Class II · Posted April 15, 2026 · Started March 25, 2026 · Ongoing
Artificial Tears Lubricant Eye Drops (glycerin 0.2%, hypromellose 0.2%, polyethylene…
- Product
- Artificial Tears Lubricant Eye Drops (glycerin 0.2%, hypromellose 0.2%, polyethylene glycol 400 1%), 0.5 oz bottles, Mfg: Geri-Care; Brooklyn, New York NDC 68788-7266-0
- Firm
- Preferred Pharmaceuticals, Inc., Anaheim, CA
- Reason
- Lack of Assurance of Sterility
- Lots
- Lot #: F1924R, F2024G, F2424E, G2424M, G2624P, J2424M
- Quantity
- 720 bottles
- Distribution
- Nationwide within the United States
- RxNorm
- Not matched to RxNorm in the FDA record
- Recall number
- D-0443-2026
Class II · Posted April 15, 2026 · Started March 24, 2026 · Ongoing
iohexol
- Product
- GE Healthcare Omnipaque (iohexol) Injection, 350 mg/mL (64.7%), Rx Only, Distributed by: GE Healthcare Inc., Marlborough, MA 01752 USA, NDC 0407-1414-91.
- Firm
- GE Healthcare Ireland Limited, Carrigtwohill, Ireland
- Reason
- Presence of particulate matter
- Lots
- Lot# 17333197; Exp. December 10, 2028 Lot# 17333198; Exp. November 17, 2028 Lot# 17396945; Exp. December 18, 2028 Lot# 17396948; Exp. December 22, 2028 Lot# 17396953; Exp. January 11, 2029 Lot# 17396956; Exp. January 9, 2029 Lot# 17423503; Exp. January 1, 2029 Lot# 17423525; Exp. January 3, 2029 Lot# 17426429; Exp. January 1, 2029 Lot# 17426440; Exp. January 4, 2029 Lot# 17431310; Exp. January 11, 2029
- Quantity
- 306,810 vials
- Distribution
- U.S. Nationwide.
- RxNorm
- iohexol
- Recall number
- D-0448-2026
Class II · Posted April 15, 2026 · Started March 24, 2026 · Ongoing
iohexol
- Product
- GE Healthcare Omnipaque (iohexol) Injection, 300 mg/mL (64.7%), Rx Only, Distributed by: GE Healthcare Inc., Marlborough, MA 01752 USA, NDC 0407-1413-63.
- Firm
- GE Healthcare Ireland Limited, Carrigtwohill, Ireland
- Reason
- Presence of particulate matter
- Lots
- Lot# 17225029; Exp. September 3, 2028 Lot# 17265376; Exp. October 3, 2028 Lot# 17270885; Exp. September 10, 2028 Lot# 17292246; Exp. October 4, 2028 Lot# 17301805; Exp. October 18, 2028 Lot# 17301807; Exp. September 7, 2028 Lot# 17301810; Exp. October 20, 2028 Lot# 17304992; Exp. October 5, 2028 Lot# 17304993; Exp. October 19, 2028 Lot# 17304996; Exp. November 25, 2028 Lot# 17321225; Exp. September 8, 2028 Lot# 17333589; Exp. November 24, 2028 Lot# 17333611; Exp. November 26. 2028 Lot# 17333613; Exp. November 23. 2028 Lot# 17357000; Exp. December 5, 2028 Lot# 17366399; Exp. December 14, 2028…
- Quantity
- 866,570 vials
- Distribution
- U.S. Nationwide.
- RxNorm
- iohexol
- Recall number
- D-0447-2026
Class II · Posted April 15, 2026 · Started March 20, 2026 · Ongoing
Vancomycin HCL
- Product
- Vancomycin HCL, 1 gram added to 250 mL, 0.9% Sodium Chloride Injection USP, Fagron Sterile Services, 8710 34th St. N. Wichita, KS 67226, NDC 71266-5082-01
- Firm
- Fagron Compounding Services, Wichita, KS
- Reason
- Lack of Assurance of Sterility; blue Break-Off-Part could detach from the administration port
- Lots
- Lot: C274-000050987, Exp.:7/12/2026; C274-000049425, Exp.: 5/2/2026; C274-000050069, Exp.: 5/30/2026; C274-000050346, Exp.: 6/10/2026; C274-000050698, Exp.: 6/27/2026; C274-000050699, Exp.:6/27/2026; C274-000050775, Exp.:7/4/2026.
