Akorn Acetylcysteine Injection Recall: CGMP Deviations Risk
Akorn recalls Acetylcysteine for Injection 6g/30mL (200mg/mL) due to CGMP deviations. Rx-only product with specific batch numbers and expiration dates. Contact for remedy.
Recall notice
CGMP Deviations
Contact the company
What happened, in plain English
Akorn is recalling Acetylcysteine for Injection 6 g/30 mL (200 mg/mL) because of manufacturing quality control issues. This is a prescription-only medication that could pose risks if used improperly. Read more at govinfonow.com/recall/40408-akorn-acetylcysteine-injection-recall-cgmp-deviations-risk.
Source Summary by GovInfoNow · govinfonow.com/recall/40408-akorn-acetylcysteine-injection-recall-cgmp-deviations-risk · Updated October 6, 2026 · FDA enforcement record: FDA #D-0916-2018
Cite this page
“Akorn Acetylcysteine Injection Recall: CGMP Deviations Risk.” GovInfoNow, updated October 6, 2026. https://govinfonow.com/recall/40408-akorn-acetylcysteine-injection-recall-cgmp-deviations-risk. Based on FDA recall #D-0916-2018 (https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0916-2018%22&limit=1).
Why it’s dangerous
CGMP deviations mean the product may not meet strict manufacturing standards. This could lead to contamination or incorrect dosing, especially since it's a prescription medication.
Who’s affected
Prescription patients using the recalled Acetylcysteine injection. Healthcare providers who dispensed the affected batches are most at risk.
How to tell if you have this one
Check the product label for the batch numbers: 061496A, 111696A, 061947A, or 091267A. The expiration dates are June 2018, November 2018, June 2019, or September 2019 respectively.
- Brand
Akorn- Category
Drug
What to do — step by step
Check Product Label
Look for batch numbers 061496A, 111696A, 061947A, or 091267A with specific expiration dates.
Where it went and when
Where it was distributed
Distributed nationwide.
FDA distribution: “U.S. 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 2.4 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-0916-2018 (June 22, 2018) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for D-0916-2018 to see it in context.
- Plain-language summary written by qwen3:4b on October 6, 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.