Valsartan Tablets USP, 80 mg, 90-count bottle, Rx only, Manufactured by: Jubilant Generics Ltd Ro...

FDA Drug Recall #D-1104-2018 — Class III — August 14, 2018

Recall Summary

Recall Number D-1104-2018
Classification Class III — Low risk
Date Initiated August 14, 2018
Status Terminated
Voluntary Voluntary: Firm initiated

Recalling Firm

Firm Jubilant Cadista Pharmaceuticals, Inc.
Location Salisbury, MD
Product Type Drugs
Quantity 9,552 bottles

Product Description

Valsartan Tablets USP, 80 mg, 90-count bottle, Rx only, Manufactured by: Jubilant Generics Ltd Roorkee 0247661 India, Marketed by: Jubilant Cardista Pharmaceuticals Inc. Salisbury, MD 21801, USA, NDC 59746-361-90

Reason for Recall

Incorrect/Undeclared Excipient: There is a potential an incorrect grade of excipient was used during manufacturing.

Distribution Pattern

Product was distributed throughout the United States to wholesalers and retailers.

Lot / Code Information

Lot #: VR217013A, Exp. 08/2019

Other Recalls from Jubilant Cadista Pharmaceuticals, Inc.

Recall # Classification Product Date
D-0096-2023 Class III Prochlorperazine Maleate Tablets, USP 5mg, 100 ... Dec 27, 2022
D-1293-2022 Class II Irbesartan Tablets, USP, 150mg, 90- count bottl... Jul 18, 2022
D-1294-2022 Class II Irbesartan Tablets, USP, 75 mg, 90- count bottl... Jul 18, 2022
D-0752-2022 Class III Methylprednisolone Tablets, USP 4mg, 100-count ... Apr 1, 2022
D-0767-2022 Class I Meclizine Hydrochloride Tablets USP, 12.5 mg, p... Mar 8, 2022

Frequently Asked Questions

Stop taking the medication and contact your pharmacist or doctor immediately. For Class I recalls, this is urgent. For Class II or III recalls, consult your doctor before stopping — abruptly discontinuing certain medications (blood pressure drugs, antidepressants, diabetes medications) can be more harmful than continuing while arranging a replacement. Check whether the recall applies to your specific lot number and expiration date. Return the product to your pharmacy and report any adverse effects to FDA MedWatch at 1-800-FDA-1088.

Not necessarily. Many drug recalls are initiated because of quality system failures or test results that suggest a product might not meet specifications — even if no patients have reported harm. The FDA uses a precautionary approach: if there is reason to believe quality standards were not met, a recall is required regardless of whether adverse effects have been reported. Class I recalls typically involve a reasonable probability of harm; Class II recalls may cause temporary health issues; Class III recalls are for products unlikely to cause adverse health consequences but that still violate regulations.

Pharmacies typically receive recall notices directly from drug wholesalers and manufacturers within days of the recall being announced. Your pharmacist can look up whether any product in your prescription history matches a recalled lot number. For current recalls, the FDA publishes updates at FDA.gov/safety/recalls-market-withdrawals-safety-alerts and sends MedWatch email alerts for significant drug safety issues. You can sign up for MedWatch alerts at FDA.gov. Most major pharmacy chains also have their own recall notification systems that automatically alert pharmacists when a recalled product is in their inventory.

What Should You Do?

Stop using this medication if affected by this recall. Contact your pharmacist or prescribing doctor immediately for guidance. Do not flush medications — use a drug take-back program.