- Quantity
- 11,680 bags
- Distribution
- Nationwide in the U.S.A.
- RxNorm
- Not matched to RxNorm in the FDA record
- Recall number
- D-0442-2026
Class II · Posted April 15, 2026 · Started March 20, 2026 · Ongoing
Vancomycin HCI
- Product
- Vancomycin HCI, 1.5 grams added to 250 mL, 0.9% Sodium Chloride Injection USP, Fagron Sterile Services, 8710 34th St. N. Wichita, KS 67226, NDC 71266-5085-01
- Firm
- Fagron Compounding Services, Wichita, KS
- Reason
- Lack of Assurance of Sterility; blue Break-Off-Part could detach from the administration port
- Lots
- Lot: C274-000050858, Exp.:7/6/2026; C274-000051018, Exp.: 7/13/2026; C274-000049194, Exp.: 4/20/2026; C274-000049591, Exp.: 5/9/2026; C274-000049592, Exp.: 5/9/2026; C274-000049823, Exp.: 5/18/2026; C274-000050301, Exp.: 6/8/2026; C274-000050411, Exp.: 6/13/2026; C274-000051056, Exp.:7/18/2026.
- Quantity
- 16,130 bags
- Distribution
- Nationwide in the U.S.A.
- RxNorm
- Not matched to RxNorm in the FDA record
- Recall number
- D-0441-2026
Class II · Posted April 15, 2026 · Started March 20, 2026 · Ongoing
Vancomycin HCI
- Product
- Vancomycin HCI, 1.25 grams added to 250 mL, 0.9% Sodium Chloride Injection USP, Fagron Sterile Services, 8710 34th St. N. Wichita, KS 67226, NDC 71266-5083-01
- Firm
- Fagron Compounding Services, Wichita, KS
- Reason
- Lack of Assurance of Sterility; blue Break-Off-Part could detach from the administration port
- Lots
- Lot: C274-000050857, Exp.:7/6/2026; C274-000049316, Exp.: 4/26/2026; C274-000049367, Exp.: 4/28/2026; C274-000049496, Exp.: 5/3/2026; C274-000049518, Exp.: 5/4/2026; C274-000049535, Exp.: 5/5/2026; C274-000049653, Exp.: 5/11/2026; C274-000049654, Exp.: 5/11/2026; C274-000049745, Exp.: 5/16/2026; C274-000050128, Exp.: 5/31/2026; C274-000050151, Exp.: 6/1/2026; C274-000050184, Exp.: 6/6/2026; C274-000050504, Exp.: 6/15/2026; C274-000050662, Exp.: 6/21/2026; C274-000050836, Exp.: 7/5/2026; C274-000051014, Exp.: 7/13/2026; C274-000051057, Exp.: 7/18/2026; C274-000051240, Exp.: 7/25/2026.
- Quantity
- 34,260 bags
- Distribution
- Nationwide in the U.S.A.
- RxNorm
- Not matched to RxNorm in the FDA record
- Recall number
- D-0440-2026
Class II · Posted April 15, 2026 · Started March 20, 2026 · Ongoing
norepinephrine Bitartrate
- Product
- norepinephrine Bitartrate, 32mg per 250mL 0.9% Sodium Chloride Injection USP, Fagron Sterile Services, 8710 34th St. N. Wichita, KS 67226, NDC 71266-5027-02
- Firm
- Fagron Compounding Services, Wichita, KS
- Reason
- Lack of Assurance of Sterility; blue Break-Off-Part could detach from the administration port
- Lots
- Lot: C274-000050004, Exp.: 4/24/2026; C274-000050295, Exp.:5/8/2026; C274-000050773, Exp.: 6/4/2026; C274-000051219, Exp.: 6/21/2026; C274-000051318, Exp.: 6/27/2026; C274-000051602, Exp.: 7/12/2026.
- Quantity
- 5140 bags
- Distribution
- Nationwide in the U.S.A.
