Lower risk Drug recall · FDA · Published August 27, 2021

Glenmark Fulvestrant Injection Recall: Risk of Contaminated Medication

Glenmark Pharmaceuticals recalls Fulvestrant injection due to lack of sterility assurance. This medication may contain contaminants that could cause infection. Affected products have specific NDC numbers and expiration dates.

Plain-English summary generated from official FDA data by GovInfoNow · Published by Carlos Caban · How we make summaries

🇺🇸 FDA recall #D-0820-2021Drug Glenmark ›

Lower-risk recall

Lack of Assurance of Sterility

Take action

Contact the company

Recalling firmGlenmark Pharmaceuticals Inc., USA750 Corporate Dr · Mahwah, NJ 07430-2009

✎ GovInfoNow plain-language explainer

Glenmark Pharmaceuticals is recalling Fulvestrant injection 250 mg/5 mL (50 mg/mL) pre-filled syringes because they may not be sterile. This could lead to infections if used improperly. Patients with this medication should contact their doctor or pharmacy for guidance. Read more at govinfonow.com/recall/35872-glenmark-fulvestrant-injection-recall-risk-of-contaminated-medication.

Source Summary by GovInfoNow · govinfonow.com/recall/35872-glenmark-fulvestrant-injection-recall-risk-of-contaminated-medication · Updated August 18, 2026 · FDA enforcement record: FDA #D-0820-2021

Cite this page

“Glenmark Fulvestrant Injection Recall: Risk of Contaminated Medication.” GovInfoNow, updated August 18, 2026. https://govinfonow.com/recall/35872-glenmark-fulvestrant-injection-recall-risk-of-contaminated-medication. Based on FDA recall #D-0820-2021 (https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0820-2021%22&limit=1).

The FDA announced on 2021-08-27 that Glenmark Pharmaceuticals Inc., USA voluntarily recalled Fulvestrant Injection 250 mg/5 mL due to a lack of assurance of sterility. The recall affects 28,658 cartons distributed nationwide.

How to tell if you have it

Brand: Glenmark
Product: 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
Lots: 30200014 Exp. 04/30/2022; 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
Quantity: 28,658 cartons

The hazard

The recall was initiated due to a lack of assurance of sterility in the Fulvestrant Injection. The FDA classified this as a Class II recall.

Context

GovInfoNow's records show Glenmark Pharmaceuticals Inc., USA has had 54 other recalls on record since 2017-11-20. Recent Glenmark recalls include the 2026-07-23 Azelaic Acid Gel recall for grainy texture risk, the 2026-05-27 Alyacen Birth Control Tablets recall for impurities risk, and the 2025-12-30 Ondansetron Tablets recall for blister packs not fully sealed. Other recent recalls of similar products include the Reliance Pemetrexed Injection recall (2026-06-24), the Fresenius Kabi 5% Dextrose Injection recall (2026-03-11), and the Cipla Lanreotide Injection recall (2026-03-13).

How to tell if you have this one

Check for the NDC numbers 68462-317-32 and lots 30200014 through 30210031 on the product label. The expiration dates range from April 30, 2022, to February 28, 2023.

Brand
Glenmark
Category
Drug

FDA recall event · 8 products

All 8 products in this recall

FDA lists each product line separately under one recall event. Check your product description, lot or code numbers against each row. Every row shares the hazard and remedy on this page.

Classification
Class II
Status
Terminated
Distribution
Nationwide.

