The Recall Desk
HighFDA (Drugs)·D-0498-2023·Announced 2023-04-12

Drug recall: Atorvastatin 20 mg tablets due to manufacturing process deviations

RemedyRepack Inc. is recalling 3,426 bottles of Atorvastatin 20 mg tablets nationwide due to Good Manufacturing Practice (cGMP) deviations. The recall was initiated voluntarily by the manufacturer.

What this means for you

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 recall involving confirmed manufacturing process deviations (cGMP violations) on a prescription medication. No illnesses or injuries have been reported; the hazard is based on compliance deficiencies rather than confirmed product contamination or harm, placing it at the high end of precautionary recalls.

Plain-English summary

RemedyRepack Inc., located in Indiana, Pennsylvania, is recalling atorvastatin 20 mg tablets due to manufacturing compliance deviations. Approximately 3,426 bottles were affected, including both 30-count and 90-count packaging sizes.

The recall was initiated due to cGMP (Good Manufacturing Practice) deviations—deficiencies in manufacturing processes and quality control procedures at the repackaging facility. While no illnesses or injuries have been reported, these deviations represent potential risks to product quality and safety.

The affected product was distributed nationwide throughout the United States. The firm voluntarily initiated this recall.

Patients taking atorvastatin from the affected lots should contact their healthcare provider if they have concerns. Do not stop taking medication without consulting a healthcare provider.

The recalled product

Product
Atorvastatin 20 mg tablets, packaged in a) 30-count bottles (NDC 70518-1977-00) and b)90-count bottles (NDC 70518-1977-01), Rx only, Repackaged by: RemedyRepack Inc., Indiana, PA 15701.
Manufacturer
RemedyRepack Inc.
Category
Drug — Statin / Cardiovascular
Hazard
  • manufacturing-deviation
  • quality-control

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 (9)

  • Lot #: a) J0659819-110922
  • Exp. Date 11/30/2023
  • J0649932-093022
  • J0649917-093022 Exp. Date 10/31/2023
  • B2010060-121222
  • Exp. Date 03/31/24 Lot #: b) B1708575-060122
  • Exp. Date 05/31/2023
  • B1879236-092922
  • Exp. Date 12/31/2023

Distribution

Distributed nationwide across the United States.

Related recalls

Same category