CLASS II Drug recall · Reported 22 Jan 2020 · FDA Enforcement Report
Sumatriptan Succinate Tablets, 50 mg recalled
Sun Pharmaceutical Industries is recalling Sumatriptan Succinate Tablets, 50 mg, distributed nationwide in the US. The recall was initiated on 26 Dec 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-0659-2020
- FDA event ID
- 84570
- Recalling firm
- Sun Pharmaceutical Industries, Cranbury, NJ
- Manufacturer
- Sun Pharmaceutical Industries, Inc.
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 26 Dec 2019
- FDA classified
- 13 Jan 2020
- Reported
- 22 Jan 2020
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Potency & Assay
Timeline
| 26 Dec 2019 | Recall initiated by company | |
| 13 Jan 2020 | Classified by FDA | +18 days |
| 22 Jan 2020 | 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 Impurities/Degradation Specifications; out-of-specification results obtained for related substance.
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
Sumatriptan Succinate Tablets, 50 mg, packaged in a) 9 (1x9) Unit-of use blister card (NDC 62756-521-69) and b) 100 count bottles, (NDC 62756-521-88), Rx only, Sun Pharma, Cranbury, NJ
Where it was distributed
Product was distributed throughout the United States to 96 distributors and 1 repacker/relabeler.
Questions about this recall
Why was it recalled?
Failed Impurities/Degradation Specifications; out-of-specification results obtained for related substance.
Which lots are affected?
a) JKU1939A, JKU1940A, JKU1940B, exp. date 04/2022 and b) JKT4175A, exp. date 11/2020
Where was it sold?
Product was distributed throughout the United States to 96 distributors and 1 repacker/relabeler.
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.
Other products in this recall event
1 other product · FDA event 84570This product is part of a recall event; the main page for the event is Sumatriptan Succinate Tablets, 100 mg recalled.
| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| CLASS II | Sumatriptan Succinate Tablets, 100 mg recalled | Sun Pharmaceutical Industries | Potency & Assay | Nationwide |
More recalls from Sun Pharmaceutical Industries
All 138| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Carbamazepine Tablets, USP, 200mg recalled | SUN Pharmaceutical Industries | Manufacturing (CGMP) Deviations | Nationwide |
| Drug | CLASS III | Fexofenadine Hydrochloride Tablets, USP 180 mg, Antihistamine recalled | SUN Pharmaceutical Industries | Potency & Assay | Nationwide |
| Drug | CLASS II | Perampanel CIII Tablets, 6mg recalled by Sun Pharmaceutical IndustriesPerampanel | SUN Pharmaceutical Industries | Packaging Defects | Nationwide |
| Drug | CLASS I | DOXOrubin Hydrochloride Liposome injection, 50 mg recalledDoxorubicin Hydrochloride | SUN Pharmaceutical Industries | Particulate Matter | Nationwide |
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Other Sumatriptan recalls
All 6| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Sumatriptan Injection, USP, 6mg recalled by Mckesson Medical-Surgical | Mckesson Medical-Surgical Inc. Corporate Office | Manufacturing (CGMP) Deviations | Nationwide |
| Drug | CLASS II | Sumatriptan Succinate Tablets, 100 mg, 9-of- use tablets recalledSumatriptan Succinate | Mckesson Medical-Surgical Inc. Corporate Office | Manufacturing (CGMP) Deviations | Nationwide |
| Drug | CLASS II | Sumatriptan Succinate Tablets, 100 mg recalled | Sun Pharmaceutical Industries | Potency & Assay | Nationwide |
| Drug | CLASS II | Imitrex STATdose System, Imitrex recalled by GlaxoSmithKlineImitrex | GlaxoSmithKline | Sterility | Nationwide |
| Drug | CLASS II | Sumatriptan Succinate Injection recalled by GlaxoSmithKline | GlaxoSmithKline | Sterility | Nationwide |