Class I Recall: UDENYCA by McKesson

drug-class-i

Filed January 16th, 2026

Detected March 27th, 2026

Summary

The FDA has initiated a Class I recall for UDENYCA (pegfilgrastim-cbqv injection) distributed by McKesson due to temperature abuse. The recall affects 116 cartons from Lot 2199821 that were stored incorrectly, posing a potential health risk.

View original document View source feed page

What changed

The Food and Drug Administration (FDA) has classified a recall of UDENYCA (pegfilgrastim-cbqv injection) initiated by McKesson as a Class I recall, indicating a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death. The recall, identified by recall number D-0353-2026, pertains to 116 cartons from Lot 2199821 due to improper storage conditions (temperature abuse), where the product was kept at controlled room temperature instead of the required refrigerated environment.

This action requires immediate attention from entities involved in the distribution and handling of this product. McKesson has initiated a voluntary recall, and affected parties must ensure that the specified serial numbers from Lot 2199821 are removed from circulation. While the recall is ongoing, the classification as Class I signifies the highest level of risk, necessitating prompt action to prevent patient exposure to potentially compromised medication. Compliance officers should verify their inventory and return procedures for this product and similar temperature-sensitive pharmaceuticals.

What to do next

Verify inventory for affected UDENYCA product (Lot 2199821, specific serial numbers).
Remove affected product from circulation and follow return procedures.
Review and reinforce cold chain storage protocols for all temperature-sensitive pharmaceuticals.

Source document (simplified)

json { "meta": { "disclaimer": "Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. We may limit or otherwise restrict your access to the API in line with our Terms of Service.", "terms": "https://open.fda.gov/terms/", "license": "https://open.fda.gov/license/", "last_updated": "2026-03-18", "results": { "skip": 0, "limit": 1, "total": 1 } }, "results": [ { "status": "Ongoing", "city": "Irving", "state": "TX", "country": "United States", "classification": "Class I", "openfda": { }, "product_type": "Drugs", "event_id": "98366", "recalling_firm": "McKesson", "address_1": "6555 State Highway 161", "address_2": "N/A", "postal_code": "75039-2402", "voluntary_mandated": "Voluntary: Firm initiated", "initial_firm_notification": "E-Mail", "distribution_pattern": "Nationwide in the USA", "recall_number": "D-0353-2026", "product_description": "UDENYCA, pegfilgrastim-cbqv injection, 6 mg/0.6mL Single Dose Prefilled Syringe, Rx only, Manufactured by Accord BioPharma, Inc., 8041 Arco Corporate Drive, Suite 200, Raleigh, NC 27617, NDC 69448-025-63", "product_quantity": "116 cartons", "reason_for_recall": "Temperature Abuse. 116 cartons with specific serial numbers of Lot 2199821, were stored incorrectly in a controlled room temperature environment instead of the required refrigerated environment.", "recall_initiation_date": "20260116", "center_classification_date": "20260226", "report_date": "20260218", "code_info": "Subset of Lot 2199821, Expires: 05/31/2027 Specific Serial Numbers being Recalled: 160R694TT06X; 1C74A686RPPG; 1W6A2M777N3V; 20825394KR8P; 242E2RK3EA92; 2DG49VH89EPG; 2WEA2ADK1P4H; 3KR2TVAG3VDH; 42M0V0G9PM84; 46E9XKDPTH1R; 4AM12WEAE48H; 4FGHR096DMNV; 4MWGWM991XNA; 4NEW8XD9DNM2; 4Y2PYDFN9YA1; 61EPX42R4K2A; 63FN9VW5CAV7; 69TG160DW2CV; 69XFP3TMTP7X; 6AWVDCNHTV61; 6CEFY72W5GPA; 6FHF1A59X0X4; 6GA64FNDVGXY; 6NW5FACPPWDW; 75V19CF2A0PA; 7HK7155YNAK3; 7R51VVA1WX9T; 7XCKXMH2EERC; 85D8MFVM66D4; 8F3Y5NFFHC64; 8RDWKPM53N5R; 8W1PVXC5NAFW; 9338DPED7P3R; 9A4CXFTGCPYN; 9FKN5NRDX99A; 9G79AR0RGAY4; 9K28G80GGYXN; 9NN7NXE40M13; A48PXEPE77YE; A8M168K58G64; AMR0RNWHTWMW; AR145NW8WTVX; AY19W6DEGRX4; C276HMDGRE49; CAY0ARAEGMCF; CKT370X2G4NP; D0DFAXCN6G5W; D54TXR8AD9Y8; DAK3XP1P3DMP; DH44AGKTX27F; E69E9K6C29VD; EK1D8P703RCH; EX947FYVW7Y6; F2K148YVNRDD; F4EVX8573F1V; FEXA7MENKWF1; FNDNMPAFH89D; G2W3WTMP5HK9; G5MN0F418FFY; G6XECANG6P01; G7FNVGWW3D72; GAHFFNX336GA; GKNTDP4AV6AA; GVPN5C4D23H6; GVPPYARK1FCD; GVXDAAA87GA1; GX7AP73W4HMH; HDTFT2W59K52; HDVG3W6VW59Y; HP703MKWGGM7; K8CGDV1301TP; KN6Y35T0A198; KVGC92YVC6XF; KYCP1Y7CK4R4; MEY2VW5MC0N9; MGH40F2679X3; N11XGETGDAVM; N9DGTY65NFGN; NH9VM1K2ECGP; NNCFT59RD1KF; NVFCXRWHX93N; P3XY0RNV0VPY; P609NH6W670V; P9Y7926YN82A; PA88CCXMWCMG; PKADTN18YR1X; PM0YHNNK6P4T; R11TYM5VE9CK; R45AXAEK4TTN; R6C3533P943P; RMW35MXX4R4K; RX75F9DA58W4; RXRCRP9272DG; RXTH041DMT5D; T2FW4C24F364; T442NHDFD7H8; TC3443DCR4F8; TK8TRR8NT92A; TT8K21TGYFWY; V255NE533X59; V6MYKEA7HN7P; V764DEYM4RYP; VCPTYV1EF0R1; VECGDTDV1Y3A; VEE09A07R9X5; VEER64AW2C51; VRN2TE3HPK5N; WF14WA03FNT2; WTP5TKRGNFGW; WWPMXV50FRM4; X1DKP0T2AE1W; X59C5AV3VDTG; XKG3T7811TD2; Y0CYY950EYK8; YCRW0EPK620Y; YNYA64T18DPW." } ] }