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Akorn, Inc. recalls

Every recall we track for Akorn, Inc. — 192 in all, from 2014–2023 — plus the complaints and injury reports the public filed about them. 4 are rated “stop using now”.

192recalls

Recalls per year, by danger level

Recalls from Akorn, Inc. peaked in 2023 (87); 172 since 2017. 2% rated “stop using now”.

2017: 7 recalls — 3 use caution, 4 not yet rated720172018: 12 recalls — 4 lower risk, 8 not yet rated1220182019: 15 recalls — 4 use caution, 8 lower risk, 3 not yet rated1520192020: 7 recalls — 1 stop using now, 1 use caution, 3 lower risk, 2 not yet rated720202021: 7 recalls — 1 stop using now, 3 lower risk, 3 not yet rated720212022: 37 recalls — 1 stop using now, 8 lower risk, 28 not yet rated3720222023: 87 recalls — 44 lower risk, 43 not yet rated8720232024: 0 recalls20242025: 0 recalls20252026 (to date): 0 recalls2026to date

All FDA recall records for Akorn, Inc. since 2017, counted by recall date (one bar per calendar year; 2026 is partial). Danger level is GovInfoNow’s plain-language rating; “not yet rated” records are still being written up.

Recalls per year for Akorn, Inc., by danger level
YearStop using nowUse cautionLower riskNot yet ratedTotal
201703047
2018004812
2019048315
202011327
202110337
20221082837
202300444387
202400000
202500000
2026 (to date)00000

Akorn, Inc. recalls before 2017

Recalls on record by year.

  • 20168
  • 201510
  • 20142

Most common reasons for Akorn, Inc. recalls

  • CGMP Deviations:27
  • CGMP Deviations2
  • Failed Impurities/Degradation Specifications2
  • Labeling: Missing Label2

What to do if you have a recalled Akorn, Inc. product

  1. Match the NDC and lot number on your bottle or box to the recall.
  2. Don’t stop a prescription on your own — ask your pharmacist or doctor for a replacement first.
  3. Report side effects to FDA MedWatch.

See this week’s new recalls.

All Akorn, Inc. recalls

60 shown

Akorn, Inc. recall questions

How many recalls has Akorn, Inc. had?

192 recalls from Akorn, Inc. are on record with U.S. safety agencies, from 2014–2023.

What is the most recent Akorn, Inc. recall?

Akorn, Inc. recalls Levofloxacin Injection 500mg/20 mL (25 mg/mL), For Intravenous Infusion, packaged in a) 20mL vials and b) 30 mL vials,, dated Apr 26, 2023. Every Akorn, Inc. recall is listed on this page, newest first.

Why are Akorn, Inc. products recalled?

The most common reasons on record: CGMP Deviations: (27); CGMP Deviations (2); Failed Impurities/Degradation Specifications (2); Labeling: Missing Label (2).

What should I do if I have a recalled Akorn, Inc. product?

Match the NDC and lot number on your bottle or box to the recall. Don’t stop a prescription on your own — ask your pharmacist or doctor for a replacement first. Report side effects to FDA MedWatch.

How do I get alerts for new Akorn, Inc. recalls?

Sign up for free email alerts on GovInfoNow — we check official CPSC, FDA, USDA and NHTSA data every day and email you only when a recall matches what you follow.