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Unrated Drug recall · FDA · Published March 13, 2025

Glenmark Cetirizine Tablets Recall: CGMP Deviations Risk

Glenmark Pharmaceuticals recalls 10mg cetirizine tablets due to CGMP deviations. Affected lots sold via Amazon and Walmart. Consumers should contact pharmacy for replacement.

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

🇺🇸 FDA recall #D-0348-2025DrugGlenmark ›
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Recalling firmGlenmark Pharmaceuticals Inc., USA750 Corporate Dr · Mahwah, NJ 07430-2009
✎ GovInfoNow plain-language explainer

What happened, in plain English

Glenmark Pharmaceuticals is recalling 10mg cetirizine hydrochloride tablets that were manufactured with CGMP deviations. This means the product may not meet quality standards, though the recall does not specify a risk of serious injury or harm. Read more at govinfonow.com/recall/32181-glenmark-cetirizine-tablets-recall-cgmp-deviations-risk.

Source Summary by GovInfoNow · govinfonow.com/recall/32181-glenmark-cetirizine-tablets-recall-cgmp-deviations-risk · Updated August 17, 2026 · FDA enforcement record: FDA #D-0348-2025

Cite this page

“Glenmark Cetirizine Tablets Recall: CGMP Deviations Risk.” GovInfoNow, updated August 17, 2026. https://govinfonow.com/recall/32181-glenmark-cetirizine-tablets-recall-cgmp-deviations-risk. Based on FDA recall #D-0348-2025 (https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0348-2025%22&limit=1).

Why it’s dangerous

CGMP deviations refer to quality control issues during manufacturing that could affect the product's safety and effectiveness. However, the recall does not specify what the exact deviation is or how it might impact the product.

Who’s affected

People who have the 10mg cetirizine tablets with specific lot numbers sold through Amazon or Walmart are affected. Those who have the product and need it for prescription use are most at risk.

How to tell if you have this one

Check the product label for the lot number: 17231980 (Amazon), 17241436-17241893 (Amazon and Walmart). The product is a prescription-only 10mg cetirizine tablet pack sold through Amazon and Walmart.

