Why it was recalled
Cross Contamination
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.
Lot numbers, UPCs & expiration codes
Lot # a) HAD1712B, Exp. date 03/2025 b) HAD1712C, exp. date 03/2025
Where it was sold
Nationwide in the USA
What to do if you have this product
- Compare the lot number and expiration date on your package with the codes above.
- Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
- If you have symptoms you think are related, contact your doctor. In an emergency call 911.
- Report side effects to FDA MedWatch at 1-800-FDA-1088.
Recall details
- Recall number
- D-0312-2025
- Classification
- Class III
- Status
- Ongoing
- Recall initiated
- Mar 4, 2025
- FDA report date
- Apr 16, 2025
- Quantity
- 852 bottles
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- SUN PHARMACEUTICAL INDUSTRIES INC
Original FDA data
Every field from FDA enforcement report D-0312-2025, exactly as published.
Show all FDA fields
- City
- Princeton
- State
- NJ
- Status
- Ongoing
- Country
- United States
- Event ID
- 96415
- Address
- 2 Independence Way
- Code information
- Lot # a) HAD1712B, Exp. date 03/2025 b) HAD1712C, exp. date 03/2025
- Postal code
- 08540-6620
- Report date
- Apr 16, 2025
- Product type
- Drugs
- Recall number
- D-0312-2025
- Classification
- Class III
- Recalling firm
- SUN PHARMACEUTICAL INDUSTRIES INC
- Product quantity
- 852 bottles
- Reason for recall
- Cross Contamination
- Voluntary / mandated
- Voluntary: Firm initiated
- 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.
- Distribution pattern
- Nationwide in the USA
- Recall initiation date
- Mar 4, 2025
- Initial firm notification
- Letter
- Center classification date
- Apr 4, 2025