The Recall Desk
Agency classClass IIOur severity:HighFDA (Drugs)·D-0425-2023·Announced 2023-03-08

Ropinirole tablets recalled due to FDA manufacturing compliance deviations

Accord Healthcare recalls 139,332 bottles of ropinirole 0.25 mg tablets distributed in the US, Puerto Rico, and Canada due to manufacturing compliance deviations identified during 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 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 classification indicates potential for adverse health consequences. No illnesses or injuries are reported in the source. The specific CGMP deviations are not detailed, making this a risk-of-harm situation where injury has not yet been reported, meeting the rubric criterion for High severity.

Plain-English summary

Accord Healthcare, Inc. is recalling ropinirole 0.25 mg tablets due to Current Good Manufacturing Practice (CGMP) deviations identified during an FDA inspection. The recall affects 139,332 bottles distributed in the United States, Puerto Rico, and Canada.

The recalled ropinirole tablets were manufactured by Intas Pharmaceuticals Limited in India and distributed under Accord Healthcare, Inc. Multiple batches are affected, with expiration dates ranging from March 2023 to May 2024. The involved lot numbers are P2102086, P2105093-P2105097, P2106490-P2106494, P2201067-P2201069, and P2203516.

Individuals taking the recalled medication should contact their healthcare provider or pharmacist for guidance on whether to continue or discontinue use.

The recalled product

Product
ROPINIROLE (ROPINIROLE)
Brand
ROPINIROLE
Manufacturer
Accord Healthcare, Inc.
Category
Drug
Hazard
Affected units
139,332

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: P2102086
  • Exp. Date 3/31/2023
  • P2105094
  • P2105095
  • P2105097
  • P2105096
  • P2105093
  • Exp. Date 7/31/2023
  • P2106490
  • P2106491
  • P2106493
  • P2106492
  • P2106494
  • Exp. Date 9/30/2023
  • P2201069
  • P2201068
  • P2201067
  • Exp. Date 1/31/2024
  • P2203516
  • Exp. Date 5/31/2024

UPCs (1)

  • 316729232012

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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