Medications & Supplements/Prescription Drugs

Sun Pharmaceutical Oxcarbazepine Tablets Recalled for Foreign Substance

Agency Publication Date: December 19, 2022

Summary

Sun Pharmaceutical Industries Inc is recalling Oxcarbazepine 600mg Tablets because a foreign substance was found in the medication. This recall affects three specific lots totaling 6,565 bottles, consisting of Lot HAC1474A (4,296 bottles), Lot HAC1474B (145 bottles), and Lot HAC1503A (2,124 bottles). No incidents or injuries have been reported to date in connection with this issue.

Risk

The presence of a foreign substance in a prescription drug can pose a risk of infection or other internal injuries if ingested. Consumers taking this medication should contact their healthcare provider to discuss alternative treatments or concerns.

What You Should Do

This recall affects Oxcarbazepine 600mg Tablets sold under the Sun Pharmaceutical Industries brand in 100-count, 500-count, and 1,000-count bottles.
Identify your medication by checking the bottle for lot numbers HAC1474A, HAC1474B, or HAC1503A, all with an expiration date of 03/2023.
Confirm the NDC codes on your bottle match those affected: 62756-185-88 (100-count), 62756-185-13 (500-count), or 62756-185-18 (1,000-count).
If you have health concerns, contact your healthcare provider or pharmacist. Return any unused product to the place of purchase for a refund, throw it away, or contact Sun Pharmaceutical Industries Inc for further instructions.
Call the FDA Consumer Complaint hotline at 1-888-723-3332 for additional questions regarding this recall.

Your Remedy Options

You have 2 options:

Option 1: Full Refund

How to: Contact your healthcare provider or pharmacist for guidance, or return any unused product to the place of purchase for a refund

Option 2: Dispose of Product

How to: Throw the product away. For prescription medications, a DEA take-back location or pharmacy mail-back program is preferred when available.

Affected Products

Product: Oxcarbazepine Tablets 600mg

Variants: 600mg, Tablets, 100-count bottle, 500-count bottle, 1,000-count bottle

Lot Numbers:

HAC1474A (Exp 03/2023)

HAC1474B (Exp 03/2023)

HAC1503A (Exp 03/2023)

NDC:

62756-185-88

62756-185-13

62756-185-18

Quantity distributed includes: Lot HAC1474A (4,296 Bottles), Lot HAC1474B (145 Bottles), and Lot HAC1503A (2,124 Bottles).

Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 91311

Status: Resolved

Manufacturer: SUN PHARMACEUTICAL INDUSTRIES INC

Sold By: Retail Pharmacies; Hospitals

Manufactured In: India, United States

Units Affected: Lot HAC1474A: 4296 Bottles, Lot HAC1474B: 145 Bottles, Lot HAC1503A: 2124 Bottles

Distributed To: Nationwide

Were You Affected by This Recall?

If you or a family member were harmed by this recalled product, you may have legal rights. Consider consulting a consumer protection attorney to understand your options for compensation.

Find an Attorney

This is general information, not legal advice. Go Backs is not a law firm and does not provide legal services.

AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.

Sources: FDA iRES · Raw API Response

openFDA Disclaimer: This recall information is sourced from the openFDA API. Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Refer to the openFDA terms of service for more information.

Summary

What You Should Do

This recall affects Oxcarbazepine 600mg Tablets sold under the Sun Pharmaceutical Industries brand in 100-count, 500-count, and 1,000-count bottles.

Identify your medication by checking the bottle for lot numbers HAC1474A, HAC1474B, or HAC1503A, all with an expiration date of 03/2023.

Confirm the NDC codes on your bottle match those affected: 62756-185-88 (100-count), 62756-185-13 (500-count), or 62756-185-18 (1,000-count).

If you have health concerns, contact your healthcare provider or pharmacist. Return any unused product to the place of purchase for a refund, throw it away, or contact Sun Pharmaceutical Industries Inc for further instructions.

Call the FDA Consumer Complaint hotline at 1-888-723-3332 for additional questions regarding this recall.

Your Remedy Options

You have 2 options:

Option 1: Full Refund

How to: Contact your healthcare provider or pharmacist for guidance, or return any unused product to the place of purchase for a refund

Option 2: Dispose of Product

How to: Throw the product away. For prescription medications, a DEA take-back location or pharmacy mail-back program is preferred when available.

Affected Products

Product: Oxcarbazepine Tablets 600mg

Variants: 600mg, Tablets, 100-count bottle, 500-count bottle, 1,000-count bottle

Lot Numbers:

HAC1474A (Exp 03/2023)

HAC1474B (Exp 03/2023)

HAC1503A (Exp 03/2023)

NDC:

62756-185-88

62756-185-13

62756-185-18

Quantity distributed includes: Lot HAC1474A (4,296 Bottles), Lot HAC1474B (145 Bottles), and Lot HAC1503A (2,124 Bottles).

Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 91311

Status: Resolved

Manufacturer: SUN PHARMACEUTICAL INDUSTRIES INC

Sold By: Retail Pharmacies; Hospitals

Manufactured In: India, United States

Units Affected: Lot HAC1474A: 4296 Bottles, Lot HAC1474B: 145 Bottles, Lot HAC1503A: 2124 Bottles

Distributed To: Nationwide