  • Brand
    Glenmark
  • Category
    Drug
FDA recall event · 39 products

All 39 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
    Ongoing
  • Distribution
    U.S. Nationwide
Recall numberProduct, codes & lotsNDC
D-0314-2025Fenofibrate Capsules 67 mg, USP, 100-count bottle, Rx Only, Manufactured by: Glenmark Pharmaceuticals Limited, Pithampur, Madhya Pradesh 454775, India, Manufactured for: Glenmark Pharmaceuticals Inc. USA, Mahwah, NJ 07430. NDC# 68462-580-01; Lot # 17230834, exp. date Mar-25 17230835, exp. date Mar-2568462-580-01, 68462-581-01, 68462-582-01
D-0315-2025Propafenone Hydrochloride Extended-Release Capsules 225mg, 60-count bottle, Rx Only, Manufactured by: Glenmark Pharmaceuticals Limited, Pithampur, Madhya Pradesh 454775, India, Manufactured for: Glenmark Pharmaceuticals Inc. USA, Mahwah, NJ 07430.NDC# 68462-408-60; Lot # 17230819, exp. date Mar-2568462-408-60, 68462-409-60, 68462-410-60
D-0316-2025Propafenone Hydrochloride Extended-Release Capsules 325mg, 60-count bottle, Rx Only Manufactured by: Glenmark Pharmaceuticals Limited, Pithampur, Madhya Pradesh 454775, India, Manufactured for: Glenmark Pharmaceuticals Inc. USA, Mahwah, NJ 07430. NDC# 68462-409-60; Lot # 17230767, exp. date Mar-2568462-408-60, 68462-409-60, 68462-410-60
D-0317-2025Solifenacin Succinate Tablets 10MG, a. 30-count bottle (NDC# 68462-387-30), b. 90-Count Bottle (NDC 68462-387-90),Rx Only, Manufactured by: Glenmark Pharmaceuticals Limited, Pithampur, Madhya Pradesh 454775, India, Manufactured for: Glenmark Pharmaceuticals Inc. USA, Mahwah, NJ 07430.; Lot # 17230762, exp. date Mar-2568462-386-30, 68462-386-90, 68462-386-14, 68462-387-30, 68462-387-90, 68462-387-14
D-0318-2025Voriconazole Tablets 200 mg, 30-count bottle, Rx Only, Manufactured by: Glenmark Pharmaceuticals Limited, Pithampur, Madhya Pradesh 454775, India, Manufactured for: Glenmark Pharmaceuticals Inc. USA, Mahwah, NJ 07430. NDC# 68462-573-30; Lot # 17230853, exp. date Mar-25 17231271, exp. date May-25 17231300, exp. date May-25 17242050, exp. date Oct-26 17231046, exp. date Apr-25 17241156, exp. date Jun-26 17241388, exp. date Jul-26 17241800, exp. date Sep-2668462-572-30, 68462-572-90, 68462-572-13, 68462-573-30, 68462-573-90, 68462-573-13
D-0319-2025Voriconazole Tablets 50mg, 30-count bottle, Rx Only, Manufactured by: Glenmark Pharmaceuticals Limited, Pithampur, Madhya Pradesh 454775, India, Manufactured for: Glenmark Pharmaceuticals Inc. USA, Mahwah, NJ 07430. NDC# 68462-572-30.; Lot # 17231045, exp. date Apr-2568462-572-30, 68462-572-90, 68462-572-13, 68462-573-30, 68462-573-90, 68462-573-13
D-0320-2025Gabapentin Tablets 600mg, 500-count bottles, Rx Only, Manufactured by: Glenmark Pharmaceuticals Limited, Pithampur, Madhya Pradesh 454775, India, Manufactured for: Glenmark Pharmaceuticals Inc. USA, Mahwah, NJ 07430. NDC# 68462-126-05.; Lot # 17231015, exp. date Apr-25 17231128, exp. date Apr-25 17231138, exp. date Apr-25 17231139, exp. date Apr-25 17231143, exp. date Apr-25 17231144, exp. date Apr-25 17231848, exp. date Aug-25 17231898, exp. date Aug-25 17231977, exp. date Aug-25 17231978, exp. date Aug-25 17232015, exp. date Aug-25 17232016, exp. date Aug-25 17232017, exp. date Aug-25 17232034, exp. date Aug-25 17232041, exp. date Aug-25 17232396, exp. date Nov-25 17232406, exp. date Nov-25 17232410, exp. date Nov-25 17232490, exp. date Nov-25 17240326, exp. date Jan-26 17240327, exp. date Jan-26 17240383, exp. date Feb-26 17240395, exp. date Feb-26 17241863, exp. date Oct-26 17241869, exp. date Oct-26 17241870, exp. date Oct-26 17231256, exp. date May-25 17231386, exp. date May-25 17231387, exp. date May-25 17231407, exp. date May-25 17231417, exp. date May-25 17231418, exp. date May-25 17231754, exp. date Jul-25 17240085, exp. date Dec-25 17240117, exp. date Dec-25 17240131, exp. date Dec-2568462-126-01, 68462-126-05, 68462-127-01, 68462-127-05
