CLASS II Drug recall · Reported 20 Feb 2013 · FDA Enforcement Report
Propranolol Hydrochloride Extended-release Capsules, USP, 80 mg recalled
Upsher Smith Laboratories is recalling Propranolol Hydrochloride Extended-release Capsules, USP, 80 mg, distributed in Florida, New Jersey. The recall was initiated on 20 Nov 2012 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-160-2013
- FDA event ID
- 63908
- Recalling firm
- Upsher Smith Laboratories, Maple Grove, MN
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 20 Nov 2012
- FDA classified
- 8 Feb 2013
- Reported
- 20 Feb 2013
- Type
- Voluntary: Firm initiated
- Customers notified by
- Telephone
- Reason category
- Potency & Assay
- Drug class
- Blood Pressure Medication
Timeline
| 20 Nov 2012 | Recall initiated by company | |
| 8 Feb 2013 | Classified by FDA | +80 days |
| 20 Feb 2013 | Published in enforcement report | +12 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 Test Requirements
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
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
Where it was distributed
FL, NJ.
Questions about this recall
Why was it recalled?
Failed Dissolution Test Requirements
Which lots are affected?
Lot #308198, Expiration Date is 03/2014
Where was it sold?
FL, NJ.
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.
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, 1 mg recalled by Upsher Smith Laboratories | Upsher Smith Laboratories | Potency & Assay | Nationwide |
| 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 III | Divalproex Sodium Delayed-Release Tablets recalled | Upsher Smith Laboratories | Other | Nationwide |
Other Propranolol recalls
All 12| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Propranolol Hydrochloride Tablets, 20 mg recalled by Cardinal HealthcarePropranolol Hydrochloride | Cardinal Healthcare | Manufacturing (CGMP) Deviations | Nationwide |
| Drug | CLASS II | Propranolol HCl recalled by Gyma Laboratories Of Amer | Gyma Laboratories Of Amer | Manufacturing (CGMP) Deviations | Nationwide |
| Drug | CLASS II | Propranolol Hydrochloride Injection, USP 1 mg/mL Single Dose Vial recalledPropranolol | Fresenius Kabi USA | Manufacturing (CGMP) Deviations | Nationwide |
| Drug | CLASS II | Propranolol HCL ER, Capsule, 60 mg recalled by Aidapak Services | Aidapak Services | Labeling Errors | 4 states |
| Drug | CLASS II | Propranolol HCL, Tablet, 10 mg recalled by Aidapak Services | Aidapak Services | Labeling Errors | 4 states |