CLASS II Drug recall · Reported 17 Apr 2019 · FDA Enforcement Report
Bismuth Subsalicylate Oral Suspension 262mg/, unit dose cups recalled
Lohxa is recalling Bismuth Subsalicylate Oral Suspension 262mg/, unit dose cups, distributed in Massachusetts, New York, Wyoming. The recall was initiated on 25 Mar 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-1130-2019
- FDA event ID
- 82538
- Recalling firm
- Lohxa, Worcester, MA
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 25 Mar 2019
- FDA classified
- 15 Apr 2019
- Reported
- 17 Apr 2019
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Other Reasons
Timeline
| 25 Mar 2019 | Recall initiated by company | |
| 15 Apr 2019 | Classified by FDA | +21 days |
| 17 Apr 2019 | Published in enforcement report | +2 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Labeling: Incorrect or Missing Lot and/or Exp Date - the label contains an incorrect Exp Date.
Product as listed by the FDA
Bismuth Subsalicylate Oral Suspension 262mg/15mL, unit dose cups, OTC, Rpkg. By.: Lohxa Worcester, MA, NDC 70166-059-01
Where it was distributed
MA, NY and WY
Questions about this recall
Why was it recalled?
Labeling: Incorrect or Missing Lot and/or Exp Date - the label contains an incorrect Exp Date.
Which lots are affected?
Lot#: M030042P, Exp. 01/2020
Where was it sold?
MA, NY and WY
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.
Other products in this recall event
1 other product · FDA event 82538| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| CLASS II | Phenobarbital Oral Solution, USP 20 mg/, unit dose cup recalled by Lohxa | Lohxa | Other | MA, NY, WY |
More recalls from Lohxa
All 4| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS I | Senna Syrup (sennosides) 8.8 mg/ unit-dose cups recalled by Lohxa | Lohxa | Sterility | Nationwide |
| Drug | CLASS I | Chlorhexidine Gluconate Oral Rinse USP, 0.12%, Alcohol Free recalled | Lohxa | Sterility | FL, NY |
| Drug | CLASS II | Phenobarbital Oral Solution, USP 20 mg/, unit dose cup recalled by Lohxa | Lohxa | Other | MA, NY, WY |
Other Bismuth Subsalicylate recalls
All 2| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Bismuth Subsalicylate, Chew Tablet, 262 mg, Over The Counter recalled | Aidapak Services | Labeling Errors | 4 states |