- RxNorm
- Not matched to RxNorm in the FDA record
- Recall number
- D-0439-2026
Class II · Posted April 15, 2026 · Started March 20, 2026 · Ongoing
norepinephrine Bitartrate,16mg per 250mL 0.9% Sodium Chloride Injection USP
- Product
- norepinephrine Bitartrate,16mg per 250mL 0.9% Sodium Chloride Injection USP, Fagron Sterile Services, 8710 34th St. N. Wichita, KS 67226, NDC 71266-5026-02
- Firm
- Fagron Compounding Services, Wichita, KS
- Reason
- Lack of Assurance of Sterility; blue Break-Off-Part could detach from the administration port
- Lots
- Lot: C274-000049934, Exp.: 4/23/2026; C274-000049963, Exp.:4/24/2026; C274-000050074, Exp.: 4/30/2026; C274-000050123, Exp.:5/1/2026; C274-000050296, Exp.: 5/9/2026; C274-000050420, Exp.: 5/16/2026; C274-000050774, Exp.:6/5/2026; C274-000050924, 6/7/2026; C274-000050961, Exp.: 6/11/2026; C274-000050991, Exp.: 6/12/2026; C274-000051139, Exp.:6/19/2026; C274-000051166, Exp.:6/20/2026; C274-000051198, Exp.:6/21/2026; C274-000051343, Exp.:6/28/2026.
- Quantity
- 25,260 bags
- Distribution
- Nationwide in the U.S.A.
- RxNorm
- Not matched to RxNorm in the FDA record
- Recall number
- D-0438-2026
Class II · Posted April 15, 2026 · Started March 19, 2026 · Ongoing
clonidine
- Product
- Clonidine Transdermal System, USP, 0.3 mg/day, supplied in cartons of 4 Systems and 4 Adhesive Covers, Rx only, Manufactured by: Actavis Laboratories UT Inc., Salt Lake City, UT 84108, Distributed by: Actavis Pharma, Inc, Parsippany, NJ, NDC 0591-3510-04 carton, NDC 0591-3510-54 pouch
- Firm
- Teva Pharmaceuticals USA, Inc, Parsippany, NJ
- Reason
- CGMP Deviations: use of an unapproved raw material
- Lots
- Lot: 100053892, Exp.: 04/2026; 100057899, Exp.: 05/2026; 100062704, Exp.: 02/2027.
- Quantity
- 113,943 Cartons
- Distribution
- Within U.S
- RxNorm
- clonidine (RxCUI 998671, 998675, 998679)
- Recall number
- D-0474-2026
Class II · Posted April 15, 2026 · Started March 19, 2026 · Ongoing
clonidine
- Product
- Clonidine Transdermal System, USP, 0.2 mg/day, supplied in cartons of 4 Systems and 4 Adhesive Covers, Rx only, Manufactured by: Actavis Laboratories UT Inc., Salt Lake City, UT 84108, Distributed by: Actavis Pharma, Inc, Parsippany, NJ, NDC 0591-3509-04 carton, NDC 0591-3509-54 pouch
- Firm
- Teva Pharmaceuticals USA, Inc, Parsippany, NJ
- Reason
- CGMP Deviations: use of an unapproved raw material
- Lots
- Lot: 100060002, Exp.: 07/2026; 100066802, Exp.: 05/2027
- Quantity
- 62,136 Cartons
- Distribution
- Within U.S
- RxNorm
- clonidine (RxCUI 998671, 998675, 998679)
- Recall number
- D-0473-2026
Class II · Posted April 15, 2026 · Started March 19, 2026 · Ongoing
clonidine
- Product
- Clonidine Transdermal System, USP, 0.1 mg/day, supplied in cartons of 4 Systems and 4 Adhesive Covers, Rx Only, Manufactured by: Actavis Laboratories UT Inc., Salt Lake City, UT 84108, Distributed by: Actavis Pharma, Inc, Parsippany, NJ, NDC 0591-3508-04 carton, NDC 0591-3508-54 pouch
- Firm
- Teva Pharmaceuticals USA, Inc, Parsippany, NJ
- Reason
- CGMP Deviations: use of an unapproved raw material
- Lots
- Lot: 100060315, Exp.: 04/2026; 100068644, Exp.: 01/2027.
