CLASS II Drug recall · Reported 16 Jan 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 26 Dec 2018 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-0350-2019
- FDA event ID
- 81876
- Recalling firm
- Glenmark Pharmaceuticals Inc., USA, Mahwah, NJ
- Manufacturer
- Glenmark Pharmaceuticals Inc., USA
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 26 Dec 2018
- FDA classified
- 8 Jan 2019
- Reported
- 16 Jan 2019
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Packaging Defects
- Drug class
- Hormones & Birth Control
Timeline
| 26 Dec 2018 | Recall initiated by company | |
| 8 Jan 2019 | Classified by FDA | +13 days |
| 16 Jan 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: Customer complaints of malfunctioning plunger of the applicator
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, Rx only, packaged in a) 8 count (NDC 68462-711-71) and b) 18 count (NDC 68462-711-88) cartons, Manufactured by: Glenmark Pharmaceuticals, Ltd., Colvale, Goa India, Manufactured for: Glenmark Pharmaceuticals, Inc., USA Mahwah, NJ
Where it was distributed
Product was distributed to 5 retailers and 4 distributors throughout the United States who may have further distributed the recalled product.
Questions about this recall
Why was it recalled?
Defective Delivery System: Customer complaints of malfunctioning plunger of the applicator
Which lots are affected?
Batch numbers: a) 20180393, exp. date 01/31/2020, 20180424, exp. date 02/29/2020, 20180425, exp. date 02/29/2020, 20180427, exp. date 02/29/2020; b) 20180338, exp. date 12/31/2019, 20180386, exp. date 01/31/2020
Where was it sold?
Product was distributed to 5 retailers and 4 distributors throughout the United States who may have further distributed the recalled product.
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 recalledBisoprolol Fumarate And Hydrochlorothiazide | 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 |