CLASS II Drug recall · Reported 18 Mar 2020 · FDA Enforcement Report
Ranitidine Oral Solution, USP, 150 mg/, [ x Dose Cups recalled
Precision Dose is recalling Ranitidine Oral Solution, USP, 150 mg/, [ x Dose Cups, distributed nationwide in the US. The recall was initiated on 13 Nov 2019 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-1004-2020
- FDA event ID
- 85039
- Recalling firm
- Precision Dose, South Beloit, IL
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 13 Nov 2019
- FDA classified
- 12 Mar 2020
- Reported
- 18 Mar 2020
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Nitrosamine Impurity
- Drug class
- Stomach & Acid Reflux Medication
Timeline
| 13 Nov 2019 | Recall initiated by company | |
| 12 Mar 2020 | Classified by FDA | +120 days |
| 18 Mar 2020 | Published in enforcement report | +6 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
CGMP Deviations: Impurity N-nitrosodimethylamine (NDMA) found in API.
Nitrosamines are impurities that can form during drug manufacturing or storage. Above the FDA acceptable intake limit, long-term exposure may raise cancer risk. The FDA advises patients to keep taking the medicine until they have a replacement.
Product as listed by the FDA
Ranitidine Oral Solution, USP, 150 mg/10 mL, [10 mL x 30 Unit Dose Cups per case, NDC: 68094-204-62; 10 mL x 100 Unit Dose Cups per case, NDC: 68094-204-61; Unit Dose Cup NDC: 68094-204-59], Rx only, Precision Dose, Inc., South Beloit, IL 61080
Where it was distributed
Nationwide USA
Questions about this recall
Why was it recalled?
CGMP Deviations: Impurity N-nitrosodimethylamine (NDMA) found in API.
Which lots are affected?
Lot number: 501290, Expiry: 11/30/19, NDC: 68094-204-61; Lot number: 501326, Expiry: 11/30/19, NDC: 68094-204-62; Lot number: 501501, Expiry: 11/30/19, NDC: 68094-204-62; Lot number: 1592, Expiry: 4/30/20, NDC: 68094-204-62; Lot number: 501679, Expiry: 4/30/20, NDC: 68094-204-61, 68094-204-62
Where was it sold?
Nationwide USA
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 Precision Dose
All 8| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Glycopyrrolate Oral Solution, 1 mg/, delivers recalled by Precision DoseGlycopyrrolate | Precision Dose | Potency & Assay | Nationwide |
| Drug | CLASS II | Acetaminophen Oral Suspension, 160 mg recalled by Precision DoseAcetaminophen | Precision Dose | Manufacturing (CGMP) Deviations | Nationwide |
| Drug | CLASS II | Acetaminophen Oral Suspension, 325 mg recalled by Precision DoseAcetaminophen | Precision Dose | Manufacturing (CGMP) Deviations | Nationwide |
| Drug | CLASS II | Chlorhexidine Gluconate Oral Rinse recalled by Precision Dose | Precision Dose | Manufacturing (CGMP) Deviations | Nationwide |
| Drug | CLASS III | Carbamazepine Oral Suspension USP, 100 mg/ Unit Dose Cups recalled | Precision Dose | Potency & Assay | Nationwide |
Other Ranitidine recalls
All 55| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Ranitidine 150 mg, a) 60 Tabs recalled by Direct Rx | Direct Rx | Nitrosamine Impurity | FL, GA |
| Drug | CLASS II | Ranitidine 300 mg, 30 Tabs recalled by Direct Rx | Direct Rx | Nitrosamine Impurity | FL, GA |
| Drug | CLASS II | Ranitidine Tablets, USP, 150 mg x 10 blister card) recalled | American Health Packaging | Nitrosamine Impurity | Nationwide |
| Drug | CLASS II | ranitidine hydrochloride, USP a) bottles recalled | PD-Rx Pharmaceuticals | Nitrosamine Impurity | 12 states |
| Drug | CLASS II | Ranitidine Hydrochloride (powder) recalled | Spectrum Laboratory Products | Nitrosamine Impurity | 11 states |