- Quantity
- 124,054 Cartons
- Distribution
- Within U.S
- RxNorm
- clonidine (RxCUI 998671, 998675, 998679)
- Recall number
- D-0472-2026
Class II · Posted April 15, 2026 · Started March 17, 2026 · Ongoing
Xanax XR
- Product
- Xanax XR, alprazolam, extended-release tablets, 3 mg, 60 Tablets bottles, Rx only, Distributed by: Viatris Specialty LLC, Morgantown, WV 06506, U.S.A, Made in Ireland, NDC 58151-506-91
- Firm
- Viatris, Inc., Canonsburg, PA
- Reason
- Failed Dissolution Specifications
- Lots
- Lot# 8177156, Exp Date: 02/28/2027
- Distribution
- US Nationwide.
- RxNorm
- Not matched to RxNorm in the FDA record
- Recall number
- D-0444-2026
Class II · Posted April 15, 2026 · Started March 13, 2026 · Ongoing
lanreotide acetate
- Product
- Lanreotide Injection, 120 mg/0.5 mL, Box contains 1 Pre-filled syringe, Single dose only, Rx Only, Manufactured by: Pharmathen International, S.A., Rodopi, Greece. Manufactured for: Cipla USA, Inc., 10 Independence Boulevard, Suite 300, Warren, NJ 07059. NDC 69097-906-67
- Firm
- Cipla USA, Inc., Warren, NJ
- Reason
- Lack of Assurance of Sterility: Due to an FDA observation at the contract manufacturing site for deficiencies in their visual inspection procedure.
- Lots
- Lot, expiry: 4401699IR1, Exp. 5/31/2026; 4401699IR2, Exp. 5/31/2026; 4401700IR1, Exp. 5/31/2026; 4401701IR1, Exp. 5/31/2026; 4401702IR1, Exp. 5/31/2026; 4401722IR1, Exp. 5/31/2026; 4401723IR1, Exp. 5/31/2026; 4401724IR1, Exp. 5/31/2026; 4401725IR1, Exp. 5/31/2026; 4401732IR1, Exp. 5/31/2026; 4401768IR1, Exp. 6/30/2026 4401769IR1, Exp. 11/30/2026; 4401787IR1, Exp. 11/30/2026; 4401815IR1, Exp. 11/30/2026; 4401816IR1, Exp. 11/30/2026; 4401834IR1, Exp. 11/30/2026; 4401835IR1, Exp. 11/30/2026; 4401846IR1, Exp. 11/30/2026; 4401851IR1, Exp. 11/30/2026; 4500017IR1, Exp. 12/31/2026; 4500031IR1, Exp…
- Distribution
- Nationwide in the USA
- RxNorm
- lanreotide acetate (RxCUI 749811, 749814, 749817)
- Recall number
- D-0423-2026
Class II · Posted April 15, 2026 · Started March 13, 2026 · Ongoing
lanreotide acetate
- Product
- Lanreotide Injection, 120 mg*/0.5 mL, Box contains 1 Pre-filled syringe and 1 safety needle, Single dose only, Rx Only, Manufactured by: Pharmathen International, S.A., Rodopi, Greece. Manufactured for: Cipla USA, Inc., 10 Independence Boulevard, Suite 300, Warren, NJ 07059. NDC: 69097-870-67
- Firm
- Cipla USA, Inc., Warren, NJ
- Reason
- Lack of Assurance of Sterility: Due to an FDA observation at the contract manufacturing site for deficiencies in their visual inspection procedure.
