Class I โ€” Serious Health Hazard

Serious health hazard โ€” there is a reasonable probability that use of or exposure to this product will cause serious adverse health consequences or death.

Hydrocodone bitartrate and acetaminophen Tablets Recalled by Vintage Pharmaceuticals LLC DBA Qualitest Pharmaceuticals Due to Superpotent (Multiple Ingredient) Drug: Complaint received of oversized...

Date: December 6, 2012
Company: Vintage Pharmaceuticals LLC DBA Qualitest Pharmaceuticals
Status: Terminated
Source: FDA (Drug)

What You Should Do

Stop using this product immediately. Do not consume, use, or distribute it.

Return the product to the place of purchase for a full refund. If you have questions, contact Vintage Pharmaceuticals LLC DBA Qualitest Pharmaceuticals directly.

Affected Products

Hydrocodone bitartrate and acetaminophen Tablets, USP, 10 mg/500 mg, packaged in a) 30-count bottles, NDC 0603-3888-16; b) 60-count bottles, NDC 0603-3888-20; c) 90-count bottles, NDC 0603-3888-02; d) 100-count bottles, NDC 0603-3888-21; e) 120-count bottles, NDC 0603-3888-22; f) 150-count bottles, NDC 0603-3888-26; g) 180-count bottles, NDC 0603-3888-04; h) 500-count bottles, NDC 0603-3888-28; and i) 1000-count bottles, NDC 0603-3888-32, Rx only, Mfg. for: Qualitest Pharmaceuticals, Huntsville, AL 35811.

Quantity: 897,379 bottles

Why Was This Recalled?

Superpotent (Multiple Ingredient) Drug: Complaint received of oversized tablets.

Where Was This Sold?

This product was distributed nationwide across all 50 states.

Affected (51 states)Not affected

About Vintage Pharmaceuticals LLC DBA Qualitest Pharmaceuticals

Vintage Pharmaceuticals LLC DBA Qualitest Pharmaceuticals has 5 total recalls tracked by RecallDetector.

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Data sourced from the FDA (Drug). Last updated March 26, 2026. View original report