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SCA Pharmaceuticals, LLC
SCA Pharmaceuticals, LLC: 57 FDA recall reports
Every drug recall the FDA has published for SCA Pharmaceuticals, LLC. The fault, and how the agency graded it.
57Reports
0Class I
0Ongoing
2024-04-03Most recent
What the classes mean
The FDA sorts every recall into one of three classes. The class is the whole story. It is also the part people skip.
Class II is the bulk of every list here. That matters. A long list of Class II says something different from one Class I.
By class
By year reported
Checking whether it affects you
The lot or code number is what matters. Not the product name. A recall covers
specific lots. Yours may not be one of them.
Check the code on your package against the report. The FDA keeps the current
list at fda.gov/safety/recalls.
The reports
The text below is quoted from the FDA record word for word.
PHENYLephrine HCl 5000 mcg/50 mL in 0.9% Sodium Chloride Injection, (Concentration = 100 mcg/mL), 50 mL Syring
D-0417-2024 · Class II · reported 2024-04-03 · Terminated
- Why it was recalled
- Lack of Assurance of Sterility
- Product
- PHENYLephrine HCl 5000 mcg/50 mL in 0.9% Sodium Chloride Injection, (Concentration = 100 mcg/mL), 50 mL Syringe, Rx Only, SCA Pharmaceuticals, 755 Rainbow Rd. Windsor, CT 06095, NDC 70004-0810-22, Bar Code 70004081022.
- Where it went
- Nationwide in the USA
- How much
- 5,948 syringes, expanded 2,102 syringes
labetalol HCl 20 mg/4mL Injection, (Concentration=5 mg/mL), 4 mL fill Syringe, Rx Only, SCA Pharma, 755 Rainbo
D-0411-2024 · Class II · reported 2024-04-03 · Terminated
- Why it was recalled
- Lack of Assurance of Sterility
- Product
- labetalol HCl 20 mg/4mL Injection, (Concentration=5 mg/mL), 4 mL fill Syringe, Rx Only, SCA Pharma, 755 Rainbow Rd., Windsor, CT 06095, NDC 70004-0700-28, Bar Code 70004070028
- Where it went
- Nationwide in the USA
- How much
- 2,458, syringes
HYDROmorphone HCl 30 mg/30 mL in 0.9% Sodium Chloride Injection, (Concentration = 1mg/mL) 30 mL fill Syringe,
D-0410-2024 · Class II · reported 2024-04-03 · Terminated
- Why it was recalled
- Lack of Assurance of Sterility
- Product
- HYDROmorphone HCl 30 mg/30 mL in 0.9% Sodium Chloride Injection, (Concentration = 1mg/mL) 30 mL fill Syringe, Rx only, SCA Pharmaceuticals, 755 Rainbow Rd., Windsor, CT 06095, NDC 70004-0303-21, Bar Code 70004030321
- Where it went
- Nationwide in the USA
- How much
- 909 syringes
PHENYLephrine HCl 40 mg in 0.9% Sodium Chloride Injection, (Concentration = 160 mcg/mL), 250 mL Bag, Rx Only,
D-0419-2024 · Class II · reported 2024-04-03 · Terminated
- Why it was recalled
- Lack of Assurance of Sterility
- Product
- PHENYLephrine HCl 40 mg in 0.9% Sodium Chloride Injection, (Concentration = 160 mcg/mL), 250 mL Bag, Rx Only, SCA Pharmaceuticals, 755 Rainbow Rd. Windsor, CT 06095, NDC 70004-0825-40, Bar Code 70004082540.
