CLASS II Drug recall · Reported 4 Jan 2017 · FDA Enforcement Report
Nadolol Tablets, USP, 40mg recalled by Sandoz Incorporated
Sandoz is recalling Nadolol Tablets, USP, 40mg, distributed in Mississippi, Ohio. The recall was initiated on 22 Dec 2016 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-0236-2017
- FDA event ID
- 76077
- Recalling firm
- Sandoz, Broomfield, CO
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 22 Dec 2016
- FDA classified
- 27 Dec 2016
- Reported
- 4 Jan 2017
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Potency & Assay
Timeline
| 22 Dec 2016 | Recall initiated by company | |
| 27 Dec 2016 | Classified by FDA | +5 days |
| 4 Jan 2017 | Published in enforcement report | +8 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 specification: recalled due to an out of specification dissolution result of 40% (Specification: NLT 80%)
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
Nadolol Tablets, USP, 40mg, packaged in 1000-count bottle, Rx Only, Manufactured by Sandoz Inc., Princeton, NJ 08540, NDC 0781-1182-10
Where it was distributed
MS and OH.
Questions about this recall
Why was it recalled?
Failed dissolution specification: recalled due to an out of specification dissolution result of 40% (Specification: NLT 80%)
Which lots are affected?
Lot GG1539
Where was it sold?
MS and OH.
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.
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Other Nadolol recalls
All 3| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Nadolol Tablets, USP 40 mg recalled by Cardinal HealthNadolol | Cardinal Health | Manufacturing (CGMP) Deviations | FL, GA, SC |
| Drug | CLASS II | Nadolol 10 mg/ Susp, Health Innov Pharmacy recalled | Health Innovations Pharmacy | Sterility | NC |