CLASS III Drug recall · Reported 11 Nov 2015 · FDA Enforcement Report
Ranitidine Syrup (Ranitidine Oral Solution, USP) 15 mg/mL (75 mg recalled
Vintage Pharmaceuticals LLC is recalling Ranitidine Syrup (Ranitidine Oral Solution, USP) 15 mg/mL (75 mg, distributed nationwide in the US. The recall was initiated on 21 Oct 2015 and the FDA has classified it as Class III.
Check your package
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
Recall details
- Recall number
- D-0162-2016
- FDA event ID
- 72493
- Recalling firm
- Vintage Pharmaceuticals LLC, Huntsville, AL
- Classification
- Class III
- Status
- Terminated
- Recall initiated
- 21 Oct 2015
- FDA classified
- 2 Nov 2015
- Reported
- 11 Nov 2015
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Potency & Assay
- Drug class
- Stomach & Acid Reflux Medication
Timeline
| 21 Oct 2015 | Recall initiated by company | |
| 2 Nov 2015 | Classified by FDA | +12 days |
| 11 Nov 2015 | Published in enforcement report | +9 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Failed Stability Specifications: Out of Specification results obtained for preservative butylparaben.
Potency and specification recalls happen when a batch tests outside its approved limits for strength, purity or dissolution, which can mean the dose delivered is higher or lower than labelled.
Product as listed by the FDA
RANITIDINE SYRUP (RANITIDINE ORAL SOLUTION, USP) 15 mg/mL (75 mg/5 mL), 473 mL (16 fl oz), Rx only. Manufactured for: QUALITEST PHARMACEUTICALS, HUNTSVILLE, AL 35811, NDC: 0603-9418-58.
Where it was distributed
U.S. Nationwide
Questions about this recall
Why was it recalled?
Failed Stability Specifications: Out of Specification results obtained for preservative butylparaben.
Which lots are affected?
Lot #: L088L13A, Expiry: 12/15; Lot #: L023F14A, Expiry: 5/16; Lot#: L024F14A, Expiry: 5/16.
Where was it sold?
U.S. Nationwide
What should I do if I have it?
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
What does Class III mean?
Class III recalls are for products unlikely to cause any adverse health consequence, usually labelling or quality issues.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
More recalls from Vintage Pharmaceuticals LLC
All 5| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS III | Hydrocortisone Lotion recalled by Vintage Pharmaceuticals LLC | Vintage Pharmaceuticals LLC | Potency & Assay | Nationwide |
| Drug | CLASS III | Temazepam Capsules USP, 7.5 mg recalled by Vintage Pharmaceuticals LLC | Vintage Pharmaceuticals LLC | Potency & Assay | Nationwide |
| Drug | CLASS II | Hydrochlorothiazide Capsules, USP, 12.5 mg recalled | Vintage Pharmaceuticals LLC | Particulate Matter | Nationwide |
| Drug | CLASS III | Ampicillin Capsules, USP, 250 mg recalled by Vintage Pharmaceuticals LLC | Vintage Pharmaceuticals LLC | Packaging Defects | OH |
Other Ranitidine (ranitidine recalls
All 6| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Ranitidine Syrup (Ranitidine Oral Solution USP), 15 mg/mL recalled | American Health Packaging | Nitrosamine Impurity | Nationwide |
| Drug | CLASS II | Ranitidine Syrup (Ranitidine Oral Solution, USP), 15 mg/mL (75 mg recalled | AuroMedics Pharma | Nitrosamine Impurity | Nationwide |
| Drug | CLASS II | Ranitidine Syrup (Ranitidine Oral Solution, USP), 15mg/mL recalled | Lannett | Nitrosamine Impurity | Nationwide |
| Drug | CLASS III | Ranitidine Syrup (Ranitidine Oral Solution, USP), 15 mg/mL (75 mg recalled | Bio-pharm | Potency & Assay | Nationwide |
| Drug | CLASS II | Ranitidine Syrup (Ranitidine Oral Solution USP) 15 mg/mL recalled | Actavis South Atlantic | Potency & Assay | Nationwide |