Urgent site urgencyFDA Class I

UDENYCA, pegfilgrastim-cbqv injection, 6 mg/0

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.

Agency: FDA Drug
Recall date: Jan 16, 2026
Status: Ongoing
Company: McKesson

1. What product was recalled?

UDENYCA, pegfilgrastim-cbqv injection, 6 mg/0

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

Quantity: 116 cartons

Code or lot text: 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.

LOT: 1C74A686RPPG
LOT: 1W6A2M777N3V
LOT: 20825394KR8P
LOT: 242E2RK3EA92
LOT: 2DG49VH89EPG
LOT: 2WEA2ADK1P4H
LOT: 3KR2TVAG3VDH
LOT: 42M0V0G9PM84
LOT: 46E9XKDPTH1R
LOT: 4AM12WEAE48H
LOT: 4FGHR096DMNV
LOT: 4MWGWM991XNA
LOT: 4NEW8XD9DNM2
LOT: 4Y2PYDFN9YA1
LOT: 61EPX42R4K2A
LOT: 63FN9VW5CAV7
LOT: 69TG160DW2CV
LOT: 69XFP3TMTP7X
LOT: 6AWVDCNHTV61
LOT: 6CEFY72W5GPA
LOT: 6FHF1A59X0X4
LOT: 6GA64FNDVGXY
LOT: 6NW5FACPPWDW
LOT: 75V19CF2A0PA
LOT: 7HK7155YNAK3
LOT: 7R51VVA1WX9T
LOT: 7XCKXMH2EERC
LOT: 85D8MFVM66D4
LOT: 8F3Y5NFFHC64
LOT: 8RDWKPM53N5R
LOT: 8W1PVXC5NAFW
LOT: 9338DPED7P3R
LOT: 9A4CXFTGCPYN
LOT: 9FKN5NRDX99A
LOT: 9G79AR0RGAY4
LOT: 9K28G80GGYXN
LOT: 9NN7NXE40M13
LOT: A48PXEPE77YE
LOT: A8M168K58G64
LOT: AMR0RNWHTWMW
LOT: AR145NW8WTVX
LOT: AY19W6DEGRX4
LOT: C276HMDGRE49
LOT: CAY0ARAEGMCF
LOT: CKT370X2G4NP
LOT: D0DFAXCN6G5W
LOT: D54TXR8AD9Y8
LOT: DAK3XP1P3DMP
LOT: DH44AGKTX27F
LOT: E69E9K6C29VD
LOT: EK1D8P703RCH
LOT: EX947FYVW7Y6
LOT: Expires: 05/31/2027 Specific Serial Numbers being Recalled: 160R694TT06X
LOT: F2K148YVNRDD
LOT: F4EVX8573F1V
LOT: FEXA7MENKWF1
LOT: FNDNMPAFH89D
LOT: G2W3WTMP5HK9
LOT: G5MN0F418FFY
LOT: G6XECANG6P01
LOT: G7FNVGWW3D72
LOT: GAHFFNX336GA
LOT: GKNTDP4AV6AA
LOT: GVPN5C4D23H6
LOT: GVPPYARK1FCD
LOT: GVXDAAA87GA1
LOT: GX7AP73W4HMH
LOT: HDTFT2W59K52
LOT: HDVG3W6VW59Y
LOT: HP703MKWGGM7
LOT: K8CGDV1301TP
LOT: KN6Y35T0A198
LOT: KVGC92YVC6XF
LOT: KYCP1Y7CK4R4
LOT: MEY2VW5MC0N9
LOT: MGH40F2679X3
LOT: N11XGETGDAVM
LOT: N9DGTY65NFGN
LOT: NH9VM1K2ECGP
LOT: NNCFT59RD1KF
LOT: NVFCXRWHX93N
LOT: P3XY0RNV0VPY
LOT: P609NH6W670V
LOT: P9Y7926YN82A
LOT: PA88CCXMWCMG
LOT: PKADTN18YR1X
LOT: PM0YHNNK6P4T
LOT: R11TYM5VE9CK
LOT: R45AXAEK4TTN
LOT: R6C3533P943P
LOT: RMW35MXX4R4K
LOT: RX75F9DA58W4
LOT: RXRCRP9272DG
LOT: RXTH041DMT5D
LOT: Subset of Lot 2199821
LOT: T2FW4C24F364
LOT: T442NHDFD7H8
LOT: TC3443DCR4F8
LOT: TK8TRR8NT92A
LOT: TT8K21TGYFWY
LOT: V255NE533X59
LOT: V6MYKEA7HN7P
LOT: V764DEYM4RYP
LOT: VCPTYV1EF0R1
LOT: VECGDTDV1Y3A
LOT: VEE09A07R9X5
LOT: VEER64AW2C51
LOT: VRN2TE3HPK5N
LOT: WF14WA03FNT2
LOT: WTP5TKRGNFGW
LOT: WWPMXV50FRM4
LOT: X1DKP0T2AE1W
LOT: X59C5AV3VDTG
LOT: XKG3T7811TD2
LOT: Y0CYY950EYK8
LOT: YCRW0EPK620Y
LOT: YNYA64T18DPW.
NDC: 69448-025
NDC: 69448-025-63
NDC: 69448-026
NDC: 69448-026-63
NDC: 69448-027
NDC: 69448-027-63
RECALL-NUMBER: D-0353-2026
UPC: 0369448025632

2. Is my exact product affected?

Compare every printed identifier. A matching value can indicate that your product is included.

3. What is the hazard?

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.

4. What should I do now?

Follow the FDA recall notice and contact the recalling company for current instructions.

5. Where was it sold or distributed?

Nationwide

6. Were injuries or illnesses reported?

No separate injury or illness statement was present in the normalized record. Check the official source for the latest report.

7. What remedy is available?

Follow the FDA recall notice and contact the recalling company for current instructions.

8. Is the recall active or closed?

The source status is Ongoing. Recall Index urgency is urgent, which is a separate deterministic site label.

9. When was the information checked?

Last checked 8/16/2026, 6:17:24 AM UTC.

2026-08-16T06:17:24.928Zcreated

10. Where is the official source?

Open the official FDA Drug source

Recall Index normalizes public source data for easier checking. Source agencies remain authoritative. Confirm identifiers and instructions at the official source.