SCA Pharmaceuticals Diltiazem 125mg Recall: Risk of Leaking Sterile Solution
SCA Pharmaceuticals recalls Diltiazem 125mg in 0.9% sodium chloride bags due to potential leakage. This could compromise sterility and safety. Affected units have specific NDC and lot numbers.
Stop using this now
Lack of Assurance of Sterility: Product made with recalled 0.9% sodium chloride bags which have the potential to leak.
Contact the company
What happened, in plain English
SCA Pharmaceuticals is recalling Diltiazem 125 mg in 0.9% sodium chloride bags because the bags may leak, risking contamination. This is a serious issue for patients using the medication as it could lead to infections or other health problems. Read more at govinfonow.com/recall/41460-sca-pharmaceuticals-diltiazem-125mg-recall-risk-of-leaking-sterile-solution.
Source Summary by GovInfoNow · govinfonow.com/recall/41460-sca-pharmaceuticals-diltiazem-125mg-recall-risk-of-leaking-sterile-solution · Updated October 7, 2026 · FDA enforcement record: FDA #D-1002-2017
Cite this page
“SCA Pharmaceuticals Diltiazem 125mg Recall: Risk of Leaking Sterile Solution.” GovInfoNow, updated October 7, 2026. https://govinfonow.com/recall/41460-sca-pharmaceuticals-diltiazem-125mg-recall-risk-of-leaking-sterile-solution. Based on FDA recall #D-1002-2017 (https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-1002-2017%22&limit=1).
Why it’s dangerous
The recalled bags have a potential to leak, which could cause the medication to become contaminated. This contamination might lead to infections or other health issues if the medication is used without proper sterility.
Who’s affected
Patients prescribed this medication by a doctor are affected. Those using the recalled product without medical supervision are at risk of infection due to potential contamination.
How to tell if you have this one
Check for the product name 'Diltiazem 125 mg in 0.9% Sodium Chloride, 1 mg per mL, Total Volume 125 mL Single Dose Container bag'. The NDC number is 70004-0541-35 and the lot number is 20170707@54.
- Brand
SCA Pharmaceuticals- Category
Drug
All 6 products in this recall
FDA lists each product line separately under one recall event. Check your product description, lot or code numbers against each row. Every row shares the hazard and remedy on this page.
- Classification
Class II- Status
Terminated- Distribution
Nationwide in the USA
| Recall number | Product, codes & lots | Quantity |
|---|---|---|
| D-0999-2017 | morphine sulfate 1 mg per mL in 0.9% Sodium Chloride, (Total morphine Dose 100 mg/100 mL), Total Volume 100 mL Single Dose Container bag, Rx Only, SCA Pharmaceuticals, 8821 Knoedl Ct, Little Rock, AR 72205, (877) 550-5059; labeled as a) NDC: 70004-0100-59; b) NDC: 70004-100-58.; Lots: a) 20170707@34, BUD:10/5/2017; 20170710@21, BUD: 10/8/2017; b) 20170706@44, BUD: 10/4/2017 | 220 bags |
| D-1000-2017 | fentaNYL (as citrate) 10 mcg per mL in 0.9% Sodium Chloride, (Total fentaNYL Dose 1,000 mcg/100 mL), Total Volume 100 mL Single Dose Container bag, Rx Only, SCA Pharmaceuticals, 8821 Knoedl Ct, Little Rock, AR 72205 (877) 550-5059; NDC: 70004-0202-32.; Lot: 20170707@27, BUD: 10/5/2017 | 130 bags |
| D-1001-2017 | ceFAZolin 3 g added to 100 mL 0.9% Sodium Chloride, Total Approximate Volume 115 mL Single Dose Container bag, Rx Only, SCA Pharmaceuticals, 8821 Knoedl Ct, Little Rock, AR 72205 (877) 550-5059; NDC: 70004-0524-32.; Lot: 20170707@26, BUD: 8/21/2017 | 108 bags |
| D-1002-2017 | Diltiazem 125 mg in 0.9% Sodium Chloride, 1 mg per mL, Total Volume 125 mL Single Dose Container bag, Rx Only, SCA Pharmaceuticals, 8821 Knoedl Ct, Little Rock, AR 72205 (877) 550-5059; NDC: 70004-0541-35.; Lot: 20170707@54, BUD: 10/4/2017 | 120 bags |
| D-1003-2017 | MAGNESIUM Sulfate 4 g added to 100 mL 0.9% Sodium Chloride, Total Approximate Volume 108 mL (does not include mfg. overfill) Single Dose Container bag, Rx Only, SCA Pharmaceuticals, 8821 Knoedl Ct, Little Rock, AR 72205 (877) 550-5059; NDC: 70004-0737-32.; Lot: 20170710@54, BUD: 10/8/2017 | 40 bags |
| D-1004-2017 | PHENYLephrine HCl 10 mg in 0.9% Sodium Chloride, (Final Concentration = 0.1 mg per mL), Total Volume 100 mL Single Dose Container bag, Rx Only, SCA Pharmaceuticals, 8821 Knoedl Ct, Little Rock, AR 72205 (877) 550-5059; NDC: 70004-0810-32.; Lot: 20170710@3, BUD: 10/8/2017 | 2 bags |
What to do — step by step
Stop Using Now
Immediately stop using the recalled Diltiazem 125 mg in 0.9% sodium chloride bags as they may leak and cause contamination.
Where it went and when
Where it was distributed
Distributed nationwide.
FDA distribution: “Nationwide in the USA” States read from FDA’s own wording; “not listed” means the notice does not name it.
Distributed nationwide.
Recall timeline
FDA terminated this recall 2.3 years after the firm started it.
- Firm started the recall
- FDA classified it Class II
- Published in FDA’s Enforcement Report
- FDA terminated the recall
Dates from the agency record only; steps without a date are left out.
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Where this comes from
The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
- Official source: FDA Recall #D-1002-2017 (July 14, 2017) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for D-1002-2017 to see it in context.
- Plain-language summary written by qwen3:4b on October 7, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
- GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.