The Recall Desk
Agency classClass IIIOur severity:LowFDA (Drugs)·D-0990-2019·Announced 2019-03-20

AvKARE Recalls Oxybutynin Chloride Tablets for Failed Dissolution Specifications

AvKARE Inc. is recalling Oxybutynin Chloride Extended-Release Tablets because they failed to meet dissolution specifications.

The agency’s classification

FDA (Drugs): Class III

Class III is a situation in which use of or exposure to a violative product is not likely to cause adverse health consequences.

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 1/5 (Low).

Cosmetic or documentation issue. No expected health impact, but the manufacturer is correcting the affected products.

Our severity reasoning: The agency classified this as an FDA Class III recall, which by definition is unlikely to cause adverse health consequences. The hazard is a quality control failure (dissolution) rather than a direct safety risk like contamination or mislabeling.

Plain-English summary

AvKARE Inc. is recalling Oxybutynin Chloride Extended-Release Tablets USP 10 mg. The recall involves 100-tablet and 500-tablet bottles (NDC 42291-634-01 and NDC 42291-634-50) manufactured for AvKARE, Inc. in Pulaski, TN. The specific lots affected are 22738 and 22739, both with an expiration date of 07/2020.

The reason for the recall is that the product failed to meet dissolution specifications. Dissolution is a critical quality attribute that ensures the drug releases its active ingredient at the appropriate rate and amount. When a drug fails these specifications, it may not deliver the intended therapeutic effect to the patient.

The affected products were distributed nationwide. Consumers and healthcare providers should check their inventory for the specific NDCs and lot numbers listed above. If the product is found, it should be returned to the supplier or the recalling firm, AvKARE Inc.

The recalled product

Product
OXYBUTYNIN CHLORIDE (OXYBUTYNIN CHLORIDE)
Brand
OXYBUTYNIN CHLORIDE
Manufacturer
AVKARE Inc.
Category
Drug — Prescription 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 (1)

  • Lots: a) 22738 Exp. 07/2020 and b) 22739 Exp. 07/2020

UPCs (4)

  • 0342291635012
  • 0342291633018
  • 0342291634503
  • 0342291633506

Distribution

Distributed nationwide across the United States.

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