The Recall Desk
Agency classClass IIOur severity:ModerateFDA (Drugs)·D-0426-2023·Announced 2023-03-08

Ropinirole Tablets Recalled for Manufacturing Practice Deviations

Accord Healthcare recalls 181,848 bottles of Ropinirole 0.5 mg tablets distributed in the U.S., Canada, and Puerto Rico due to manufacturing practice deviations identified during an FDA inspection.

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 2/5 (Moderate).

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: FDA Class II recall with no reported illnesses or injuries. The hazard is related to manufacturing deviations without specific product defect or reported harm, consistent with a Moderate severity classification.

Plain-English summary

Accord Healthcare, Inc. is recalling 181,848 bottles of Ropinirole 0.5 mg tablets distributed in the United States, including Puerto Rico, and Canada. The recall affects multiple batches with expiration dates ranging from March 31, 2023 through May 31, 2024.

An FDA inspection identified Current Good Manufacturing Practice (CGMP) deviations in the manufacturing process, prompting this Class II recall. The specific affected batches and their expiration dates are listed on the FDA's recall notice.

Ropinirole is a prescription medication used to treat Parkinson's disease and restless leg syndrome. Patients who believe they have affected bottles should contact their healthcare provider or pharmacist for guidance about their medication.

More information about this recall, including the complete list of affected batch numbers, is available on the FDA's official drug recall website.

The recalled product

Product
ROPINIROLE (ROPINIROLE)
Brand
ROPINIROLE
Manufacturer
Accord Healthcare, Inc.
Category
Drug
Hazard
Affected units
181,848

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)

  • Batches: P2102133
  • P2102135
  • P2102136
  • Exp. Date 3/31/2023
  • P2104998
  • P2104997
  • P2104991
  • P2104992
  • P2104990
  • P2104993
  • P2105000
  • P2104999
  • P2105002
  • P2105001
  • Exp. Date 7/31/2023
  • P2106812
  • Exp. Date
  • 9/30/2023
  • P2200433
  • P2200434

UPCs (1)

  • 316729233019

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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