Prescription azelaic acid gel recalled for manufacturing process deviations
Glenmark Pharmaceuticals recalls azelaic acid gel 15% nationwide due to manufacturing process deviations. Patients should consult their healthcare provider about their prescription.
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 for manufacturing deviations without reported illnesses, injuries, or hospitalizations. Per the rubric, FDA Class II without hospitalization reports scores lower than 4, and a theoretical manufacturing hazard with no reported harm scores at most 3. The voluntary, precautionary nature of the recall supports a Moderate (2) classification.
Plain-English summary
Glenmark Pharmaceuticals Inc., USA is recalling Azelaic Acid Gel 15% (50-gram containers) nationwide. The affected lot is 19241453 with an expiration date of March 2026.
The recall was initiated due to Current Good Manufacturing Practice (CGMP) deviations identified during manufacturing. This is a voluntary, firm-initiated recall.
Azelaic Acid Gel is a prescription topical medication. Patients currently using this medication from the affected lot should consult their healthcare provider before taking any action. Healthcare providers should advise patients on appropriate next steps based on their individual medical needs.
The recalled product
- Product
- AZELAIC ACID (AZELAIC ACID)
- Brand
- AZELAIC ACID
- Manufacturer
- Glenmark Pharmaceuticals Inc., USA
- Category
- Drug — Topical
- Hazard
- Affected units
- 14,004
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 (2)
- Lot# 19241453
- Exp MARCH 2026
UPCs (1)
- 0368462626528
Distribution
Distributed nationwide across the United States.
Related recalls
Same brand · AZELAIC ACID
- ModerateAzelaic Acid Gel 15% Recalled Over Grainy, Gritty, or Sandy Texture
FDA (Drugs) · 2026-08-05
- ModerateAzelaic acid gel recalled after complaints of gritty texture in tubes
FDA (Drugs) · 2025-10-01
Same manufacturer · Glenmark Pharmaceuticals Inc., USA
See all →- ModerateAlyacen 7/7/7 birth control tablets failed total impurities specification
FDA (Drugs) · 2026-06-24
- ModerateOndansetron tablets recalled because blister packs are not fully sealed
FDA (Drugs) · 2026-01-07
- CriticalFrozen chopped methi recalled after testing positive for Salmonella
FDA (Drugs) · 2025-12-17
- ModerateBisoprolol and hydrochlorothiazide tablets recalled over traces of another drug
FDA (Drugs) · 2025-12-10
- ModerateOral contraceptive packs recalled after failing impurities and degradation specifications
FDA (Drugs) · 2025-10-22
Same hazard · manufacturing deviation
See all →- HighBaxter Recalls Vancomycin Injection Due to Manufacturing Deviations
FDA (Drugs) · 2026-09-09
- SevereBaxter Recalls Clindamycin Injection Due to Manufacturing Deviations
FDA (Drugs) · 2026-09-09
- ModerateSynjardy XR Tablets Recalled Due to Manufacturing Deviations
FDA (Drugs) · 2026-07-08
- ModerateDuloxetine delayed-release capsules recalled for N-nitroso impurity contamination
FDA (Drugs) · 2026-05-13
- ModerateFentanyl Citrate Injectable Solution Recalled for cGMP Deviations
FDA (Drugs) · 2026-05-06