Drug and Supplement Recalls
Amneal Pharmaceuticals LLC. recalls Amneal Pharmaceuticals LLC.Ropivacaine Hydrochloride Injection, USP, 500mg/100mL IV bag
FOR IMMEDIATE RELEASE – 04/18/2025 – Bridgewater, NJ, Amneal Pharmaceutical LLC, is recalling two lots of Ropivacaine Hydrochloride Injection, USP, 500mg/100mL, Infusion bags to the hospital/user level as the products may contain an inert fiber identified as polypropylene fibers from the IV bag.
Risk Statement: Introduction of polypropylene particulates into the epidural space (or inadvertent administration into the intrathecal space) may result in a variety of adverse events. There is a reasonable probability that particulate matter in the epidural space may cause an epidural inflammatory process to meningitis or potentially damage the spinal cord. Administered intrathecally, particulate matter could result in inflammation, hydrocephalus (water on the brain), which could lead to embolization and organ damage.
To date, Amneal Pharmaceuticals has received no reports of adverse events or injuries related to this recall.
Q’Apel Medical, Inc. recalls Q’Apel Medical 072 Aspiration System
Fremont, CA – April 18, 2025 – On April 7, 2025, the U.S. Food and Drug Administration (“FDA” or “the agency”), classified Q’Apel Medical, Inc.’s (“Q’Apel” or “the company”) voluntary recall of 1,617 units of its 072 Aspiration System (also known under the product name “Hippo”, which includes “Cheetah”; collectively, the “product”) as Class I.
On February 26, 2025, the company initiated a discontinuation and recall of 1,617 units of its 072 Aspiration System product. The recall was initiated because the company received a Warning Letter from FDA that raised questions about whether the features and characteristics of the distal tip of the Hippo aspiration catheter were within the scope of its 510(k) clearance. Rather than pursue a new regulatory pathway, the company chose to voluntarily remove all affected product lots and discontinue the 072 Aspiration System line as part of its strategic shift toward newer technologies
Q’Apel has submitted three Medical Device Reportable events for the Hippo product to date; these adverse events include a reported tip detachment, retrieved without patient injury; a vessel rupture; and a vasospasm. Based on the company’s investigation of these events, factors other than the device’s distal tip likely contributed to the reported adverse events.
Food and Beverage Recalls
Gerber Products Company recalls Gerber Gerber® Soothe N Chew® Teething Sticks
ARLINGTON, Va., April 18, 2025
On January 31, 2025, Gerber Products Company initiated a recall and discontinuation of all batches of GERBER® SOOTHE N CHEW® TEETHING STICKS due to a potential choking hazard for babies and young children.
We are issuing a second press release about this recall due to recent reports of recalled product still available for sale on some retailer shelves and online. The previous announcement on January 31st is linked on the FDA website.
GERBER® SOOTHE N CHEW® TEETHING STICKS were distributed nationwide.
Harvest NYC Inc recalls Hofood99 Inc Enoki Mushrooms
Harvest NYC Inc Recalls Enoki Mushroom Due to Possible Health Risk
Harvest NYC Inc of Brooklyn, NY 11231 is recalling its 200g packages of Enoki Mushroom, because they may be contaminated with Listeria monocytogenes, an organism which can cause serious and sometimes fatal infections in young children, frail or elderly people and others with weakened immune systems. Although healthy persons may suffer only short-term symptoms such as high fever, severe headache, stiffness, nausea, abdominal pain, and diarrhea, Listeria infection can cause miscarriages and stillbirths among pregnant women.
The recalled Enoki Mushrooms were distributed nationwide in retail stores. The product comes in a 200g, green plastic package marked with UPC Barcode 6975730520101 on the back label, distributed by Hofood99 Inc., 21903 56th Ave Oakland Gardens, NY 11364.
No illnesses have been reported to date in connection with this problem.
May Flower Internation, Inc. recalls May Flower International Soybean Paste
May Flower International Inc., Issue Allergy Alert on Undeclared Wheat in “Beijing Soybean Paste”
May Flower International Inc of Maspeth, NY, is recalling its 8.82-ounce/250g packages of “Beijing Soybean Paste” food treats because they may contain undeclared wheat. People who have allergies to wheat run the risk of serious or life-threatening allergic reaction if they consume these products.
The recalled “Beijing Soybean Paste” were distributed nationwide in retail stores.
The Beijing Soybean Paste is packaged in 8.82-ounce/250g plastic packages, with UPC 6917799000385. The labeling indicates that the product was packed For Fu Xiang Yuan Trading Inc New York City NY 11378. (Please see attached photo.) The product is distributed between 03/25/2023 to 03/05/2024 by May Flower International Inc.
No illnesses or allergic reactions involving this product have been reported to date.
Supplement Manufacturing Partners, Inc. recalls Dorado Nutrition/Space Garden Spermidine/Spermidin
Supplement Manufacturing Partners, Inc. is recalling Dorado Nutrition brand Spermidine Maximum Strength 10 MG per serving, because it contains undeclared wheat. People who have an allergy or severe sensitivity to wheat run the risk of serious or life-threatening allergic reaction if they consume this product.
Spermidine Maximum Strength 10 MG per serving was sold online at Amazon from 05/22/2024 to 04/04/2025.
Product was also sold in Germany as Spermidin 60 Kapseln 38g under Deep Green GmbH aka Space Garden.
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