Medications & Supplements/Prescription Drugs

Marksans Pharma Inc.: Ibuprofen Tablets and Caplets Recalled for Unusual Odor

Agency Publication Date: January 24, 2018

Summary

Marksans Pharma Inc. is recalling over 309 million units of Ibuprofen Tablets and Caplets in 200 mg, 400 mg, 600 mg, and 800 mg strengths. The recall was initiated due to numerous complaints of an unusual odor coming from the medication, which was traced back to deficiencies in Current Good Manufacturing Practice (CGMP) standards. These prescription and over-the-counter medications were manufactured in India and distributed in bulk packs to various repackaging firms before being sent to pharmacies nationwide.

Risk

The unusual odor indicates a potential chemical or quality deviation during the manufacturing process. While no specific injuries were reported, consuming medication that fails to meet quality standards could lead to unforeseen adverse health effects or a loss of therapeutic efficacy.

What You Should Do

Check your medication bottles for Ibuprofen Tablets or Caplets (200 mg, 400 mg, 600 mg, or 800 mg) and verify if the NDC numbers match 25000-117-30, 25000-136-20, 25000-114-30, 25000-121-29, 25000-122-28, or 25000-123-27.
If you are using 200 mg caplets, look for lot numbers HH6001 or HH6002 with an expiration of 04/18. For 200 mg tablets, check for lots HI6001, HI6002, or HI6003 (Exp 02/18) and a large range of HJ-series lots (HJ6080 through HJ6220) with expiration dates from February to August 2018.
For 400 mg tablets, check for lots HK6001 through HK6015 (Exp 09/18). For 600 mg tablets, look for HN-series lots (HN6004 through HN6027) with expiration dates between March and September 2018. For 800 mg tablets, check HM-series lots (HM6067 through HM6139) with expiration dates between February and September 2018.
Immediately stop using any affected medication and contact your healthcare provider or pharmacist for guidance on an alternative treatment.
Return any unused product to the pharmacy or place of purchase for a full refund and contact Marksans Pharma Inc. for further instructions regarding the return of the product.
Call the FDA Consumer Complaint hotline for any additional questions or to report adverse effects at 1-888-723-3332 (1-888-SAFEFDA).

Your Remedy Options

Full Refund

Healthcare provider consultation and pharmacy refund

How to: Contact your healthcare provider or pharmacist for guidance. Return any unused product to the pharmacy for a refund

Affected Products

Product: Ibuprofen Tablets, USP 200 mg Caplets (6 x 6500 count bulk packs)

Model:

NDC 25000-117-30

Lot Numbers:

HH6001 (Exp 04/18)

HH6002 (Exp 04/18)

Date Ranges: April 2018

Product: Ibuprofen Tablets, USP 200 mg Tablets (6 x 6500 count bulk packs)

Model:

NDC 25000-136-20

Lot Numbers:

HI6001 (Exp 02/18)

HI6002 (Exp 02/18)

HI6003 (Exp 02/18)

Date Ranges: February 2018

Product: Ibuprofen Tablets, USP 200 mg Tablets (6 x 6500 count bulk packs)

Model:

NDC 25000-114-30

Lot Numbers (141):

HJ6080 (Exp 02/18)

HJ6081 (Exp 02/18)

HJ6082 (Exp 02/18)

HJ6083 (Exp 02/18)

HJ6084 (Exp 02/18)

HJ6085 (Exp 02/18)

HJ6086 (Exp 02/18)

HJ6087 (Exp 02/18)

HJ6088 (Exp 02/18)

HJ6089 (Exp 02/18)

HJ6090 (Exp 02/18)

HJ6091 (Exp 02/18)

HJ6092 (Exp 02/18)

HJ6093 (Exp 02/18)

HJ6094 (Exp 02/18)

HJ6095 (Exp 02/18)

HJ6096 (Exp 02/18)

HJ6097 (Exp 02/18)

HJ6098 (Exp 02/18)

HJ6099 (Exp 02/18)

HJ6100 (Exp 02/18)

HJ6101 (Exp 02/18)

HJ6102 (Exp 02/18)

HJ6103 (Exp 02/18)

HJ6104 (Exp 02/18)

HJ6105 (Exp 02/18)

HJ6106 (Exp 02/18)

HJ6107 (Exp 02/18)

HJ6108 (Exp 02/18)

HJ6109 (Exp 02/18)

HJ6110 (Exp 02/18)

HJ6111 (Exp 02/18)

HJ6112 (Exp 02/18)

HJ6113 (Exp 03/18)

HJ6114 (Exp 03/18)

HJ6115 (Exp 03/18)