- Where it went
- Nationwide in the USA
- How much
- 400 bags
fentaNYL 100 mcg/50 mL, Bupivacaine HCl 0.125% in 0.9% Sodium Chloride 50 mL Injection (fentaNYL Concentration
D-0399-2024 · Class II · reported 2024-04-03 · Terminated
- Why it was recalled
- Lack of Assurance of Sterility
- Product
- fentaNYL 100 mcg/50 mL, Bupivacaine HCl 0.125% in 0.9% Sodium Chloride 50 mL Injection (fentaNYL Concentration = 2 mcg/mL), EPIDURAL USE ONLY, 50 mL fill Syringe, Rx only, SCA Pharmaceuticals, 755 Rainbow Rd, Windsor, CT 06095, NDC 70004-0231-22, Bar Code 70004023122
- Where it went
- Nationwide in the USA
- How much
- 324 syringes
fentaNYL 1,250 mcg/25 mL Injection (Concentration = 50 mcg/mL), 25 mL fill in a 30 mL Single Dose Syringe, RX
D-0402-2024 · Class II · reported 2024-04-03 · Terminated
- Why it was recalled
- Lack of Assurance of Sterility
- Product
- fentaNYL 1,250 mcg/25 mL Injection (Concentration = 50 mcg/mL), 25 mL fill in a 30 mL Single Dose Syringe, RX Only, repackaged by SCA Pharma. SCA Pharmaceuticals, 755 Rainbow Rd. Windsor, CT 06095, NDC 70004-0200-17, Bar code 70004020017
- Where it went
- Nationwide in the USA
- How much
- 1,259 syringes
HYDROmorphone HCl 10 mg/50 mL in 0.9% Sodium Chloride Injection (Concentration = 0.2 mg/ml) 50 mL fill Syringe
D-0407-2024 · Class II · reported 2024-04-03 · Terminated
- Why it was recalled
- Lack of Assurance of Sterility
- Product
- HYDROmorphone HCl 10 mg/50 mL in 0.9% Sodium Chloride Injection (Concentration = 0.2 mg/ml) 50 mL fill Syringe, Rx only, SCA Pharmaceuticals, 755 Rainbow Rd., Windsor, CT 06095, NDC 70004-0300-22, Bar Code 70004030022
- Where it went
- Nationwide in the USA
- How much
- 1,023 syringes
PHENYLephrine HCl 400 mcg/10 mL in 0.9% Sodium Chloride Injection, (Concentration = 40 mcg/mL), 10 mL fill 12
D-0418-2024 · Class II · reported 2024-04-03 · Terminated
- Why it was recalled
- Lack of Assurance of Sterility
- Product
- PHENYLephrine HCl 400 mcg/10 mL in 0.9% Sodium Chloride Injection, (Concentration = 40 mcg/mL), 10 mL fill 12 mL Syringe, Rx Only, SCA Pharmaceuticals, 755 Rainbow Rd. Windsor, CT 06095, NDC 70004-0811-12, Bar Code 70004081112.
- Where it went
- Nationwide in the USA
- How much
- 10,017 syringes, expanded 2579 syringes
SUCcinylcholine Chloride 100 mg/5mL Injection (Concentration = 20mg/mL), 5 mL fill 6 mL Syringe, Rx only, Repa
D-0424-2024 · Class II · reported 2024-04-03 · Terminated
- Why it was recalled
- Lack of Assurance of Sterility
- Product
- SUCcinylcholine Chloride 100 mg/5mL Injection (Concentration = 20mg/mL), 5 mL fill 6 mL Syringe, Rx only, Repackaged by SCA Pharma, 755 Rainbow Rd., Windsor, CT 06095, NDC 70004-0908-09, Bar Code 70004090809
- Where it went
- Nationwide in the USA
- How much
- 5,079 syringe
fentaNYL 2,500 mcg/250 mL in 0.9% Sodium Chloride Injection (Concentration = 10 mcg/mL), 250 mL Bag, Rx only,
D-0395-2024 · Class II · reported 2024-04-03 · Terminated
- Why it was recalled
- Lack of Assurance of Sterility
