The Recall Desk
ModerateFDA (Drugs)·D-1025-2018·Announced 2018-08-08

West-Ward Recalls Doxycycline Hyclate Tablets for Failed Dissolution Specifications

West-Ward Columbus Inc. is recalling Doxycycline Hyclate 100 mg tablets because they failed dissolution specifications.

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, which is a moderate risk. The hazard is a failure to meet dissolution specifications, which is a quality issue that may affect drug efficacy but does not involve a high-risk pathogen or immediate physical injury hazard like choking or fire.

Plain-English summary

West-Ward Columbus Inc. is recalling Doxycycline Hyclate Tablets, USP, 100 mg, 500-count bottles. The recall involves 29,048 bottles, containing a total of 14,524,000 tablets. The affected product is identified by Lot# 71545A and has an expiry date of 07/19.

The recall was initiated because the product failed dissolution specifications. This means the tablets may not dissolve in the body as intended, which could affect the delivery of the medication.

The product was distributed nationwide in the USA. Consumers and healthcare providers should check their inventory for the specific lot number and expiry date listed above. If the product is found, it should be returned to the pharmacy or point of purchase for a refund or replacement.

The recalled product

Product
DOXYCYCLINE HYCLATE (DOXYCYCLINE HYCLATE)
Brand
DOXYCYCLINE HYCLATE

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)

  • Lot# 71545A
  • Expiry date: 07/19

UPCs (1)

  • 0301432112508

Distribution

Distributed nationwide across the United States.

Part of a larger recall action

This product is one of 2 recalled by West-Ward Columbus 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 2 products in this recall →