HJ6116 (Exp 03/18)

HJ6117 (Exp 03/18)

HJ6118 (Exp 03/18)

HJ6119 (Exp 03/18)

HJ6120 (Exp 03/18)

HJ6121 (Exp 03/18)

HJ6122 (Exp 03/18)

HJ6123 (Exp 03/18)

HJ6124 (Exp 03/18)

HJ6125 (Exp 03/18)

HJ6126 (Exp 03/18)

HJ6127 (Exp 03/18)

HJ6128 (Exp 03/18)

HJ6129 (Exp 03/18)

Date Ranges: February 2018 - August 2018

Product: Ibuprofen Tablets, USP 400 mg Tablets (6 x 3500 count bulk packs)

Model:

NDC 25000-121-29

Lot Numbers:

HK6001 (Exp 09/18)

HK6002 (Exp 09/18)

HK6003 (Exp 09/18)

HK6004 (Exp 09/18)

HK6005 (Exp 09/18)

HK6006 (Exp 09/18)

HK6007 (Exp 09/18)

HK6008 (Exp 09/18)

HK6009 (Exp 09/18)

HK6010 (Exp 09/18)

HK6011 (Exp 09/18)

HK6012 (Exp 09/18)

HK6013 (Exp 09/18)

HK6014 (Exp 09/18)

HK6015 (Exp 09/18)

Date Ranges: September 2018

Product: Ibuprofen Tablets, USP 600 mg Tablets (6 x 2500 count bulk packs)

Model:

NDC 25000-122-28

Lot Numbers:

HN6004 (Exp 03/18)

HN6005 (Exp 03/18)

HN6006 (Exp 03/18)

HN6007 (Exp 03/18)

HN6008 (Exp 03/18)

HN6009 (Exp 03/18)

HN6010 (Exp 03/18)

HN6011 (Exp 03/18)

HN6012 (Exp 03/18)

HN6013 (Exp 03/18)

HN6014 (Exp 03/18)

HN6015 (Exp 04/18)

HN6016 (Exp 04/18)

HN6017 (Exp 04/18)

HN6018 (Exp 04/18)

HN6019 (Exp 04/18)

HN6020 (Exp 04/18)

HN6021 (Exp 04/18)

HN6022 (Exp 04/18)

HN6023 (Exp 04/18)

HN6024 (Exp 07/18)

HN6025 (Exp 09/18)

HN6026 (Exp 09/18)

HN6027 (Exp 09/18)

Date Ranges: March 2018 - September 2018

Product: Ibuprofen Tablets, USP 800 mg Tablets (6 x 1900 count bulk packs)

Model:

NDC 25000-123-27

Lot Numbers (73):

HM6067 (Exp 02/18)

HM6068 (Exp 02/18)

HM6069 (Exp 02/18)

HM6070 (Exp 02/18)

HM6072 (Exp 02/18)

HM6073 (Exp 02/18)

HM6074 (Exp 02/18)

HM6075 (Exp 02/18)

HM6076 (Exp 02/18)

HM6077 (Exp 02/18)

HM6078 (Exp 02/18)

HM6079 (Exp 02/18)

HM6080 (Exp 02/18)

HM6081 (Exp 02/18)

HM6082 (Exp 02/18)

HM6083 (Exp 02/18)

HM6084 (Exp 02/18)

HM6085 (Exp 02/18)

HM6086 (Exp 02/18)

HM6087 (Exp 02/18)

HM6088 (Exp 02/18)

HM6089 (Exp 02/18)

HM6090 (Exp 02/18)

HM6091 (Exp 02/18)

HM6092 (Exp 02/18)

HM6093 (Exp 02/18)

HM6094 (Exp 02/18)

HM6095 (Exp 02/18)

HM6096 (Exp 02/18)

HM6097 (Exp 03/18)

HM6098 (Exp 03/18)

HM6099 (Exp 03/18)

HM6100 (Exp 08/18)

HM6101 (Exp 08/18)

HM6102 (Exp 08/18)

HM6103 (Exp 08/18)

HM6104 (Exp 08/18)

HM6105 (Exp 08/18)

HM6106 (Exp 08/18)

HM6107 (Exp 08/18)

HM6108 (Exp 08/18)

HM6109 (Exp 08/18)

HM6110 (Exp 08/18)

HM6111 (Exp 08/18)

HM6112 (Exp 08/18)

HM6113 (Exp 08/18)

HM6114 (Exp 08/18)

HM6115 (Exp 08/18)

HM6116 (Exp 08/18)

Date Ranges: February 2018 - September 2018

Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 78822

Status: Resolved

Manufacturer: Marksans Pharma Inc.

