The Recall Desk
ModerateFDA (Drugs)·D-0237-2018·Announced 2018-01-31

Ibuprofen Tablets Recalled by FDA Due to Odor Complaints and CGMP Deficiencies

Marksans Pharma Inc. is recalling 205,088,000 ibuprofen tablets due to odor complaints linked to CGMP deficiencies. The product was distributed nationwide in the USA.

What this means for you

Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.

Our severity reasoning: The recall is classified as FDA Class II, and the hazard is odor complaints related to CGMP deficiencies without reported illnesses or injuries, fitting the criteria for a moderate severity voluntary precautionary recall.

Plain-English summary

Marksans Pharma Inc. is recalling 205,088,000 Ibuprofen Tablets, USP 200 mg, due to complaints of odor related to Current Good Manufacturing Practice (CGMP) deficiencies. The tablets are prescription-only and were manufactured in India. The recall covers specific lots with expiration dates ranging from February 2018 to August 2018.

The affected product was distributed to repackaging firms in New York, which then distributed the tablets nationwide in the United States. The recall is classified as FDA Class II, indicating a situation where use of, or exposure to, the violative product may cause temporary or medically reversible adverse health consequences.

Consumers and healthcare providers should stop using the recalled ibuprofen tablets and return them to the pharmacy or point of purchase for a refund or replacement. Patients should consult their healthcare provider for alternative treatment options if necessary.

The recalled product

Product
IBUPROFEN (IBUPROFEN)
Brand
IBUPROFEN
Manufacturer
Marksans Pharma Inc.
Category
Drug — Prescription Medication
Hazard
Affected units
205,088,000

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (20)

  • Lot #: HJ6080
  • HJ6081
  • HJ6082
  • HJ6083
  • HJ6084
  • HJ6085
  • HJ6086
  • HJ6087
  • HJ6088
  • HJ6089
  • HJ6090
  • HJ6091
  • HJ6092
  • HJ6093
  • HJ6094
  • HJ6095
  • HJ6096
  • HJ6097
  • HJ6098
  • HJ6099

UPCs (9)

  • 0325000114022
  • 0325000117146
  • 0325000114039
  • 0325000117030
  • 0325000117023
  • 0325000114145
  • 0325000117696
  • 0325000114718
  • 0325000114701

Distribution

Distributed nationwide across the United States.

The notice also names 1 state specifically:

Part of a larger recall action

This product is one of 6 recalled by Marksans Pharma Inc. under a single FDA (Drugs) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 6 products in this recall →

Related recalls

Same brand · IBUPROFEN

Same manufacturer · Marksans Pharma Inc.

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Same hazard · odor

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