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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
Medications & Supplements/Prescription Drugs

SCA Injectable Medications Recalled for Lack of Sterility Assurance

Agency Publication Date: March 25, 2024
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Summary

SCA Pharmaceuticals, LLC has recalled 112,812 units of various injectable medications, including fentanyl, hydromorphone, and phenylephrine, because they lack assurance of sterility. Using these products could potentially lead to serious or life-threatening infections, as the lack of sterility assurance means the medications may be contaminated with microorganisms. No injuries or adverse events have been reported to date, and the products were distributed nationwide to healthcare facilities and hospitals.

Risk

A lack of sterility assurance in injectable medications poses a significant health risk because the product is administered directly into the bloodstream or body tissues. If contaminated, the medication can cause severe infections that are especially dangerous for patients who are already ill or have weakened immune systems.

What You Should Do

  1. This recall affects 25 different types of sterile injectable medications sold in bags, syringes, and cassettes under the SCA Pharmaceuticals brand, including fentanyl, hydromorphone, phenylephrine, diltiazem, labetalol, midazolam, neostigmine, sodium citrate, succinylcholine, and vancomycin.
  2. Healthcare facility staff should check their medication inventory for specific lot numbers and expiration dates, such as Diltiazem lot 1223049625 (Exp 1/24/24) or Fentanyl lot 1223045757 (Exp 12/27/23). See the Affected Products section below for the full list of affected codes.
  3. Stop using the recalled product. Contact the manufacturer or your distributor to arrange return.
  4. Call the FDA Consumer Complaint hotline at 1-888-723-3332 if you have additional questions or wish to report a concern.

Your Remedy Options

๐Ÿ“‹Other Action
How to: Stop using the recalled product. Contact the manufacturer or your distributor to arrange return.

Affected Products

Product: Diltiazem HCl 125 mg in 0.9% Sodium Chloride Injection (125 mL Bag)
Variants: 1 mg/mL
UPC Codes:
70004054135
Lot Numbers:
1223049625 (Exp 1/24/24)
NDC:
70004-0541-35

Recall #: D-0394-2024

Product: fentaNYL 2,500 mcg/250 mL in 0.9% Sodium Chloride Injection (250 mL Bag)
Variants: 10 mcg/mL
UPC Codes:
70004022940
Lot Numbers:
1223045757 (Exp 12/27/23)
1223049716 (Exp 5/25/24)
NDC:
70004-0229-40

Recall #: D-0395-2024

Product: fentaNYL 2,500 mcg/50 mL Injection (50 mL Bag)
Variants: 50 mcg/mL
UPC Codes:
70004022230
Lot Numbers:
1223048351 (Exp 11/30/23)
1223048532 (Exp 12/07/23)
NDC:
70004-0222-30

Recall #: D-0396-2024

Product: fentaNYL 200 mcg/100 mL, Bupivacaine HCl 0.125% in 0.9% Sodium Chloride Injection (100 mL Bag)
Variants: fentaNYL 2 mcg/mL
UPC Codes:
70004023132
Lot Numbers:
1223048855 (Exp 12/6/23)
NDC:
70004-0231-32

Recall #: D-0397-2024

Product: fentaNYL 200 mcg/100 mL, Bupivacaine HCl 0.125% in 0.9% Sodium Chloride Injection (100 mL Yellow CADD Cassette)
Variants: fentaNYL 2 mcg/mL
UPC Codes:
70004023164
Lot Numbers:
1223049754 (Exp 01/12/24)
1223049992 (Exp 01/23/24)
1223050066 (Exp 01/25/24)
NDC:
70004-0231-64

Recall #: D-0398-2024

Product: fentaNYL 100 mcg/50 mL, Bupivacaine HCl 0.125% in 0.9% Sodium Chloride Injection (50 mL Syringe)
Variants: fentaNYL 2 mcg/mL
UPC Codes:
70004023122
Lot Numbers:
1223049125 (Exp 12/04/23)
NDC:
70004-0231-22

