Class III U.S. Food and Drug Administration

Glenmark Pharmaceuticals Inc., USA Bisoprolol Fumarate and Hydrochlorothiazide recall: Cross Contamination with Other Products: Testing of reserve samples showed

Recall published 11 months ago

Cross Contamination with Other Products: Testing of reserve samples showed presence of traces of ezetimibe

The hazard: Drug safety concern

A problem with this medicine prompted the recall. With prescriptions, the first move is a conversation rather than a decision.

What the notice says: Cross Contamination with Other Products: Testing of reserve samples showed presence of traces of ezetimibe

Why it matters: The FDA recorded an enforcement action against this product. The classification and the summary above describe how serious the agency considers it.

Recall details

Recall number
D-0199-2026
Published
December 10, 2025
Risk level
Class III
Status
Ongoing
Issued by
U.S. Food and Drug Administration
Brand
Glenmark Pharmaceuticals Inc., USA
Product type
Prescription & OTC drugs
Units affected
11,136 bottles
Distribution
Nationwide
Made in
United States
Lot / code info
Lot #: (a): Lot 17232401, exp 11/2025; Lot 17240974, exp 05/2026 (b): Lot 17232401, exp 11/2025; Lot 17240974, exp 05/2026 (c): Lot 17232401, exp 11/2025; Lot 17240974, exp 05/2026

Products covered by this recall

Bisoprolol Fumarate and Hydrochlorothiazide Tablets, USP, 2.5 mg/6.25 mg, packaged as (a) 30-count bottles, NDC-68462-878-30; (b) 100-count bottle, NDC-68462-878-01; (c) 500-count bottles, NDC-68462-878-05; Rx Only, Manufactured by: Glenmark Pharmaceuticals Limited, Pithampur, Madhya Pradesh 454775, Inda. Manufactured for: Glenmark Pharmaceuticals, Inc., USA, Mahwah, NJ 07430.

Check your product

The notice names 19 codes you can read straight off the package. Type the one printed on yours and the list below narrows to it.

Lot or batch code

Usually ink-stamped near the seam, the cap or the bottom of the pack.

  • 17232401
  • exp 11
  • 2025
  • 17240974
  • exp 05
  • 2026
  • 2026 — 11
  • 136 bottles

Best-by / use-by date

Printed beside the lot code, not on the price sticker.

  • 11
  • 2025
  • 05
  • 2026
  • 2026 — 11
  • 136 bottles

Package size

Match the net weight or the piece count on the front of the pack.

  • 2.5 mg
  • 6.25 mg
  • 30 count
  • 100 count
  • 500 count

Codes are lifted verbatim from the FDA — Drug enforcement notice. A code that is missing here may still be covered — the official notice is the complete list.

What to do about Drug safety

Glenmark Pharmaceuticals Inc., USA — A problem with this medicine prompted the recall. With prescriptions, the first move is a conversation rather than a decision.

  1. Check the lot number on your pack against the codes listed above.
  2. Ask the dispensing pharmacy for a replacement from an unaffected lot.
  3. Keep the carton; the lot number is often printed only on the outer pack.
  4. Report side effects you think the product caused to FDA MedWatch.

Getting a replacement supply

Do not let a refund question interrupt your treatment. Deal with the supply first and the money second.

  • Call the pharmacy before you run low. They can see which lot they dispensed to you and will usually swap it the same day.
  • Insurers do not normally count a recall replacement against a refill limit. If one is refused, ask the pharmacist to call it through as a recall override.
  • Over-the-counter products are refunded at the till like any other purchase; the recall notice on your phone is enough to explain the return.
  • If the manufacturer runs a direct reimbursement form, it will be linked from the official notice on this page.

Company contact: Glenmark Pharmaceuticals Inc., USA — 619 River Dr, Elmwood Park, NJ, 07407-1317

The official notice

This page summarises a notice published by U.S. Food and Drug Administration. The agency notice is the authoritative version — read it before you act, and treat it as the final word if anything here looks different.

Open the FDA — Drug enforcement record U.S. Food and Drug Administration recalls

Questions people ask about this recall

Why was Glenmark Pharmaceuticals Inc., USA prescription & otc drugs recalled?

Cross Contamination with Other Products: Testing of reserve samples showed presence of traces of ezetimibe Cross Contamination with Other Products: Testing of reserve samples showed presence of traces of ezetimibe

How do I know if I have the recalled product?

Match the codes printed on your package against the notice: lot code 17232401, exp 11, 2025; best-by date 11 or 2025. If the code on your package is not on that list, your unit is outside the recall.

What should I do with it right now?

Check the lot number on your pack against the codes listed above.

Can I get my money back?

Call the pharmacy before you run low. They can see which lot they dispensed to you and will usually swap it the same day.

Where was the recalled product sold?

It was distributed nationwide.

Related recalls