The Recall Desk
ModerateFDA (Drugs)·D-0167-2021·Announced 2020-12-23

AvKARE Recalls Sildenafil Tablets Due to Packaging Mix-Up with Trazodone

AvKARE Inc. is recalling 38,715 bottles of Sildenafil 100 mg tablets because they were inadvertently packaged with trazodone at a third-party facility.

What this means for you

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: The recall is classified as FDA Class II, but the source text does not report any illnesses, injuries, or hospitalizations. The hazard is a packaging error (product mix-up) without confirmed adverse health consequences, fitting the 'Moderate' criteria for low-risk contamination or voluntary precautionary recalls.

Plain-English summary

AvKARE Inc. is recalling 38,715 bottles of Sildenafil Tablets USP 100 mg (NDC 42291-748-01). The recall affects Lot 36884 with an expiration date of 03/2022. These prescription-only medications were distributed nationwide within the United States.

The recall was initiated due to a product mix-up at a third-party bottling facility. Bottles of sildenafil and trazodone were inadvertently packaged together during the bottling process. This error creates a risk that patients may receive or dispense the wrong medication.

Consumers and healthcare providers should check their inventory for bottles matching the specific lot and expiration date listed above. If found, these products should be returned to the pharmacy or point of distribution for proper handling and disposal.

The recalled product

Product
Sildenafil Tablets USP 100 mg, Rx Only, 100-count Bottle, Manufactured for: AvKARE Pulaski, TN 38478, NDC 42291-748-01.
Manufacturer
AVKARE Inc.
Category
Drug — Prescription Medication
Hazard
Affected units
38,715

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 (1)

  • Lot: 36884 Exp. 03/2022

Distribution

Distributed nationwide across the United States.

Part of a larger recall action

This product is one of 2 recalled by AVKARE 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 2 products in this recall →

Related recalls

Same manufacturer · AVKARE Inc.

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Same hazard · product mix up

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