The Recall Desk
Agency classClass IIOur severity:ModerateFDA (Drugs)·D-0483-2023·Announced 2023-04-05

Drug Recall: Simvastatin 5 mg tablets due to manufacturing compliance violations

Direct Rx is recalling 51 bottles of Simvastatin 5 mg tablets nationwide due to Good Manufacturing Practice deviations. The recall is voluntary and was initiated in March 2023.

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 for manufacturing compliance violations with no reported illnesses or injuries. The rubric classifies voluntary precautionary recalls without reported harm as Moderate (score 2).

Plain-English summary

Direct Rx is recalling Simvastatin, USP, 5 mg tablets in 90-count bottles with National Drug Code (NDC) 61919-0710-90 due to Good Manufacturing Practice (cGMP) deviations. The recall affects 51 bottles that were distributed nationwide in the United States.

The affected lot numbers are 03JA2209, 28FE2225, 28AP2211, and 07AP2203, with an expiration date of June 30, 2023. The FDA classified this as a Class II recall on March 24, 2023. The recall was initiated by Direct Rx on March 13, 2023, on a voluntary basis and was terminated on June 17, 2024.

The recalled product

Product
Simvastatin, USP, 5 mg Tablets, Rx Only, Packaged as a 90-count bottle, NDC 61919-0710-90 Packaged and Distributed By: Direct Rx, Dawsonville, GA 30534
Manufacturer
Direct Rx
Category
Drug
Hazard
Affected units
51

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 (6)

  • Lot
  • expiry: 03JA2209
  • 28FE2225
  • 28AP2211
  • 07AP2203
  • exp 6/30/23

Distribution

Distributed nationwide across the United States.

Part of a larger recall action

This product is one of 11 recalled by Direct Rx 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 11 products in this recall →

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