SCA Pharmaceuticals PHENYLephrine 40mg Solution Recall: Risk of Contamination
SCA Pharmaceuticals recalls PHENYLephrine 40mg in 0.9% Sodium Chloride 250mL (Rx only) due to potential contamination and leakage risks. Affected units have specific lot numbers and expiration dates.
Recall notice
Lack of Assurance of Sterility; product has the potential to leak.
Contact the company
What happened, in plain English
SCA Pharmaceuticals is recalling PHENYLephrine 40mg in 0.9% Sodium Chloride 250mL solutions because they may leak and risk contamination. This could lead to serious health issues if used improperly. Read more at govinfonow.com/recall/41451-sca-pharmaceuticals-phenylephrine-40mg-solution-recall-risk-of-contamination.
Source Summary by GovInfoNow · govinfonow.com/recall/41451-sca-pharmaceuticals-phenylephrine-40mg-solution-recall-risk-of-contamination · Updated October 7, 2026 · FDA enforcement record: FDA #D-1027-2017
Cite this page
“SCA Pharmaceuticals PHENYLephrine 40mg Solution Recall: Risk of Contamination.” GovInfoNow, updated October 7, 2026. https://govinfonow.com/recall/41451-sca-pharmaceuticals-phenylephrine-40mg-solution-recall-risk-of-contamination. Based on FDA recall #D-1027-2017 (https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-1027-2017%22&limit=1).
Why it’s dangerous
The product has a potential to leak, which could cause contamination. This contamination risk may lead to serious health issues if the medication is used without proper sterility.
Who’s affected
Prescription drug users who have the specific lot numbers and expiration dates listed in the recall. Patients using this medication for medical purposes are most at risk.
How to tell if you have this one
Check for the product name 'PHENYLephrine 40 mg in 0.9% Sodium Chloride 250 mL' with the lot numbers 20170429 (28 units) or 20170509 (65 units) and expiration dates up to July 28, 2017 or August 7, 2017.
- Brand
SCA Pharmaceuticals- Category
Drug
All 30 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
| Recall number | Product, codes & lots |
|---|---|
| D-1005-2017 | BUPIVacaine HCl 0.1% PF (From 0.75%) in 0.9% Sodium Chloride, 250 mL Bag, Preservative Free (Waste From 250 mL Bag), Rx only, SCA Pharmaceuticals 8821 Knoedl Ct Little Rock, AR 72205 --- NDC# 70004-0060-40; Lots: 20170429@33 BUD: 7/28/2017, 20170503@23 BUD: 8/1/2017 |
| D-1006-2017 | BUPIVacaine HCl 0.125% In 250 mL 0.9% Sodium Chloride Bag, Preservative Free (Total Dose Bupivacaine 312.5 mg per 250 mL), Rx only, SCA Pharmaceuticals 8821 Knoedl Ct Little Rock, AR 72205 --- NDC# 70004-0062-40; Lot: 20170502@32 BUD: 7/31/2017 |
| D-1007-2017 | BUPIVacaine HCl 0.2% IN 0.9% Sodium Chloride 250 mL Bag Preservative Free (Total Dose Bupivacaine 500 mg per 250 mL), Rx only, SCA Pharmaceuticals 8821 Knoedl Ct Little Rock, AR 72205 --- NDC# 70004-0066-40; Lot: 20170501@69 BUD: 7/30/2017 |
| D-1008-2017 | fentaNYL (as citrate) 5 mcg/mL In 250 mL 0.9% Sodium Chloride Injection Bag (Total fentaNYL Dose 1250 mcg/ 250 mL), Preservative Free, Rx only, SCA Pharmaceuticals 8821 Knoedl Ct Little Rock, AR 72205 --- NDC# 70004-0201-40; Lots: 20170428@57 BUD: 7/27/2017; 20170428@58 BUD: 7/27/2017; 20170511@24 BUD: 8/9/2017 |
