FDA recalls Gabapentin 400mg capsules from Sun Pharmaceutical for cross contamination
Sun Pharmaceutical is voluntarily recalling 852 bottles of Gabapentin 400mg capsules nationwide due to cross contamination. The recall affects Lot HAD1712B and HAD1712C, both expiring March 2025.
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: This is an FDA Class III recall (the lowest classification) for a voluntary, precautionary recall involving contamination. With no adverse events reported in the recall notice, it meets criteria for Moderate (Score 2) severity per FDA standards.
Plain-English summary
Sun Pharmaceutical Industries Inc. is voluntarily recalling 852 bottles of Gabapentin Capsules, USP 400 mg (prescription only) distributed nationwide in the United States. The affected lots are HAD1712B and HAD1712C, both with an expiration date of March 2025. These capsules were packaged in either 500-count bottles (NDC 62756-139-05) or 1000-count bottles (NDC 62756-139-04).
The recall has been initiated due to cross contamination identified during manufacturing. The specific nature of the contamination has not been detailed in the recall notice.
The recall was initiated by the manufacturer on March 4, 2025, and remains ongoing as of April 16, 2025. Consumers who have this medication should consult with their healthcare provider or pharmacist about their treatment options.
The recalled product
- Product
- GABAPENTIN (GABAPENTIN)
- Brand
- GABAPENTIN
- Manufacturer
- SUN PHARMACEUTICAL INDUSTRIES INC
- Category
- Drug — Anticonvulsant Medication
- Hazard
- cross-contamination
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.
Related recalls
Same brand · GABAPENTIN
- HighGabapentin Capsules Nationwide Recall for Failed Impurity Specifications
FDA (Drugs) · 2025-10-29
- ModerateGabapentin Prescription Capsules Recalled for Failed Impurity Specifications
FDA (Drugs) · 2025-10-29
- HighGabapentin capsules recalled due to inadequately sealed blister packaging
FDA (Drugs) · 2025-07-09
- ModeratePrescription Gabapentin Capsules Recalled for Defective Blister Packaging
FDA (Drugs) · 2025-07-09
- ModeratePrescription Gabapentin 300 mg Capsules Recalled for Cross Contamination
FDA (Drugs) · 2025-04-16
Same category
- CriticalWarfarin Tablets Recalled After Mix-Up Between 2.5 mg and 5 mg Strengths
FDA (Drugs) · 2026-07-21
- ModerateFDA Recalls Pred Mild Ophthalmic Suspension Due to Failed Stability Specifications
FDA (Drugs) · 2026-06-03
- ModerateNicotine Transdermal System Patches Recalled for Oxidative Impurity Specification Failure
FDA (Drugs) · 2026-06-03
- HighLiraglutide Injection Recalled Due to Particulate Matter in Cartridges
FDA (Drugs) · 2026-05-27
- LowPrimidone Tablets Recalled for Cross-Contamination with Acemetacin
FDA (Drugs) · 2026-05-27