The Recall Desk
ModerateFDA (Drugs)·D-0478-2023·Announced 2023-04-05

Prescription Drug Ropinirole 0.25 mg Tablets Recalled for Manufacturing Deviations

Direct Rx is recalling Ropinirole, USP, 0.25 mg tablets (NDC 72189-0364-30, Lot 21JU2210) nationwide due to Good Manufacturing Practice (cGMP) deviations. The firm voluntarily initiated this recall on March 13, 2023.

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: This is an FDA Class II recall with no reported illnesses, injuries, or deaths mentioned in the source. The hazard is a cGMP manufacturing deviation without a specified health risk. As a voluntary precautionary recall initiated by the firm with manufacturing process issues but no reported health effects, this meets the criteria for Moderate severity.

Plain-English summary

Direct Rx is recalling Ropinirole, USP, 0.25 mg tablets packaged in 30-count bottles (National Drug Code 72189-0364-30, Lot 21JU2210 with expiration date July 31, 2023) distributed nationwide in the United States. Nine bottles of this medication were affected.

The recall was initiated due to cGMP (Good Manufacturing Practice) deviations identified during manufacturing. Direct Rx voluntarily initiated this recall on March 13, 2023, and the FDA classified it as a Class II recall.

Patients and healthcare providers who possess this medication should contact their healthcare provider or pharmacist for guidance. Consumers should not dispose of medications in household trash or wastewater; instead, follow local medication disposal instructions or contact their pharmacy.

The recalled product

Product
Ropinirole, USP, 0.25 mg Tablets, Rx Only, Packaged as a 30-count bottle, NDC 72189-0364-30; Packaged and Distributed By: Direct Rx, Dawsonville, GA 30534
Manufacturer
Direct Rx
Category
Drug
Hazard
Affected units
9

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 (3)

  • Lot
  • expiry: 21JU2210
  • exp 7/31/23

Distribution

Distributed nationwide across the United States.

Part of a larger recall action

This product is one of 11 recalled by Direct Rx 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 11 products in this recall →

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