Avkare Oxybutynin Chloride Extended-Release Tablets Recall

Why it was recalled

Failed Dissolution Specifications

Product description

Oxybutynin Chloride Extended-Release Tablets USP 10 mg, a) 100 tablets (NDC 42291-634-01) and b) 500 tablets (NDC 42291-634-50) bottles, Rx Only Manufactured for: AvKARE, Inc. Pulaski, TN 38478

Lot numbers, UPCs & expiration codes

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

Where it was sold

Nationwide.

What to do if you have this product

Compare the lot number and expiration date on your package with the codes above.
Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
If you have symptoms you think are related, contact your doctor. In an emergency call 911.
Report side effects to FDA MedWatch at 1-800-FDA-1088.

Recall details

Recall number: D-0990-2019
Classification: Class III
Status: Terminated
Recall initiated: Mar 1, 2019
FDA report date: Mar 20, 2019
Quantity: a) 2947 and b) 3379
Recall type: Voluntary: Firm initiated
Recalling firm: AVKARE Inc.

Original FDA data

Every field from FDA enforcement report D-0990-2019, exactly as published.

Show all FDA fields

City: Pulaski
State: TN
Status: Terminated
Country: United States
Event ID: 82296
Address: 615 N 1st St
Code information: Lots: a) 22738 Exp. 07/2020 and b) 22739 Exp. 07/2020
Postal code: 38478-2403
Report date: Mar 20, 2019
Product type: Drugs
Recall number: D-0990-2019
Classification: Class III
Recalling firm: AVKARE Inc.
Product quantity: a) 2947 and b) 3379
Termination date: Jan 14, 2020
Reason for recall: Failed Dissolution Specifications
Voluntary / mandated: Voluntary: Firm initiated
Product description: Oxybutynin Chloride Extended-Release Tablets USP 10 mg, a) 100 tablets (NDC 42291-634-01) and b) 500 tablets (NDC 42291-634-50) bottles, Rx Only Manufactured for: AvKARE, Inc. Pulaski, TN 38478
Distribution pattern: Nationwide.
Recall initiation date: Mar 1, 2019
Initial firm notification: Letter
Center classification date: Mar 11, 2019

How we source this data

Source: U.S. Food and Drug Administration enforcement report D-0990-2019, published Mar 20, 2019. View the source record (openFDA) · FDA enforcement reports

Last checked against FDA data: Oct 2, 2026. Content last changed: Oct 2, 2026.

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