CLASS II Drug recall · Reported 31 Jan 2018 · FDA Enforcement Report
Ibuprofen Tablets, USP 200 mg, Caplets (Capsule-Shaped Tablets) bulk recalled
Marksans Pharma is recalling Ibuprofen Tablets, USP 200 mg, Caplets (Capsule-Shaped Tablets) bulk, distributed nationwide in the US. The recall was initiated on 9 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-0235-2018
- FDA event ID
- 78822
- Recalling firm
- Marksans Pharma, Hauppauge, NY
- Brand
- Ibuprofen
- Manufacturer
- MARKSANS PHARMA LIMITED
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 9 Jan 2018
- FDA classified
- 24 Jan 2018
- Reported
- 31 Jan 2018
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Manufacturing (CGMP) Deviations
- Drug class
- Pain Medication
Timeline
| 9 Jan 2018 | Recall initiated by company | |
| 24 Jan 2018 | Classified by FDA | +15 days |
| 31 Jan 2018 | Published in enforcement report | +7 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: Various strengths of ibuprofen tablets/caplets are being recalled due to complaints of odor related to CGMP deficiencies.
Product as listed by the FDA
Ibuprofen Tablets, USP 200 mg, 6 x 6500 Caplets (Capsule-Shaped Tablets) bulk packed in double polybag shipper packs for further packaging, Rx only, Manufactured by: Marksans Pharma Ltd., Plot No. L-82, L-83, Verna Indl. Estate, Verna, Goa - 403 722, India, NDC 25000-117-30.
Where it was distributed
Distributed to repackaging firms in NY who then distributed Nationwide in the USA.
Questions about this recall
Is Ibuprofen Tablets, USP 200 mg, Caplets (Capsule-Shaped Tablets) bulk recalled?
Yes. Marksans Pharma recalled Ibuprofen Tablets, USP 200 mg, Caplets (Capsule-Shaped Tablets) bulk on 9 Jan 2018. The recall is Class II and its status is Terminated. Recall number D-0235-2018.
Why was it recalled?
CGMP Deviations: Various strengths of ibuprofen tablets/caplets are being recalled due to complaints of odor related to CGMP deficiencies.
Which lots are affected?
Lot #: HH6001, HH6002, Exp 04/18
Where was it sold?
Distributed to repackaging firms in NY who then distributed Nationwide in the USA.
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 21 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 Marksans Pharma
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|---|---|---|---|---|---|
| Drug | CLASS II | Time-Cap Labs, Inc. Metformin Hydrochloride Extended recalledMetformin Hydrochloride Extended Release | Marksans Pharma | Nitrosamine Impurity | Nationwide |
| Drug | CLASS II | Time-Cap Labs, Inc. Metformin Hydrochloride recalled by Marksans PharmaMetformin Hydrochloride Extended Release | Marksans Pharma | Nitrosamine Impurity | Nationwide |
| Drug | CLASS II | Time-Cap Labs, Inc. Metformin Hydrochloride recalled by Marksans PharmaMetformin Hydrochloride Extended Release | Marksans Pharma | Nitrosamine Impurity | Nationwide |
| Drug | CLASS II | Ibuprofen Tablets, USP 400 mg, Tablets bulk recalled by Marksans Pharma | Marksans Pharma | Manufacturing (CGMP) Deviations | Nationwide |
| Drug | CLASS II | Ibuprofen Tablets, USP 200 mg, Tablets bulk recalled by Marksans Pharma | Marksans Pharma | Manufacturing (CGMP) Deviations | Nationwide |
Other Ibuprofen recalls
All 38| 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 | 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 |
| Drug | CLASS II | Ibuprofen Tablets, USP 400mg, Generic for Motrin, Pkg Size recalled | Preferred Pharmaceuticals | Potency & Assay | CA, NV |