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
Mylan Pharmaceuticals Inc. recalled 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 under a Class III classification, reported 20180620. Current status: Terminated.
- Recall number
- D-0877-2018
- Recalling firm
- Mylan Pharmaceuticals Inc.
- Classification
- Class III
- Status
- Terminated
- Report date
- 20180620
- Initiation date
- 20180607
- Termination date
- 20190620
Reason for recall
Superpotent Drug: Composite assay results obtained during routine stability testing were slightly above specification.
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
What Class III means
Class I is the most serious FDA recall category. It means there is a reasonable probability that using the product will cause serious adverse health consequences or death.
Current status
This recall has been terminated by the FDA, meaning the agency considers the action no longer necessary.
What to do if you have this product
If you hold this product, stop using it as directed by the recall notice and contact the pharmacy or prescriber that supplied it for a replacement or for disposal instructions. Do not rely on this page alone: confirm lot numbers against the official FDA enforcement report before taking action.
Other recalls by Mylan Pharmaceuticals Inc.
| Recall | Product | Classification | Status | Reported |
|---|---|---|---|---|
| D-0049-2021 | Candesartan Cilexetil and Hydrochlorothiazide Tablets, USP 32 mg/12.5 mg, packaged in a) 90-count bottles (NDC 0378-3002-77) and b) 500-count bottles (NDC 0378-3002-05), Rx only, Manufactured for: Mylan Pharmaceuticals Inc. Morgantown, WV 26505 U.S.A. | Class III | Terminated | 20201028 |
| D-1057-2020 | Tacrolimus Capsules, USP 5mg, 100-count bottle, Rx only, Mylan Pharmaceuticals Inc., Morgantown, WV 26505, NDC 0378-2047-01 | Class III | Terminated | 20200401 |
| D-1031-2020 | Sotalol HCL Tablets, USP (AF) 80 mg, 100 count bottles, Rx Only, Mylan Pharmaceuticals Inc. Morgantown, WV 26505 USA. NDC 00378-5123-01 | Class II | Terminated | 20200325 |
| D-0791-2020 | Nizatidine Capsules, USP 150 mg, Rx Only, Mylan Pharmaceuticals Inc., NDC 0378-5150-91. | Class II | Terminated | 20200129 |
| D-0792-2020 | Nizatidine Capsules, USP 300 mg, Rx Only, Mylan Pharmaceuticals Inc., NDC 0378-5300-93. | Class II | Terminated | 20200129 |
| D-0186-2020 | Alprazolam Tablets, USP 0.5 mg, 500-count bottles, Rx only, Manufactured for: Mylan Pharmaceuticals Inc. Morgantown, WV 26505 Made in Australia, NDC 0378-4003-05 | Class II | Terminated | 20191113 |
Recent Class III recalls
| Recall | Product | Firm | Status | Reported |
|---|---|---|---|---|
| D-0035-2027 | Tretinoin Cream UPS, 0.05%, 20g, Rx only, Mfd. by: Taro Pharmaceuticals Inc., Brampton, Ontario, Canada L6T 1C1, Dist. by: Taro Pharmaceuticals USA Inc., Hawthorne, NY 10532, NDC 51672-1394-0. | SUN PHARMACEUTICAL INDUSTRIES INC | Ongoing | 20261014 |
| D-0033-2027 | Tretinoin Cream USP, 0.05%, 45g tube, Rx only, Mfd by: Taro Pharmaceuticals Inc., Brampton, Ontario, Canada L6T 1C1, Dist. by: Taro Pharmaceuticals USA Inc., Hawthorne, NY 10532, NDC 51672-1394-9. | SUN PHARMACEUTICAL INDUSTRIES INC | Ongoing | 20261014 |
| D-0034-2027 | Tretinoin Cream USP, 0.05%, 45 g tube, Manufactured for: Northstar Rx LLC, Memphis, TN 38141, Manufactured by: Taro Pharmaceuticals Inc., Brampton, Ontario, Canada L6T 1C1, Product of Canada, NDC 16714-249-02. | SUN PHARMACEUTICAL INDUSTRIES INC | Ongoing | 20261014 |
| D-0867-2026 | Olanzapine Tablets, USP 5 mg, 30-count bottle, Rx Only, Manufactured For: Macleods Pharma USA, Inc. Princeton, NJ, 08540; Manufactured by: Macleods Pharmaceuticals, Ltd, Baddi, Himachal Pradesh, INDIA, NDC 33342-068-07. | Macleods Pharmaceuticals Limited | Ongoing | 20260930 |
| D-0835-2026 | Povidone Iodine 1.25% / Proparacaine HCl 0.5% Ophthalmic Solution, 10 mL per dropper bottle, For Office Use Only, Imprimis NJOF, LLC, 1705 Route 46 West, Unit 6B, Ledgewood, NJ 07852, NDC 71384-732-10 | ImprimisRx NJ LLC | Ongoing | 20260916 |
| D-0836-2026 | Fluphenazine Hydrochloride Tablets, USP, 1mg, 100-count bottles, Rx Only, Marketed by: Ajanta Pharma USA Inc., Bridgewater, NJ 08807, Made in India, NDC 27241-255-01. | Ajanta Pharma USA Inc | Ongoing | 20260916 |
Frequently asked questions
What product is affected by recall D-0877-2018?
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 The recalling firm is Mylan Pharmaceuticals Inc..
How serious is a Class III recall?
Class I is the most serious FDA recall category. It means there is a reasonable probability that using the product will cause serious adverse health consequences or death.
What should I do with the recalled product?
Stop using it, check the lot number against the official notice, and return it or ask your pharmacy how to dispose of it. Speak to a healthcare professional if you have already used it and feel unwell.
Recall records are reproduced from the FDA enforcement report. Always confirm lot numbers and current guidance with the FDA or the recalling firm before acting.