FDA Issues Class II Recall for QuVa Pharma Compounded Epidural Drug Products Due to Sterility Concerns

QuVa Pharma, Inc. has voluntarily initiated a nationwide Class II recall of multiple compounded epidural drug formulations containing fentanyl citrate combined with bupivacaine or ropivacaine. The recall affects 3 specific products: (1) fentanyl citrate PF 200 mcg/100 mL (2 mcg/mL) with 0.1% bupivacaine HCl, (2) fentanyl citrate PF 200 mcg/100 mL with 0.125% bupivacaine HCl, and (3) fentanyl citrate PF 200 mcg/100 mL with 0.2% ropivacaine HCl. These compounded injectable solutions, prepared for epidural use only and not for intravenous administration, were distributed across the US for institutional or office use. The affected lots have expiration dates ranging from April 8 to April 28, 2025.

The recall was prompted by a lack of assurance of sterility for the impacted drug products, raising concerns about potential microbial contamination. While no adverse events have been reported to date, compromised sterility in compounded sterile preparations may lead to serious or life-threatening infections. The US Food and Drug Administration (FDA) classified the recall as Class II, indicating the use of the product could cause temporary or medically reversible adverse health consequences. A total of 4075 cassettes across the 3 formulations are affected, with the firm notifying consignees via letter as of March 6, 2025.

These compounded formulations are indicated for epidural analgesia and anesthesia, typically used in pain management during labor, postoperative settings, or chronic pain procedures. Fentanyl is a potent synthetic opioid, while bupivacaine and ropivacaine are long-acting local anesthetics. Health care providers, especially pharmacists responsible for institutional inventory and sterile compounding oversight, are urged to review their stocks, discontinue use of affected lots, and follow QuVa Pharma’s recall instructions.