The Recall Desk
ModerateFDA (Drugs)·D-0694-2018·Announced 2018-05-02

Time-Cap Recalls Ibuprofen Caplets Due to Odor Complaints and CGMP Deficiencies

Time-Cap Laboratories is recalling specific lots of Ibuprofen Caplets 200 mg due to odor complaints and CGMP deficiencies. The recall covers nationwide distribution.

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 involves CGMP deficiencies with odor complaints, but no illnesses or injuries are reported, fitting the criteria for a moderate severity voluntary precautionary recall.

Plain-English summary

Time-Cap Laboratories, Inc. is recalling specific lots of Ibuprofen Caplets USP 200 mg. The affected products include 50, 100, and 500 caplet bottles, as well as bulk bottles, manufactured by Marksans Pharma, Ltd. in India. The recall is limited to products with the lot code F066C.

The recall was initiated due to complaints regarding odor, which are attributed to Current Good Manufacturing Practice (CGMP) deficiencies. The source text does not report any illnesses or injuries associated with the use of these products.

Consumers who have purchased these specific lots should stop using the product and contact Time-Cap Laboratories, Inc. for further instructions or a refund. The recall is distributed nationwide.

The recalled product

Product
IBUPROFEN (IBUPROFEN)
Brand
IBUPROFEN
Manufacturer
Time-Cap Laboratories, Inc.
Category
Drug — Nonsteroidal Anti-inflammatory Drug
Hazard

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 (1)

  • a) F066C b) F066C c) F066C

UPCs (5)

  • 0349483600018
  • 0349483601015
  • 0349483600056
  • 0349483114171
  • 0349483600506

Distribution

Distributed nationwide across the United States.

Part of a larger recall action

This product is one of 11 recalled by Time-Cap Laboratories, 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 11 products in this recall →

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Same brand · IBUPROFEN

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Same hazard · cgmp deficiency

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