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Glenmark Pharmaceuticals Inc., USA recalls

Every recall we track for Glenmark Pharmaceuticals Inc., USA — 141 in all, from 2017–2026 — plus the complaints and injury reports the public filed about them. 8 are rated “stop using now”.

141recalls
1,871complaints & reports
1,067injuries reported
160deaths reported

Recalls per year, by danger level

Recalls from Glenmark Pharmaceuticals Inc., USA more than doubled in 2025 (73, up from 25 in 2024). 6% rated “stop using now”.

2017: 1 recall — 1 lower risk120172018: 3 recalls — 3 lower risk320182019: 13 recalls — 1 stop using now, 8 lower risk, 4 not yet rated1320192020: 0 recalls20202021: 8 recalls — 1 stop using now, 2 lower risk, 5 not yet rated820212022: 9 recalls — 1 use caution, 5 lower risk, 3 not yet rated920222023: 7 recalls — 1 use caution, 5 lower risk, 1 not yet rated720232024: 25 recalls — 2 stop using now, 5 use caution, 9 lower risk, 9 not yet rated2520242025: 73 recalls — 4 stop using now, 4 use caution, 15 lower risk, 50 not yet rated7320252026 (to date): 2 recalls — 2 lower risk22026to date

All FDA recall records for Glenmark Pharmaceuticals Inc., USA since 2017, counted by recall date (one bar per calendar year; 2026 is partial). Danger level is GovInfoNow’s plain-language rating; “not yet rated” records are still being written up.

Recalls per year for Glenmark Pharmaceuticals Inc., USA, by danger level
YearStop using nowUse cautionLower riskNot yet ratedTotal
201700101
201800303
2019108413
202000000
202110258
202201539
202301517
2024259925
202544155073
2026 (to date)00202

Most common reasons for Glenmark Pharmaceuticals Inc., USA recalls

  • CGMP Deviations49
  • CGMP Deviations: Presence of NDMA impurity detected in product.6
  • Failed Dissolution Specifications4
  • cGMP deviations3
  • Defective delivery system; product is not foaming or is coming out as liquid.2

What to do if you have a recalled Glenmark Pharmaceuticals Inc., USA product

  1. Match the NDC and lot number on your bottle or box to the recall.
  2. Don’t stop a prescription on your own — ask your pharmacist or doctor for a replacement first.
  3. Report side effects to FDA MedWatch.

See this week’s new recalls.

All Glenmark Pharmaceuticals Inc., USA recalls

55 shown

Glenmark Pharmaceuticals Inc., USA recall questions

How many recalls has Glenmark Pharmaceuticals Inc., USA had?

141 recalls from Glenmark Pharmaceuticals Inc., USA are on record with U.S. safety agencies, from 2017–2026.

What is the most recent Glenmark Pharmaceuticals Inc., USA recall?

Glenmark Pharmaceuticals Inc., USA recalls Azelaic Acid Gel, 15%, 50 gram tubes, For Topical Use only, Rx only, Distributed by: Glenmark Pharmaceuticals Inc.,, dated Jul 23, 2026. Every Glenmark Pharmaceuticals Inc., USA recall is listed on this page, newest first.

Why are Glenmark Pharmaceuticals Inc., USA products recalled?

The most common reasons on record: CGMP Deviations (49); CGMP Deviations: Presence of NDMA impurity detected in product. (6); Failed Dissolution Specifications (4); cGMP deviations (3).

What should I do if I have a recalled Glenmark Pharmaceuticals Inc., USA product?

Match the NDC and lot number on your bottle or box to the recall. Don’t stop a prescription on your own — ask your pharmacist or doctor for a replacement first. Report side effects to FDA MedWatch.

How do I get alerts for new Glenmark Pharmaceuticals Inc., USA recalls?

Sign up for free email alerts on GovInfoNow — we check official CPSC, FDA, USDA and NHTSA data every day and email you only when a recall matches what you follow.