The Recall Desk
SevereFDA (Drugs)·D-0660-2020·Announced 2020-01-22

Sun Pharma Recalls Sumatriptan Tablets Due to Impurity Failures

Sun Pharmaceutical Industries is recalling 207,585 blisters of Sumatriptan Succinate 100 mg tablets due to failed impurity specifications.

What this means for you

Illness, injury, or structural failure has been reported. Stop using the product immediately and contact the manufacturer for a refund or repair.

Our severity reasoning: The recall is classified as FDA Class II, which corresponds to a Severe severity score per the rubric for significant potential harm.

Plain-English summary

Sun Pharmaceutical Industries, Inc. is recalling 207,585 blisters of Sumatriptan Succinate Tablets, 100 mg, packaged in 9 unit-of-use blister cards. The recall is due to failed impurities and degradation specifications, specifically out-of-specification results for related substances.

The affected product is prescription-only and was distributed throughout the United States to 96 distributors and 1 repacker/relabeler. The recall includes lots JKT4174A (exp. 11/2021), JKU0622A (exp. 01/2022), and JKU1308A (exp. 02/2022).

Consumers and healthcare providers should check their inventory for these specific lot numbers and expiration dates. If found, the product should be returned to the pharmacy or distributor for disposal or replacement.

The recalled product

Product
Sumatriptan Succinate Tablets, 100 mg packaged in 9 (1X9) Unit-of-use blister card, (62756-0522-69), Rx only, Sun Pharma, Cranbury, NJ
Manufacturer
Sun Pharmaceutical Industries, Inc.
Category
Drug — Prescription Medication
Hazard
Affected units
207,585

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 (4)

  • JKT4174A
  • exp. date 11/2021 JKU0622A
  • exp. date 01/2022 JKU1308A
  • exp. date 02/2022

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 manufacturer · Sun Pharmaceutical Industries, Inc.

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Same hazard · impurity

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