buPROPion HCl Extended-Release Tablets, USP (SR), 100 mg, 60 count bottles, Rx Only, Manufactur...
FDA Drug Recall #D-0618-2018 — Class III — March 15, 2018
Recall Summary
| Recall Number | D-0618-2018 |
| Classification | Class III — Low risk |
| Date Initiated | March 15, 2018 |
| Status | Terminated |
| Voluntary | Voluntary: Firm initiated |
Recalling Firm
| Firm | InvaGen Pharmaceuticals, Inc. |
| Location | Hauppauge, NY |
| Product Type | Drugs |
| Quantity | N/A |
Product Description
buPROPion HCl Extended-Release Tablets, USP (SR), 100 mg, 60 count bottles, Rx Only, Manufactured for: Cipla USA Inc. 1560 Sawgrass Corporate Parkway Suite 130 Sunrise, FL 33323, Manufactured by: InvaGen Pharmaceuticals, Inc. (a subsidiary of Cipla Ltd.) Hauppauge, NY 11788 --- NDC 69097-877-03
Reason for Recall
Failed Dissolution Specifications; during stability testing
Distribution Pattern
Nationwide
Lot / Code Information
Lot# I1606579 and Lot# I1606580 Exp: 05/2018; Lot# I1612114 and Lot# I1612115 Exp: 11/2018
Other Recalls from InvaGen Pharmaceuticals, Inc.
| Recall # | Classification | Product | Date |
|---|---|---|---|
| D-0220-2024 | Class I | Vigabatrin for Oral Solution, USP 500 mg per pa... | Nov 17, 2023 |
| D-1272-2020 | Class III | Gabapentin Tablets USP, 600 mg, Rx Only, 500-co... | May 14, 2020 |
| D-1454-2019 | Class III | Testosterone Topical Solution 30mg of testoster... | Jun 12, 2019 |
| D-1125-2019 | Class II | Testosterone Cypionate Injection, USP, 1000 mg/... | Mar 22, 2019 |
| D-1123-2019 | Class II | Testosterone Cypionate Injection, USP, 2000 mg/... | Mar 22, 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.