Sold By: Repackaging firms in New York; Pharmacies nationwide

Manufactured In: India, United States

Units Affected: 6 products (2,853,500 Caplets; 4,127,500 tablets; 205,088,000 tablets; 21,584,100 tablets; 23,088,900 tablets; 52,549,000 tablets)

Distributed To: Nationwide

Were You Affected by This Recall?

If you or a family member were harmed by this recalled product, you may have legal rights. Consider consulting a consumer protection attorney to understand your options for compensation.

Find an Attorney

This is general information, not legal advice. Go Backs is not a law firm and does not provide legal services.

AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.

Sources: FDA iRES · Raw API Response

openFDA Disclaimer: This recall information is sourced from the openFDA API. Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Refer to the openFDA terms of service for more information.

Summary

What You Should Do

Check your medication bottles for Ibuprofen Tablets or Caplets (200 mg, 400 mg, 600 mg, or 800 mg) and verify if the NDC numbers match 25000-117-30, 25000-136-20, 25000-114-30, 25000-121-29, 25000-122-28, or 25000-123-27.

If you are using 200 mg caplets, look for lot numbers HH6001 or HH6002 with an expiration of 04/18. For 200 mg tablets, check for lots HI6001, HI6002, or HI6003 (Exp 02/18) and a large range of HJ-series lots (HJ6080 through HJ6220) with expiration dates from February to August 2018.

For 400 mg tablets, check for lots HK6001 through HK6015 (Exp 09/18). For 600 mg tablets, look for HN-series lots (HN6004 through HN6027) with expiration dates between March and September 2018. For 800 mg tablets, check HM-series lots (HM6067 through HM6139) with expiration dates between February and September 2018.

Immediately stop using any affected medication and contact your healthcare provider or pharmacist for guidance on an alternative treatment.

Return any unused product to the pharmacy or place of purchase for a full refund and contact Marksans Pharma Inc. for further instructions regarding the return of the product.

Call the FDA Consumer Complaint hotline for any additional questions or to report adverse effects at 1-888-723-3332 (1-888-SAFEFDA).

Affected Products

Product: Ibuprofen Tablets, USP 200 mg Caplets (6 x 6500 count bulk packs)

Model:

NDC 25000-117-30

Lot Numbers:

HH6001 (Exp 04/18)

HH6002 (Exp 04/18)

Date Ranges: April 2018

Product: Ibuprofen Tablets, USP 200 mg Tablets (6 x 6500 count bulk packs)

Model:

NDC 25000-136-20

Lot Numbers:

HI6001 (Exp 02/18)

HI6002 (Exp 02/18)

HI6003 (Exp 02/18)

Date Ranges: February 2018

Product: Ibuprofen Tablets, USP 200 mg Tablets (6 x 6500 count bulk packs)

Model:

NDC 25000-114-30

Lot Numbers (141):

HJ6080 (Exp 02/18)

HJ6081 (Exp 02/18)

HJ6082 (Exp 02/18)

HJ6083 (Exp 02/18)

HJ6084 (Exp 02/18)

HJ6085 (Exp 02/18)

HJ6086 (Exp 02/18)

HJ6087 (Exp 02/18)

HJ6088 (Exp 02/18)

HJ6089 (Exp 02/18)

HJ6090 (Exp 02/18)

HJ6091 (Exp 02/18)

HJ6092 (Exp 02/18)

HJ6093 (Exp 02/18)

HJ6094 (Exp 02/18)

HJ6095 (Exp 02/18)

HJ6096 (Exp 02/18)

HJ6097 (Exp 02/18)

HJ6098 (Exp 02/18)

HJ6099 (Exp 02/18)

HJ6100 (Exp 02/18)

HJ6101 (Exp 02/18)

HJ6102 (Exp 02/18)

HJ6103 (Exp 02/18)

HJ6104 (Exp 02/18)

HJ6105 (Exp 02/18)

HJ6106 (Exp 02/18)

HJ6107 (Exp 02/18)

HJ6108 (Exp 02/18)

HJ6109 (Exp 02/18)

HJ6110 (Exp 02/18)

HJ6111 (Exp 02/18)

HJ6112 (Exp 02/18)

HJ6113 (Exp 03/18)

HJ6114 (Exp 03/18)

HJ6115 (Exp 03/18)

HJ6116 (Exp 03/18)

HJ6117 (Exp 03/18)

HJ6118 (Exp 03/18)

HJ6119 (Exp 03/18)

HJ6120 (Exp 03/18)

HJ6121 (Exp 03/18)

HJ6122 (Exp 03/18)

HJ6123 (Exp 03/18)