- Product
- fentaNYL 2,500 mcg/250 mL in 0.9% Sodium Chloride Injection (Concentration = 10 mcg/mL), 250 mL Bag, Rx only, SCA Pharmaceuticals, 755 Rainbow Rd., Windsor, CT 06095, 877.550.5059, NDC 70004-0229-40 BAR code 70004022940
- Where it went
- Nationwide in the USA
- How much
- 548 bags
fentaNYL 2,500 mcg/50 mL in 0.9 % Sodium Chloride Injection (Concentration = 50 mcg/mL) 50 mL Single Dose Syri
D-0403-2024 · Class II · reported 2024-04-03 · Terminated
- Why it was recalled
- Lack of Assurance of Sterility
- Product
- fentaNYL 2,500 mcg/50 mL in 0.9 % Sodium Chloride Injection (Concentration = 50 mcg/mL) 50 mL Single Dose Syringe, Rx Only, SCA Pharmaceuticals, 755 Rainbow Rd. Windsor, CT 06095, NDC 70004-0202-22, Bar code 70004020022,
- Where it went
- Nationwide in the USA
- How much
- 500 syringes
neostigmine methylsulfate 5 mg/5 mL Injection, (Concentration = 1mg/mL), 5 mL fill 6 mL Syringe, Rx Only, SCA
D-0413-2024 · Class II · reported 2024-04-03 · Terminated
- Why it was recalled
- Lack of Assurance of Sterility
- Product
- neostigmine methylsulfate 5 mg/5 mL Injection, (Concentration = 1mg/mL), 5 mL fill 6 mL Syringe, Rx Only, SCA Pharma, 755 Rainbow Rd., Windsor, CT 06095, NDC 70004-0750-09, Bar Code 70004075009
- Where it went
- Nationwide in the USA
- How much
- 1,122 syringes
HYDROmorphone HCl 6 mg/30 mL in 0.9% Sodium Chloride, (Concentration = 0.2mg/ml) 30 mL Syringe, Rx only, SCA P
D-0406-2024 · Class II · reported 2024-04-03 · Terminated
- Why it was recalled
- Lack of Assurance of Sterility
- Product
- HYDROmorphone HCl 6 mg/30 mL in 0.9% Sodium Chloride, (Concentration = 0.2mg/ml) 30 mL Syringe, Rx only, SCA Pharmaceuticals, 755 Rainbow Rd., Windsor, CT 06095, NDC 70004-0300-18, Bar Code 70004030018
- Where it went
- Nationwide in the USA
- How much
- 1,425 syringes
Sodium Citrate 4% 3 mL, Anticoagulation Solution Injection (Concentration = 40/mg/mL) 3mL fill Syringe, Repack
D-0422-2024 · Class II · reported 2024-04-03 · Terminated
- Why it was recalled
- Lack of Assurance of Sterility
- Product
- Sodium Citrate 4% 3 mL, Anticoagulation Solution Injection (Concentration = 40/mg/mL) 3mL fill Syringe, Repackaged by SCA Pharma, 755 Rainbow Rd., Windsor, CT 06095, NDC 70004-0900-25, Bar Code 70004090025
- Where it went
- Nationwide in the USA
- How much
- 9,624 syringes
fentaNYL 500 mcg/100 mL, Bupivacaine HCl 0.04% in 0.9% Sodium Chloride 100 mL Injection (fentaNYL Concentratio
D-0400-2024 · Class II · reported 2024-04-03 · Terminated
- Why it was recalled
- Lack of Assurance of Sterility
- Product
- fentaNYL 500 mcg/100 mL, Bupivacaine HCl 0.04% in 0.9% Sodium Chloride 100 mL Injection (fentaNYL Concentration = 5 mcg/mL), EPIDURAL USE ONLY, 100 mL Yellow CADD Cassette, Rx only, SCA Pharmaceuticals, 755 Rainbow Rd., Windsor, CT 06095, NDC 70004-0289-64, Bar Code 70004028964
- Where it went
- Nationwide in the USA
- How much
- 412 cassettes
