SCA Pharmaceuticals, LLC. recalls labetalol HCl injection 20 mg/4 mL (5mg/mL), 4 mL syringe, Rx Only, for IV Use, SCA Pharmaceuticals, Windsor, CT 06095
SCA Pharmaceuticals recalls labetalol HCl injection 4 mL syringes with incorrect lot numbers and expiration dates that could lead to medication errors.
Lower-risk recall
Labeling; Incorrect or Missing Lot number/Expiration Date; some product labels incorrectly indicates a compounding date of 12/27/2018 and use-by date of 03/27/2019 instead of 12/27/2017 and use-by-date of 03/27/2018
Contact the company & request your remedy
What happened, in plain English
SCA Pharmaceuticals is recalling labetalol HCl injection 20 mg/4 mL syringes because some labels show wrong compounding dates and expiration dates. This could cause medication errors if healthcare providers use the product without checking the correct dates. Read more at govinfonow.com/recall/40802-sca-pharmaceuticals-recalls-labetalol-iv-injection-due-to-incorrect-labeling.
Source Summary by GovInfoNow · govinfonow.com/recall/40802-sca-pharmaceuticals-recalls-labetalol-iv-injection-due-to-incorrect-labeling · Updated October 7, 2026 · FDA enforcement record: FDA #D-0603-2018
Cite this page
“SCA Pharmaceuticals Recalls Labetalol IV Injection Due to Incorrect Labeling.” GovInfoNow, updated October 7, 2026. https://govinfonow.com/recall/40802-sca-pharmaceuticals-recalls-labetalol-iv-injection-due-to-incorrect-labeling. Based on FDA recall #D-0603-2018 (https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0603-2018%22&limit=1).
Why it’s dangerous
The product labels incorrectly show a compounding date of 12/27/2018 and use-by date of 03/27/2019 instead of 12/27/2017 and 03/27/2018. This mismatch could lead to using expired medication or incorrect dosing.
Who’s affected
Healthcare providers who use this medication for IV administration may be affected. Patients receiving labetalol injections from this product are at risk of medication errors due to incorrect labeling.
How to tell if you have this one
Check for the lot number 1217000213 and expiration date 03/27/2019 on the label. The product is sold under NDC 70004-0700-28 and UPC 70004070028.
- Brand
SCA Pharmaceuticals- Product
SCA Pharmaceuticals, LLC. recalls labetalol HCl injection 20 mg/4 mL (5mg/mL), 4 mL syringe, Rx Only, for IV Use, SCA Pharmaceuticals, Windsor, CT 06095- Category
Drug
What to do — step by step
Check Label Dates
Verify the lot number and expiration date on the label to ensure they match the correct dates of 12/27/2017 and 03/27/2018.
Questions people ask
Why is this product being recalled?
The product labels incorrectly show a compounding date of 12/27/2018 and use-by date of 03/27/2019 instead of 12/27/2017 and 03/27/2018.
What should I do if I have this product?
Check the label for the lot number 1217000213 and expiration date 03/27/2019. If the dates are incorrect, contact SCA Pharmaceuticals for guidance.
Is there a risk of serious injury from this product?
The recall is for labeling errors that could lead to medication errors, but there is no indication of serious injury in normal use.
Contact SCA Pharmaceuticals
We’ve drafted a message you can send SCA Pharmaceuticals to request your refund or repair — edit it as you like.
Subject: Recall D-0603-2018 — SCA Pharmaceuticals SCA Pharmaceuticals, LLC. recalls labetalol HCl injection 20 mg/4 mL (5mg/mL), Hello, I own a SCA Pharmaceuticals, LLC. recalls labetalol HCl injection 20 mg/4 mL (5mg/mL), 4 mL syringe, Rx Only, for IV Use, SCA Pharmaceuticals, Windsor, CT 06095 that is covered by recall D-0603-2018 from SCA Pharmaceuticals. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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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-0603-2018 (February 22, 2018) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for D-0603-2018 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.