Spirit Pharmaceuticals, LLC recalls Ibuprofen Tablets USP, 200 mg, 100-count bottles, OTC, Distributed By: Spirit Pharmaceuticals, LLC Ronkonkoma, NY
Spirit Pharmaceuticals recalls 200mg Ibuprofen tablets due to previous CGMP deviations. This OTC product (NDC 68210-0800-1) may be unsafe from prior quality issues.
Lower-risk recall
CGMP deviations: Ibuprofen is being recalled in response to previous recall
Contact the company & request your remedy
What happened, in plain English
Spirit Pharmaceuticals is recalling 200mg Ibuprofen tablets because of previous quality control problems. This recall follows a previous recall and may involve products that don't meet safety standards. Read more at govinfonow.com/recall/40947-spirit-pharmaceuticals-ibuprofen-tablets-recall-cgmp-deviations.
Source Summary by GovInfoNow · govinfonow.com/recall/40947-spirit-pharmaceuticals-ibuprofen-tablets-recall-cgmp-deviations · Updated October 7, 2026 · FDA enforcement record: FDA #D-0583-2018
Cite this page
“Spirit Pharmaceuticals Ibuprofen Tablets Recall: CGMP Deviations.” GovInfoNow, updated October 7, 2026. https://govinfonow.com/recall/40947-spirit-pharmaceuticals-ibuprofen-tablets-recall-cgmp-deviations. Based on FDA recall #D-0583-2018 (https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0583-2018%22&limit=1).
Why it’s dangerous
The recall is due to previous quality control deviations in manufacturing. This means the tablets may not meet safety standards, though the specific risk isn't detailed in the notice.
Who’s affected
People who bought Spirit Pharmaceuticals' 200mg Ibuprofen tablets (100-count bottles) from pharmacies or online. Those with chronic pain or inflammation who use these tablets regularly are most at risk.
How to tell if you have this one
Check for the 200mg Ibuprofen tablets in 100-count bottles with NDC code 68210-0800-1. The lot number HJ6138 is also associated with this product.
- Brand
Spirit Pharmaceuticals- Category
Drug
What to do — step by step
Check Product Details
Look for the NDC code 68210-0800-1 and lot number HJ6138 on the bottle.
Questions people ask
Why is this product being recalled?
This recall is due to previous quality control deviations in manufacturing, as stated in the notice.
Is there a risk of serious injury from this product?
The recall notice does not specify a risk of serious injury; it mentions previous CGMP deviations.
How do I know if I have the recalled product?
Check for the NDC code 68210-0800-1 and lot number HJ6138 on the bottle.
Contact Spirit Pharmaceuticals
We’ve drafted a message you can send Spirit Pharmaceuticals to request your refund or repair — edit it as you like.
Subject: Recall D-0583-2018 — Spirit Pharmaceuticals Spirit Pharmaceuticals Hello, I own a Spirit Pharmaceuticals that is covered by recall D-0583-2018 from Spirit 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-0583-2018 (January 10, 2018) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for D-0583-2018 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.