CLASS III Drug recall · Reported 13 Apr 2016 · FDA Enforcement Report
Ranitidine Syrup (Ranitidine Oral Solution, USP), 15 mg/mL (75 mg recalled
Bio-pharm is recalling Ranitidine Syrup (Ranitidine Oral Solution, USP), 15 mg/mL (75 mg, distributed nationwide in the US. The recall was initiated on 17 Dec 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-0809-2016
- FDA event ID
- 72819
- Recalling firm
- Bio-pharm, Levittown, PA
- Classification
- Class III
- Status
- Terminated
- Recall initiated
- 17 Dec 2015
- FDA classified
- 1 Apr 2016
- Reported
- 13 Apr 2016
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Potency & Assay
- Drug class
- Stomach & Acid Reflux Medication
Timeline
| 17 Dec 2015 | Recall initiated by company | |
| 1 Apr 2016 | Classified by FDA | +106 days |
| 13 Apr 2016 | Published in enforcement report | +12 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Failed Impurities/Degradation Specifications: Product recalled due to elevated impurity result detected during routine stability testing.
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), 16 fl oz Bottle, Rx only, Mfd For: Heritage Pharmaceuticals Inc., Eatontown, NJ 07724, NDC 23155-291-51
Where it was distributed
Nationwide and Puerto Rico
Questions about this recall
Why was it recalled?
Failed Impurities/Degradation Specifications: Product recalled due to elevated impurity result detected during routine stability testing.
Which lots are affected?
Lot #s: 14G008, 14G013, 14G010, 14G015, 14G016, 14G021, 14G026, 14G028, Exp. 01/2016; 14K027, 14K023, Exp. 04/2016; 15B040, 15B041, Exp. 08/2016; 15E042, Exp. 11/2016; 15F019, 15F021, Exp. 12/2016; 15G038, Exp. 01/2017; 15H004, 15H008, Exp. 02/2017
Where was it sold?
Nationwide and Puerto Rico
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 Bio-pharm
All 2| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Rugby Children's Pain and Fever Acetaminophen Oral recalled by Bio-pharm | Bio-pharm | Potency & Assay | Nationwide |
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 | Vintage Pharmaceuticals LLC | Potency & Assay | Nationwide |
| Drug | CLASS II | Ranitidine Syrup (Ranitidine Oral Solution USP) 15 mg/mL recalled | Actavis South Atlantic | Potency & Assay | Nationwide |