Recall #: D-0399-2024

Product: fentaNYL 500 mcg/100 mL, Bupivacaine HCl 0.04% in 0.9% Sodium Chloride Injection (100 mL Yellow CADD Cassette)
Variants: fentaNYL 5 mcg/mL
UPC Codes:
70004028964
Lot Numbers:
1223049261 (Exp 12/25/23)
1223049724 (Exp 01/11/24)
NDC:
70004-0289-64

Recall #: D-0400-2024

Product: fentaNYL 500 mcg/100 mL, Bupivacaine HCl 0.075% in 0.9% Sodium Chloride Injection (100 mL Yellow CADD Cassette)
Variants: fentaNYL 5 mcg/mL
UPC Codes:
70004025164
Lot Numbers:
1223048722 (Exp 11/29/23)
1223049096 (Exp 12/15/23)
NDC:
70004-0251-64

Recall #: D-0401-2024

Product: fentaNYL 1,250 mcg/25 mL Injection (25 mL in 30 mL Syringe)
Variants: 50 mcg/mL
UPC Codes:
70004020017
Lot Numbers:
1223048522 (Exp 12/07/23)
1223049168 (Exp 01/04/24)
1223049552 (Exp 01/19/24)
NDC:
70004-0200-17

Recall #: D-0402-2024

Product: fentaNYL 2,500 mcg/50 mL in 0.9 % Sodium Chloride Injection (50 mL Syringe)
Variants: 50 mcg/mL
UPC Codes:
70004020022
Lot Numbers:
1223048959 (Exp 12/11/23)
1223049009 (Exp 12/12/23)
1223049170 (Exp 12/20/23)
1223049245 (Exp 12/22/23)
NDC:
70004-0202-22

Recall #: D-0403-2024

Product: HYDROmorphone HCl 20 mg/100mL in 0.9% Sodium Chloride Injection (100 mL Grey CADD Cassette)
Variants: 0.2 mg/mL
UPC Codes:
70004030063
Lot Numbers:
1223049529 (Exp 01/03/24)
NDC:
70004-0300-63

Recall #: D-0404-2024

Product: HYDROmorphone HCl 6 mg/30 mL in 0.9% Sodium Chloride Injection (30 mL fill 35 mL Plungerless Syringe)
Variants: 0.2 mg/mL
UPC Codes:
70004030016
Lot Numbers:
1223048530 (Exp 11/22/23)
1223048692 (Exp 11/29/23)
1223048739 (Exp 11/30/23)
1223048826 (Exp 12/05/23)
1223048963 (Exp 12/08/23)
1223048964 (Exp 12/11/23)
1223049111 (Exp 12/15/23)
1223049128 (Exp 12/19/23)
1223049210 (Exp 12/21/23)
1223049234 (Exp 12/22/23)
1223049257 (Exp 12/22/23)
1223049322 (Exp 12/27/23)
1223049416 (Exp 12/28/23)
1223049528 (Exp 01/03/24)
1223049559 (Exp 01/04/24)
1223049614 (Exp 01/05/24)
1223049632 (Exp 01/08/24)
1223049725 (Exp 01/11/24)
1223049792 (Exp 01/15/24)
1223049793 (Exp 01/15/24)
1223049905 (Exp 01/19/24)
1223050029 (Exp 1/24/24)
1223050061 (Exp 01/25/24)
1223050179 (Exp 01/29/24)
NDC:
70004-0300-16

Recall #: D-0405-2024

Product: HYDROmorphone HCl 6 mg/30 mL in 0.9% Sodium Chloride (30 mL Syringe)
Variants: 0.2 mg/mL
UPC Codes:
70004030018
Lot Numbers:
1223048451 (Exp 11/20/23)
1223048923 (Exp 12/07/23)
1223049097 (Exp 12/15/23)
1223049129 (Exp 12/19/23)
NDC:
70004-0300-18

