Gabapentin Capsules Recalled for Cross Contamination
Sun Pharmaceutical Industries is recalling Gabapentin Capsules, USP 300 mg, due to cross contamination. The recall affects approximately 12,876 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: FDA classified this as Class III, which by definition indicates it is unlikely to cause adverse health consequences. The source text states only "cross contamination" as the reason without specifying what contaminant or harm is involved, and no illnesses or injuries are reported.
Plain-English summary
Sun Pharmaceutical Industries Inc. is recalling Gabapentin Capsules, USP 300 mg (Rx Only) due to cross contamination. The recalled product is available in 500-count bottles (NDC 62756-138-05) and 1000-count bottles (NDC 62756-138-04), distributed nationwide in the United States.
The recall covers specific lot numbers: HAD1458A (expires 04/2025), HAD2718A (expires 07/2025), and HAD3432A (expires 08/2025). Approximately 12,876 bottles are affected. This is a voluntary recall initiated by the manufacturer.
Patients taking the recalled gabapentin should contact their healthcare provider or pharmacist for instructions. Consumers with affected product should not stop taking their medication without medical guidance, as abrupt discontinuation may cause adverse health effects. Return unused product to the pharmacy.
The recalled product
- Product
- GABAPENTIN (GABAPENTIN)
- Brand
- GABAPENTIN
- Manufacturer
- SUN PHARMACEUTICAL INDUSTRIES INC
- Category
- Drug — Oral Prescription
- Hazard
- Affected units
- 12,876
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 (6)
- Lot # a) HAD1458A
- Exp. date 04/2025
- HAD2718A
- Exp. date 07/2025
- b) HAD3432A
- exp. date 08/2025
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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