HJ6124 (Exp 03/18)

HJ6125 (Exp 03/18)

HJ6126 (Exp 03/18)

HJ6127 (Exp 03/18)

HJ6128 (Exp 03/18)

HJ6129 (Exp 03/18)

Date Ranges: February 2018 - August 2018

Product: Ibuprofen Tablets, USP 400 mg Tablets (6 x 3500 count bulk packs)

Model:

NDC 25000-121-29

Lot Numbers:

HK6001 (Exp 09/18)

HK6002 (Exp 09/18)

HK6003 (Exp 09/18)

HK6004 (Exp 09/18)

HK6005 (Exp 09/18)

HK6006 (Exp 09/18)

HK6007 (Exp 09/18)

HK6008 (Exp 09/18)

HK6009 (Exp 09/18)

HK6010 (Exp 09/18)

HK6011 (Exp 09/18)

HK6012 (Exp 09/18)

HK6013 (Exp 09/18)

HK6014 (Exp 09/18)

HK6015 (Exp 09/18)

Date Ranges: September 2018

Product: Ibuprofen Tablets, USP 600 mg Tablets (6 x 2500 count bulk packs)

Model:

NDC 25000-122-28

Lot Numbers:

HN6004 (Exp 03/18)

HN6005 (Exp 03/18)

HN6006 (Exp 03/18)

HN6007 (Exp 03/18)

HN6008 (Exp 03/18)

HN6009 (Exp 03/18)

HN6010 (Exp 03/18)

HN6011 (Exp 03/18)

HN6012 (Exp 03/18)

HN6013 (Exp 03/18)

HN6014 (Exp 03/18)

HN6015 (Exp 04/18)

HN6016 (Exp 04/18)

HN6017 (Exp 04/18)

HN6018 (Exp 04/18)

HN6019 (Exp 04/18)

HN6020 (Exp 04/18)

HN6021 (Exp 04/18)

HN6022 (Exp 04/18)

HN6023 (Exp 04/18)

HN6024 (Exp 07/18)

HN6025 (Exp 09/18)

HN6026 (Exp 09/18)

HN6027 (Exp 09/18)

Date Ranges: March 2018 - September 2018

Product: Ibuprofen Tablets, USP 800 mg Tablets (6 x 1900 count bulk packs)

Model:

NDC 25000-123-27

Lot Numbers (73):

HM6067 (Exp 02/18)

HM6068 (Exp 02/18)

HM6069 (Exp 02/18)

HM6070 (Exp 02/18)

HM6072 (Exp 02/18)

HM6073 (Exp 02/18)

HM6074 (Exp 02/18)

HM6075 (Exp 02/18)

HM6076 (Exp 02/18)

HM6077 (Exp 02/18)

HM6078 (Exp 02/18)

HM6079 (Exp 02/18)

HM6080 (Exp 02/18)

HM6081 (Exp 02/18)

HM6082 (Exp 02/18)

HM6083 (Exp 02/18)

HM6084 (Exp 02/18)

HM6085 (Exp 02/18)

HM6086 (Exp 02/18)

HM6087 (Exp 02/18)

HM6088 (Exp 02/18)

HM6089 (Exp 02/18)

HM6090 (Exp 02/18)

HM6091 (Exp 02/18)

HM6092 (Exp 02/18)

HM6093 (Exp 02/18)

HM6094 (Exp 02/18)

HM6095 (Exp 02/18)

HM6096 (Exp 02/18)

HM6097 (Exp 03/18)

HM6098 (Exp 03/18)

HM6099 (Exp 03/18)

HM6100 (Exp 08/18)

HM6101 (Exp 08/18)

HM6102 (Exp 08/18)

HM6103 (Exp 08/18)

HM6104 (Exp 08/18)

HM6105 (Exp 08/18)

HM6106 (Exp 08/18)

HM6107 (Exp 08/18)

HM6108 (Exp 08/18)

HM6109 (Exp 08/18)

HM6110 (Exp 08/18)

HM6111 (Exp 08/18)

HM6112 (Exp 08/18)

HM6113 (Exp 08/18)

HM6114 (Exp 08/18)

HM6115 (Exp 08/18)

HM6116 (Exp 08/18)

Date Ranges: February 2018 - September 2018

Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 78822

Status: Resolved

Manufacturer: Marksans Pharma Inc.

Sold By: Repackaging firms in New York; Pharmacies nationwide

Manufactured In: India, United States

Units Affected: 6 products (2,853,500 Caplets; 4,127,500 tablets; 205,088,000 tablets; 21,584,100 tablets; 23,088,900 tablets; 52,549,000 tablets)

Distributed To: Nationwide