Recall #: D-0406-2024

Product: HYDROmorphone HCl 10 mg/50 mL in 0.9% Sodium Chloride Injection (50 mL Syringe)
Variants: 0.2 mg/mL
UPC Codes:
70004030022
Lot Numbers:
1223048801 (Exp 12/04/23)
1223049225 (Exp 12/21/23)
1223049264 (Exp 12/25/23)
1223049291 (Exp 12/26/23)
1223049726 (Exp 01/11/24)
NDC:
70004-0300-22

Recall #: D-0407-2024

Product: HYDROmorphone HCl 25 mg/25 mL in 0.9% Sodium Chloride Injection (25 mL fill 30 mL Syringe)
Variants: 1 mg/mL
UPC Codes:
70004030317
Lot Numbers:
1223048491 (Exp 11/21/23)
NDC:
70004-0303-17

Recall #: D-0408-2024

Product: HYDROmorphone HCl 30 mg/30mL in 0.9% Sodium Chloride Injection (30 mL fill 35 mL Plungerless Syringe)
Variants: 1 mg/mL
UPC Codes:
70004030316
Lot Numbers:
1223048357 (Exp 11/15/23)
1223048461 (Exp 11/20/23)
1223048486 (Exp 11/21/23)
1223048694 (Exp 12/01/23)
1223048865 (Exp 12/06/23)
1223048967 (Exp 12/11/23)
1223049098 (Exp 12/15/23)
1223049133 (Exp 12/19/23)
1223049175 (Exp 12/20/23)
1223049268 (Exp 12/25/23)
1223049457 (Exp 01/01/24)
1223049561 (Exp 01/04/24)
1223049604 (Exp 01/05/24)
1223049648 (Exp 01/09/24)
1223049870 (Exp 01/17/24)
1223049942 (Exp 01/19/24)
1223049973 (Exp 01/23/24)
1223050060 (Exp 01/25/24)
NDC:
70004-0303-16

Recall #: D-0409-2024

Product: HYDROmorphone HCl 30 mg/30 mL in 0.9% Sodium Chloride Injection (30 mL fill Syringe)
Variants: 1 mg/mL
UPC Codes:
70004030321
Lot Numbers:
1223048258 (Exp 11/10/23)
1223048890 (Exp 12/07/23)
1223049134 (Exp 12/19/23)
NDC:
70004-0303-21

Recall #: D-0410-2024

Product: labetalol HCl 20 mg/4mL Injection (4 mL fill Syringe)
Variants: 5 mg/mL
UPC Codes:
70004070028
Lot Numbers:
1223047334 (Exp 12/23/23)
1223048170 (Exp 02/01/24)
NDC:
70004-0700-28

Recall #: D-0411-2024

Product: Midazolam HCl 100 mg/100 mL in 0.9% Sodium Chloride Injection (100 mL Bag)
Variants: 1 mg/mL
UPC Codes:
70004041159
Lot Numbers:
1223044958 (Exp 11/10/23)
1223045436 (Exp 11/30/23)
1223046132 (Exp 12/28/23)
1223046385 (Exp 01/06/24)
1223048807 (Exp 04/17/24)
1223049030 (Exp 04/26/24)
1223049328 (Exp 05/10/2024)
1223048948 (Exp 04/21/2024)
1223048631 (Exp 04/10/2024)
1223050389 (Exp 06/21/2024)
NDC:
70004-0411-59

Recall #: D-0412-2024

Product: neostigmine methylsulfate 5 mg/5 mL Injection (5 mL Syringe)
Variants: 1 mg/mL
UPC Codes:
70004075009
Lot Numbers:
1223048138 (Exp 1/31/24)
NDC:
70004-0750-09