D-0321-2025Lacosamide Tablets 200mg, 60-count bottle, Rx Only, Manufactured by: Glenmark Pharmaceuticals Limited, Pithampur, Madhya Pradesh 454775, India, Manufactured for: Glenmark Pharmaceuticals Inc. USA, Mahwah, NJ 07430. NDC# 68462-681-60.; Lot # 17230982, exp. date Apr-25 17230986, exp. date, Apr-25 17231001, exp. date, Apr-25 17240197, exp. date Jan-26 17240198, exp. date Jan-26 17240215, exp. date Jan-26 17240846, exp. date Apr-26 17240847, exp. date Apr-2668462-678-30, 68462-678-60, 68462-678-10, 68462-679-30, 68462-679-60, 68462-679-10, 68462-680-30, 68462-680-60, 68462-680-10, 68462-681-30, 68462-681-60, 68462-681-10
D-0322-2025Frovatriptan Succinate Tablets 2.5mg, 9-count bottle, Rx Only, Manufactured by: Glenmark Pharmaceuticals Limited, Pithampur, Madhya Pradesh 454775, India, Manufactured for: Glenmark Pharmaceuticals Inc. USA, Mahwah, NJ 07430. NDC# 68462-694-97; Lot # 17231352, exp. date Jun-25 17231649, exp. date Jul-2568462-694-97
D-0323-2025Rufinamide Tablets 200mg, 120-count bottle, Rx Only, Manufactured by: Glenmark Pharmaceuticals Limited, Pithampur, Madhya Pradesh 454775, India, Manufactured for: Glenmark Pharmaceuticals Inc. USA, Mahwah, NJ 07430. NDC# 68462-713-08; Lot # 17231643, exp. date Jul-25 17231644, exp. date Jul-2568462-713-30, 68462-713-08, 68462-713-05, 68462-714-08, 68462-714-05
D-0324-2025Nitroglycerin Sublingual Tablets 0.4MG 100-count carton, Rx Only, Manufactured by: Glenmark Pharmaceuticals Limited, Pithampur, Madhya Pradesh 454775, India, Manufactured for: Glenmark Pharmaceuticals Inc. USA, Mahwah, NJ 07430. NDC# 68462-639-45.; Lot # 17232024, exp. date Aug-25 17232071, exp. date Sep-25 17232072, exp. date Sep-2568462-638-01, 68462-639-01, 68462-639-25, 68462-639-45, 68462-640-01
D-0325-2025Pravastatin Sodium Tablets 80mg, 90-count bottle, Rx Only, Manufactured by: Glenmark Pharmaceuticals Limited, Pithampur, Madhya Pradesh 454775, India, Manufactured for: Glenmark Pharmaceuticals Inc. USA, Mahwah, NJ 07430. NDC# 68462-198-90.; Lot # 17221771, exp. date Aug-25 17230930, exp. date Apr-26 17230931, exp. date Apr-26 17231252, exp. date May-26 17231274, exp. date May-26 17231855, exp. date Aug-26 17231916, exp. date Aug-26 17231917, exp. date Aug-26 17231945, exp. date Aug-2668462-195-90, 68462-195-05, 68462-196-90, 68462-196-05, 68462-197-90, 68462-197-05, 68462-198-90, 68462-198-05
D-0326-2025Fluphenazine Hydrochloride Tablets, 10mg, 100-Count Bottle, Rx Only, Manufactured by: Glenmark Pharmaceuticals Limited, Pithampur, Madhya Pradesh 454775, India, Manufactured for: Glenmark Pharmaceuticals Inc. USA, Mahwah, NJ 07430. NDC# 68462-338-01; Lot # 17232206, exp. date Sep-2568462-914-01, 68462-914-05, 68462-914-14, 68462-336-01, 68462-336-05, 68462-336-14, 68462-337-01, 68462-337-05, 68462-337-14, 68462-338-01, 68462-338-05, 68462-338-14
D-0327-2025Fluphenazine Hydrochloride Tablets 2.5mg, 100-count bottle, Rx Only, Manufactured by: Glenmark Pharmaceuticals Limited, Pithampur, Madhya Pradesh 454775, India, Manufactured for: Glenmark Pharmaceuticals Inc. USA, Mahwah, NJ 07430. NDC# 68462-336-01; Lot # 17232214, exp. date Sep-2568462-914-01, 68462-914-05, 68462-914-14, 68462-336-01, 68462-336-05, 68462-336-14, 68462-337-01, 68462-337-05, 68462-337-14, 68462-338-01, 68462-338-05, 68462-338-14
D-0328-2025Metformin Hydrochloride Extended-Release Tablets 1000mg, 90-count bottle. Manufactured by: Glenmark Pharmaceuticals Limited, Pithampur, Madhya Pradesh 454775, India, Manufactured for: Glenmark Pharmaceuticals Inc. USA, Mahwah, NJ 07430. NDC 68462-521-90.; Lot # 17232088, exp. date Sep-25 17232093, exp. date Sep-2568462-520-01, 68462-520-05, 68462-520-10, 68462-521-90, 68462-521-01, 68462-521-05
D-0329-2025Indomethacin Extended-Release Capsules, 75mg, 60-count bottles, Manufactured by: Glenmark Pharmaceuticals Limited, Pithampur, Madhya Pradesh 454775, India, Manufactured for: Glenmark Pharmaceuticals Inc. USA, Mahwah, NJ 07430. NDC# 68462-325-60; Lot # 17232323, exp. date Oct-25 17232335, exp. date Oct-25 17232323, exp. date Oct-2568462-325-60, 68462-325-90, 68462-325-01, 68462-325-05, 68462-325-10