- Lots
- Lot, expiry: 4401666IR1, Exp 8/31/2027; 4401703IR1, Exp 9/30/2027; 4401703IR2, EXP 9/30/2027; 4401704IR1, Exp 9/30/2027; 4401705IR1, Exp 9/30/2027; 4401706IR1, Exp 9/30/2027; 4401720IR1, Exp 9/30/2027; 4401721IR1, Exp 9/30/2027; 4401733IR1, Exp 9/30/2027; 4401770IR1, Exp 9/30/2027; 4401777IR1, Exp 9/30/2027; 4401788IR1, Exp 10/31/2027; 4401804IR1, Exp 10/31/2027; 4401805IR1, Exp 10/31/2027; 4401824IR1, Exp 10/31/2027; 4401860IR1, Exp 10/31/2027; 4500019IR1, Exp 11/30/2027; 4500035IR1, Exp 11/30/2027; 4500036IR1, Exp 11/30/2027; 4500078IR1, Exp 11/30/2027; 4500079IR1, Exp 11/30/2027…
- Quantity
- 54,583 syringes
- Distribution
- Nationwide in the USA
- RxNorm
- lanreotide acetate (RxCUI 749811, 749814, 749817)
- Recall number
- D-0422-2026
Class II · Posted April 15, 2026 · Started March 11, 2026 · Ongoing
dextrose monohydrate
- Product
- 5% Dextrose Injection, USP 12.5 g per 250 mL (50 mg per mL) 250 mL in a 250 mL freeflex bag, Fresenius Kabi USA, LLC ("Fresenius Kabi"), Unit of Use NDC: 65219-458-05, Unit of Sale NDC Number: 65219-458-30.
- Firm
- Fresenius Kabi USA, LLC, Lake Zurich, IL
- Reason
- Lack of Assurance of Sterility
- Lots
- Batch# 6402165, Exp Date: 05/30/2028.
- Distribution
- US Nationwide , Alaska, and Puerto Rico.
- RxNorm
- dextrose monohydrate (RxCUI 1795607, 1795609, 1795610, 1795612, 1795616)
- Recall number
- D-0437-2026
Class II · Posted April 15, 2026 · Started March 11, 2026 · Ongoing
dextrose monohydrate
- Product
- 5% Dextrose Injection, USP 5 g per 100 mL (50 mg per mL) 100 mL in a 100 mL freeflex bag, Fresenius Kabi USA, LLC ("Fresenius Kabi"), Unit of Use NDC: 65219-464-05, Unit of Sale NDC Number: 65219-464-50.
- Firm
- Fresenius Kabi USA, LLC, Lake Zurich, IL
- Reason
- Lack of Assurance of Sterility
- Lots
- Batch# 6402399, 6402400, 6402401, Exp Date: 02/28/2027.
- Distribution
- US Nationwide , Alaska, and Puerto Rico.
- RxNorm
- dextrose monohydrate (RxCUI 1795607, 1795609, 1795610, 1795612, 1795616)
- Recall number
- D-0436-2026
Class II · Posted April 15, 2026 · Started March 11, 2026 · Ongoing
dextrose monohydrate
- Product
- 5% Dextrose Injection, USP 2.5 g per 50 mL (50 mg per mL) 50 mL in a 100 mL freeflex bag, Fresenius Kabi USA, LLC ("Fresenius Kabi"), Unit of Use NDC: 65219-456-05, Unit of Sale NDC Number: 65219-456-60.
- Firm
- Fresenius Kabi USA, LLC, Lake Zurich, IL
- Reason
- Lack of Assurance of Sterility
- Lots
- Batch# 6402296, Exp Date: 07/31/2026.
- Distribution
- US Nationwide , Alaska, and Puerto Rico.
- RxNorm
- dextrose monohydrate (RxCUI 1795607, 1795609, 1795610, 1795612, 1795616)
- Recall number
- D-0435-2026
Class II · Posted April 15, 2026 · Started March 11, 2026 · Ongoing
sodium chloride
- Product
- 0.9% Sodium Chloride Injection, USP 900 mg per 100 mL (9 mg per mL), 1,000 mL in a Single Dose freeflex bag, Rx only, BD Becton, Dickson and Company, 1 Becton Drive, Franklin Lakes, NJ 07417, Distributed by BD, Manufactured by Fresenius Kabi, Unit of Sale NDC Number: 17271-701-07.
- Firm
- Fresenius Kabi USA, LLC, Lake Zurich, IL
- Reason
- Lack of Assurance of Sterility
- Lots
- Batch# 24EU10010, Exp Date: 05/31/2027.
- Distribution
- US Nationwide , Alaska, and Puerto Rico.
