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Recall data is sourced from official U.S. government agencies (CPSC, FDA, NHTSA, USDA) and processed using AI to improve readability. This site is not affiliated with or endorsed by any government agency. Always refer to the original agency notice for authoritative information.

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Medium RiskFDA Drug
Medical Devices

CAPS Various IV Bags and Syringes Recalled Due to Lack of Sterility

Agency Publication Date: August 1, 2023
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Summary

Central Admixture Pharmacy Services (CAPS), Inc. is recalling approximately 957,309 various intravenous (IV) bags and syringes used for treatments such as neonatal nutrition, heart surgery support, and anesthesia. These products, which include common medications like Heparin, Oxytocin, and Vancomycin, are being recalled because the company lacks validation data to ensure their decontamination cycles were effective. This means the products may not be sterile, which can lead to serious infections in hospital patients. No injuries or illnesses have been reported to date.

Risk

A lack of sterility assurance in injectable medications poses a significant risk of infection to patients. Because these IV bags and syringes are used directly in the bloodstream or during surgical procedures, any contamination could cause life-threatening complications, especially in vulnerable populations such as newborn infants in neonatal care.

What You Should Do

  1. This recall affects a wide range of IV bags and syringes manufactured by CAPS, Inc., including neonatal TPN starter bags, cardioplegia solutions, and generic medications such as Vancomycin, Heparin, and Oxytocin.
  2. Healthcare facilities should identify affected products by checking the label for the product name, National Drug Code (NDC), and lot number.
  3. Check the lot number and expiration date printed on each bag or syringe label. See the Affected Products section below for the full list of affected codes.
  4. Stop using the recalled product. Contact the manufacturer or your distributor to arrange return.
  5. Call the FDA Consumer Complaint hotline at 1-888-723-3332 (1-888-SAFEFDA) for additional information regarding this recall.

Your Remedy Options

๐Ÿ“‹Other Action

Hospital and clinic quarantine and return.

How to: Stop using the recalled product. Contact the manufacturer or your distributor to arrange return.

Affected Products

Product: Neonatal TPN Starter Bag, Amino Acids (trophamine) 2%/Dextrose 10% with CALCIUM and HEPARIN (250mL)
Variants: 2%/10%, IV Bag, Rx only
Lot Numbers:
36-254909 (Exp. 7/22/2023)
36-256333 (Exp. 7/29/2023)
NDC:
72196-0416-1

Recall #: D-0993-2023

Product: Neonatal TPN Starter Bag, Amino Acids (trophamine) 2%/Dextrose 10% with CALCIUM (250mL)
Variants: 2%/10%, IV Bag, Rx only
Lot Numbers:
36-254911 (Exp. 7/22/2023)
NDC:
72196-0401-1

Recall #: D-0992-2023

Product: CARDIOPLEGIA SOLUTION, 60 mEq K, Induction 4:1, High Potassium (830 mL)
Variants: IV Bag, 60 mEq K
Lot Numbers:
36-251685 (Exp. 7/15/2023)
36-252364 (Exp. 7/17/2023)
NDC:
72196-0100-1

Recall #: D-1028-2023

Product: CARDIOPLEGIA SOLUTION, 106 mEq K, Modified St. Thomas Solution High Potassium High Sodium Bicarbonate (1000 mL)
Variants: IV Bag, 106 mEq K, Rx only
Lot Numbers:
36-253949 (Exp. 7/20/2023)
36-255411 (Exp. 7/23/2023)
NDC:
72196-0204-1

Recall #: D-1029-2023

Product: CARDIOPLEGIA SOLUTION 122 mEq K, Modified St. Thomas Formula High Potassium (1000 mL)
Variants: IV Bag, 122 mEq K, Rx only
Lot Numbers:
36-256332 (Exp. 7/29/2023)
NDC:
72196-0209-1

