The Recall Desk
Agency classClass IIOur severity:ModerateFDA (Drugs)·D-0524-2023·Announced 2023-04-12

Simvastatin Tablets Recalled Due to Manufacturing Process Deviations

Preferred Pharmaceuticals is recalling Simvastatin Tablets, USP, 20 mg, in three package sizes due to manufacturing process deviations at Accord Healthcare. The affected tablets were 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 illnesses, injuries, or hospitalizations. The hazard is manufacturing process deviations without a specific identified defect or confirmed harm, making it a precautionary recall rather than a severe or critical event.

Plain-English summary

Preferred Pharmaceuticals, Inc. is recalling Simvastatin Tablets, USP, 20 mg across three package sizes (30-count, 60-count, and 90-count bottles) due to manufacturing process deviations identified during a U.S. Food and Drug Administration inspection of Accord Healthcare, Inc.

The recalled tablets were distributed nationwide. Specific lot numbers and expiration dates are provided in the official FDA recall notice.

Consumers who have affected medication should contact their healthcare provider or pharmacy. Lot numbers can be checked against the official FDA recall information to determine if a specific product is affected.

The recalled product

Product
Simvastatin Tablets, USP, 20 mg, Packaged as: a) 90-count bottle (NDC 68788-9869-9); b) 60-count bottle (NDC 68788-9869-6); c) 30-count bottle (NDC 68788-9869-3), Rx only, Manufactured for: Accord Healthcare, lnc., 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 (20)

  • a) Lot: A0923R
  • Exp. Date: 2/28/2025
  • A1222K
  • B1822C
  • Exp. Date: 5/31/2024
  • C3022D
  • F2322V
  • Exp. Date: 6/30/2024
  • H1522H
  • Exp. Date: 8/31/2024
  • I1621O
  • Exp. Date: 1/31/2024
  • I2222G
  • J1822R
  • Exp. Date: 9/30/2024
  • L1621N
  • b) Lot: F0822Q
  • I0122J
  • L0821C
  • c) Lot: I1521P

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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