Use caution Drug recall · FDA · Published August 13, 2015

Qualitest Ampicillin Recall: Missing Package Insert

Qualitest recalls 360 bottles of Ampicillin Capsules due to unapproved labeling. Check your lot number for details.

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

🇺🇸 FDA recall #D-1350-2015Drug Qualitest Pharmaceuticals ›

Use caution until it’s fixed

Labeling: Incorrect Or Missing Package Insert: Product is labeled with unapproved labeling.

Take action

Contact the company

Recalling firmVintage Pharmaceuticals LLC, DBA Qualitest Pharmaceuticals150 Vintage Dr NE · Huntsville, AL 35811-8216

✎ GovInfoNow plain-language explainer

Qualitest Pharmaceuticals is recalling 360 bottles of Ampicillin Capsules, USP, 250 mg because the product is labeled with unapproved labeling. Specifically, the package insert included with the medication may be incorrect or missing. This recall was issued on August 13, 2015. Read more at govinfonow.com/recall/43857-vintage-pharmaceuticals-llc-dba-qualitest-pharmaceuticals-recalls-ampicillin-capsules-usp.

Source Summary by GovInfoNow · govinfonow.com/recall/43857-vintage-pharmaceuticals-llc-dba-qualitest-pharmaceuticals-recalls-ampicillin-capsules-usp · Updated October 12, 2026 · FDA enforcement record: FDA #D-1350-2015

Cite this page

“Qualitest Ampicillin Recall: Missing Package Insert.” GovInfoNow, updated October 12, 2026. https://govinfonow.com/recall/43857-vintage-pharmaceuticals-llc-dba-qualitest-pharmaceuticals-recalls-ampicillin-capsules-usp. Based on FDA recall #D-1350-2015 (https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-1350-2015%22&limit=1).

The FDA announced on Aug. 13, 2015, that Qualitest Pharmaceuticals recalled Ampicillin Capsules USP, 250 mg, due to incorrect or missing package inserts containing unapproved labeling. The agency classified the Class III recall as voluntary and initiated by the firm.

How to tell if you have it

Brand: Qualitest Pharmaceuticals
Product: Ampicillin Capsules 250 mg
NDC: 67253-180-50
Lot #: 52217
Expiry: 04/18
Quantity: 360 bottles

The hazard

The product is labeled with unapproved labeling because the package insert is incorrect or missing. The FDA classified this as a Class III recall.

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 American Regent Levocarnitine Injection Recall (April 16, 2026), Dabur Circle K Antibiotic Ointment Recall (June 2, 2026) and Dabur Lil Drug Store Antibiotic Ointment Recall (June 2, 2026).

How to tell if you have this one

Check your bottle for the following details: Brand/Manufacturer Qualitest Pharmaceuticals (Vintage Pharmaceuticals LLC), Product Ampicillin Capsules, USP 250 mg, NDC 67253-180-50, Lot Number 52217, and Expiry Date 04/18.

Brand
Qualitest Pharmaceuticals
Category
Drug

Based on the official FDA remedy

What to do — step by step

Check Your Bottle
Verify if your bottle matches the recalled NDC 67253-180-50 and Lot Number 52217.
Contact Your Pharmacist
Speak with your pharmacist or healthcare provider to determine if you have the affected product and what steps to take next.

Where it went and when

Where it was distributed

Distributed in Ohio.

FDA distribution: “U.S. Including: OH” States read from FDA’s own wording; “not listed” means the notice does not name it.

States: Ohio.

Recall timeline

FDA terminated this recall 8 days after the firm started it.

Aug 13, 2015Firm started the recall
Aug 20, 2015FDA classified it Class III
Aug 21, 2015FDA terminated the recall
Aug 26, 2015Published in FDA’s Enforcement Report

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

Similar recalls

Other Qualitest Pharmaceuticals recalls

Latest drug recalls

Keep exploring

Link to this recall

<a href="https://govinfonow.com/recall/43857-vintage-pharmaceuticals-llc-dba-qualitest-pharmaceuticals-recalls-ampicillin-capsules-usp">Qualitest Ampicillin Recall: Missing Package Insert (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-1350-2015 (August 13, 2015) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for D-1350-2015 to see it in context.
Plain-language summary written by qwen3.6:35b-a3b on October 12, 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.