Recall #: D-1030-2023

Product: rocuronium 50 mg/5 mL (10 mg/mL)
Variants: Syringe, Rx only
Lot Numbers (85):
36-238805 (Exp. 7/10/2023)
36-238806 (Exp. 7/10/2023)
36-238808 (Exp. 7/10/2023)
36-238809 (Exp. 7/10/2023)
36-238810 (Exp. 7/10/2023)
36-238811 (Exp. 7/10/2023)
36-239229 (Exp. 7/11/2023)
36-239319 (Exp. 7/11/2023)
36-239320 (Exp. 7/11/2023)
36-239321 (Exp. 7/11/2023)
36-239322 (Exp. 7/11/2023)
36-239453 (Exp. 7/12/2023)
36-239454 (Exp. 7/12/2023)
36-239455 (Exp. 7/12/2023)
36-239851 (Exp. 7/13/2023)
36-239852 (Exp. 7/13/2023)
36-240204 (Exp. 7/16/2023)
36-240509 (Exp. 7/17/2023)
36-240510 (Exp. 7/17/2023)
36-240511 (Exp. 7/17/2023)
36-241263 (Exp. 7/19/2023)
36-241266 (Exp. 7/19/2023)
36-241362 (Exp. 7/20/2023)
36-241363 (Exp. 7/20/2023)
36-241365 (Exp. 7/20/2023)
36-241880 (Exp. 7/23/2023)
36-241881 (Exp. 7/23/2023)
36-241882 (Exp. 7/23/2023)
36-242376 (Exp. 7/24/2023)
36-242377 (Exp. 7/24/2023)
36-242603 (Exp. 7/25/2023)
36-242618 (Exp. 7/25/2023)
36-242643 (Exp. 7/26/2023)
36-242644 (Exp. 7/26/2023)
36-242645 (Exp. 7/26/2023)
36-243534 (Exp. 7/30/2023)
36-243535 (Exp. 7/30/2023)
36-243831 (Exp. 7/31/2023)
36-244831 (Exp. 8/01/2023)
36-244833 (Exp. 8/01/2023)
36-244841 (Exp. 8/01/2023)
36-244842 (Exp. 8/01/2023)
36-244845 (Exp. 8/01/2023)
36-244855 (Exp. 8/01/2023)
36-245803 (Exp. 8/02/2023)
36-246288 (Exp. 8/03/2023)
36-246289 (Exp. 8/03/2023)
36-246290 (Exp. 8/03/2023)
36-246291 (Exp. 8/03/2023)
36-246369 (Exp. 8/03/2023)
NDC:
72196-6010-1

Repackaged by CAPS Inc. Recall #: D-0947-2023

Product: vancomycin 1 g/250 mL added to 0.9% sodium chloride, 4 mg/mL
Variants: IV Bag, Rx only
Lot Numbers:
36-245576 (Exp. 8/2/2023)
36-254436 (Exp. 9/5/2023)
36-254442 (Exp. 9/5/2023)
36-255131 (Exp. 9/6/2023)
36-256045 (Exp. 9/11/2023)
36-239523 (Exp. 7/12/2023)
36-248987 (Exp. 8/16/2023)
36-240797 (Exp. 7/17/2023)
36-241979 (Exp. 7/24/2023)
36-242705 (Exp. 7/26/2023)
36-251733 (Exp. 8/29/2023)
36-251738 (Exp. 8/29/2023)
NDC:
72196-6064-1

