Stop using now Drug recall · FDA · Published December 6, 2012

Qualitest Recalls Hydrocodone/Acetaminophen Tablets Due to Oversized Pills

Qualitest Pharmaceuticals is recalling specific lots of Hydrocodone bitartrate and acetaminophen tablets because complaints of oversized tablets were received.

Plain-English summary generated from official FDA data by GovInfoNow · Published by Carlos Caban · How we make summaries

🇺🇸 FDA recall #D-138-2013Drug Qualitest Pharmaceuticals ›

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

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Contact the company

Recalling firmVintage Pharmaceuticals LLC DBA Qualitest Pharmaceuticals120 Vintage Dr NE · Huntsville, AL 35811-8216

✎ GovInfoNow plain-language explainer

Qualitest Pharmaceuticals has recalled Hydrocodone bitartrate and acetaminophen Tablets, USP, 10 mg/500 mg due to complaints of oversized tablets. The recall affects approximately 897,379 bottles distributed nationwide and in Puerto Rico. These products are prescription-only medications manufactured for Qualitest Pharmaceuticals. Read more at govinfonow.com/recall/48457-vintage-pharmaceuticals-llc-dba-qualitest-pharmaceuticals-recalls-hydrocodone-bitartrate-and.

Source Summary by GovInfoNow · govinfonow.com/recall/48457-vintage-pharmaceuticals-llc-dba-qualitest-pharmaceuticals-recalls-hydrocodone-bitartrate-and · Updated October 13, 2026 · FDA enforcement record: FDA #D-138-2013

Cite this page

“Qualitest Recalls Hydrocodone/Acetaminophen Tablets Due to Oversized Pills.” GovInfoNow, updated October 13, 2026. https://govinfonow.com/recall/48457-vintage-pharmaceuticals-llc-dba-qualitest-pharmaceuticals-recalls-hydrocodone-bitartrate-and. Based on FDA recall #D-138-2013 (https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-138-2013%22&limit=1).

The FDA announced on Dec. 6, 2012, that Qualitest Pharmaceuticals is recalling Hydrocodone bitartrate and acetaminophen tablets due to oversized pills. The agency classified the recall as Class I.

How to tell if you have it

Brand: Qualitest Pharmaceuticals
Product: Hydrocodone/Acetaminophen Tablets, USP, 10 mg/500 mg
NDCs: 0603-3888-16 (30-count), 0603-3888-20 (60-count), 0603-3888-02 (90-count), 0603-3888-21 (100-count), 0603-3888-22 (120-count), 0603-3888-26 (150-count), 0603-3888-04 (180-count), 0603-3888-28 (500-count), 0603-3888-32 (1000-count)
Lot codes: All beginning with "C" (e.g., C1160712C, C0930812A) with expiration dates of 12/13
Distribution: Nationwide and Puerto Rico

The hazard

The recall addresses complaints of oversized tablets in the affected lots. The FDA classified this as a Class I recall, indicating a high risk of adverse health consequences.

Context

GovInfoNow's records show Qualitest Pharmaceuticals has 11 other recalls on record since July 6, 2012. Other recent recalls include a May 8, 2017 recall of Hydrocortisone Lotion for assay specifications and a Jan. 16, 2017 recall of Dexamethasone Elixir for impurities. Similar products have been recalled recently, including Golden State Medical's April 27, 2026 Primidone Tablets recall and Ajanta Pharma's Aug. 25, 2026 Fluphenazine Tablets recall.

How to tell if you have this one

Check your bottle for the NDC number 0603-3888 followed by -16, -20, -02, -21, -22, -26, -04, -28, or -32. Verify the lot number begins with the letter 'C' (e.g., C1160712C). The expiration date on these recalled bottles is 12/13.

Brand
Qualitest Pharmaceuticals
Category
Drug

Based on the official FDA remedy

What to do — step by step

Stop taking the medication
Do not consume any tablets from the recalled lots due to the risk of oversized pills.
Contact your pharmacist or doctor
Speak with your healthcare provider or pharmacist immediately to discuss alternative treatment options and proper disposal.

Where it went and when

Where it was distributed

Distributed nationwide.

FDA distribution: “Nationwide and Puerto Rico” States read from FDA’s own wording; “not listed” means the notice does not name it.

Distributed nationwide.

Recall timeline

FDA terminated this recall 8.6 years after the firm started it.

Dec 6, 2012Firm started the recall
Jan 30, 2013FDA classified it Class I
Feb 6, 2013Published in FDA’s Enforcement Report
Jul 20, 2021FDA terminated the recall

Dates from the agency record only; steps without a date are left out.

✎ GovInfoNow

Questions people ask

From the GovInfoNow team · based on the FDA notice · How we make summaries

Which specific lot numbers are recalled?

All lots beginning with the letter 'C' are recalled, including C1160712C, C0930812A, C1110412A, C1141012B, C1160712A, C0950812B, C1110412B, C1151012B, C1160712B, C1530512A, and many others listed in the record with an expiration date of 12/13.

What are the NDC numbers for the recalled product?

The recalled products have NDC numbers 0603-3888-16 (30-count), 0603-3888-20 (60-count), 0603-3888-02 (90-count), 0603-3888-21 (100-count), 0603-3888-22 (120-count), 0603-3888-26 (150-count), 0603-3888-04 (180-count), 0603-3888-28 (500-count), and 0603-3888-32 (1000-count).

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Link to this recall

<a href="https://govinfonow.com/recall/48457-vintage-pharmaceuticals-llc-dba-qualitest-pharmaceuticals-recalls-hydrocodone-bitartrate-and">Qualitest Recalls Hydrocodone/Acetaminophen Tablets Due to Oversized Pills (GovInfoNow)</a>

Where this comes from

The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.

Official source: FDA Recall #D-138-2013 (December 6, 2012) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for D-138-2013 to see it in context.
Plain-language summary written by qwen3.6:35b-a3b on October 13, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.