CLASS II Drug recall · Reported 14 Mar 2018 · FDA Enforcement Report
Ibuprofen Tablets USP, 200 mg recalled by Spirit Pharmaceuticals
Spirit Pharmaceuticals is recalling Ibuprofen Tablets USP, 200 mg, distributed in New York. The recall was initiated on 10 Jan 2018 and the FDA has classified it as Class II.
Check your package
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
Recall details
- Recall number
- D-0583-2018
- FDA event ID
- 79361
- Recalling firm
- Spirit Pharmaceuticals, Ronkonkoma, NY
- Brand
- Valumeds Ibuprofen
- Manufacturer
- SPIRIT PHARMACEUTICALS LLC
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 10 Jan 2018
- FDA classified
- 9 Mar 2018
- Reported
- 14 Mar 2018
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Manufacturing (CGMP) Deviations
- Drug class
- Pain Medication
Timeline
| 10 Jan 2018 | Recall initiated by company | |
| 9 Mar 2018 | Classified by FDA | +58 days |
| 14 Mar 2018 | Published in enforcement report | +5 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
CGMP deviations: Ibuprofen is being recalled in response to previous recall
Product as listed by the FDA
Ibuprofen Tablets USP, 200 mg, 100-count bottles, OTC, Distributed By: Spirit Pharmaceuticals, LLC Ronkonkoma, NY 11779, NDC 68210-0800-1
Where it was distributed
NY
Questions about this recall
Why was it recalled?
CGMP deviations: Ibuprofen is being recalled in response to previous recall
Which lots are affected?
Lot#: HJ6138
Where was it sold?
NY
What should I do if I have it?
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
More recalls from Spirit Pharmaceuticals
All 2| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Acetaminophen, Regular Strength Pain Reliever recalled | Spirit Pharmaceuticals | Manufacturing (CGMP) Deviations | Nationwide |
Other Ibuprofen recalls
All 41| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Children's Ibuprofen Oral Suspension, USP, 100 mg recalledIbuprofen | Strides Pharma | Particulate Matter | Nationwide |
| Drug | CLASS III | IBU (ibuprofen) recalled by Dr. Reddy's LaboratoriesIBU | Dr. Reddy's Laboratories | Other | Nationwide |
| Drug | CLASS II | Ibuprofen 800mg, Generic for: Motrin, Each tablet contains recalled | Direct Rx | Potency & Assay | Nationwide |
| Drug | CLASS II | IBU Ibuprofen Tablets, USP, 600 mg recalled by Dr. Reddy's LaboratoriesIBU | Dr. Reddy's Laboratories | Potency & Assay | Nationwide |
| Drug | CLASS II | IBU Ibuprofen Tablets, USP, 400 mg recalled by Dr. Reddy's LaboratoriesIBU | Dr. Reddy's Laboratories | Potency & Assay | Nationwide |