CLASS II Drug recall · Reported 28 Aug 2019 · FDA Enforcement Report
Bexarotene Capsules, 75 mg recalled by Upsher Smith Laboratories
Upsher Smith Laboratories is recalling Bexarotene Capsules, 75 mg per, distributed in Kentucky, Louisiana, New Jersey, Ohio. The recall was initiated on 29 Jul 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-1836-2019
- FDA event ID
- 83501
- Recalling firm
- Upsher Smith Laboratories, Maple Grove, MN
- Brand
- Bexarotene
- Manufacturer
- Upsher-Smith Laboratories, Inc.
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 29 Jul 2019
- FDA classified
- 19 Aug 2019
- Reported
- 28 Aug 2019
- Type
- Voluntary: Firm initiated
- Customers notified by
- Telephone
- Reason category
- Potency & Assay
Timeline
| 29 Jul 2019 | Recall initiated by company | |
| 19 Aug 2019 | Classified by FDA | +21 days |
| 28 Aug 2019 | Published in enforcement report | +9 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Failed Dissolution Specifications
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
Bexarotene Capsules, 75 mg, 100 capsules per bottle, Rx Only, Manufactured for: Upsher-Smith Laboratories, LLC, Maple Grove, MN 55369. NDC: 0832-0285-00
Where it was distributed
KY, OH, NJ, LA
Questions about this recall
Is Bexarotene Capsules, 75 mg per recalled?
Yes. Upsher Smith Laboratories recalled Bexarotene Capsules, 75 mg per on 29 Jul 2019. The recall is Class II and its status is Terminated. Recall number D-1836-2019.
Why was it recalled?
Failed Dissolution Specifications
Which lots are affected?
Lot: A2610. exp 3/2020
Where was it sold?
KY, OH, NJ, LA
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 21 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 Upsher Smith Laboratories
All 6| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Bumetanide Tablets, USP, 1 mg recalled by Upsher Smith LaboratoriesBumetanide | Upsher Smith Laboratories | Potency & Assay | Nationwide |
| Drug | CLASS II | Bumetanide Tablets, USP, 2 mg recalled by Upsher Smith LaboratoriesBumetanide | 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 |