Udenyca pegfilgrastim-cbqv injection 6 mg/0.6mL Recall
UDENYCA, pegfilgrastim-cbqv injection, 6 mg/0.6mL Single Dose Prefilled Syringe, Rx only, Manufactured by Accord BioPharma, Inc., 8041 Arco Corporate…
What is the FDA recall status?
The FDA record lists this recall as ongoing. FDA enforcement data is not a live recall-lifecycle tracker. Follow the official instructions and check the agency notice or firm for current guidance.
Why was Udenyca pegfilgrastim-cbqv injection 6 mg/0.6mL recalled?
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.
What should I do if I have this product?
Follow the firm and FDA instructions for the affected product. Contact the recalling firm for current guidance.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare your product with the product description and available lot, UPC or model codes below from the official FDA record to check whether it is covered by this recall. If an identifier is missing or unclear, check the complete official notice or contact the firm; an incomplete match here does not establish that your product is unaffected.
Full 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
Which lot codes, UPCs or models are affected?
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.
- Agency record number
- D-0353-2026
- Product
- UDENYCA, pegfilgrastim-cbqv injection, 6 mg/0.6mL Single Dose Prefilled Syringe, Rx only, Manufactured by Accord BioPharma, Inc., 8041 Arco Corporate…
- Recalling firm
- McKesson
- Quantity
- 116 cartons
- Distribution
- Nationwide in the USA
- Recall started
- January 16, 2026
- Report date
- February 18, 2026
- Classification
- Class I
- Status
- Ongoing
- Agency
- FDA (drug)