Recall #: D-0948-2023

Product: succinylcholine 200 mg/10 mL (20 mg/mL)
Variants: Syringe, Rx only
Lot Numbers (77):
36-238812 (Exp. 7/10/2023)
36-238813 (Exp. 7/10/2023)
36-238814 (Exp. 7/10/2023)
36-238815 (Exp. 7/10/2023)
36-238816 (Exp. 7/10/2023)
36-238819 (Exp. 7/10/2023)
36-239281 (Exp. 7/11/2023)
36-239282 (Exp. 7/11/2023)
36-239284 (Exp. 7/11/2023)
36-239459 (Exp. 7/12/2023)
36-239460 (Exp. 7/12/2023)
36-239628 (Exp. 7/12/2023)
36-239629 (Exp. 7/12/2023)
36-239879 (Exp. 7/13/2023)
36-239880 (Exp. 7/13/2023)
36-239881 (Exp. 7/13/2023)
36-240272 (Exp. 7/16/2023)
36-240512 (Exp. 7/17/2023)
36-240513 (Exp. 7/17/2023)
36-240514 (Exp. 7/17/2023)
36-240515 (Exp. 7/17/2023)
36-240724 (Exp. 7/17/2023)
36-240991 (Exp. 7/18/2023)
36-240992 (Exp. 7/18/2023)
36-240993 (Exp. 7/18/2023)
36-241267 (Exp. 7/19/2023)
36-241269 (Exp. 7/19/2023)
36-241364 (Exp. 7/20/2023)
36-241366 (Exp. 7/20/2023)
36-241367 (Exp. 7/20/2023)
36-241368 (Exp. 7/20/2023)
36-241669 (Exp. 7/21/2023)
36-241670 (Exp. 7/21/2023)
36-241735 (Exp. 7/21/2023)
36-242079 (Exp. 7/24/2023)
36-242080 (Exp. 7/24/2023)
36-242081 (Exp. 7/24/2023)
36-242082 (Exp. 7/24/2023)
36-242083 (Exp. 7/24/2023)
36-242084 (Exp. 7/24/2023)
36-242085 (Exp. 7/24/2023)
36-242624 (Exp. 7/26/2023)
36-242627 (Exp. 7/26/2023)
36-242628 (Exp. 7/26/2023)
36-242629 (Exp. 7/26/2023)
36-243046 (Exp. 7/27/2023)
36-243047 (Exp. 7/27/2023)
36-243048 (Exp. 7/27/2023)
36-243049 (Exp. 7/27/2023)
36-243050 (Exp. 7/27/2023)
NDC:
72196-6011-2

Repackaged by CAPS Inc. Recall #: D-0949-2023

Product: vancomycin 1.25 g/250 mL added to dextrose 5%, 5 mg/mL
Variants: IV Bag, Rx only
Lot Numbers:
36-245562 (Exp. 8/2/2023)
36-254425 (Exp. 9/5/2023)
36-255129 (Exp. 9/6/2023)
36-238965 (Exp. 7/10/2023)
36-256041 (Exp. 9/11/2023)
36-241129 (Exp. 7/19/2023)
36-241130 (Exp. 7/19/2023)
36-241438 (Exp. 7/20/2023)
36-242703 (Exp. 7/26/2023)
36-243163 (Exp. 7/27/2023)
36-243164 (Exp. 7/27/2023)
36-251724 (Exp. 8/29/2023)
36-251727 (Exp. 8/29/2023)
NDC:
72196-6073-1

Recall #: D-0950-2023

Product: dilTIAZem 125mg/125mL (1 mg/mL), added to dextrose 5%
Variants: IV Bag, Rx only
Lot Numbers:
36-243946 (Exp. 7/11/2023)
36-243947 (Exp. 7/11/2023)
36-243948 (Exp. 7/11/2023)
36-243949 (Exp. 7/11/2023)
36-255120 (Exp. 8/17/2023)
36-246829 (Exp. 7/18/2023)
36-246831 (Exp. 7/18/2023)
36-246832 (Exp. 7/18/2023)
36-255961 (Exp. 8/21/2023)
36-256896 (Exp. 8/25/2023)
NDC:
72196-6054-1

Recall #: D-0951-2023

Product: glycopyrrolate 1 mg/5 mL (0.2 mg/mL), For Anesthesia Use
Variants: Syringe, Rx only
Lot Numbers:
36-247022 (Exp. 08/07/2023)
36-239877 (Exp. 07/13/2023)
36-241448 (Exp. 07/20/2023)
36-251782 (Exp. 08/29/2023)
NDC:
72196-6084-1

Recall #: D-0952-2023

Product: dilTIAZem 125mg/125mL (1 mg/mL), added to 0.9% sodium chloride
Variants: IV Bag, Rx only
Lot Numbers:
36-244893 (Exp. 7/12/2023)
36-244894 (Exp. 7/12/2023)
36-244895 (Exp. 7/12/2023)
36-246428 (Exp. 7/14/2023)
36-246429 (Exp. 7/14/2023)
36-246647 (Exp. 7/14/2023)
36-246648 (Exp. 7/14/2023)
36-254364 (Exp. 8/15/2023)
36-254365 (Exp. 8/15/2023)
36-254366 (Exp. 8/15/2023)
36-254367 (Exp. 8/15/2023)
36-254368 (Exp. 8/15/2023)
36-246824 (Exp. 7/18/2023)
36-246825 (Exp. 7/18/2023)
36-246828 (Exp. 7/18/2023)
36-256157 (Exp. 8/21/2023)
36-256890 (Exp. 8/25/2023)
NDC:
72196-6055-1

