The Recall Desk
Agency classClass IIOur severity:ModerateFDA (Drugs)·D-0512-2023·Announced 2023-04-12

Atorvastatin Calcium Tablets 20 mg Recalled Due to Manufacturing Practice Deviations

Preferred Pharmaceuticals is recalling Atorvastatin Calcium Tablets 20 mg nationwide due to manufacturing practice deviations at the manufacturer, Accord Healthcare, Inc., identified during 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 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 based on manufacturing practice (cGMP) deviations identified during inspection. The source does not report any adverse events, illnesses, or specific product quality defects, making this a precautionary recall triggered by manufacturing compliance issues rather than a confirmed product hazard.

Plain-English summary

Preferred Pharmaceuticals, Inc. is recalling Atorvastatin Calcium Tablets, USP, 20 mg due to manufacturing practice deviations. The recall affects multiple lot numbers with expiration dates between April 2023 and March 2024. Affected package sizes include 90-count bottles (375 bottles, NDC 68788-7631-9) and 30-count bottles (323 bottles, NDC 68788-7631-3). The tablets are manufactured by Accord Healthcare, Inc., Durham, North Carolina, and distributed nationwide in the USA.

The U.S. Food and Drug Administration identified current Good Manufacturing Practice (cGMP) deviations at Accord Healthcare during an inspection. These deviations relate to the manufacturing processes used to produce the recalled tablets.

Patients taking Atorvastatin should not discontinue use without consulting their healthcare provider, as this medication is used to treat cardiovascular disease. Consumers who have purchased the recalled tablets should contact their pharmacy or healthcare provider for guidance. Healthcare providers and patients should verify whether their medication matches the affected lot numbers and expiration dates listed with the recalling firm or the FDA.

The recalled product

Product
Atorvastatin Calcium Tablets, USP, 20 mg, packaged in: a) 90-count bottle (NDC 68788-7631-9); b) 30-count bottle (NDC 68788-7631-3), Rx only, Manufactured: Accord Healthcare, Inc., Durham, NC 27703
Manufacturer
Preferred Pharmaceuticals, 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 (19)

  • a) Lot: B1522B
  • Exp 4/30/2023
  • lot:C0222H
  • C0322B
  • Exp 5/31/2023
  • lot: E1022H
  • F13220
  • H2222P
  • Exp 6/30/2023
  • Lot: I1422V
  • K01220
  • Exp 12/31/2023
  • Lot: L2722H
  • Exp 3/31/2024
  • b) Lot:C0322B
  • lot:H1122G
  • 12322Q
  • lot: J1222U
  • Exp 12/31/2023.

Distribution

Distributed nationwide across the United States.

Part of a larger recall action

This product is one of 17 recalled by Preferred Pharmaceuticals, 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 17 products in this recall →

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