Gabapentin Capsules 400 mg Recalled for Cross Contamination
Sun Pharmaceutical Industries Inc. is recalling Gabapentin Capsules 400 mg due to cross contamination. The recall affects 852 bottles distributed nationwide.
The agency’s classification
FDA (Drugs): Class III
Class III is a situation in which use of or exposure to a violative product is not likely to cause adverse health consequences.
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 1/5 (Low).
Cosmetic or documentation issue. No expected health impact, but the manufacturer is correcting the affected products.
Our severity reasoning: The FDA classified this as Class III, which by definition is unlikely to cause adverse health consequences. The source text does not report any illnesses or injuries, and no specific contaminant or health hazard is detailed.
Plain-English summary
Sun Pharmaceutical Industries Inc. is voluntarily recalling Gabapentin Capsules, USP 400 mg, Rx Only, due to cross contamination. The affected product was packaged in 500-count bottles (NDC 62756-139-05, Lot HAD1712B, Exp. 03/2025) and 1000-count bottles (NDC 62756-139-04, Lot HAD1712C, Exp. 03/2025). A total of 852 bottles were distributed nationwide in the USA.
The product is manufactured by Sun Pharmaceutical Industries Ltd. in Halol-Baroda Highway, Halol-389 350, Gujarat, India, and distributed by Sun Pharmaceutical Industries, Inc. in Cranbury, NJ 08512. The recall was initiated on March 4, 2025, and classified as Class III by the FDA on April 4, 2025.
Patients currently taking the recalled Gabapentin Capsules should consult their healthcare provider or pharmacist. Do not stop taking the medication without medical guidance. Contact Sun Pharmaceutical Industries Inc. with questions about this recall.
The recalled product
- Product
- GABAPENTIN (GABAPENTIN)
- Brand
- GABAPENTIN
- Manufacturer
- SUN PHARMACEUTICAL INDUSTRIES INC
- Category
- Drug — Prescription Oral
- Hazard
- Affected units
- 852
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 (3)
- Lot # a) HAD1712B
- Exp. date 03/2025 b) HAD1712C
- exp. date 03/2025
UPCs (5)
- 0362756204010
- 0362756202016
- 0362756138025
- 0362756137028
- 0362756139022
Distribution
Distributed nationwide across the United States.
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
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