Qualitest Recalls Ranitidine Syrup Due to Stability Failure
Qualitest recalls specific lots of Ranitidine Syrup because preservative levels failed stability specifications. Check your bottle's lot number and expiry date.
Use caution until it’s fixed
Failed Stability Specifications: Out of Specification results obtained for preservative butylparaben.
Contact the company
What happened, in plain English
Qualitest Pharmaceuticals is recalling Ranitidine Syrup (15 mg/mL) because testing showed the preservative butylparaben was out of specification for stability. This defect means the product may not remain sterile or effective as intended during its shelf life. The recall affects 61,146 bottles distributed nationwide. Read more at govinfonow.com/recall/43424-vintage-pharmaceuticals-llc-dba-qualitest-pharmaceuticals-recalls-ranitidine-syrup-ranitidine.
Source Summary by GovInfoNow · govinfonow.com/recall/43424-vintage-pharmaceuticals-llc-dba-qualitest-pharmaceuticals-recalls-ranitidine-syrup-ranitidine · Updated October 11, 2026 · FDA enforcement record: FDA #D-0162-2016
Cite this page
“Qualitest Recalls Ranitidine Syrup Due to Stability Failure.” GovInfoNow, updated October 11, 2026. https://govinfonow.com/recall/43424-vintage-pharmaceuticals-llc-dba-qualitest-pharmaceuticals-recalls-ranitidine-syrup-ranitidine. Based on FDA recall #D-0162-2016 (https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0162-2016%22&limit=1).
Why it’s dangerous
The recall is due to failed stability specifications for the preservative butylparaben. This means the preservative levels may be insufficient to prevent microbial growth or maintain product integrity over time, potentially compromising the safety and efficacy of the drug.
Who’s affected
Patients who have been prescribed Ranitidine Syrup from Qualitest Pharmaceuticals between October 2015 and May 2016 are affected. Individuals with these specific lot numbers should check their medication immediately.
How to tell if you have this one
Look for bottles labeled 'Ranitidine Syrup (Ranitidine Oral Solution, USP) 15 mg/mL (75 mg/5 mL), 473 mL (16 fl oz)' manufactured by Qualitest Pharmaceuticals. Check the NDC 0603-9418-58 and verify if your bottle has one of these lot numbers: L088L13A (Expiry 12/15), L023F14A (Expiry 5/16), or L024F14A (Expiry 5/16).
- Brand
Qualitest Pharmaceuticals- Category
Drug
What to do — step by step
Check Your Lot Number
Compare the lot number and expiry date on your bottle against the recalled lots: L088L13A, L023F14A, or L024F14A.
Contact Your Pharmacist
If you have a recalled bottle, contact your pharmacy or healthcare provider to discuss replacing the medication.
Where it went and when
Where it was distributed
Distributed nationwide.
FDA distribution: “U.S. Nationwide” States read from FDA’s own wording; “not listed” means the notice does not name it.
Distributed nationwide.
Recall timeline
FDA terminated this recall 12 months after the firm started it.
- Firm started the recall
- FDA classified it Class III
- Published in FDA’s Enforcement Report
- FDA terminated the recall
Dates from the agency record only; steps without a date are left out.
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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-0162-2016 (October 21, 2015) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for D-0162-2016 to see it in context.
- Plain-language summary written by qwen3.6:35b-a3b on October 11, 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.