KVK-Tech Hydrocodone Bitartrate and Homatropine Recall

Why it was recalled

Failed Impurities/Degradation Specifications

Product description

Hydrocodone Bitartrate and Homatropine Methlybromide tablets, USP, 5 mg/ 1.5 mg, 30-count bottle, Rx only, Mfd. By:KVK-Tech, Inc., Newtown, PA, 18940 NDC 10702-055-03

Lot numbers, UPCs & expiration codes

Lot: 15684A, Exp 7/2021

Where it was sold

Distributed Nationwide in the USA

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-0386-2021
Classification: Class III
Status: Terminated
Recall initiated: Apr 27, 2021
FDA report date: May 26, 2021
Quantity: 17,096 bottles
Recall type: Voluntary: Firm initiated
Recalling firm: KVK-Tech, Inc.

Original FDA data

Every field from FDA enforcement report D-0386-2021, exactly as published.

Show all FDA fields

City: Newtown
State: PA
Status: Terminated
Country: United States
Event ID: 87810
Address: 110 Terry Dr
Code information: Lot: 15684A, Exp 7/2021
Postal code: 18940-3427
Report date: May 26, 2021
Product type: Drugs
Recall number: D-0386-2021
Classification: Class III
Recalling firm: KVK-Tech, Inc.
Product quantity: 17,096 bottles
Termination date: Oct 5, 2022
Reason for recall: Failed Impurities/Degradation Specifications
Voluntary / mandated: Voluntary: Firm initiated
Product description: Hydrocodone Bitartrate and Homatropine Methlybromide tablets, USP, 5 mg/ 1.5 mg, 30-count bottle, Rx only, Mfd. By:KVK-Tech, Inc., Newtown, PA, 18940 NDC 10702-055-03
Distribution pattern: Distributed Nationwide in the USA
Recall initiation date: Apr 27, 2021
Initial firm notification: Letter
Center classification date: May 17, 2021

How we source this data

Source: U.S. Food and Drug Administration enforcement report D-0386-2021, published May 26, 2021. 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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