The Recall Desk
ModerateFDA (Drugs)·D-1276-2020·Announced 2020-06-03

PD-Rx Recalls Doxycycline Hyclate Tablets for Failed Dissolution Specifications

PD-Rx Pharmaceuticals is recalling Doxycycline Hyclate 100 mg tablets because they failed to meet dissolution specifications. The recall covers 14,030 bottles distributed nationwide.

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 due to failed dissolution specifications, which is a quality control issue that could potentially affect drug efficacy but is not associated with reported serious injuries or deaths.

Plain-English summary

PD-Rx Pharmaceuticals, Inc. is recalling Doxycycline Hyclate tablets USP, 100 mg, because the product failed to meet dissolution specifications. The recall involves 14,030 bottles of the prescription medication, which is available in various package sizes including 6, 10, 14, 20, 28, 30, 60, 120, 210, 300, and 400-count bottles. The affected lots have expiration dates ranging from June 30, 2020, to January 31, 2021.

The affected product was distributed nationwide in the United States. Doxycycline is a prescription antibiotic used to treat various bacterial infections. The recall is classified as Class II by the FDA, indicating that violation of good manufacturing practice (GMP) or other requirements could result in temporary or medically reversible adverse health consequences.

Consumers and healthcare providers should stop using the affected lots of Doxycycline Hyclate tablets and contact their pharmacist or healthcare provider for a replacement or refund. Patients should not discontinue their medication without consulting their healthcare provider, as stopping antibiotics early can lead to treatment failure or resistance.

The recalled product

Product
DOXYCYCLINE (DOXYCYCLINE HYCLATE)
Brand
DOXYCYCLINE
Manufacturer
PD-Rx Pharmaceuticals, Inc.
Category
Drug — Antibiotic
Hazard
Affected units
14,030

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 (20)

  • Lots: a) L18B72
  • Exp 12/31/2020
  • b)I18B83
  • Exp 06/30/2020
  • c) H18B11
  • I18A53
  • J18F97
  • Exp 10/31/2020
  • K18A33
  • Exp 11/30/2020
  • K18D17
  • L18A11
  • L18A29
  • L18D81
  • d) H18F60
  • I18C26
  • I18D61
  • Exp. 06/30/2020
  • J18B80
  • K18C97 Exp 11/30/2020

UPCs (1)

  • 0355289866954

Distribution

Distributed nationwide across the United States.

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