The Recall Desk
ModerateFDA (Drugs)·D-0659-2020·Announced 2020-01-22

Sun Pharmaceutical Recalls Sumatriptan Succinate Tablets Due to Impurities

Sun Pharmaceutical Industries is recalling specific lots of Sumatriptan Succinate 50 mg tablets because they failed impurity specifications.

What this means for you

Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.

Our severity reasoning: The recall is classified as FDA Class II, which typically indicates a temporary or medically reversible adverse health consequence. The source text does not report any specific illnesses, injuries, or fatalities, and the hazard is related to impurity specifications rather than a high-risk pathogen or structural defect.

Plain-English summary

Sun Pharmaceutical Industries, Inc. is recalling specific lots of Sumatriptan Succinate 50 mg tablets. The recall was initiated because the product failed impurities and degradation specifications, resulting in out-of-specification results for a related substance.

The affected products are packaged in 9 (1x9) unit-of-use blister cards (NDC 62756-521-69) and 100-count bottles (NDC 62756-521-88). The specific lot codes involved are JKU1939A, JKU1940A, and JKU1940B with an expiration date of 04/2022, and JKT4175A with an expiration date of 11/2020. The product was distributed throughout the United States to 96 distributors and 1 repacker/relabeler.

Consumers and healthcare providers should check their inventory for these specific lot numbers and expiration dates. If the product matches the recalled description, it should be returned to the pharmacy or supplier for a refund or replacement. Patients should consult their healthcare provider for alternative treatment options if they have been using the affected medication.

The recalled product

Product
SUMATRIPTAN SUCCINATE (SUMATRIPTAN SUCCINATE)
Brand
SUMATRIPTAN SUCCINATE
Manufacturer
Sun Pharmaceutical Industries, Inc.
Category
Drug — Prescription Medication
Hazard

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (5)

  • a) JKU1939A
  • JKU1940A
  • JKU1940B
  • exp. date 04/2022 and b) JKT4175A
  • exp. date 11/2020

UPCs (2)

  • 0362756521889
  • 0362756522886

Distribution

Distribution scope not specified by the agency.

Part of a larger recall action

This product is one of 2 recalled by Sun Pharmaceutical Industries, Inc. under a single FDA (Drugs) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 2 products in this recall →

Related recalls

Same brand · SUMATRIPTAN SUCCINATE

Same manufacturer · Sun Pharmaceutical Industries, Inc.

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Same hazard · impurities

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