The Recall Desk
Agency classClass IIOur severity:ModerateFDA (Drugs)·D-0371-2023·Announced 2023-03-08

Prescription Drug Recall: Atorvastatin Calcium Tablets for Manufacturing Deviations

Accord Healthcare is recalling Atorvastatin Calcium 10 mg tablets distributed in the United States, Puerto Rico, and Canada following FDA inspection findings of manufacturing deviations.

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 illnesses, hospitalizations, or injuries. The hazard is theoretical manufacturing deviations without a named specific quality defect. Per the editorial rubric, when no illnesses are reported and the hazard is theoretical, the score is at most 3. This precautionary recall warrants a Moderate classification.

Plain-English summary

Accord Healthcare, Inc. is recalling Atorvastatin Calcium Tablets USP, 10 mg, Rx Only, distributed in the United States, Puerto Rico, and Canada. A total of 256,106 bottles are affected, covering multiple batch numbers with expiration dates between March 31, 2023 and June 30, 2024.

The recall was initiated following an FDA inspection that identified Current Good Manufacturing Practice (CGMP) deviations. CGMP violations indicate that the manufacturer's quality control and production processes did not meet FDA regulatory standards for pharmaceutical manufacturing.

Consumers holding affected bottles of Atorvastatin Calcium 10 mg should verify their batch number against the recall records and contact their pharmacy or healthcare provider for guidance on obtaining replacement medication.

The recalled product

Product
ATORVASTATIN CALCIUM (ATORVASTATIN CALCIUM)
Brand
ATORVASTATIN CALCIUM
Manufacturer
Accord Healthcare, Inc.
Category
Drug
Hazard
Affected units
256,106

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)R2100455
  • Exp. Date 3/31/2023
  • R2200274
  • Exp. Date 1/31/2024
  • R2200700
  • Exp. Date 5/31/2024
  • b) R2101342
  • R2101343
  • R2101476
  • Exp. Date 9/30/2023
  • R2101364
  • R2101365
  • R2101366
  • R2101367
  • Exp. Date 10/31/2023
  • R2101612
  • R2101613
  • R2101614
  • Exp. Date 11/30/2023
  • R2200222

UPCs (2)

  • 316729044158
  • 316729044172

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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