Recall number	Product, codes & lots	Quantity	NDC
D-0820-2021	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; 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	28658 cartons	68462-317-40, 68462-317-32
D-0821-2021	Naproxen Sodium Tablets, USP 275 mg 100 Tablets Rx Only NDC 68462-178-01 Manufactured by: Glenmark Pharmaceuticals Inc., USA 4147 Goldmine Road Monroe, NC 28110 Manufactured for: Glenmark Pharmaceuticals Inc., USA Mahwah, NJ 07430; Lots: 29190087 Exp. 10/31/2021; 29190088 Exp. 10/31/2021; 29190089 Exp. 10/31/2021; 29200077 Exp. 11/30/2022; 29200078 Exo, 11/30/2022	9552 bottles	68462-188-01, 68462-188-05, 68462-189-01, 68462-189-05, 68462-190-30, 68462-190-50, 68462-190-01, 68462-190-05, 68462-178-01, 68462-178-05, 68462-179-01, 68462-179-05
D-0822-2021	Naproxen Sodium Tablets, USP 550 mg Rx Only Manufactured by: Glenmark Pharmaceuticals Inc., USA 4147 Goldmine Road Monroe, NC 28110 Manufactured for: Glenmark Pharmaceuticals Inc., USA Mahwah, NJ 07430 a) 100 Tablets NDC 68462-179-01; b) 500 Tablets NDC 68462-179-05; Lots: a) 29190082 Exp. 09/30/2021; 29190083 Exp. 09/30/2021; 29190084 Exp. 10/31/2021; 29190085 Exp. 10/31/2021; 29200001 Exp. 12/31/2021; 29200003 Exp. 01/31/2022; 29200004 Exp. 01/31/2022; 29200005 Exp. 01/31/2022; 29200012 Exp. 02/28/2022; 29200013 Exp. 02/28/2022; b) 29200010 Exp. 02/28/2022	a) 31248 bottles; b) 300 bottles	68462-188-01, 68462-188-05, 68462-189-01, 68462-189-05, 68462-190-30, 68462-190-50, 68462-190-01, 68462-190-05, 68462-178-01, 68462-178-05, 68462-179-01, 68462-179-05
D-0823-2021	Chlorzoxazone Tablets USP 375 mg 100 Tablets Rx Only NDC 68462-724-01 Manufactured by: Glenmark Pharmaceuticals Inc., USA 4147 Goldmine Road Monroe, NC 28110 Manufactured for: Glenmark Pharmaceuticals Inc., USA Mahwah, NJ 07430; Lots: 29200022 Exp. 03/31/2022; 29200024 Exp. 03/31/2022; 29200035 Exp. 06/30/2022	1800 bottles	—
D-0824-2021	Chlorzoxazone Tablets USP 750 mg 100 Tablets Rx Only NDC 68462-725-01 Manufactured by: Glenmark Pharmaceuticals Inc., USA 4147 Goldmine Road Monroe, NC 28110 Manufactured for: Glenmark Pharmaceuticals Inc., USA Mahwah, NJ 07430; Lots: 29200023 Exp. 03/31/2022; 29200025 Exp. 03/31/2022; 29200036 Exp. 06/30/2022; 29200056 Exp. 09/30/2022; 29200070 Exp. 11/30/2022	4752 bottles	—
D-0825-2021	Zonisamide Capsules USP 50 mg 100 Capsules Rx Only NDC 68462-129-01 Manufactured by: Glenmark Pharmaceuticals Inc., USA Monroe, NC 28110 Manufactured for: Glenmark Pharmaceuticals Inc., USA Mahwah, NJ 07430; Lots: 29190043 Exp. 05/31/2022; 29190044 Exp. 05/31/2022; 29190045 Exp. 05/31/2022	15936 bottles	68462-128-01, 68462-128-05, 68462-129-01, 68462-129-05, 68462-130-01, 68462-130-05
D-0826-2021	Zonisamide Capsules USP 100 mg Rx Only Manufactured by: Glenmark Pharmaceuticals Inc., USA Monroe, NC 28110 Manufactured for: Glenmark Pharmaceuticals Inc., USA Mahwah, NJ 07430 a) 100 Capsules NDC 68462-130-01; b) 500 Capsules NDC 68462-130-05; Lots: a) 29200014 Exp. 02/28/2023; 29200015 Exp. 03/31/2023; 29200016 Exp. 03/31/2023; 29200030 Exp. 05/31/2023; 29200031 Exp. 05/31/2023; 29200032 Exp. 05/31/2023; 29200033 Exp. 06/30/2023; 29200037 Exp. 06/30/2023; 29200038 Exp. 06/30/2023; 29200039 Exp. 07/31/2023; 29200041 Exp. 07/31/2023; 29200042 Exp. 07/31/2023; 29200048 Exp. 08/31/2023; 29200049 Exp. 08/31/2023; 29200050 Exp. 08/31/2023; 29200072 Exp. 11/30/2023; 29200073 Exp. 11/30/2023; 29200074 Exp. 11/30/2023; 29200075 Exp. 11/30/2023; 29200076 Exp. 11/30/2023; b) 29200014 Exp. 02/28/2023; 29200015 Exp. 03/31/2023; 29200016 Exp. 03/31/2023	a) 216,454 bottles; b) 2166 bottles	68462-128-01, 68462-128-05, 68462-129-01, 68462-129-05, 68462-130-01, 68462-130-05
D-0827-2021	Arformoterol Tartrate Inhalation Solution 15 mcg*/2 mL For Oral Inhalation Only Rx Only Manufactured by: Glenmark Pharmaceuticals Inc., USA Monroe, NC 28110 Manufactured for: Glenmark Pharmaceuticals Inc., USA Mahwah, NJ 07430 a) 60x2 mL Sterile Unit-Dose Vials NDC 68462-833-65; b) 30x2 mL Sterile Unit-Dose Vials NDC 68462-833-35; Lots: a) 30210041 Exp. 03/31/2023; 30210045 Exp. 04/30/2023; 30210046 Exp. 04/30/2023; 30210050 Exp. 03/31/2023; 30210051 Exp. 04/30/2023; 30210058 Exp. 04/30/2023; b) 30210042 Exp. 03/31/2023; 30210047 Exp. 04/30/2023; 30210048 Exp. 04/30/2023; 30210052 Exp. 04/30/2023; 30210053 Exp. 04/30/2023; 30210054 Exp. 04/30/2023; 30210059 Exp. 04/30/2023; 30210060 Exp. 04/30/2023; 30210061 Exp. 04/30/2023; 30210062 Exp. 04/30/2023; 30210063 Exp. 04/30/2023; 30210064 Exp. 05/31/2023	a) 5362 inhalers; b) 5593 inhalers	—

Based on the official FDA remedy

What to do — step by step

Check Product Label
Look for the NDC number 68462-317-32 and expiration dates between April 30, 2022, and February 28, 2023.

Where it went and when

Where it was distributed

Distributed nationwide.

FDA distribution: “Nationwide.” States read from FDA’s own wording; “not listed” means the notice does not name it.

Distributed nationwide.

Recall timeline

FDA terminated this recall 2.1 years after the firm started it.

Aug 27, 2021Firm started the recall
Sep 21, 2021FDA classified it Class II
Sep 29, 2021Published in FDA’s Enforcement Report
Oct 4, 2023FDA terminated the recall

Dates from the agency record only; steps without a date are left out.

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Link to this recall

<a href="https://govinfonow.com/recall/35872-glenmark-fulvestrant-injection-recall-risk-of-contaminated-medication">Glenmark Fulvestrant Injection Recall: Risk of Contaminated Medication (GovInfoNow)</a>

Where this comes from

The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.

Official source: FDA Recall #D-0820-2021 (August 27, 2021) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for D-0820-2021 to see it in context.
Plain-language summary written by qwen3:4b on August 18, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.