The Recall Desk
Agency classClass IIOur severity:ModerateFDA (Drugs)·D-0410-2023·Announced 2023-03-08

Simvastatin Tablets Recalled Due to Manufacturing Practice Deviations

Accord Healthcare is recalling Simvastatin 20 mg tablets due to manufacturing practice deviations discovered during an FDA inspection. The recall affects 1,394,208 bottles 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: This is a Class II recall due to manufacturing process deviations discovered during FDA inspection. No illnesses or injuries have been reported. As the specific hazard resulting from these deviations is not identified in the source, this is scored as a precautionary manufacturing-related recall.

Plain-English summary

Accord Healthcare is recalling Simvastatin 20 mg tablets manufactured by Intas Pharmaceuticals Limited due to manufacturing practice deviations discovered during an FDA inspection.

The recall includes 1,394,208 bottles distributed across the United States, Puerto Rico, and Canada. Affected products include both 90-count and 1,000-count bottles with multiple batch numbers and expiration dates ranging from March 2023 through May 2025.

The FDA identified Current Good Manufacturing Practice (CGMP) deviations at the manufacturing facility. These deviations indicate non-compliance with manufacturing standards designed to ensure drug quality and safety.

Patients should consult their healthcare provider regarding their Simvastatin prescription, particularly if they have taken medication from an affected batch. For information about specific batch numbers and further details, consumers can visit the FDA's drug recalls website or contact Accord Healthcare directly.

The recalled product

Product
SIMVASTATIN (SIMVASTATIN)
Brand
SIMVASTATIN
Manufacturer
Accord Healthcare, Inc.
Category
Drug — Prescription Drug
Hazard
Affected units
1,394,208

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) P2102261
  • P2102284
  • P2102319
  • Exp. Date 3/31/2023
  • P2103536
  • Exp. Date 5/31/2023
  • P2104344
  • P2104342
  • P2104355
  • P2104356
  • P2104296
  • P2104380
  • Exp. Date 6/30/2023
  • R2200238
  • R2200239
  • Exp. Date 1/31/2024
  • R2200383
  • Exp. Date 2/28/2025
  • b) R2000554
  • R2000553

UPCs (2)

  • 316729005159
  • 316729005173

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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