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.
The agency’s classification
FDA (Drugs): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. 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.
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