The Recall Desk
ModerateFDA (Drugs)·D-0430-2023·Announced 2023-03-08

Ropinirole Tablets Recalled Due to Manufacturing Practice Deviations

Accord Healthcare is recalling 8,184 bottles of Ropinirole 4 mg tablets due to manufacturing practice deviations found during an FDA inspection. The recalled batches were distributed in the United States, Puerto Rico, and Canada.

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 a Class II FDA recall based on manufacturing practice deviations identified during inspection. No illnesses or injuries have been reported. Per the rubric, when no illnesses/injuries are reported and the hazard is theoretical, the score is at most 3. The precautionary nature of this recall supports a Moderate rating.

Plain-English summary

Accord Healthcare, Inc. is recalling Ropinirole Tablets USP 4 mg due to Current Good Manufacturing Practice (CGMP) deviations identified during an FDA inspection. Approximately 8,184 bottles are affected by this recall.

The affected batches are: P2106136 (expiration date 8/31/2023), P2106813 and P2106814 (expiration date 9/30/2023), and P2202764 (expiration date 4/30/2024). These tablets were distributed throughout the United States, including Puerto Rico, and Canada.

Patients should check if their medication is part of this recall by comparing the batch number and expiration date on their bottle with the recalled batches listed above. Anyone who has a recalled batch should contact their healthcare provider or pharmacist for instructions.

Patients should not discontinue use of Ropinirole without consulting their healthcare provider, as abruptly stopping this prescription medication could have health consequences.

The recalled product

Product
ROPINIROLE (ROPINIROLE)
Brand
ROPINIROLE
Manufacturer
Accord Healthcare, Inc.
Category
Drug — Prescription Tablet
Hazard
  • manufacturing-defect

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 (7)

  • Batches: P2106136
  • Exp. Date 8/31/2023
  • P2106813
  • P2106814
  • Exp. Date 9/30/2023
  • P2202764
  • Exp. Date 4/30/2024

UPCs (1)

  • 316729237017

Distribution

Distribution scope not specified by the agency.

Related recalls

Same brand · ROPINIROLE

Same category