Recall #: D-0953-2023

Product: EPINEPHrine 4mg/250mL added to 0.9% sodium chloride
Variants: IV Bag, Rx only
Lot Numbers:
36-239250 (Exp. 7/10/2023)
36-240225 (Exp. 7/16/2023)
36-241268 (Exp. 7/19/2023)
36-241270 (Exp. 7/19/2023)
36-241443 (Exp. 7/20/2023)
36-242436 (Exp. 7/25/2023)
36-242439 (Exp. 7/25/2023)
36-243517 (Exp. 7/30/2023)
36-243738 (Exp. 7/30/2023)
36-245656 (Exp. 8/2/2023)
36-246154 (Exp. 8/3/2023)
36-246169 (Exp. 8/3/2023)
36-246672 (Exp. 8/3/2023)
36-246673 (Exp. 8/3/2023)
36-246674 (Exp. 8/3/2023)
36-247015 (Exp. 8/7/2023)
36-247016 (Exp. 8/7/2023)
36-247017 (Exp. 8/7/2023)
36-247339 (Exp. 8/8/2023)
36-247341 (Exp. 8/8/2023)
36-247342 (Exp. 8/8/2023)
36-247343 (Exp. 8/8/2023)
36-249466 (Exp. 8/17/2023)
36-249467 (Exp. 8/17/2023)
36-249591 (Exp. 8/18/2023)
36-249592 (Exp. 8/18/2023)
36-251338 (Exp. 8/27/2023)
36-251940 (Exp. 8/30/2023)
36-254371 (Exp. 9/4/2023)
36-254372 (Exp. 9/4/2023)
36-254373 (Exp. 9/4/2023)
36-254375 (Exp. 9/4/2023)
NDC:
72196-8093-1

Recall #: D-0954-2023

Product: vancomycin 1.25 g/250 mL added to 0.9% Sodium Chloride, 5 mg/mL
Variants: IV Bag, Rx only
Lot Numbers:
36-254431 (Exp. 9/5/2023)
36-255125 (Exp. 9/6/2023)
36-255126 (Exp. 9/6/2023)
36-255127 (Exp. 9/6/2023)
36-248083 (Exp. 8/10/2023)
36-238973 (Exp. 7/10/2023)
36-238980 (Exp. 7/10/2023)
36-239520 (Exp. 7/12/2023)
36-240087 (Exp. 7/13/2023)
36-248979 (Exp. 8/16/2023)
36-248980 (Exp. 8/16/2023)
36-248981 (Exp. 8/16/2023)
36-240760 (Exp. 7/17/2023)
36-240761 (Exp. 7/17/2023)
36-240762 (Exp. 7/17/2023)
36-240837 (Exp. 7/18/2023)
36-240838 (Exp. 7/18/2023)
36-241131 (Exp. 7/19/2023)
36-241132 (Exp. 7/19/2023)
36-241436 (Exp. 7/20/2023)
36-251065 (Exp. 8/24/2023)
36-241980 (Exp. 7/24/2023)
36-242707 (Exp. 7/26/2023)
36-243153 (Exp. 7/27/2023)
36-243155 (Exp. 7/27/2023)
36-243156 (Exp. 7/27/2023)
36-252188 (Exp. 8/31/2023)
36-252189 (Exp. 8/31/2023)
36-252191 (Exp. 8/31/2023)
36-252192 (Exp. 8/31/2023)
36-252198 (Exp. 8/31/2023)
36-252201 (Exp. 8/31/2023)
36-243951 (Exp. 7/31/2023)
NDC:
72196-6074-1