- RxNorm
- sodium chloride (RxCUI 1807631, 1807632, 1807633, 1807634, 1807639)
- Recall number
- D-0434-2026
Class II · Posted April 15, 2026 · Started March 11, 2026 · Ongoing
sodium chloride
- Product
- 0.9% Sodium Chloride Injection, USP, 900 mg per 100 mL (9 mg per mL) 1,000 mL in a Single Dose freeflex bag, 1,000 mLx10, Fresenius Medical Care, Waltham, MA 02451, Distributed by: Fresenius Medical Care RTG, LLC, Manufactured by: Fresenius Kabi, Unit of Use NDC: 65219-282-01, Unit of Sale NDC Number: 65219-282-10.
- Firm
- Fresenius Kabi USA, LLC, Lake Zurich, IL
- Reason
- Lack of Assurance of Sterility
- Lots
- Batch# 23SU10001, Exp Date: 12/31/2026; Batch# 24AU10003, 24AU10004, 24AU10005, 24AU10008, Exp Date: 01/31/2027; Batch # 24EU10001, 24EU10002, Exp Date: 05/31/2027; Batch# 24PU10002, Exp Date: 11/30/2027; Batch# 25BU10003, Exp Date: 02/29/2028; Batch# 25EU10005, Exp Date: 05/31/2028.
- Distribution
- US Nationwide , Alaska, and Puerto Rico.
- RxNorm
- sodium chloride (RxCUI 1807639)
- Recall number
- D-0433-2026
Class II · Posted April 15, 2026 · Started March 11, 2026 · Ongoing
sodium chloride
- Product
- 0.9% Sodium Chloride Injection, USP 900 mg per 100 mL (9 mg per mL) 500 mL in a Single Dose freeflex bag, 500 mL x 20, Manufactured for: Fresenius Kabi USA, LLC ("Fresenius Kabi"), IL 60047, Unit of Use NDC: 65219-432-20, Unit of Sale NDC Number: 65219-432-85.
- Firm
- Fresenius Kabi USA, LLC, Lake Zurich, IL
- Reason
- Lack of Assurance of Sterility
- Lots
- Batch# 23DU10004, Exp Date: 04/30/2026; Batch# 23HU10006, Exp Date: 06/30/2026.
- Distribution
- US Nationwide , Alaska, and Puerto Rico.
- RxNorm
- sodium chloride (RxCUI 1807634, 1807639)
- Recall number
- D-0432-2026
Class II · Posted April 15, 2026 · Started March 11, 2026 · Ongoing
sodium chloride
- Product
- 0.9% Sodium Chloride Injection, USP, 900 mg per 100 mL (9 mg per mL) 250 mL in a Single Dose freeflex bag, Rx only, BD Becton, Dickson and Company, 1 Beckton Drive, Franklin Lakes, NJ 07417, Distributed by BD, Manufactured by: Fresenius Kabi USA, LLC ("Fresenius Kabi"), Unit of Sale NDC Number: 17271-701-05.
- Firm
- Fresenius Kabi USA, LLC, Lake Zurich, IL
- Reason
- Lack of Assurance of Sterility
- Lots
- Batch# 6402290, 6402291, Exp Date: 01/31/2028; Batch# 6402411, Exp Date: 02/29/2028; Batch# 6402412, 6402419, 6402424, 6402425, 6402426, 6402427, Exp Date: 03/31/2028; Batch# 6402479, 6402480, 6402517, 6402571, Exp Date: 05/31/2028; Batch# 6402518, Exp Date: 06/30/2028.
- Distribution
- US Nationwide , Alaska, and Puerto Rico.
- RxNorm
- sodium chloride (RxCUI 1807631, 1807632, 1807633, 1807634, 1807639)
- Recall number
- D-0431-2026
Class II · Posted April 15, 2026 · Started March 11, 2026 · Ongoing
sodium chloride
- Product
- 0.9% Sodium Chloride Injection, USP, 900 mg per 100 mL (9 mg per mL) 100 mL in a Single Dose freeflex bag, Rx only, BD Beckton, Dickson and Company, 1 Beckton Drive, Franklin Lakes, NJ 07417 USA, Distributed by BD, Manufactured by: Fresenius Kabi USA, LLC ("Fresenius Kabi"), Unit of Sale NDC Number: 17271-701-03.
