-1706 (8 a.m.-6 p.m. EST, Monday - Thursday, 8 a.m. -4 p.m. EST, Friday) | For detailed return/replacement/credit information | | American Regent, Inc. Pharmacovigilance | Phone: 800-734-9236 Email: [email protected] | To report adverse events | | American Regent, Inc. Product Quality Complaints | Phone: 888-354-4855 (9 a.m. -5 p.m. EST, Monday - Friday) Email: [email protected] | For product quality complaints | | American Regent, Inc. Medical Information | Phone: 888-354-4855 (9 a.m.-5 p.m. EST, Monday - Friday)Email: [email protected] | For medical questions |

American Regent, Inc. issues voluntary nationwide recall of one lot of Papaverine Hydrochloride Injection, USP 60 mg/ 2 mL due to the presence of visible particulate matter. When a company announces a recall, market withdrawal, or safety alert, the FDA posts the company's announcement as a public service. FDA does not endorse either the product or the company. Summary. * Company Announcement Date: - July 24, 2026 * FDA Publish Date: - July 27, 2026 * Product Type: - Drugs * Reason for Announcement: - Products were found to contain particulate matter * Company Name: - American Regent, Inc. * Brand Name: - American Regent, Inc. * Product Description: - Papaverine Hydrochloride Injection, USP 60 mg/ 2 mL Company Announcement. July 24, 2026 - Shirley, NY, American Regent, Inc. is conducting a nationwide voluntary recall of a single lot of Papaverine Hydrochloride Injection, USP, 60 mg/2 mL single dose vial to the consumer level. The product is being recalled due to the presence of particulate matter identified as glass and/or paraformaldehyde. Risk Statement: The administration of an injectable product containing particulate matter may result in local irritation or swelling. The particulate matter could travel through and block blood vessels in the heart, lungs or brain which can cause stroke and even lead to death. Patients with underlying cardiovascular or pulmonary compromise may be at increased risk. To date, American Regent, Inc. has not received any reports of adverse events related to this recall. Papaverine is a prescription medication that relaxes smooth muscles and widens blood vessels, primarily used to treat visceral spasms, poor blood circulation, and erectile dysfunction. Papaverine Hydrochloride Injection, USP, is a clear, colorless pale-yellow solution and is available in a 2 mL single-dose vial containing 30 mg/mL Papaverine Hydrochloride Injection, USP Lot # 25202 was distributed nationwide in the United States beginning September 30, 2025. NDC, lot, expiration date and distribution dates can be found on the table below. Product Description: Papaverine Hydrochloride Injection, USP 60 mg/2 mL Single dose vial NDC: 0517-4002-25 Lot#: 25202 Expiration Date: 11/30/2026 Distribution Dates: 9/30/2025 American Regent, Inc. is notifying its distributors and customers by letter and is arranging for return/replacement etc. of all recalled products. Distributors/retailers/healthcare facilities that have the product which is being recalled should stop using and return to place of purchase or discard the product. Consumers and healthcare professionals with questions regarding this recall can contact American Regent Inc. using the below information. This product is an intravenous injection and is to be used by or under the direction of a physician. Patients that use this product which is being recalled should stop using them and contact their doctor or health care provider. 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. | Contact Center | Contact Information | Area of Support | | American Regent, Inc. Customer Service | Phone: 800-645-1706 (8:00AM-6:00PM EST, Monday - Thursday, 8:00AM-4:00PM EST, Friday) | For detailed return/replacement/credit information | | American Regent, Inc. Pharmacovigilance | Phone: 800-734-9236 Email: [email protected] | To report adverse events | | American Regent, Inc. Product Quality Complaints | Phone: 888-354-4855 (9:00AM-5:00PM EST, Monday - Friday) Email: [email protected] | For product quality complaints | | American Regent, Inc. Medical Information | Phone: 888-354-4855 (9:00AM-5:00PM EST, Monday - Friday) Email: [email protected] | For medical questions | 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. American Regent, Inc. is committed to the safety of patients who rely on its products and is taking this precautionary action to protect public health. Company Contact Information. * Consumers: - (800) 645-1706

American Regent recalls Papaverine Injection nationwide. When glass and medicine don't mix. Walking a tightrope in pharmaceutical production is no small feat, but American Regent, Inc. just stepped off the safety line with a recall of their Papaverine Hydrochloride Injection. Investors Hangout, LLC is talking visible glass and paraformaldehyde floating in those vials like unwelcome party guests. That's a gamble nobody wants to take, especially when you're injecting it straight into the bloodstream. The stakes: Health risk in a bottle. Now here's the rub: if this gunk gets injected, it could lead to local irritation, or worse, block blood vessels in critical areas like the heart, lungs, or brain. Best case scenario? You've got some irritation. Worst? You're looking at strokes or death. It's a dangerous line to walk, especially for those already dealing with cardiovascular or pulmonary issues. "Nobody's reported problems yet, but this ain't a bet you want to place." From distribution to recall: the details. The recalled batch, Lot #25202, made its way around the U.S. starting from September 30, 2025. American Regent didn't waste time getting the word out, notifying distributors and healthcare providers via formal letters. But let's break it down - why did this take almost a year to come to light? Crucial steps for stakeholders. * Cease usage and return the product to its purchase point. * Health facilities, retailers, and consumers are urged to discard or return the vials. * Contact healthcare professionals if the drug has been used. Sure, American Regent is taking steps to mitigate the damage, but national recalls are no picnic. Investors Hangout, LLC is talking production line inspections, possibly halts, and a blow to the company's reliability perception. You can practically hear their stock value holding its breath. Pharmaceutical oversight under the spotlight. Sold under the radar until last September, these vials pack 60 mg in a pale-yellow solution meant to ease visceral spasms and boost circulation. With no reports of adverse events yet, healthcare providers would be wise to tread carefully and follow guidance to avoid any hit or miss scenarios. American Regent's commitment to safety. Now, they claim their commitment to patient safety is top-tier. They're working closely with the FDA in an effort to spell out transparency. Here's hoping this isn't a case of too little, too late. Communication lines are open with customer service covering details about returns, replacements, and the full lowdown of the recall. While investors should probably keep watch on American Regent, this recall isn't sending shockwaves across the stock market just yet. The regulatory hiccups, though, raise questions for potential future oversight and quality measures in pharmaceutical manufacturing. And in this landscape, vigilance and swift action are the golden rules. If you're holding any stake in the healthcare sector or pharmaceuticals, keep an eye peeled for broader implications. Recalls like this signal a hiccup in the seemingly smooth operations, but they're crucial for ensuring safety and maintaining trust in medical supply chains.