| D-1009-2017 | fentaNYL (as citrate) 10 mcg per mL in 0.9% Sodium Chloride 250 mL Bag, Rx only, SCA Pharmaceuticals 8821 Knoedl Ct Little Rock, AR 72205 --- NDC# 70004-0202-40; Lots: 20170502@18 BUD: 7/31/2017; 20170502@39 BUD: 7/31/2017; 20170502@62 BUD: 7/31/2017; 20170503@22 BUD: 8/1/2017; 20170503@4 BUD: 8/1/2017; 20170503@54 BUD: 8/1/2017; 20170504@10 BUD: 8/2/2017; 20170505@15 BUD: 8/3/2017; 20170506@23 BUD: 8/4/2017 |
| D-1010-2017 | fentaNYL as citrate 5 mcg/mL in 0.9% Sodium Chloride 1 mL in Single Dose syringe, Rx only, SCA Pharmaceuticals 8821 Knoedl Ct Little Rock, AR 72205 --- NDC# 70004-0225-24; Lot: 20170510@40 BUD: 8/8/2017 |
| D-1011-2017 | fentaNYL 2 mcg/mL+Bupivacaine 0.0625% PF in 0.9% Sodium Chloride 250 mL, Rx only, SCA Pharmaceuticals 8821 Knoedl Ct Little Rock, AR 72205 ---- NDC# 70004-0226-40; Lots: 20170429@29 BUD: 7/28/2017; 20170512@24 BUD: 8/10/2017 |
| D-1012-2017 | fentaNYL 10 mcg/mL PF in NS 1 mL Fill in 3 mL syringe, Rx only, SCA Pharmaceuticals, 8821 Knoedl Ct Little Rock, AR 72205 --- NDC# 70004-0229-05; Lot: 20170512@19 BUD: 8/10/2017 |
| D-1013-2017 | fentaNYL 10 mcg/mL PF in Sodium Chloride 250 mL (Total Dose=2500 mcg), Rx only, SCA Pharmaceuticals 8821 Knoedl Ct Little Rock, AR 72205 --- NDC# 70004-0229-40; Lots: 20170509@20 BUD: 8/7/2017; 20170509@21 BUD: 8/7/2017; 20170509@46 BUD: 8/7/2017; 20170511@33 BUD: 8/9/2017 |
| D-1014-2017 | fentaNYL 2 mcg/mL + BUPIvacaine 0.1% PF in 0.9% NS 250 mL, Rx only, SCA Pharmaceuticals 8821 Knoedl Ct Little Rock, AR 72205 --- NDC# 70004-0230-40; Lots: 20170502@47 BUD: 7/31/2017; 20170502@56 BUD: 7/31/2017; 20170505@26 BUD: 8/3/2017; 20170506@25 BUD: 8/4/2017 |
| D-1015-2017 | fentaNYL 2 mcg/mL + BUPIvacaine 0.125% PF in 0.9% Sodium Chloride 250 mL, Rx only, SCA Pharmaceuticals 8821 Knoedl Ct Little Rock, AR 72205 --- NDC# 70004-0254-40; Lots: 20170503@75 BUD: 8/1/2017; 20170511@21 BUD: 8/9/2017 |
| D-1016-2017 | fentaNYL 3 mcg/mL + BUPIvacaine 0.1% in 0.9% Sodium Chloride 250 mL, Rx only, SCA Pharmaceuticals 8821 Knoedl Ct Little Rock, AR 72205 --- NDC# 70004-0290-40; Lot: 20170506@27 BUD: 8/4/2017 |
| D-1017-2017 | Hydromorphone 0.5 mg/mL in 0.9% Sodium Chloride 1 mL Fill in 3 mL BD syringe, Rx only, SCA Pharmaceuticals 8821 Knoedl Ct Little Rock, AR 72205 --- NDC# 70004-0302-05; Lot: 20170508@75 BUD: 8/6/2017 |
| D-1018-2017 | ePHEDrine Sulfate 5 mg/mL in NS 5 mL Fill in 12 mL Syringe (25 mg), Rx only, SCA Pharmaceuticals 8821 Knoedl Ct Little Rock, AR 72205 --- NDC# 70004-0600-11; Lots: 20170503@28 BUD: 7/17/2017; 20170508@60 BUD: 7/22/2017 |
| D-1019-2017 | EPINEPHrine HCl 4 mg in 0.9% Sodium Chloride 250 mL, Rx only, SCA Pharmaceuticals 8821 Knoedl Ct Little Rock, AR 72205 --- NDC# 70004-0613-40; Lots: 20170508@51 BUD: 9/10/2017; 20170503@17 BUD: 9/5/2017 |
| D-1020-2017 | NORepinephrine 4 mg in 0.9% Sodium Chloride 250 mL from Stock, Rx only, SCA Pharmaceuticals 8821 Knoedl Ct Little Rock, AR 72205 --- NDC# 70004-0771-40; Lots: 20170502@36 BUD: 7/31/2017; 20170512@1 BUD: 8/10/2017; 20170504@13 BUD: 8/2/2017; 20170504@18 BUD: 8/2/2017 |
| D-1021-2017 | NORepinephrine Bitartrate 8 mg in 0.9% Sodium Chloride 250 mL, Rx only, SCA Pharmaceuticals 8821 Knoedl Ct Little Rock, AR 72205 --- NDC# 70004-0774-40; Lots: 20170502@31 BUD: 7/16/2017; 20170508@34 BUD: 7/22/2017; 20170508@70 BUD: 7/22/2017; 20170512@15 BUD: 7/26/2017 |
| D-1022-2017 | NORepinephrine Bitartrate 16 mg in 0.9% Sodium Chloride 250 mL from Stock, Rx only, SCA Pharmaceuticals 8821 Knoedl Ct Little Rock, AR 72205 --- NDC# 70004-0775-40; Lots: 20170512@8 BUD: 8/10/2017; 20170506@18 BUD: 8/4/2017 |
