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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 90541

2 recalled-product records grouped only because every row carries this exact official event ID.

Open FDA event record

Event summary

Timeline bucket
June 29, 2022
Product types
Drug
Classifications
Class II
Statuses
Terminated
Recalling firm wording
Glenmark Pharmaceuticals Inc., USA

Dossier provenance

Source snapshots represented here

  • openFDA Drug Enforcement Report-date coverage June 20, 2012–July 08, 2026 Known gap: openFDA describes 2004-present coverage, but the current export has no report-date records in this interval.

Enforcement coverage uses report dates; product initiation dates can precede those bounds. Device-enrichment coverage uses FDA event_date_initiated.

How coverage and grouping work

Complete imported group

Every recalled product in this event

2 official enforcement rows

Product dates, classifications, firms, and source wording remain attached to their individual rows. Opening this dossier never hides products that did not match a prior timeline filter.

drug · product 1 of 2

Telmisartan and Hydrochlorothiazide Tablets USP, 80 mg/25 mg, 30 Tablets, Rx Only, Manufactured by: Glenmark Pharmaceuticals Ltd., Plot no 2, Phase-2, Pharma Zone, SEZ Pithampur, District Dhar, Madhya Pradesh 454775, India, Manufactured for: Glenmark Pharmaceuticals Inc, USA, Mahwah, NJ 07430, NDC 68462-842-13.

D-1305-2022
Recall number
D-1305-2022
Initiated
June 29, 2022
Classification
Class II
Status
Terminated
Quantity
72288 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Defective Container: Recall of these batches has been initiated due to complaints of difficult to open blister and tablet breaks while opening the blister .

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Defective Container: Recall of these batches has been initiated due to complaints of difficult to open blister and tablet breaks while opening the blister .

Code information

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

Distribution pattern

nationwide

drug · product 2 of 2

Telmisartan and Hydrochlorothiazide Tablets USP, 80 mg/12.5 mg, 30 Tablets, Rx Only, Manufactured by: Glenmark Pharmaceuticals Ltd., Plot no 2, Phase-2, Pharma Zone, SEZ Pithampur, District Dhar, Madhya Pradesh 454775, India, Manufactured for: Glenmark Pharmaceuticals Inc,m USA, Mahwah, NJ 07430, NDC 68462-841-13.

D-1306-2022
Recall number
D-1306-2022
Initiated
June 29, 2022
Classification
Class II
Status
Terminated
Quantity
Unavailable

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Defective Container: Recall of these batches has been initiated due to complaints of difficult to open blister and tablet breaks while opening the blister .

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Defective Container: Recall of these batches has been initiated due to complaints of difficult to open blister and tablet breaks while opening the blister .

Code information

Lots 17210929 & 17210930, Exp Date 05/2023; Lot 17211203, Exp Date 06/2023 & Lots 17211643, 17211646 & 17211649, Exp Date 08/2023

Distribution pattern

nationwide