Food, drugs, devices › Upsher Smith Laboratories, Inc.
Drug recall: Propranolol Hydrochloride Extended-release Capsules, USP, 80 mg, 100 Capsules, Rx only, Manufactured for Upsher Smith La
FDA enforcement event 63908 is a drug recall by Upsher Smith Laboratories, Inc. of Maple Grove, MN, initiated 20 Nov 2012 and classified Class II, with 1 product record.
FDA defines Class II as a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote. 56% of the 209 drug enforcement events initiated in 2012 carry the same class.
Status: Terminated, terminated 12 Jul 2013. Initiation: voluntary: firm initiated. Upsher Smith Laboratories, Inc. has 5 enforcement events on this register, with a median of 1 product record per event.
Recall classification reflects the relative degree of health hazard. Text in quotation marks is FDA's. openFDA export dated 28 Sep 2026.
Recalling firm
Upsher Smith Laboratories, Inc., Maple Grove, MN.
Reason for recall
"Failed Dissolution Test Requirements"
Distribution
"FL, NJ."
Product records
| Recall number | Product | Quantity | Class | Status | Report date |
|---|---|---|---|---|---|
| D-160-2013 | Propranolol Hydrochloride Extended-release Capsules, USP, 80 mg, 100 Capsules, Rx only, Manufactured for Upsher Smith Laboratories, Inc Minneapolis MN 55447 --- NDC 0245-0085-11, UPC 3 0245-0085-11 9 | 60 bottles | Class II | Terminated | 20 Feb 2013 |
Context
Other enforcement events for Upsher Smith Laboratories, Inc.
| Initiated | Product (first record) | Type | Class | Records |
|---|---|---|---|---|
| 29 Jul 2019 | Bexarotene Capsules, 75 mg, 100 capsules per bottle, Rx Only, Manufactured for: Upsher-Smith Laboratories, LLC, Maple Gr | Drug | Class II | 1 |
| 19 Sep 2018 | Bumetanide Tablets, USP, 1 mg, 100-count bottle, Rx only, Manufactured by: Upser-Smith Laboratories, LLC, Maple Grove, M | Drug | Class II | 2 |
| 14 Apr 2014 | Oxandrolone Tablets, USP, 10 mg, Rx Only, C-III, 60-count bottle, Manufactured for: Upsher-Smith Labs, Minneapolis, MN 5 | Drug | Class III | 1 |
| 10 Dec 2012 | Divalproex Sodium Delayed-Release Tablets, USP, 500 mg Valproic Acid Activity, 100-count tablets per bottle, Rx only, Ma | Drug | Class III | 1 |
All 5 events for Upsher Smith Laboratories, Inc.
Questions and answers
Why was this drug recalled?
FDA's record gives the reason for recall as: "Failed Dissolution Test Requirements"
What does Class II mean?
FDA classifies recalls by relative degree of health hazard. Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote.
Where was the product distributed?
FDA's distribution pattern field reads: "FL, NJ."
Is the recall still ongoing?
FDA lists the status as Terminated; the termination date is 12 Jul 2013. "Terminated" means FDA has determined that all reasonable efforts to remove or correct the product have been made.
Where does this data come from?
openFDA enforcement reports (food, drug and device), CC0, export dated 28 Sep 2026. Text in quotation marks is FDA's. The FDA enforcement report linked above is authoritative.
Provenance
Source: openFDA drug enforcement reports (CC0), export dated 28 Sep 2026; records grouped by FDA event number. The class shown for the event is the most severe class among its records. Errors in processing are corrected at the next build; see corrections.