Gabapentin Tablet, Film Coated
FDA Recall NDC 62756-202
FDA Enforcement Report: View Recall Date, Reasons, and Safety Status
Active & Historical Enforcement Reports
The FDA has identified 2 recorded enforcement report(s) associated with Gabapentin (NDC 62756-202). A significant event, classified as Class III, was initiated on Mar 04, 2025 by Sun Pharmaceutical Industries, Inc.. The reported reason for this action was: "Cross Contamination"
This recall is currently ONGOING. Healthcare providers and patients are advised to check their inventory immediately against the affected codes provided below.
This recall is currently ONGOING. Healthcare providers and patients are advised to check their inventory immediately against the affected codes provided below.
Reported Recall Events
Class III Ongoing
Cross Contamination
Mar 04, 2025
Apr 16, 2025
12,876 bottles
Recall Profile & Regulatory Data
Event ID
96415
Classification
Class III
Enforcement Status
Ongoing
Recalling Firm
SUN PHARMACEUTICAL INDUSTRIES INC
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
Nationwide in the USA
Product Description
Gabapentin Capsules, USP 300 mg, Rx Only, Packaged in a) 500-count bottles, NDC 62756-138-05; b) 1000-count bottles, NDC 62756-138-04, Distributed by: Sun Pharmaceutical Industries, Inc. Cranbury, NJ 08512, Manufactured by: Sun Pharmaceutical Industries Ltd. Halol-Baroda Highway, Halol-389 350, Gujarat, India.
Batch or Lot Expiration Information
Lot# a) HAD1458A, Exp. date 04/2025, HAD2718A, Exp. date 07/2025, b) HAD3432A, exp. date 08/2025
Affected Packages Involved in this Recall
62756-137-02Product
62756-137-03Product
62756-137-05Product
62756-137-04Product
62756-137-01Product
62756-138-02Product
62756-138-03Product
62756-138-05Product
62756-138-04Product
62756-138-01Product
62756-139-02Product
62756-139-03Product
62756-139-05Product
62756-139-04Product
62756-139-01Product
62756-202-01Product
62756-202-03Product
62756-204-01Product
62756-204-03Product
Class III Ongoing
Cross Contamination
Mar 04, 2025
Apr 16, 2025
852 bottles
Recall Profile & Regulatory Data
Event ID
96415
Classification
Class III
Enforcement Status
Ongoing
Recalling Firm
SUN PHARMACEUTICAL INDUSTRIES INC
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
Nationwide in the USA
Product Description
Gabapentin Capsules, USP 400 mg, Rx Only, Packaged in a) 500-count bottles, NDC 62756-139-05; b) 1000-count bottles, NDC 62756-139-04; Distributed by: Sun Pharmaceutical Industries, Inc. Cranbury, NJ 08512, Manufactured by: Sun Pharmaceutical Industries Ltd. Halol-Baroda Highway, Halol-389 350, Gujarat, India.
Batch or Lot Expiration Information
Lot# a) HAD1712B, Exp. date 03/2025 b) HAD1712C, exp. date 03/2025
Affected Packages Involved in this Recall
62756-137-02Product
62756-137-03Product
62756-137-05Product
62756-137-04Product
62756-137-01Product
62756-138-02Product
62756-138-03Product
62756-138-05Product
62756-138-04Product
62756-138-01Product
62756-139-02Product
62756-139-03Product
62756-139-05Product
62756-139-04Product
62756-139-01Product
62756-202-01Product
62756-202-03Product
62756-204-01Product
62756-204-03Product
About FDA Recall Enforcement Reports
FDA recall data documents classified recall actions associated with a product. Most recalls are limited to specific lots, batches, or package configurations rather than every unit of a drug.
If a recall is listed for an NDC, review the affected lot information and package details carefully. Patients and healthcare professionals should confirm whether a specific product in hand matches the lot or package information before assuming it is affected.