| D-1023-2017 | PHENYLephrine HCl 60 mg in 0.9% Sodium Chloride 250 mL, Rx only, SCA Pharmaceuticals 8821 Knoedl Ct Little Rock, AR 72205 --- NDC# 70004-0809-40; Lots: 20170502@53 BUD: 7/31/2017; 20170505@16 BUD: 8/3/2017 |
| D-1024-2017 | PHENYLephrine HCl 25 mg in 0.9% Sodium Chloride 250 mL, Rx only, SCA Pharmaceuticals 8821 Knoedl Ct Little Rock, AR 72205 --- NDC# 70004-0810-40; Lots: 20170512@20 BUD: 8/10/2017; 20170504@61 BUD: 8/2/2017 |
| D-1025-2017 | PHENYLephrine HCl 10 mg in 0.9% Sodium Chloride 250 mL Bag, Preservative Free, Rx only, SCA Pharmaceuticals 8821 Knoedl Ct Little Rock, AR 72205 --- NDC# 70004-0811-40; Lots: 20170503@26 BUD: 8/1/2017; 20170510@48 BUD: 8/8/2017 |
| D-1026-2017 | PHENYLephrine 10 mg in 0.9% Sodium Chloride 250 mL bag, Rx only, SCA Pharmaceuticals 8821 Knoedl Ct Little Rock, AR 72205 ---- NDC# 70004-0811-59; Lots: 20170503@29 BUD: 8/1/2017; 20170512@22 BUD: 8/10/2017; 20170509@64 BUD: 8/7/2017 |
| D-1027-2017 | PHENYLephrine 40 mg in 0.9% Sodium Chloride 250 mL, Rx only, SCA Pharmaceuticals 8821 Knoedl Ct Little Rock, AR 72205 --- NDC# 70004-0812-40; Lots: 20170429@28 BUD: 7/28/2017; BUD: 20170509@65 BUD: 8/7/2017 |
| D-1028-2017 | PHENYLephrine 100 mg in 0.9% Sodium Chloride 250 mL Bag, Rx only, SCA Pharmaceuticals 882PHENYLephrine 100 mg 1 Knoedl Ct Little Rock, AR 72205 --- NDC# 70004-0813-40; Lot: 20170503@16 BUD: 8/1/2017 |
| D-1029-2017 | PHENYLephrine 200 mg in 0.9% Sodium Chloride 250 mL, Rx only, SCA Pharmaceuticals 8821 Knoedl Ct Little Rock, AR 72205 --- NDC# 70004-0815-40; Lot: 20170511@51 BUD: 8/9/2017 |
| D-1030-2017 | PHENYLephrine 20 mg in 0.9% Sodium Chloride 250 mL Bag, Rx only, SCA Pharmaceuticals 8821 Knoedl Ct Little Rock, AR 72205 --- NDC# 70004-0816-40; Lot: 20170503@19 BUD: 8/1/2017 |
| D-1031-2017 | PHENYLephrine 50 mg in 0.9% Sodium Chloride 250 mL, Rx only, SCA Pharmaceuticals 8821 Knoedl Ct Little Rock, AR 72205 --- NDC# 70004-0820-40; Lots: 20170512@6 BUD: 8/10/2017; 20170511@56 BUD: 8/9/2017 |
| D-1032-2017 | Potassium Chloride 20 meq Added to Sodium Chloride 0.9% 250 mL, Rx only, SCA Pharmaceuticals 8821 Knoedl Ct Little Rock, AR 72205 --- NDC# 70004-0832-40; Lots: 20170501@66 BUD: 7/15/2017 |
| D-1033-2017 | Potassium Chloride 40 meq Added to Sodium Chloride 0.9% 250 mL, Rx only, SCA Pharmaceuticals 8821 Knoedl Ct Little Rock, AR 72205 ---- NDC# 70004-0833-40; Lots: 20170509@10 BUD: 7/23/2017 |
| D-1034-2017 | fentaNYL 2 mcg/mL + Ropivacaine 0.2% PF in NS 250 mL, Rx only, SCA Pharmaceuticals 8821 Knoedl Ct Little Rock, AR 72205 --- NDC# 70004-0260-40; Lots: 20170509@17 BUD: 8/7/2017 |
What to do — step by step
Check Product Details
Look for the lot numbers 20170429 (28 units) or 20170509 (65 units) and expiration dates up to July 28, 2017 or August 7, 2017.
Where it went and when
Where it was distributed
Distributed nationwide.
FDA distribution: “Nationwide” States read from FDA’s own wording; “not listed” means the notice does not name it.
Distributed nationwide.
Recall timeline
FDA terminated this recall 22 months 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.
Similar recalls
Latest drug recalls
Keep exploring
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-1027-2017 (July 14, 2017) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for D-1027-2017 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.