CLASS II Drug recall · Reported 31 Jan 2018 · FDA Enforcement Report

Ibuprofen Tablets, USP 400 mg, Tablets bulk recalled by Marksans Pharma

Marksans Pharma is recalling Ibuprofen Tablets, USP 400 mg, 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

Lot, batch or date codesLot #: HK6001, HK6002, HK6003, HK6004, HK6005, HK6006, HK6007, HK6008, HK6009, HK6010, HK6011, HK6012, HK6013, HK6014, HK6015, Exp 09/18

Quantity recalled21,584,100 tablets

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-0238-2018
FDA event ID: 78822
Recalling firm: Marksans Pharma, Hauppauge, NY
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 400 mg, 6 x 3500 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 25000-121-29.

Where it was distributed

Distributed to repackaging firms in NY who then distributed Nationwide in the USA.

Nationwide New York

Questions about this recall

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 #: HK6001, HK6002, HK6003, HK6004, HK6005, HK6006, HK6007, HK6008, HK6009, HK6010, HK6011, HK6012, HK6013, HK6014, HK6015, Exp 09/18

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 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.

Other products in this recall event

5 other products · FDA event 78822

This product is part of a recall event; the main page for the event is Ibuprofen Tablets, USP 600 mg, Tablets bulk recalled by Marksans Pharma.

Reported	Class	Recall	Company	Reason	Where
31 Jan 2018	CLASS II	Ibuprofen Tablets, USP 600 mg, Tablets bulk recalled by Marksans Pharma	Marksans Pharma	Manufacturing (CGMP) Deviations	Nationwide
31 Jan 2018	CLASS II	Ibuprofen Tablets, USP 200 mg, Caplets (Capsule-Shaped Tablets) bulk recalledIbuprofen	Marksans Pharma	Manufacturing (CGMP) Deviations	Nationwide
31 Jan 2018	CLASS II	Ibuprofen Tablets, USP 800 mg, Tablets bulk recalled by Marksans Pharma	Marksans Pharma	Manufacturing (CGMP) Deviations	Nationwide
31 Jan 2018	CLASS II	Ibuprofen Tablets, USP 200 mg, Tablets bulk recalled by Marksans PharmaIbuprofen	Marksans Pharma	Manufacturing (CGMP) Deviations	Nationwide
31 Jan 2018	CLASS II	Ibuprofen Tablets, USP 200 mg, Tablets bulk recalled by Marksans Pharma	Marksans Pharma	Manufacturing (CGMP) Deviations	Nationwide

More recalls from Marksans Pharma

All 9

Reported	Class	Recall	Company	Reason	Where
11 Nov 2020Drug	CLASS II	Time-Cap Labs, Inc. Metformin Hydrochloride Extended recalledMetformin Hydrochloride Extended Release	Marksans Pharma	Nitrosamine Impurity	Nationwide
11 Nov 2020Drug	CLASS II	Time-Cap Labs, Inc. Metformin Hydrochloride recalled by Marksans PharmaMetformin Hydrochloride Extended Release	Marksans Pharma	Nitrosamine Impurity	Nationwide
1 Jul 2020Drug	CLASS II	Time-Cap Labs, Inc. Metformin Hydrochloride recalled by Marksans PharmaMetformin Hydrochloride Extended Release	Marksans Pharma	Nitrosamine Impurity	Nationwide
31 Jan 2018Drug	CLASS II	Ibuprofen Tablets, USP 200 mg, Tablets bulk recalled by Marksans Pharma	Marksans Pharma	Manufacturing (CGMP) Deviations	Nationwide
31 Jan 2018Drug	CLASS II	Ibuprofen Tablets, USP 200 mg, Tablets bulk recalled by Marksans PharmaIbuprofen	Marksans Pharma	Manufacturing (CGMP) Deviations	Nationwide

Other Ibuprofen recalls

All 41

Reported	Class	Recall	Company	Reason	Where
25 Mar 2026Drug	CLASS II	Children's Ibuprofen Oral Suspension, USP, 100 mg recalledIbuprofen	Strides Pharma	Particulate Matter	Nationwide
27 Nov 2024Drug	CLASS III	IBU (ibuprofen) recalled by Dr. Reddy's LaboratoriesIBU	Dr. Reddy's Laboratories	Other	Nationwide
13 Nov 2024Drug	CLASS II	Ibuprofen 800mg, Generic for: Motrin, Each tablet contains recalled	Direct Rx	Potency & Assay	Nationwide
4 Sep 2024Drug	CLASS II	IBU Ibuprofen Tablets, USP, 600 mg recalled by Dr. Reddy's LaboratoriesIBU	Dr. Reddy's Laboratories	Potency & Assay	Nationwide
4 Sep 2024Drug	CLASS II	IBU Ibuprofen Tablets, USP, 400 mg recalled by Dr. Reddy's LaboratoriesIBU	Dr. Reddy's Laboratories	Potency & Assay	Nationwide