West-Ward Recalls Doxycycline Hyclate Tablets Due to Dissolution Failure
West-Ward Columbus Inc. is recalling Doxycycline Hyclate 100 mg tablets because they failed a dissolution test at the end of their shelf life.
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 typically involves a situation that might cause temporary or medically reversible health consequences. The specific defect is a failure to meet dissolution specifications at the end of shelf life, which is a quality control issue rather than a contamination or mislabeling of a common allergen.
Plain-English summary
West-Ward Columbus Inc. is recalling Doxycycline Hyclate Tablets USP, 100 mg, in 50-count and 500-count bottles. The recall involves specific lots with expiration dates in June 2020 and June 2021. The affected products were distributed nationwide in the United States.
The recall was initiated because the dissolution test at the 24-month time point, which corresponds to the end of the product's shelf life, yielded an out-of-specification result. This means the tablets may not dissolve as required by the United States Pharmacopeia (USP) standards at the end of their labeled expiration date.
Consumers and healthcare providers should stop using the affected lots and return them to the pharmacy or point of purchase for a refund or replacement. Patients should consult their healthcare provider for alternative treatment options if they have been prescribed these specific lots.
The recalled product
- Product
- DOXYCYCLINE HYCLATE (DOXYCYCLINE HYCLATE)
- Brand
- DOXYCYCLINE HYCLATE
- Manufacturer
- West-Ward Columbus Inc
- Category
- Drug — Antibiotic
- Hazard
- Affected units
- 68,376
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 (6)
- Lot #: a) 71846B
- Exp 6/2021
- b) 71726A
- Exp 6/2020
- 71846B
- 71853A
UPCs (1)
- 0301432112508
Distribution
Distributed nationwide across the United States.
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