The Recall Desk
ModerateFDA (Drugs)·D0034-2015·Announced 2014-10-29

New GPC Inc. Recalls Whitfield's Ointment for Labeling Deficiencies

New GPC Inc. is recalling 4,320 units of Whitfield's Ointment B.P. in New York due to missing drug listings and non-compliant labeling.

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 minor labeling errors and regulatory non-compliance (lack of listing/approval) without reports of illness or injury, fitting the Moderate severity criteria.

Plain-English summary

New GPC Inc. has initiated a recall of 4,320 units of Whitfield's Ointment B.P. (15g) manufactured in Guyana. The affected products were distributed in New York and include batch numbers 202504 and 310455.

The recall was issued because the products do not meet monograph requirements. Specifically, the items lack a required drug listing, fail to meet Over-the-Counter (OTC) drug labeling requirements, and are labeled as 'Not Approved for sale in U.S.A.'

Consumers who possess these specific batches of Whitfield's Ointment B.P. should stop using the product and contact the recalling firm for further instructions.

The recalled product

Product
Whitfield's OINTMENT B.P., Net Contents: 15g. Manufactured by: NEW GPC INC. A1 Farm, EBD. Country of Origin Guyana.
Manufacturer
New Gpc Inc.
Affected units
4,320

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 (2)

  • Batch Numbers: 202504
  • 310455

Distribution

Distributed in 1 state:

Part of a larger recall action

This product is one of 7 recalled by New Gpc 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 7 products in this recall →