RecallRadar

FDA Drug recall D-0240-2018

Ibuprofen Tablets, USP 800 mg, 6 x 1900 Tablets bulk packed in double polybag shipper packs for further packaging, Rx only, Manufactured by…

On 2018-01-31 the FDA classified a Class II recall of Ibuprofen Tablets, USP 800 mg, 6 x 1900 Tablets bulk packed in double polybag shipper packs for further packaging, Rx only, Manufactured by… by Marksans Pharma, citing CGMP Deviations: Various strengths of ibuprofen tablets/caplets are being recalled due to complaints of odor related to CGMP deficiencies.

Read the official FDA Drug notice

AgencyFDA Drug
Recall numberD-0240-2018
ClassificationClass II
Statusterminated
Initiated2018-01-09
Published2018-01-31
Last updated2026-09-13 11:52 UTC
CompanyMarksans Pharma
DistributionUS

Product

Ibuprofen Tablets, USP 800 mg, 6 x 1900 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 25000-123-27.

Reason

CGMP Deviations: Various strengths of ibuprofen tablets/caplets are being recalled due to complaints of odor related to CGMP deficiencies.

Identifiers

code_info
Lot #: Lot #: HM6067, HM6068, HM6069, HM6070, HM6072, HM6072, HM6073, HM6074, HM6075, HM6076, HM6077, HM6078, HM6079, H…Lot #: Lot #: HM6067, HM6068, HM6069, HM6070, HM6072, HM6072, HM6073, HM6074, HM6075, HM6076, HM6077, HM6078, HM6079, HM6080, HM6081, HM6082, HM6083, HM6084, HM6085, HM6086, HM6087, HM6088, HM6089, HM6090, HM6091, HM6092, HM6093, HM6094, HM6095, HM6096, Exp 02/18; HM6097, HM6098, HM6099, Exp 03/18; HM6100, HM6101, HM6102, HM6103, HM6104, HM6105, HM6106, HM6107, HM6108, HM6109, HM6110, HM6111, HM6112, HM6113, HM6114, HM6115, HM6116, HM6117, HM6118, HM6119, HM6120, HM6121, HM6122, HM6123, HM6124, HM6125, HM6126, HM6127, HM6128, HM6129, HM6130, HM6131, HM6132, Exp 08/18; HM6133, HM6134, HM6135, HM6136, HM6137, HM6128, HM6139; Exp 09/18

Status history

No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:52 UTC. Current status: terminated.

Source

Official record: https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0240-2018%22

RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.