The Recall Desk
Agency classClass IIOur severity:ModerateFDA (Drugs)·D-0428-2023·Announced 2023-03-08

Ropinirole Tablets Recalled by Accord Healthcare Following FDA Inspection

Accord Healthcare is recalling 25,344 bottles of Ropinirole 2 mg tablets due to manufacturing deviations discovered during an FDA inspection. The recall affects medications 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 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 precautionary recall due to manufacturing deviations with no reported illnesses or injuries. Per the rubric, theoretical hazards without reported harm score at most 3; this precautionary manufacturing recall falls within the Moderate category.

Plain-English summary

Accord Healthcare, Inc. is recalling 25,344 bottles of Ropinirole Tablets USP 2 mg due to Current Good Manufacturing Practice (CGMP) deviations discovered during an FDA inspection. The medication was manufactured by Intas Pharmaceuticals Limited and distributed in the United States, Puerto Rico, and Canada.

The affected product carries NDC number 16729-235-01 and includes the following batches: P2106370 and P2106369 (expiration date 9/30/2023), and batch P2201254 (expiration date 2/29/2024). Consumers should verify their medication against these batch numbers and expiration dates.

Patients currently taking Ropinirole should contact their healthcare provider or pharmacist to determine whether their medication is affected by this recall and to discuss next steps. The FDA has classified this as a Class II recall.

The recalled product

Product
ROPINIROLE (ROPINIROLE)
Brand
ROPINIROLE
Manufacturer
Accord Healthcare, Inc.
Category
Drug
Hazard
Affected units
25,344

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 (5)

  • Batches: P2106370
  • P2106369
  • Exp. Date 9/30/2023
  • P2201254
  • Exp. Date 2/29/2024

UPCs (1)

  • 316729235013

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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