PHENYLephrine HCl 800 mcg/10 mL in 0.9% Sodium Chloride Injection, (Concentration = 80mcg/mL) 10 mL fill 12 mL
D-0421-2024 · Class II · reported 2024-04-03 · Terminated
- Why it was recalled
- Lack of Assurance of Sterility
- Product
- PHENYLephrine HCl 800 mcg/10 mL in 0.9% Sodium Chloride Injection, (Concentration = 80mcg/mL) 10 mL fill 12 mL Syringe, Rx Only, SCA Pharmaceuticals, 755 Rainbow Rd., Windsor, CT 06095, NDC 70004-0816-12-K, Bar Code 700040081612. (same finished product as F078140, but with RFID for KitCheck compatibility)
- Where it went
- Nationwide in the USA
- How much
- 2,427 syringes
HYDROmorphone HCl 20 mg/100mL in 0.9% Sodium Chloride Injection, 100 mL Grey CADD Cassette (20 mg/100 mL), CII
D-0404-2024 · Class II · reported 2024-04-03 · Terminated
- Why it was recalled
- Lack of Assurance of Sterility
- Product
- HYDROmorphone HCl 20 mg/100mL in 0.9% Sodium Chloride Injection, 100 mL Grey CADD Cassette (20 mg/100 mL), CII, Rx only, SCA Pharmaceuticals, 755 Rainbow Rd., Windsor, CT 06095, NDC 70004-0300-63, Bar Code 70004030063
- Where it went
- Nationwide in the USA
- How much
- 256 cassettes
PHENYLephrine HCl 800 mcg/10 mL in 0.9% Sodium Chloride Injection, (Concentration = 80mcg/mL) 10 mL fill 12 mL
D-0420-2024 · Class II · reported 2024-04-03 · Terminated
- Why it was recalled
- Lack of Assurance of Sterility
- Product
- PHENYLephrine HCl 800 mcg/10 mL in 0.9% Sodium Chloride Injection, (Concentration = 80mcg/mL) 10 mL fill 12 mL Syringe, Rx Only, SCA Pharmaceuticals, 755 Rainbow Rd., Windsor, CT 06095, NDC 70004-0816-12, Bar Code 700040081612.
- Where it went
- Nationwide in the USA
- How much
- 3,671 syringes, expanded 1,911 syringes
HYDROmorphone HCl 25 mg/25 mL in 0.9% Sodium Chloride Injection, (Concentration = 1mg/mL), 25 mL fill 30 mL Sy
D-0408-2024 · Class II · reported 2024-04-03 · Terminated
- Why it was recalled
- Lack of Assurance of Sterility
- Product
- HYDROmorphone HCl 25 mg/25 mL in 0.9% Sodium Chloride Injection, (Concentration = 1mg/mL), 25 mL fill 30 mL Syringe, Rx only, SCA Pharmaceuticals, 755 Rainbow Rd., Windsor, CT 06095, NDC 70004-0303-17, Bar Code 7004030317
- Where it went
- Nationwide in the USA
- How much
- 399 syringes
Midazolam HCl 100 mg/100 mL in 0.9% Sodium Chloride Injection, (Concentration = 1mg/mL) 100 mL Bag, Rx Only, S
D-0412-2024 · Class II · reported 2024-04-03 · Terminated
- Why it was recalled
- Lack of Assurance of Sterility
- Product
- Midazolam HCl 100 mg/100 mL in 0.9% Sodium Chloride Injection, (Concentration = 1mg/mL) 100 mL Bag, Rx Only, SCA Pharmaceuticals, 755 Rainbow Rd., Windsor, CT 06095, NDC 70004-0411-59, Bar Code 70004041159
- Where it went
- Nationwide in the USA
- How much
- 1,508 bags; expanded 1,015 bags
Diltiazem HCl 125 mg in 0.9% Sodium Chloride Injection (Concentration = 1mg/mL), 125 mL Bag, Rx only, SCA Phar
D-0394-2024 · Class II · reported 2024-04-03 · Terminated
- Why it was recalled
- Lack of Assurance of Sterility
- Product