Recall #: D-0413-2024

Product: PHENYLephrine HCl 1000 mcg/10 mL in 0.9% Sodium Chloride Injection (10 mL fill 12 mL Syringe)
Variants: 100 mcg/mL
UPC Codes:
70004081012
Lot Numbers:
1223045536 (Exp 12/06/23)
1223045710 (Exp 12/10/23)
1223046574 (Exp 01/12/24)
1223047579 (Exp 02/21/24)
1223047764 (Exp 03/06/24)
1223048363 (Exp 03/30/24)
1223048364 (Exp 03/30/24)
1223048566 (Exp 04/06/24)
1223048573 (Exp 04/07/24)
1223048574 (Exp 04/07/24)
1223048643 (Exp 04/11/24)
1223048697 (Exp 04/12/24)
1223048742 (Exp 04/13/24)
1223048065 (Exp 04/06/2024)
1223048395 (Exp 03/27/2024)
1223048397 (Exp 03/27/2024)
1223049980 (Exp 06/05/2024)
NDC:
70004-0810-12

Recall #: D-0414-2024

Product: PHENYLephrine HCl 500 mcg/5 mL in 0.9% Sodium Chloride Injection (5 mL fill 12 mL Syringe)
Variants: 100 mcg/mL
UPC Codes:
70004081011
Lot Numbers:
1223045053 (Exp 11/15/23)
1223046179 (Exp 12/28/23)
1223047477 (Exp 02/16/24)
1223047602 (Exp 02/22/24)
1223047971 (Exp 03/14/24)
1223048269 (Exp 03/27/24)
1223048181 (Exp 03/22/2024)
NDC:
70004-0810-11

Recall #: D-0415-2024

Product: PHENYLephrine HCl 500 mcg/5 mL in 0.9% Sodium Chloride Injection (5 mL Syringe with RFID)
Variants: 100 mcg/mL, KitCheck Compatible
UPC Codes:
70004081011
Lot Numbers:
1223048431 (Exp 04/05/24)
1223049023 (Exp 04/25/24)
NDC:
70004-0810-11-K

Recall #: D-0416-2024

Product: PHENYLephrine HCl 5000 mcg/50 mL in 0.9% Sodium Chloride Injection (50 mL Syringe)
Variants: 100 mcg/mL
UPC Codes:
70004081022
Lot Numbers:
1223045282 (Exp 11/24/23)
1223045370 (Exp 11/26/23)
1223045624 (Exp 12/07/23)
1223045723 (Exp 12/10/23)
1223045732 (Exp 12/10/23)
1223046128 (Exp 12/24/23)
1223046133 (Exp 12/24/23)
1223047112 (Exp 02/02/24)
1223047232 (Exp 2/07/24)
1223047398 (Exp 02/15/24)
1223047456 (Exp 02/16/24)
1223047569 (Exp 02/18/24)
1223047694 (Exp 02/24/24)
1223047780 (Exp 03/07/24)
1223047859 (Exp 03/08/24)
1223048119 (Exp 03/20/24)
1223048183 (Exp 03/22/24)
1223048837 (Exp 04/18/24)
1223048838 (Exp 04/18/24)
1223048982 (Exp 04/24/24)
1223049144 (Exp 05/02/24)
1223049145 (Exp 05/02/24)
1223049147 (Exp 05/02/24)
1223049821 (Exp 05/30/24)
1223048037 (Exp 03/16/2024)
1223048047 (Exp 03/17/2024)
1223049146 (Exp 05/02/2024)
1223049149 (Exp 05/02/2024)
1223049373 (Exp 05/10/2024)
1223048909 (Exp 04/20/2024)
1223048696 (Exp 04/12/2024)
1223050181 (Exp 06/12/2024)
NDC:
70004-0810-22

Recall #: D-0417-2024

Product: PHENYLephrine HCl 400 mcg/10 mL in 0.9% Sodium Chloride Injection (10 mL fill 12 mL Syringe)
Variants: 40 mcg/mL
UPC Codes:
70004081112
Lot Numbers:
1223045040 (Exp 11/13/23)
1223046397 (Exp 01/06/24)
1223046505 (Exp 01/10/24)
1223047254 (Exp 02/08/24)
1223047436 (Exp 02/15/24)
1223047938 (Exp 03/13/24)
1223049150 (Exp 05/02/24)
1223049300 (Exp 05/09/24)
1223048569 (Exp 04/06/2024)
1223049600 (Exp 05/19/2024)
NDC:
70004-0811-12

