The Recall Desk
Agency classClass IIOur severity:HighFDA (Drugs)·D-0429-2023·Announced 2023-03-08

FDA Recalls Ropinirole 3mg Tablets due to CGMP Deviations

Accord Healthcare's Ropinirole 3mg tablets are being recalled due to manufacturing compliance deviations identified during an FDA inspection. The recall affects 14,928 bottles distributed in the United States, Puerto Rico, and Canada.

The agency’s classification

FDA (Drugs): Class II

Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 3/5 (High).

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: FDA Class II recall due to CGMP deviations discovered during facility inspection. No illnesses or injuries have been reported. This qualifies as a risk-of-harm product with theoretical safety concerns from manufacturing control failures, but without reported injury.

Plain-English summary

Accord Healthcare, Inc. is recalling Ropinirole 3mg tablets due to manufacturing compliance deviations identified during an FDA facility inspection. Approximately 14,928 bottles have been distributed to pharmacy channels in the United States, Puerto Rico, and Canada.

The recall was initiated following an FDA inspection that identified Current Good Manufacturing Practice (CGMP) deviations at the manufacturing facility. These deviations indicate that the facility was not operating in full compliance with FDA requirements for pharmaceutical manufacturing controls and quality assurance.

Patients currently taking this medication should consult their healthcare provider or pharmacist before making any changes to their treatment. Do not discontinue use without medical guidance. Healthcare providers and pharmacists should identify and quarantine affected product. For return and replacement instructions, contact Accord Healthcare using the information on recalled product packaging.

The recalled product

Product
ROPINIROLE (ROPINIROLE)
Brand
ROPINIROLE
Manufacturer
Accord Healthcare, Inc.
Category
Drug — Prescription Medication
Hazard
Affected units
14,928

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 (10)

  • Batches: P2105099
  • P2105098
  • Exp. Date 7/31/2023
  • P2106507
  • P2106508
  • P2106510
  • P2106509
  • Exp. Date 9/30/2023
  • P2202750
  • Exp. Date 4/30/2024

UPCs (1)

  • 316729236010

Distribution

Distributed in 1 state:

Part of a larger recall action

This product is one of 67 recalled by Accord Healthcare, Inc. 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 67 products in this recall →

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