- Diltiazem HCl 125 mg in 0.9% Sodium Chloride Injection (Concentration = 1mg/mL), 125 mL Bag, Rx only, SCA Pharmaceuticals, 755 Rainbow Rd., Windsor, CT 06095; NDC 70004-0541-35, Bar Code 70004054135
- Where it went
- Nationwide in the USA
- How much
- 381 Bags
fentaNYL 200 mcg/100 mL, Bupivacaine HCl 0.125% in 0.9% Sodium Chloride 100 mL Injection, (fentaNYL Concentrat
D-0398-2024 · Class II · reported 2024-04-03 · Terminated
- Why it was recalled
- Lack of Assurance of Sterility
- Product
- fentaNYL 200 mcg/100 mL, Bupivacaine HCl 0.125% in 0.9% Sodium Chloride 100 mL Injection, (fentaNYL Concentration = 2 mcg/mL), EPIDURAL USE ONLY, 100 mL Yellow CADD Cassette, Rx only, SCA Pharmaceuticals, 755 Rainbow Rd., Windsor, CT 06095, NDC 70004-0231-64, Bar Code 70004023164
- Where it went
- Nationwide in the USA
- How much
- 613 Cassettes
PHENYLephrine HCl 1000 mcg/10 mL in 0.9% Sodium Chloride Injection, (Concentration = 100 mcg/mL), 10 mL fill 1
D-0414-2024 · Class II · reported 2024-04-03 · Terminated
- Why it was recalled
- Lack of Assurance of Sterility
- Product
- PHENYLephrine HCl 1000 mcg/10 mL in 0.9% Sodium Chloride Injection, (Concentration = 100 mcg/mL), 10 mL fill 12 mL Syringe, Rx Only, SCA Pharmaceuticals, 755 Rainbow Rd. Windsor, CT 06095, NDC 70004-0810-12, Bar Code 70004081012
- Where it went
- Nationwide in the USA
- How much
- 33,072 syringes; expanded 9,041 syringes
fentaNYL 500 mcg/100 mL, Bupivacaine HCl 0.075% in 0.9% Sodium Chloride 100 mL Injection (fentaNYL Concentrati
D-0401-2024 · Class II · reported 2024-04-03 · Terminated
- Why it was recalled
- Lack of Assurance of Sterility
- Product
- fentaNYL 500 mcg/100 mL, Bupivacaine HCl 0.075% in 0.9% Sodium Chloride 100 mL Injection (fentaNYL Concentration = 5 mcg/mL), EPIDURAL USE ONLY, 100 mL Yellow CADD Cassette, Rx only, SCA Pharmaceuticals, 755 Rainbow Rd., Windsor, CT 06095, NDC 70004-0251-64, Bar Code 70004025164
- Where it went
- Nationwide in the USA
- How much
- 130 cassettes
HYDROmorphone HCl 6 mg/30 mL in 0.9% Sodium Chloride Injection, (Concentration = 0.2 mg/ml) 30 mL fill 35 mL P
D-0405-2024 · Class II · reported 2024-04-03 · Terminated
- Why it was recalled
- Lack of Assurance of Sterility
- Product
- HYDROmorphone HCl 6 mg/30 mL in 0.9% Sodium Chloride Injection, (Concentration = 0.2 mg/ml) 30 mL fill 35 mL Plungerless Syringe, Rx only, SCA Pharmaceuticals, 755 Rainbow Rd., Windsor, CT 06095, NDC 70004-0300-16, Bar Code 70004030016
- Where it went
- Nationwide in the USA
- How much
- 5,734 syringes
VANCOMYCIN 1.25 g added to 0.9% Sodium Chloride 250 mL Injection, 250 mL bag, Rx only, SCA Pharmaceuticals, 75
D-0425-2024 · Class II · reported 2024-04-03 · Terminated
- Why it was recalled
- Lack of Assurance of Sterility
- Product
- VANCOMYCIN 1.25 g added to 0.9% Sodium Chloride 250 mL Injection, 250 mL bag, Rx only, SCA Pharmaceuticals, 755 Rainbow Rd., Windsor, CT 06095, NDC 70004-0923-59, Bar Code 70004092359
- Where it went
- Nationwide in the USA
- How much
- 368 bags
