CLASS II Drug recall · Reported 19 Jun 2019 · FDA Enforcement Report
Estradiol Vaginal Inserts USP 10 mcg recalled
Glenmark Pharmaceuticals Inc., USA is recalling Estradiol Vaginal Inserts USP 10 mcg, distributed nationwide in the US. The recall was initiated on 3 Jun 2019 and the FDA has classified it as Class II.
Check your package
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
Recall details
- Recall number
- D-1340-2019
- FDA event ID
- 83019
- Recalling firm
- Glenmark Pharmaceuticals Inc., USA, Mahwah, NJ
- Manufacturer
- Glenmark Pharmaceuticals Inc., USA
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 3 Jun 2019
- FDA classified
- 11 Jun 2019
- Reported
- 19 Jun 2019
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Packaging Defects
- Drug class
- Hormones & Birth Control
Timeline
| 3 Jun 2019 | Recall initiated by company | |
| 11 Jun 2019 | Classified by FDA | +8 days |
| 19 Jun 2019 | Published in enforcement report | +8 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Defective Delivery System: Estradiol Vaginal Inserts USP plunger is not functioning properly.
Packaging recalls include wrong labels, wrong products in the wrong bottle, missing leaflets, short-filled or empty capsules and seals that fail.
Product as listed by the FDA
Estradiol Vaginal Inserts USP 10 mcg, packaged in box of 8 Vaginal Inserts (with disposable applicators), Rx Only, Manufactured by: Glenmark Pharmaceuticals Ltd. Colvale-Bardez, Goa 403 513 India, Manufactured for: Glenmark Pharmaceuticals Inc., Mahwah, NJ 07430 USA, NDC 68462-711-71
Where it was distributed
U.S.A. Nationwide
Questions about this recall
Why was it recalled?
Defective Delivery System: Estradiol Vaginal Inserts USP plunger is not functioning properly.
Which lots are affected?
Lot#: 20180516, Exp 4/30/2020
Where was it sold?
U.S.A. Nationwide
What should I do if I have it?
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
More recalls from Glenmark Pharmaceuticals Inc., USA
All 141| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Azelaic Acid Gel, 15% tubes, For Topical Use only recalledAzelaic Acid | Glenmark Pharmaceuticals Inc., USA | Manufacturing (CGMP) Deviations | Nationwide |
| Drug | CLASS II | Alyacen 7/7/7, Norethindrone recalled by Glenmark PharmaceuticalsAlyacen 1/35 | Glenmark Pharmaceuticals Inc., USA | Potency & Assay | Nationwide |
| Drug | CLASS II | Ondansetron Orally Disintegrating Tablets, USP, 4mg recalledOndansetron | Glenmark Pharmaceuticals Inc., USA | Packaging Defects | Nationwide |
| Drug | CLASS III | Nebivolol Tablets, 20 mg recalled by Glenmark PharmaceuticalsNebivolol | Glenmark Pharmaceuticals Inc., USA | Other | Nationwide |
| Drug | CLASS III | Bisoprolol Fumarate and Hydrochlorothiazide Tablets recalled | Glenmark Pharmaceuticals Inc., USA | Packaging Defects | Nationwide |
Other Estradiol recalls
All 71| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Estradiol Gel, 0.1%, 0.25 mg per packet, 30 packets recalledEstradiol | ANI Pharmaceuticals | Other | Nationwide |
| Drug | CLASS II | Estradiol, 6 mg, 1 Sterile Pellet recalled by F.H. INVESTMENTS, Inc. ( | F.H. Investments Inc. ( | Particulate Matter | Nationwide |
| Drug | CLASS II | Estradiol, 22 mg, 1 Sterile Pellet recalled by F.H. INVESTMENTS, Inc. ( | F.H. Investments Inc. ( | Particulate Matter | Nationwide |
| Drug | CLASS II | Estradiol, 18 mg, 1 Sterile Pellet recalled by F.H. INVESTMENTS, Inc. ( | F.H. Investments Inc. ( | Particulate Matter | Nationwide |
| Drug | CLASS II | Estradiol,15 mg, 1 Sterile Pellet recalled by F.H. INVESTMENTS, Inc. ( | F.H. Investments Inc. ( | Particulate Matter | Nationwide |