The Recall Desk
Agency classClass IIOur severity:ModerateFDA (Drugs)·D-0502-2023·Announced 2023-04-12

Rosuvastatin 40mg tablets recalled nationwide for manufacturing process deviations

RemedyRepack is voluntarily recalling Rosuvastatin 40mg tablets due to manufacturing practice deviations. The recall affects specific lot numbers expiring 07/31/2025 distributed nationwide.

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 recall with no reported adverse events or illnesses. This is a voluntary precautionary recall due to manufacturing practice deviations (cGMP violations), matching Moderate severity criteria.

Plain-English summary

RemedyRepack Inc. is recalling Rosuvastatin 40mg tablets nationwide due to deviations in current Good Manufacturing Practice (cGMP) in the repackaging process. The firm voluntarily initiated this recall on March 20, 2023, and the recall was terminated on October 19, 2023.

The affected product was packaged in 45-count bottles (NDC 70518-1311-01) with lot numbers B2038806-123022, B2014185-121422, and B1925528-102522, and in 90-count bottles (NDC 70518-0484-00) with lot numbers B2080829-012823, B1938007-110222, and B2038746-123022. All affected product expires on 07/31/2025. A total of 76 of the 45-count bottles and 151 of the 90-count bottles are subject to recall.

The product was distributed to consignees nationwide within the United States. The recall number is D-0502-2023.

The recalled product

Product
Rosuvastatin 40mg tablets, packaged in a) 45-count bottles (NDC 70518-1311-01), and b) 90-count bottles (NDC 70518-0484-00), Rx only, Repackaged by: RemedyRepack Inc., Indiana, PA 15701.
Manufacturer
RemedyRepack Inc.
Category
Drug
Hazard

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 (7)

  • Lot # a): B2038806-123022
  • B2014185-121422
  • B1925528-102522
  • Exp. Date 07/31/2025. Lot #: b): B2080829-012823
  • B1938007-110222
  • B2038746-123022
  • Exp. Date 07/31/2025.

Distribution

Distributed nationwide across the United States.

Part of a larger recall action

This product is one of 14 recalled by RemedyRepack 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 14 products in this recall →

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