HYDROmorphone HCl 30 mg/30mL in 0.9% Sodium Chloride Injection, (Concentration = 1 mg/ml) 30 mL fill 35 mL Plu
D-0409-2024 · Class II · reported 2024-04-03 · Terminated
- Why it was recalled
- Lack of Assurance of Sterility
- Product
- HYDROmorphone HCl 30 mg/30mL in 0.9% Sodium Chloride Injection, (Concentration = 1 mg/ml) 30 mL fill 35 mL Plungerless Syringe, Rx only, SCA Pharmaceuticals, 755 Rainbow Rd., Windsor, CT 06095, NDC 70004-0303-16, Bar Code 70004030316
- Where it went
- Nationwide in the USA
- How much
- 5392 syringes
PHENYLephrine HCl 500 mcg/5 mL in 0.9% Sodium Chloride Injection, (Concentration = 100 mcg/mL), 5 mL fill 12 m
D-0415-2024 · Class II · reported 2024-04-03 · Terminated
- Why it was recalled
- Lack of Assurance of Sterility
- Product
- PHENYLephrine HCl 500 mcg/5 mL in 0.9% Sodium Chloride Injection, (Concentration = 100 mcg/mL), 5 mL fill 12 mL Syringe, Rx Only, SCA Pharmaceuticals, 755 Rainbow Rd. Windsor, CT 06095, NDC 70004-0810-11, Bar Code 70004081011
- Where it went
- Nationwide in the USA
- How much
- 7,198 syringes; expanded 1,289 syringes
SUCcinylcholine Chloride 200 mg/10mL Injection (Concentration = 20mg/mL), 10 mL fill 12 mL Syringe, Rx only, R
D-0423-2024 · Class II · reported 2024-04-03 · Terminated
- Why it was recalled
- Lack of Assurance of Sterility
- Product
- SUCcinylcholine Chloride 200 mg/10mL Injection (Concentration = 20mg/mL), 10 mL fill 12 mL Syringe, Rx only, Repackaged by SCA Pharma, 755 Rainbow Rd., Windsor, CT 06095, NDC 70004-0908-12, Bar Code 70004090812
- Where it went
- Nationwide in the USA
- How much
- 8,755 syringe
PHENYLephrine HCl 500 mcg/5 mL in 0.9% Sodium Chloride Injection, (Concentration = 100 mcg/mL), 5 mL fill 12 m
D-0416-2024 · Class II · reported 2024-04-03 · Terminated
- Why it was recalled
- Lack of Assurance of Sterility
- Product
- PHENYLephrine HCl 500 mcg/5 mL in 0.9% Sodium Chloride Injection, (Concentration = 100 mcg/mL), 5 mL fill 12 mL Syringe, Rx Only, SCA Pharmaceuticals, 755 Rainbow Rd. Windsor, CT 06095, NDC 70004-0810-11-K, Bar Code 70004081011. (same finished product as F078140, but with RFID for KitCheck
- Where it went
- Nationwide in the USA
- How much
- 1,118 syringes in kits
Showing the 30 most recent of 57. The rest are searchable at the FDA enforcement report database.
Read these counts with three things in mind
A firm with more recalls usually makes more products. A contract packer runs
hundreds of lines. It will out-recall a company with one product whatever either
does. This is not a safety ranking.
Most recalls here are voluntary. A firm found its own fault and pulled the stock.
That is the system working. It lands in this database looking the same as a recall
the FDA had to push for.
Terminated means the FDA considers the recall finished. It is not a verdict.
It does not mean anyone was harmed.
Source: openFDA enforcement reports, retrieved 2026-08-05. FDA dataset last updated 2026-07-29.
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