The Recall Desk
ModerateFDA (Drugs)·D-1288-2020·Announced 2020-06-10

Harvard Drug Group Recalls Doxycycline Hyclate Tablets for Dissolution Failure

The Harvard Drug Group is recalling Doxycycline Hyclate 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 where use of the product may cause temporary or medically reversible health consequences. The specific defect is a failure to meet dissolution specifications, which is a quality control issue rather than a direct contamination or acute safety hazard like a structural defect or high-risk pathogen.

Plain-English summary

The Harvard Drug Group is recalling Doxycycline Hyclate Tablets, USP, 100 mg. The affected products are packaged in 3x10 and 5x10 unit dose cartons and were manufactured by West-Ward Pharmaceutical Corp. and distributed by Major Pharmaceuticals.

The recall was initiated because the dissolution test at the 24-month time point, which corresponds to the end of the shelf life, yielded an out-of-specification result. This means the tablets may not dissolve properly as required by United States Pharmacopeia standards.

A total of 16,443 cartons were distributed nationwide within the United States. The affected lots are R00828D (Exp. 08/2020), R00732D (Exp. 05/2020), R00783D (Exp. 06/2020), and R00827D (Exp. 08/2020). Consumers and healthcare providers should check their inventory for these specific lot numbers and expiration dates. If found, the medication should be returned to the pharmacy or distributor for a replacement or refund.

The recalled product

Product
DOXYCYCLINE HYCLATE (DOXYCYCLINE HYCLATE)
Brand
DOXYCYCLINE HYCLATE
Manufacturer
The Harvard Drug Group
Category
Drug — Antibiotic
Hazard
Affected units
16,443

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 (8)

  • Lot #: a) R00828D
  • Exp. date 08/2020
  • b) R00732D
  • Exp. date 05/2020
  • R00783D
  • Exp. date 06/2020
  • R00827D
  • Exp. date 08/2020

Distribution

Distributed nationwide across the United States.

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Same hazard · dissolution failure

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