CLASS II Drug recall · Reported 7 Aug 2013 · FDA Enforcement Report
Ranitidine Syrup (Ranitidine Oral Solution USP) 15 mg/mL recalled
Actavis South Atlantic is recalling Ranitidine Syrup (Ranitidine Oral Solution USP) 15 mg/mL, distributed nationwide in the US. The recall was initiated on 15 May 2013 and the FDA has classified it as Class II.
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-829-2013
- FDA event ID
- 65338
- Recalling firm
- Actavis South Atlantic, Sunrise, FL
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 15 May 2013
- FDA classified
- 30 Jul 2013
- Reported
- 7 Aug 2013
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Potency & Assay
- Drug class
- Stomach & Acid Reflux Medication
Timeline
| 15 May 2013 | Recall initiated by company | |
| 30 Jul 2013 | Classified by FDA | +76 days |
| 7 Aug 2013 | Published in enforcement report | +8 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Failed Impurity/Degradation Specification; "Related Compound C"
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, Rx Only. Manufactured by VistaPharm, Inc., Birmingham, AL 35242. Distributed by Actavis Mid Atlantic LLC 1877 Kawai Road, Lincolnton, NC 28092 USA
Where it was distributed
Nationwide
Questions about this recall
Why was it recalled?
Failed Impurity/Degradation Specification; "Related Compound C"
Which lots are affected?
Lot Numbers: 247900, 251000, 256000, 261200, 263600, 266700, 277100, 280300 and 284300.
Where was it sold?
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 II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
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 Actavis South Atlantic
All 3| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS III | buPROPion Hydrochloride Extended-Release Tablets (XL) recalled | Actavis South Atlantic | Potency & Assay | Nationwide |
| Drug | CLASS III | buPROPion Hydrochloride Extended-Release Tablets (XL) recalled | Actavis South Atlantic | 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 | Bio-pharm | Potency & Assay | Nationwide |
| Drug | CLASS III | Ranitidine Syrup (Ranitidine Oral Solution, USP) 15 mg/mL (75 mg recalled | Vintage Pharmaceuticals LLC | Potency & Assay | Nationwide |