Losartan Potassium Tablets, USP, 25 mg, 1000 film coated tablets per bottle, Rx Only, Manufacture...

FDA Drug Recall #D-0895-2023 — Class II — June 26, 2023

Recall Summary

Recall Number D-0895-2023
Classification Class II — Moderate risk
Date Initiated June 26, 2023
Status Terminated
Voluntary Voluntary: Firm initiated

Recalling Firm

Firm Strides Pharma Inc.
Location East Brunswick, NJ
Product Type Drugs
Quantity 2,700 HDPE Bottles

Product Description

Losartan Potassium Tablets, USP, 25 mg, 1000 film coated tablets per bottle, Rx Only, Manufactured by: Vivimed Life Sciences Private Limited, Plot No. 101, 102, 107 & 108, SIDCO Pharmaceutical Complex, Alathur, Kanchipuram- 603 110, Tamilnadu, India, NDC 64380-933-08

Reason for Recall

Presence of Foreign Substance: Presence of a small piece of blue plastic embedded in the tablet.

Distribution Pattern

Nationwide in the USA.

Lot / Code Information

Lot#: 7901903A, exp. date 04/2024

Other Recalls from Strides Pharma Inc.

Recall # Classification Product Date
D-0260-2024 Class II Methoxsalen Capsules, USP 10mg, 50-count bottle... Dec 29, 2023
D-1330-2022 Class II Prednisone Tablets USP, 20 mg, 100-count bottle... Jul 19, 2022
D-0973-2022 Class II Losartan Potassium Tablets, USP, 50 mg, Rx Only... May 18, 2022
D-0974-2022 Class II Losartan Potassium Tablets, USP, 100 mg, Rx Onl... May 18, 2022
D-0972-2022 Class II Losartan Potassium Tablets, USP 25 mg, Rx only... May 18, 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.