CLASS II Drug recall · Reported 31 Oct 2018 · FDA Enforcement Report
Bumetanide Tablets, USP, 1 mg recalled by Upsher Smith Laboratories
Upsher Smith Laboratories is recalling Bumetanide Tablets, USP, 1 mg, distributed nationwide in the US. The recall was initiated on 19 Sep 2018 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-0280-2019
- FDA event ID
- 81174
- Recalling firm
- Upsher Smith Laboratories, Maple Grove, MN
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 19 Sep 2018
- FDA classified
- 21 Nov 2018
- Reported
- 31 Oct 2018
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Potency & Assay
Timeline
| 19 Sep 2018 | Recall initiated by company | |
| 31 Oct 2018 | Published in enforcement report | +42 days |
| 21 Nov 2018 | Classified by FDA | +21 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 is Out of Specification for an unspecified degradation product.
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
Bumetanide Tablets, USP, 1 mg, 100-count bottle, Rx only, Manufactured by: Upser-Smith Laboratories, LLC, Maple Grove, MN 55369, NDC 0832-0541-11
Where it was distributed
Nationwide USA, Puerto Rico and Guam
Questions about this recall
Why was it recalled?
Failed impurities/ degradation specifications: Product is Out of Specification for an unspecified degradation product.
Which lots are affected?
Lot#: 375716, Exp 4/30/2020; 372957, 372958, 372959, Exp 3/31/2020; 374541, 375717, 376688, Exp 5/31/2020
Where was it sold?
Nationwide USA, Puerto Rico and Guam
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 6 Oct 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 81174This product is part of a recall event; the main page for the event is Bumetanide Tablets, USP, 2 mg recalled by Upsher Smith Laboratories.
| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| CLASS II | Bumetanide Tablets, USP, 2 mg recalled by Upsher Smith Laboratories | Upsher Smith Laboratories | Potency & Assay | Nationwide |
More recalls from Upsher Smith Laboratories
All 6| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Bexarotene Capsules, 75 mg recalled by Upsher Smith LaboratoriesBexarotene | Upsher Smith Laboratories | Potency & Assay | 4 states |
| Drug | CLASS II | Bumetanide Tablets, USP, 2 mg recalled by Upsher Smith Laboratories | Upsher Smith Laboratories | Potency & Assay | Nationwide |
| Drug | CLASS III | Oxandrolone Tablets, USP, 10 mg recalled by Upsher Smith Laboratories | Upsher Smith Laboratories | Labeling Errors | Nationwide |
| Drug | CLASS II | Propranolol Hydrochloride Extended-release Capsules, USP, 80 mg recalled | Upsher Smith Laboratories | Potency & Assay | FL, NJ |
| Drug | CLASS III | Divalproex Sodium Delayed-Release Tablets recalled | Upsher Smith Laboratories | Other | Nationwide |
Other Bumetanide recalls
All 6| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Bumetanide Tablets, USP, 2 mg recalled by Cardinal Healthcare | Cardinal Healthcare | Manufacturing (CGMP) Deviations | Nationwide |
| Drug | CLASS II | Bumetanide Tablets, USP, 2 mg recalled by Upsher Smith Laboratories | Upsher Smith Laboratories | Potency & Assay | Nationwide |
| Drug | CLASS II | Bumetanide, Tablet, 1 mg recalled by Aidapak Services | Aidapak Services | Labeling Errors | 4 states |
| Drug | CLASS II | Bumetanide, Tablet, 0.5 mg recalled by Aidapak Services | Aidapak Services | Labeling Errors | 4 states |
| Drug | CLASS III | Bumetanide Tablets USP 0.5 mg recalled by SandozBumetanide | Sandoz | Potency & Assay | Nationwide |