- Firm
- Fresenius Kabi USA, LLC, Lake Zurich, IL
- Reason
- Lack of Assurance of Sterility
- Lots
- Batch# 6402153, Exp Date: 11/30/2026; Batch# 6402297, 6402298, Exp Date: 01/31/2027; Batch# 6402377, 6402378, 6402379, Exp Date: 02/28/2027; Batch # 6402429, 6402430, 6402431, 6402432, 6402433, Exp Date: 03/31/2027; Batch# 6402434, Exp Date: 04/30/2027; Batch# 6402512, Exp Date: 05/2027; Batch# 6402574, 6402576, Exp Date: 06/30/2027.
- Distribution
- US Nationwide , Alaska, and Puerto Rico.
- RxNorm
- sodium chloride (RxCUI 1807631, 1807632, 1807633, 1807634, 1807639)
- Recall number
- D-0430-2026
Class II · Posted April 15, 2026 · Started March 11, 2026 · Ongoing
sodium chloride
- Product
- 0.9% Sodium Chloride Injection, USP, 50 mL x60, Becton, Dickson and Company, 1 Beckton Drive, Franklin Lakes, NJ 07417 USA, Distributed by BD, Manufactured by Fresenius Kabi USA, LLC ("Fresenius Kabi"), Unit of Sale NDC Number: 17271-701-02.
- Firm
- Fresenius Kabi USA, LLC, Lake Zurich, IL
- Reason
- Lack of Assurance of Sterility
- Lots
- Batch# 6402428, Exp Date: 10/31/2026; Batch# 6402481, 6402482, Exp Date: 11/30/2026.
- Distribution
- US Nationwide , Alaska, and Puerto Rico.
- RxNorm
- sodium chloride (RxCUI 1807631, 1807632, 1807633, 1807634, 1807639)
- Recall number
- D-0429-2026
Class II · Posted April 15, 2026 · Started March 11, 2026 · Ongoing
sodium chloride
- Product
- 0.9% Sodium Chloride Injection, USP, (4,500 mg per 500 mL) (9 mg per mL) 500 mL in a 500 mL freeflex bag, Rx only, Fresenius Kabi USA, LLC ("Fresenius Kabi"), Lake Zurich, IL 60047, Unit of Use NDC: 65219-472-05, Unit of Sale NDC Number: 65219-472-20.
- Firm
- Fresenius Kabi USA, LLC, Lake Zurich, IL
- Reason
- Lack of Assurance of Sterility
- Lots
- Batch# 24LU10013, 24LU10014, Exp Date: 09/30/2027; Batch# 24NU10001, 24NU10002, Exp Date: 10/31/2027.
- Distribution
- US Nationwide , Alaska, and Puerto Rico.
- RxNorm
- sodium chloride (RxCUI 1807631, 1807632, 1807633, 1807634, 1807639)
- Recall number
- D-0428-2026
Class II · Posted April 15, 2026 · Started March 11, 2026 · Ongoing
sodium chloride
- Product
- 0.9% Sodium Chloride Injection, USP, (2,250 mg per 250 mL) (9 mg per mL) 250 mL in a 250 mL freeflex bag, Rx only, Fresenius Kabi USA, LLC ("Fresenius Kabi"), Lake Zurich, IL 60047, Unit of Use NDC: 65219-470-05, Unit of Sale NDC Number: 65219-470-30.
- Firm
- Fresenius Kabi USA, LLC, Lake Zurich, IL
- Reason
- Lack of Assurance of Sterility
- Lots
- Batch# 23SU10008, Exp Date: 12/31/2026; Batch# 24JU10003, Exp Date: 07/31/2027; Batch# 24LU10011, 24LU10012, Exp Date: 9/30/2027; Batch# 6402273, 6402275, Exp Date: 01/31/2028; Batch# 6402420, 6402421, 6402422, 6402423, Exp Date: 03/31/2028; Batch# 6402473, 6402474, 6402475, 6402476, 6402485, Exp Date: 04/30/2028; Batch# 6402516, Exp Date: 05/31/2028.
- Distribution
- US Nationwide , Alaska, and Puerto Rico.
- RxNorm
- sodium chloride (RxCUI 1807631, 1807632, 1807633, 1807634, 1807639)
- Recall number
- D-0427-2026