Qualitest recalls 10mg/500mg hydrocodone and acetaminophen tablets due to oversized pills causing superpotent drug levels. Check your lot number C1440512A.
Superpotent (Multiple Ingredient) Drug: Confirmed customer complaints of oversized tablets resulting in superpotent assays of both the hydrocodone and acetaminophen components.
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📍Recalling firmVintage Pharmaceuticals LLC DBA Qualitest Pharmaceuticals120 Vintage Dr NE · Huntsville, AL 35811-8216
✎ GovInfoNow plain-language explainer
Qualitest Pharmaceuticals is recalling a specific batch of Hydrocodone Bitartrate and Acetaminophen Tablets, USP (10 mg/500 mg) because the tablets are oversized. This defect has resulted in superpotent assays for both active ingredients, meaning patients may receive a higher dose than prescribed. The recall affects 14,445 bottles distributed nationwide. Read more at govinfonow.com/recall/48565-vintage-pharmaceuticals-llc-dba-qualitest-pharmaceuticals-recalls-hydrocodone-bitartrate-and.
“Qualitest Hydrocodone/Acetaminophen Recall: Superpotent Tablets.” GovInfoNow, updated October 13, 2026. https://govinfonow.com/recall/48565-vintage-pharmaceuticals-llc-dba-qualitest-pharmaceuticals-recalls-hydrocodone-bitartrate-and. Based on FDA recall #D-057-2013 (https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-057-2013%22&limit=1).
Vintage Pharmaceuticals LLC, doing business as Qualitest Pharmaceuticals, is recalling Hydrocodone Bitartrate and Acetaminophen Tablets due to oversized tablets that may result in superpotent assays. The Food and Drug Administration announced the Class I recall on September 10, 2012.
How to tell if you have it
Brand: Qualitest Pharmaceuticals
Product: HYDROCODONE BITARTRATE and ACETAMINOPHEN TABLETS, USP, 10 mg/500 mg
Packaging: 100-count bottle
NDC: 0603-3888-21
Lot number: C1440512A
Expiration date: 12/13
Quantity: 14,445 bottles
The hazard
The recall addresses confirmed customer complaints of oversized tablets resulting in superpotent assays of both the hydrocodone and acetaminophen components. The FDA classified this as a Class I hazard.
Context
GovInfoNow's records show Vintage Pharmaceuticals LLC, DBA Qualitest Pharmaceuticals has 11 other recalls on record since July 6, 2012. Other recent recalls of similar products include Qualitest Hydrocortisone Lotion Recall (May 8, 2017), Qualitest Dexamethasone Elixir Recall (Jan. 16, 2017), and Qualitest TEMAZEPAM 7.5mg Capsules Recall (Dec. 22, 2016). Other recent recalls of similar products include Ajanta Pharma Fluphenazine Tablets Recall (Aug. 25, 2026), CoValence Laboratories Remedy Gel Hydrocortisone 1% Recall (March 18, 2026), and Unichem busPIRone 5mg Tablets Recall (April 13, 2026).
How to tell if you have this one
Look for a 100-count bottle of Hydrocodone Bitartrate and Acetaminophen Tablets, USP, 10 mg/500 mg. The bottle must have NDC 0603-3888-21 and Lot number C1440512A with an expiration date of 12/13. The product is manufactured for Qualitest Pharmaceuticals in Huntsville, AL.
Brand
Qualitest Pharmaceuticals
Category
Drug
Where it went and when
Where it was distributed
Distributed nationwide.
Nationwide
Not listed
FDA distribution: “Nationwide.” States read from FDA’s own wording; “not listed” means the notice does not name it.
Distributed nationwide.
Recall timeline
FDA published this recall 3 months after the firm started it.
1Firm started the recall
2FDA classified it Class I
3Published in FDA’s Enforcement Report
Dates from the agency record only; steps without a date are left out.
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-057-2013 (September 10, 2012) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for D-057-2013 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.