CLASS II Drug recall · Reported 29 Sep 2021 · FDA Enforcement Report

Fulvestrant Injection 250 mg recalled by Glenmark Pharmaceuticals

Glenmark Pharmaceuticals Inc., USA is recalling Fulvestrant Injection 250 mg/ (50 mg/mL) For Intramuscular Use Only Contains-dose, distributed nationwide in the US. The recall was initiated on 27 Aug 2021 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesLots: 30200014 Exp. 04/30/2022; 30200015 Exp. 05/31/2022; 30200015 Exp. 05/31/2022; 30200016 Exp. 05/31/2022; 30200036 Exp. 09/30/2022; 30200038 Exp. 09/30/2022; 30200039 Exp. 09/30/2022; 30200040 Exp. 09/30/2022; 30210001 Exp. 12/31/2022; 30210002 Exp. 12/31/2022; 30210003 Exp. 01/31/2023; 30210004 Exp. 01/31/2023; 30210005 Exp. 01/31/2023; 30210006 Exp. 01/31/2023; 30210014 Exp. 02/28/2023; 30210022 Exp. 02/28/2023; 30210028 Exp. 02/28/2023; 30210029 Exp. 02/28/2023; 30210030 Exp. 02/28/2023; 30210031 Exp. 02/28/2023

NDC68462-317

Quantity recalled28658 cartons

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-0820-2021
FDA event ID: 88591
Recalling firm: Glenmark Pharmaceuticals Inc., USA, Mahwah, NJ
Brand: Fulvestrant
Manufacturer: GLENMARK PHARMACEUTICALS INC., USA
Classification: Class II
Status: Terminated
Recall initiated: 27 Aug 2021
FDA classified: 21 Sep 2021
Reported: 29 Sep 2021
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Sterility
Drug class: Injectable & IV Drugs

Timeline

27 Aug 2021	Recall initiated by company
21 Sep 2021	Classified by FDA	+25 days
29 Sep 2021	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

Lack of Assurance of Sterility

A sterility recall means a product that must be sterile, such as an injection or eye drop, may be contaminated. Using a non-sterile product can cause serious infection.

Product as listed by the FDA

Fulvestrant Injection 250 mg/5 mL (50 mg/mL) For Intramuscular Use Only Contains 2 single-dose pre-filled syringes Rx only NDC 68462-317-32

Where it was distributed

Nationwide.

Nationwide

Questions about this recall

Why was it recalled?

Lack of Assurance of Sterility

Which lots are affected?

Lots: 30200014 Exp. 04/30/2022; 30200015 Exp. 05/31/2022; 30200015 Exp. 05/31/2022; 30200016 Exp. 05/31/2022; 30200036 Exp. 09/30/2022; 30200038 Exp. 09/30/2022; 30200039 Exp. 09/30/2022; 30200040 Exp. 09/30/2022; 30210001 Exp. 12/31/2022; 30210002 Exp. 12/31/2022; 30210003 Exp. 01/31/2023; 30210004 Exp. 01/31/2023; 30210005 Exp. 01/31/2023; 30210006 Exp. 01/31/2023; 30210014 Exp. 02/28/2023; 30210022 Exp. 02/28/2023; 30210028 Exp. 02/28/2023; 30210029 Exp. 02/28/2023; 30210030 Exp. 02/28/2023; 30210031 Exp. 02/28/2023

Where was it sold?

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.

Other products in this recall event

7 other products · FDA event 88591

Reported	Class	Recall	Company	Reason	Where
29 Sep 2021	CLASS II	Zonisamide Capsules USP 50 mg recalled by Glenmark PharmaceuticalsZonisamide	Glenmark Pharmaceuticals Inc., USA	Manufacturing (CGMP) Deviations	Nationwide
29 Sep 2021	CLASS II	Chlorzoxazone Tablets USP 750 mg recalled by Glenmark Pharmaceuticals	Glenmark Pharmaceuticals Inc., USA	Manufacturing (CGMP) Deviations	Nationwide
29 Sep 2021	CLASS II	Naproxen Sodium Tablets, USP 550 mg recalled by Glenmark PharmaceuticalsNaproxen Sodium	Glenmark Pharmaceuticals Inc., USA	Manufacturing (CGMP) Deviations	Nationwide
29 Sep 2021	CLASS II	Naproxen Sodium Tablets, USP 275 mg recalled by Glenmark PharmaceuticalsNaproxen Sodium	Glenmark Pharmaceuticals Inc., USA	Manufacturing (CGMP) Deviations	Nationwide
29 Sep 2021	CLASS II	Zonisamide Capsules USP 100 mg recalled by Glenmark PharmaceuticalsZonisamide	Glenmark Pharmaceuticals Inc., USA	Manufacturing (CGMP) Deviations	Nationwide
29 Sep 2021	CLASS II	Chlorzoxazone Tablets USP 375 mg recalled by Glenmark Pharmaceuticals	Glenmark Pharmaceuticals Inc., USA	Manufacturing (CGMP) Deviations	Nationwide
29 Sep 2021	CLASS II	Arformoterol Tartrate Inhalation Solution 15 mcg*/ For Oral recalled	Glenmark Pharmaceuticals Inc., USA	Sterility	Nationwide

More recalls from Glenmark Pharmaceuticals Inc., USA

All 141

Reported	Class	Recall	Company	Reason	Where
5 Aug 2026Drug	CLASS II	Azelaic Acid Gel, 15% tubes, For Topical Use only recalledAzelaic Acid	Glenmark Pharmaceuticals Inc., USA	Manufacturing (CGMP) Deviations	Nationwide
24 Jun 2026Drug	CLASS II	Alyacen 7/7/7, Norethindrone recalled by Glenmark PharmaceuticalsAlyacen 1/35	Glenmark Pharmaceuticals Inc., USA	Potency & Assay	Nationwide
7 Jan 2026Drug	CLASS II	Ondansetron Orally Disintegrating Tablets, USP, 4mg recalledOndansetron	Glenmark Pharmaceuticals Inc., USA	Packaging Defects	Nationwide
17 Dec 2025Drug	CLASS III	Nebivolol Tablets, 20 mg recalled by Glenmark PharmaceuticalsNebivolol	Glenmark Pharmaceuticals Inc., USA	Other	Nationwide
10 Dec 2025Drug	CLASS III	Bisoprolol Fumarate and Hydrochlorothiazide Tablets recalled	Glenmark Pharmaceuticals Inc., USA	Packaging Defects	Nationwide

Other Fulvestrant recalls

All 2

Reported	Class	Recall	Company	Reason	Where
24 Aug 2022Drug	CLASS II	Fulvestrant Injection 250mg/ (50 mg/mL) recalledFulvestrant	Zydus Pharmaceuticals	Potency & Assay	Nationwide