The Recall Desk
Agency classClass IIOur severity:ModerateFDA (Drugs)·D-0526-2023·Announced 2023-04-12

Prescription Tadalafil tablets recalled for manufacturing process deviations

Preferred Pharmaceuticals is recalling 32 bottles of Tadalafil 20 mg tablets due to manufacturing process deviations identified during FDA inspection. The recalled lots expire January 31, 2024.

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 for manufacturing process deviations without reported illnesses or injuries. No specific contamination or defect is identified, classifying this as a precautionary recall.

Plain-English summary

Preferred Pharmaceuticals, Inc. is recalling 32 bottles of Tadalafil 20 mg tablets distributed nationwide. The affected lots are C0822E, F1121B, and G2721L, all with an expiration date of January 31, 2024.

The recall was initiated due to current Good Manufacturing Practice (cGMP) deviations discovered at the manufacturing facility (Accord Healthcare) following an FDA inspection. cGMP compliance ensures the safety, purity, and quality of pharmaceutical products. The specific nature of the manufacturing deviations is not detailed in the recall notice.

Patients currently taking this medication should not stop without consulting their healthcare provider. Individuals with affected lots should contact their pharmacy or doctor to determine if their supply is involved and to arrange an alternative source if needed.

For more information, consumers may contact the FDA's division of drug safety or speak with their healthcare provider or pharmacist.

The recalled product

Product
TADALAFIL (TADALAFIL)
Brand
TADALAFIL
Manufacturer
Preferred Pharmaceuticals, Inc.
Category
Drug
Hazard
Affected units
32

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 (5)

  • Lot: C0822E
  • Exp 1/31/2024
  • F1121B
  • G2721L
  • Exp 1/31/2024.

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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