The Recall Desk
Agency classClass IIOur severity:ModerateFDA (Drugs)·D-0516-2023·Announced 2023-04-12

Finasteride Tablets Recalled Due to Manufacturing Process Deviations

Preferred Pharmaceuticals is recalling specific lots of Finasteride Tablets, 5 mg due to manufacturing process deviations discovered during FDA inspection of manufacturer Accord Healthcare. No illnesses or injuries have been reported.

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: This is an FDA Class II recall for manufacturing process deviations without reported illnesses, injuries, or identified product contamination. The hazard is manufacturing non-compliance rather than a detected safety defect.

Plain-English summary

Preferred Pharmaceuticals, Inc. is recalling Finasteride Tablets, USP, 5 mg distributed nationwide in the United States. The affected products are packaged in 30-count bottles (NDC 68788-6976-3) and 90-count bottles (NDC 68788-6976-9). A total of 135 bottles of 30-count and 24 bottles of 90-count packaging have been distributed.

The recall was initiated following FDA inspection of Accord Healthcare, Inc., the manufacturing facility, which identified current Good Manufacturing Practice (cGMP) deviations. These deviations indicate non-compliance with required manufacturing standards and quality control procedures. No illnesses or injuries have been reported related to this recall.

Patients who have received affected lots should contact their healthcare provider or pharmacist for guidance. The specific affected lot numbers and expiration dates are provided in the FDA's official recall announcement. Do not discontinue use of Finasteride without medical guidance, as treatment interruption could have medical consequences.

The recalled product

Product
Finasteride Tablets, USP, 5 mg, packaged in: a) 30-count bottles (NDC 68788-6976-3); b) 90-count bottles (NDC 68788-6976-9), 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 (15)

  • a) Lot: A1321V
  • D0221J
  • Exp. Date:8/31/2023
  • Lot: A1322J
  • Exp. Date: 5/31/2024
  • Lot: F0221Q
  • I0121E
  • I1021R
  • J1122D
  • Exp. Date: 10/31/2023
  • b) Lot: B0422J
  • Lot: C1721K
  • Exp. Date: 8/31/2023
  • Lot: K1022Q
  • Exp. Date:11/30/2024.

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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