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.
What this means for you
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
- cgmp-deviation
- quality-control
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
Distribution scope not specified by the agency.
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- ModerateRopinirole Tablets Recalled Due to Manufacturing Quality Violations
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- ModerateRopinirole Tablets Recalled by Accord Healthcare Following FDA Inspection
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- HighRopinirole tablets recalled due to manufacturing practice deviations
FDA (Drugs) · 2023-03-08
- HighRopinirole tablets recalled due to FDA manufacturing compliance deviations
FDA (Drugs) · 2023-03-08
- ModerateRopinirole Tablets Recalled Due to Manufacturing Practice Deviations
FDA (Drugs) · 2023-03-08
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