Recall #: D-0955-2023

Product: PHENYLephrine 1,000 mcg/10mL, (100mcg/mL) in 0.9% sodium chloride
Variants: Syringe, Rx only
Lot Numbers (157):
36-239063 (Exp. 7/10/2023)
36-239064 (Exp. 7/10/2023)
36-239065 (Exp. 7/10/2023)
36-239066 (Exp. 7/10/2023)
36-239067 (Exp. 7/10/2023)
36-239068 (Exp. 7/10/2023)
36-239069 (Exp. 7/10/2023)
36-239204 (Exp. 7/10/2023)
36-239196 (Exp. 7/11/2023)
36-239197 (Exp. 7/11/2023)
36-239198 (Exp. 7/11/2023)
36-239199 (Exp. 7/11/2023)
36-239200 (Exp. 7/11/2023)
36-239201 (Exp. 7/11/2023)
36-239202 (Exp. 7/11/2023)
36-239203 (Exp. 7/11/2023)
36-239205 (Exp. 7/11/2023)
36-239206 (Exp. 7/11/2023)
36-239483 (Exp. 7/12/2023)
36-239487 (Exp. 7/12/2023)
36-239488 (Exp. 7/12/2023)
36-239489 (Exp. 7/12/2023)
36-239490 (Exp. 7/12/2023)
36-239639 (Exp. 7/12/2023)
36-239640 (Exp. 7/12/2023)
36-239641 (Exp. 7/12/2023)
36-239788 (Exp. 7/13/2023)
36-239789 (Exp. 7/13/2023)
36-239790 (Exp. 7/13/2023)
36-239793 (Exp. 7/13/2023)
36-239797 (Exp. 7/13/2023)
36-239798 (Exp. 7/13/2023)
36-240139 (Exp. 7/16/2023)
36-240140 (Exp. 7/16/2023)
36-240141 (Exp. 7/16/2023)
36-240142 (Exp. 7/16/2023)
36-240143 (Exp. 7/16/2023)
36-240319 (Exp. 7/17/2023)
36-240320 (Exp. 7/17/2023)
36-240321 (Exp. 7/17/2023)
36-240322 (Exp. 7/17/2023)
36-240812 (Exp. 7/17/2023)
36-241074 (Exp. 7/18/2023)
36-241075 (Exp. 7/18/2023)
36-241076 (Exp. 7/18/2023)
36-241077 (Exp. 7/18/2023)
36-241136 (Exp. 7/19/2023)
36-241357 (Exp. 7/20/2023)
36-241358 (Exp. 7/20/2023)
36-241359 (Exp. 7/20/2023)
NDC:
72196-6009-1

Recall #: D-0965-2023

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 92707
Status: Resolved
Manufacturer: Central Admixture Pharmacy Services, Inc.
Sold By: Authorized hospital pharmacies; Healthcare facilities
Manufactured In: United States
Units Affected: 95 products (77,554 Syringes.; 3,980 bags; 26,208 Syringes; 4824 bags; 2,260 bags; 770 Syringes; 3,699 bags; 9,121 bags; 15,304 bags; 10,480 bags; 333 Bags; 6,784 bags; 4,570 bags; 7518 bag; 8,363 bags; 1,853 bags.; 9,432 bags; 472 bags; 499,304 Syringes; 3,648 bags; 6,772 bags; 2,914 bags; 6,782 bags; 5,588 bags; 1927 bags; 1937 bags; 3821 bags; 358 bags; 751 bags; 6037 bags; 7,509 bags; 11,824 bags; 5,834 bags; 52 bags; 448 bags; 6,468 Syringes; 463 bags; 9504 bags; 128 bags; 130,250 bags; I,I87 bags.; 80 bags; 7469 bags; 234 bags; 24 bags; 48 bags; 188 bags; 68 bags; 80 bags; 296 bags; 356 bags; 420 bags; 84 bags; 516 bags; 68 bags; 96 bags; 497 bags; 224 bags; 304 bags; 108 bags; 156 bags; 124 bags; 244 bags; 192 bags; 420 bags; 33,073 bags; 2692 bags; 80 bags; 48 bags.; 80 bags; 48; 192; 212 bags; 28 bags; 44 bags; 80 bags; 56 bags; 308 bags; 36 bags; 12 IV bags; 132 bags; 196 bags; 144 bags.; 80 bags.; 284; 56 bags; 80 bags.; 148 bags; 172 bags; 88 bags; 356 bags; 184 bags; 84 bags; 72 bags; 104 bags)
Distributed To: Nationwide

Were You Affected by This Recall?

If you or a family member were harmed by this recalled product, you may have legal rights. Consider consulting a consumer protection attorney to understand your options for compensation.

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AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.

Sources: FDA iRES ยท Raw API Response

openFDA Disclaimer: This recall information is sourced from the openFDA API. 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. Refer to the openFDA terms of service for more information.