The Recall Desk
Agency classClass IIOur severity:HighFDA (Drugs)·D-0411-2023·Announced 2023-03-08

Simvastatin 40 mg tablets recalled for manufacturing practice deviations

Accord Healthcare is recalling 1,190,484 bottles of Simvastatin 40 mg tablets distributed in the United States, Puerto Rico, and Canada due to Current Good 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 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. This recall represents a risk-of-harm product where manufacturing control deviations have been identified but no illnesses or injuries have been reported, placing it at the High severity level per the rubric.

Plain-English summary

Accord Healthcare, Inc. is recalling 1,190,484 bottles of Simvastatin Tablets USP 40 mg across multiple batches. The recall follows an FDA inspection that identified Current Good Manufacturing Practice (CGMP) deviations at the manufacturing facility. These deviations relate to manufacturing and quality control procedures.

The affected product was distributed throughout the United States, including Puerto Rico, and Canada. The recall affects multiple batches with expiration dates ranging from February 2023 through May 2025. Affected batches are identified by specific lot numbers listed in the recall notice.

Consumers who have this medication should consult their healthcare provider about whether they should continue taking the product or switch to an alternative. Patients should not stop taking their medication without medical guidance. Those with questions about whether their medication is affected should check the lot number on their prescription bottle against the recall information.

The recalled product

Product
SIMVASTATIN (SIMVASTATIN)
Brand
SIMVASTATIN
Manufacturer
Accord Healthcare, Inc.
Category
Drug
Hazard
Affected units
1,190,484

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: a) P2103713
  • P2103692
  • Exp. Date 5/31/2023
  • P2104950
  • P2104984
  • P2104969
  • P2104996
  • P2105274
  • P2105314
  • P2105316
  • Exp. Date 7/31/2023
  • R2101074
  • R2101077
  • R2101078
  • R2101079
  • R2101083
  • R2101084
  • R2101117
  • Exp. Date 8/31/2023
  • R2101330

UPCs (2)

  • 316729006156
  • 316729006170

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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