Recall #: D-0418-2024

Product: PHENYLephrine HCl 40 mg in 0.9% Sodium Chloride Injection (250 mL Bag)
Variants: 160 mcg/mL
UPC Codes:
70004082540
Lot Numbers:
1223050005 (Exp 01/13/24)
NDC:
70004-0825-40

Recall #: D-0419-2024

Product: PHENYLephrine HCl 800 mcg/10 mL in 0.9% Sodium Chloride Injection (10 mL fill 12 mL Syringe)
Variants: 80 mcg/mL
UPC Codes:
700040081612
Lot Numbers:
1223045974 (Exp 12/18/23)
1223046535 (Exp 01/11/24)
1223049152 (Exp 05/02/24)
1223048067 (Exp 04/06/2024)
1223048792 (Exp 04/17/2024)
NDC:
70004-0816-12

Recall #: D-0420-2024

Product: PHENYLephrine HCl 800 mcg/10 mL in 0.9% Sodium Chloride Injection (10 mL Syringe with RFID)
Variants: 80 mcg/mL, KitCheck Compatible
UPC Codes:
700040081612
Lot Numbers:
1223048610 (Exp 04/10/24)
1223048611 (Exp 04/10/24)
1223048726 (Exp 04/13/24)
1223050163 (Exp 06/12/24)
NDC:
70004-0816-12-K

Recall #: D-0421-2024

Product: Sodium Citrate 4% 3 mL Anticoagulation Solution Injection (3 mL fill Syringe)
Variants: 40 mg/mL
UPC Codes:
70004090025
Lot Numbers:
1223048444 (Exp 11/20/23)
1223049011 (Exp 12/12/23)
1223049673 (Exp 01/09/24)
1223049771 (Exp 01/12/24)
NDC:
70004-0900-25

Recall #: D-0422-2024

Product: SUCcinylcholine Chloride 200 mg/10mL Injection (10 mL fill 12 mL Syringe)
Variants: 20 mg/mL
UPC Codes:
70004090812
Lot Numbers:
1223049047 (Exp 11/29/23)
1223049221 (Exp 12/06/23)
1223049343 (Exp 12/12/23)
1223049423 (Exp 12/14/23)
1223049451 (Exp 12/14/23)
1223049452 (Exp 12/14/23)
1223049482 (Exp 12/14/23)
NDC:
70004-0908-12

Recall #: D-0423-2024

Product: SUCcinylcholine Chloride 100 mg/5mL Injection (5 mL fill 6 mL Syringe)
Variants: 20 mg/mL
UPC Codes:
70004090809
Lot Numbers:
1223049085 (Exp 11/29/23)
1223049364 (Exp 12/12/23)
NDC:
70004-0908-09

Recall #: D-0424-2024

Product: VANCOMYCIN 1.25 g in 0.9% Sodium Chloride 250 mL Injection (250 mL Bag)
UPC Codes:
70004092359
Lot Numbers:
1223049049 (Exp 12/28/23)
NDC:
70004-0923-59

Recall #: D-0425-2024

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 93456
Status: Resolved
Manufacturer: SCA Pharmaceuticals, LLC
Sold By: Healthcare facilities; Hospitals
Manufactured In: United States
Units Affected: 32 products (381 Bags; 548 bags; 500 bags; 242 bags; 613 Cassettes; 324 syringes; 412 cassettes; 130 cassettes; 1,259 syringes; 500 syringes; 256 cassettes; 5,734 syringes; 1,425 syringes; 1,023 syringes; 399 syringes; 5392 syringes; 909 syringes; 2,458, syringes; 1,508 bags; expanded 1,015 bags; 1,122 syringes; 33,072 syringes; expanded 9,041 syringes; 7,198 syringes; expanded 1,289 syringes; 1,118 syringes in kits; 5,948 syringes, expanded 2,102 syringes; 10,017 syringes, expanded 2579 syringes; 400 bags; 3,671 syringes, expanded 1,911 syringes; 2,427 syringes; 9,624 syringes; 8,755 syringe; 5,079 syringe; 368 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.