The Recall Desk
ModerateFDA (Drugs)·D-1305-2022·Announced 2022-08-17

Prescription Drug Recall: Telmisartan-Hydrochlorothiazide Tablets Due to Defective Packaging

Glenmark Pharmaceuticals recalls 72,288 units of Telmisartan-Hydrochlorothiazide 80/25 mg tablets nationwide due to defective blister packaging that is difficult to open and causes tablets to break.

What this means for you

Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.

Our severity reasoning: This is an FDA Class II recall involving defective blister packaging with no reported illnesses or injuries. The hazard is a packaging defect rather than contamination or allergen exposure, meeting the criteria for Moderate severity.

Plain-English summary

Glenmark Pharmaceuticals Inc., USA has recalled 72,288 units of Telmisartan and Hydrochlorothiazide Tablets USP, 80 mg/25 mg, distributed nationwide. The recall was initiated due to complaints involving defective blister packaging that is difficult to open and causes tablets to break when the blister is opened.

The affected product lots are: Lots 17210935 and 17210936 (expiration 05/2023), Lot 17211206 (expiration 06/2023), and Lots 17211652, 17211655, and 17211658 (expiration 08/2023). The product NDC is 68462-842-13, with related package NDCs 68462-840-13 and 68462-841-13.

No illnesses or injuries have been reported in association with this recall. This is an FDA Class II recall.

The recalled product

Product
TELMISARTAN AND HYDROCHLOROTHIAZIDE (TELMISARTAN AND HYDROCHLOROTHIAZIDE)
Brand
TELMISARTAN AND HYDROCHLOROTHIAZIDE
Manufacturer
Glenmark Pharmaceuticals Inc., USA
Category
Drug
Hazard
  • defective-packaging
  • tablet-breakage

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (5)

  • Lots 17210935 & 17210936.
  • Exp Date 05/2023 Lot 17211206
  • Exp Date 06/2023 Lots 17211652
  • 17211655 & 17211658
  • Exp Date 08/2023

UPCs (3)

  • 0368462842133
  • 0368462841136
  • 0368462840139

Distribution

Distributed nationwide across the United States.

Related recalls

Same brand · TELMISARTAN AND HYDROCHLOROTHIAZIDE

Same category