CLASS III Drug recall · Reported 8 Nov 2017 · FDA Enforcement Report
Carbamazepine Oral Suspension USP, 100 mg/ Unit Dose Cups recalled
Precision Dose is recalling Carbamazepine Oral Suspension USP, 100 mg/ Unit Dose Cups (, distributed nationwide in the US. The recall was initiated on 25 Sep 2017 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-0057-2018
- FDA event ID
- 78359
- Recalling firm
- Precision Dose, South Beloit, IL
- Classification
- Class III
- Status
- Terminated
- Recall initiated
- 25 Sep 2017
- FDA classified
- 1 Nov 2017
- Reported
- 8 Nov 2017
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Potency & Assay
- Drug class
- Seizure Medication
Timeline
| 25 Sep 2017 | Recall initiated by company | |
| 1 Nov 2017 | Classified by FDA | +37 days |
| 8 Nov 2017 | Published in enforcement report | +7 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Subpotent Drug: low out of specification results.
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
Carbamazepine Oral Suspension USP, 100 mg/5 mL, 5 mL Unit Dose Cups (NDC 68094-301-59), packaged in 10-count cups per tray, 3 trays per case containing a total of 5 mL x 30 Unit Dose Cups per case (NDC 68094-301-62), Rx only, Pkg: Precision Dose, Inc., S. Beloit, IL 61080.
Where it was distributed
Nationwide in the USA
Questions about this recall
Why was it recalled?
Subpotent Drug: low out of specification results.
Which lots are affected?
Lot number: 500105, Exp 04/30/18
Where was it sold?
Nationwide in the 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 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 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 II | Ranitidine Oral Solution, USP, 150 mg/, [ x Dose Cups recalled | Precision Dose | Nitrosamine Impurity | Nationwide |
Other Carbamazepine recalls
All 13| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Carbamazepine Tablets, USP, 200mg recalled | SUN Pharmaceutical Industries | Manufacturing (CGMP) Deviations | Nationwide |
| Drug | CLASS II | Carbamazepine Tablets, USP, 200mg recalledCarbamazepine | Golden State Medical Supply | Manufacturing (CGMP) Deviations | Nationwide |
| Drug | CLASS II | Carbamazepine Extended-Release Tablets recalledCarbamazepine | Amerisource Health Services | Potency & Assay | Nationwide |
| Drug | CLASS II | Carbamazepine Tablets, USP 200 mg recalled by Torrent PharmaCarbamazepine | Torrent Pharma | Potency & Assay | Nationwide |
| Drug | CLASS II | Carbamazepine 200mg Tablets, USP, 200 mg Unit Dose recalledCarbamazepine | The Harvard Drug Group | Potency & Assay | NC |