Maxzide-25 (Triamterene and hydrochlorothiazide) tablets, USP, 37.5 mg/ 25 mg, 100-count bottle,...
FDA Drug Recall #D-0877-2018 — Class III — June 7, 2018
Recall Summary
| Recall Number | D-0877-2018 |
| Classification | Class III — Low risk |
| Date Initiated | June 7, 2018 |
| Status | Terminated |
| Voluntary | Voluntary: Firm initiated |
Recalling Firm
| Firm | Mylan Pharmaceuticals Inc. |
| Location | Morgantown, WV |
| Product Type | Drugs |
| Quantity | 1,620 bottles |
Product Description
Maxzide-25 (Triamterene and hydrochlorothiazide) tablets, USP, 37.5 mg/ 25 mg, 100-count bottle, Rx only, Mylan Pharmaceuticals Inc., Morgantown, WV 26505, NDC 0378-0464-01
Reason for Recall
Superpotent Drug: Composite assay results obtained during routine stability testing were slightly above specification.
Distribution Pattern
Product was distributed throughout the United States
Lot / Code Information
Lot #: 3087136, Exp 5/20
Other Recalls from Mylan Pharmaceuticals Inc.
| Recall # | Classification | Product | Date |
|---|---|---|---|
| D-0049-2021 | Class III | Candesartan Cilexetil and Hydrochlorothiazide T... | Oct 2, 2020 |
| D-1057-2020 | Class III | Tacrolimus Capsules, USP 5mg, 100-count bottle,... | Mar 23, 2020 |
| D-1031-2020 | Class II | Sotalol HCL Tablets, USP (AF) 80 mg, 100 count ... | Mar 9, 2020 |
| D-0791-2020 | Class II | Nizatidine Capsules, USP 150 mg, Rx Only, Mylan... | Jan 7, 2020 |
| D-0792-2020 | Class II | Nizatidine Capsules, USP 300 mg, Rx Only, Mylan... | Jan 7, 2020 |
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.