TOPIRAMATE Tablets 200 mg, 60 Tablet Bottles, Rx Only. Manufactured by Cadila Healthcare Ltd. Ahm...
FDA Drug Recall #D-0015-2015 — Class II — September 15, 2014
Recall Summary
| Recall Number | D-0015-2015 |
| Classification | Class II — Moderate risk |
| Date Initiated | September 15, 2014 |
| Status | Terminated |
| Voluntary | Voluntary: Firm initiated |
Recalling Firm
| Firm | Zydus Pharmaceuticals USA Inc |
| Location | Pennington, NJ |
| Product Type | Drugs |
| Quantity | 14,568 Bottles |
Product Description
TOPIRAMATE Tablets 200 mg, 60 Tablet Bottles, Rx Only. Manufactured by Cadila Healthcare Ltd. Ahmedabad, India Distributed by: Zydus Pharmaceuticals USA Inc. Pennington, NJ USA 08534. NDC 68382-141-14.
Reason for Recall
Presence of Foreign Tablets: Presence of topiramate 100 mg tablets comingled with 200 mg tablets.
Distribution Pattern
U.S. Nationwide
Lot / Code Information
Lot #: MN9828, Expiry: Oct 2015.
Other Recalls from Zydus Pharmaceuticals USA Inc
| Recall # | Classification | Product | Date |
|---|---|---|---|
| D-0834-2020 | Class II | Ethacrynate Sodium for Injection, USP, 50mg/via... | Jan 31, 2020 |
| D-1453-2019 | Class II | MethylPREDNISolone Tablets, USP 8 mg, 25 tablet... | May 6, 2019 |
| D-1441-2019 | Class II | Anastrozole Tablets, USP, 1 mg, 1,000-count bot... | May 6, 2019 |
| D-1448-2019 | Class II | MethylPREDNISolone Tablets, USP, 4 mg, 100 tabl... | May 6, 2019 |
| D-1446-2019 | Class II | Pramipexole Dihydrochloride Tablets 0.5 mg, 90-... | May 6, 2019 |
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.