Telmisartan and Hyrdochlorothiazide Tablets 40mg/12.5 mg, 30-count bottles, Rx Only, Manufactur...

FDA Drug Recall #D-1003-2019 — Class II — February 25, 2019

Recall Summary

Recall Number D-1003-2019
Classification Class II — Moderate risk
Date Initiated February 25, 2019
Status Terminated
Voluntary Voluntary: Firm initiated

Recalling Firm

Firm Macleods Pharma Usa Inc
Location Plainsboro, NJ
Product Type Drugs
Quantity 93227 bottles

Product Description

Telmisartan and Hyrdochlorothiazide Tablets 40mg/12.5 mg, 30-count bottles, Rx Only, Manufactured for:Macleods Pharma USA, Inc. Plainsboro, NJ 08536, Manufactured for: Macleods Pharmaceuticals Ltd. Baddi, Himchal Pradesh INDIA, NDC 33342-128-07

Reason for Recall

Failed Content Uniformity Specifications: The product is out of specification for blend uniformity.

Distribution Pattern

Nationwide within the United States

Lot / Code Information

Lot #: BTL703A, Exp. Feb-19; BTL705A, Exp Apr-19; BTL706A, BTL707A, BTL708A, Exp May-19; BTL709A, Exp Nov-19; BTL710A, BTL711A, BTL801A, Exp. Dec-19; BTL802A, BTL803A, Exp.Feb-20; BTL804A, BTL805A, Exp. Apr-20; BTL807A, BTL807B, Exp May- 20; BTL809A, BTL810A, Exp Jul-20; BTL811A, Exp Sep-20; BTL812A, BTL813A Exp Oct-20

Other Recalls from Macleods Pharma Usa Inc

Recall # Classification Product Date
D-1174-2022 Class II Eszopiclone Tablets, USP 1 mg, packaged in 30-... Jun 16, 2022
D-1164-2022 Class II Losartan potassium & Hydrochlorothiazide Tablet... Jun 10, 2022
D-0833-2022 Class II Losartan Potassium Tablets, USP, 50 mg, a) 30-c... Apr 15, 2022
D-0832-2022 Class II Losartan Potassium Tablets, USP, 25 mg, a) 90-c... Apr 15, 2022
D-0834-2022 Class II Losartan Potassium Tablets, USP, 100 mg, a) 30-... Apr 15, 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.