D-0330-2025Lacosamide Tablets, 100mg , 60-count bottle, Rx Only, Manufactured by: Glenmark Pharmaceuticals Limited, Pithampur, Madhya Pradesh 454775, India, Manufactured for: Glenmark Pharmaceuticals Inc. USA, Mahwah, NJ 07430. NDC# 68462-679-60; Lot # 17232533, exp. date Nov-25 17232534, exp. date Nov-25 17240606, exp. date Mar-26 17240619, exp. date Mar-26 17240911, exp. date May-26 17240912, exp. date May-26 17241121, exp. date Jun-26 17241124, exp. date Jun-2668462-678-30, 68462-678-60, 68462-678-10, 68462-679-30, 68462-679-60, 68462-679-10, 68462-680-30, 68462-680-60, 68462-680-10, 68462-681-30, 68462-681-60, 68462-681-10
D-0331-2025Nitroglycerin Sublingual Tablets 0.3MG, 100-count bottles, Manufactured by: Glenmark Pharmaceuticals Limited, Pithampur, Madhya Pradesh 454775, India, Manufactured for: Glenmark Pharmaceuticals Inc. USA, Mahwah, NJ 07430.NDC# 68462-638-01; Lot # 17232361, exp. date Nov-25 17232367, exp. date Nov-25 17240037, exp. date Dec-25 17240038, exp. date Dec-2568462-638-01, 68462-639-01, 68462-639-25, 68462-639-45, 68462-640-01
D-0332-2025Saxagliptin Tablets 5mg, a). 30-count bottle (NDC# 68462-727-30) b.) 90-count bottle ( 68462-727-90), Rx Only, Manufactured by: Glenmark Pharmaceuticals Limited, Pithampur, Madhya Pradesh 454775, India, Manufactured for: Glenmark Pharmaceuticals Inc. USA, Mahwah, NJ 07430.; Lot # 17232460, exp. date Nov-25 17232460, exp. date Nov-25 17241194, exp. date Jun-26 17241194, exp. date Jun-2668462-726-30, 68462-726-90, 68462-726-05, 68462-727-30, 68462-727-90, 68462-727-05, 68462-727-14
D-0333-2025Solifenacin Succinate Tablets 5mg, a.) 30-count bottle (NDC# 68462-386-30) b.) 90-count bottle (NDC# 68462-386-90), Rx Only. Manufactured by: Glenmark Pharmaceuticals Limited, Pithampur, Madhya Pradesh 454775, India, Manufactured for: Glenmark Pharmaceuticals Inc. USA, Mahwah, NJ 07430.; 30 count bottle: 17232395, exp. date Nov-25 17232400, exp. date Nov-25 90-count bottle: 17232395, exp. date Nov-2568462-386-30, 68462-386-90, 68462-386-14, 68462-387-30, 68462-387-90, 68462-387-14
D-0334-2025Teriflunomide Tablets, 14mg, 30-count bottle, Rx Only, Manufactured by: Glenmark Pharmaceuticals Limited, Pithampur, Madhya Pradesh 454775, India, Manufactured for: Glenmark Pharmaceuticals Inc. USA, Mahwah, NJ 07430. NDC# 68462-424-30; Lot # 17232462, exp. date Nov-2568462-423-15, 68462-423-85, 68462-423-30, 68462-424-15, 68462-424-85, 68462-424-30
D-0335-2025Ranolazine Extended-Release Tablets 1000mg, 60-count bottle, Rx Only, Manufactured by: Glenmark Pharmaceuticals Limited, Pithampur, Madhya Pradesh 454775, India, Manufactured for: Glenmark Pharmaceuticals Inc. USA, Mahwah, NJ 07430. NDC# 68462-320-60; Lot # 17240040, exp. date Dec-2568462-319-60, 68462-319-05, 68462-320-60, 68462-320-05
D-0336-2025Carvedilol Tablets, USP 12.5 mg, 500-count bottle, Rx Only, Manufactured by: Glenmark Pharmaceuticals Limited, Pithampur, Madhya Pradesh 454775, India, Manufactured for: Glenmark Pharmaceuticals Inc. USA, Mahwah, NJ 07430 NDC# 68462-164-05.; Lot # 17240238, exp. date Jan-26 17240243, exp. date Jan-26 17240245, exp. date Jan-26 17240248, exp. date Jan-2668462-162-60, 68462-162-01, 68462-162-18, 68462-162-05, 68462-162-10, 68462-163-60, 68462-163-01, 68462-163-18, 68462-163-05, 68462-163-10, 68462-164-60, 68462-164-01, 68462-164-18, 68462-164-05, 68462-164-10, 68462-165-60, 68462-165-01, 68462-165-18, 68462-165-05, 68462-165-10
D-0337-2025Lacosamide Tablets, 50mg, 60-count bottles, Rx Only, Manufactured by: Glenmark Pharmaceuticals Limited, Pithampur, Madhya Pradesh 454775, India, Manufactured for: Glenmark Pharmaceuticals Inc. USA, Mahwah, NJ 07430.NDC# 68462-678-60; Lot # 17240221, exp. date Jan-26 17240222, exp. date Jan-2668462-678-30, 68462-678-60, 68462-678-10, 68462-679-30, 68462-679-60, 68462-679-10, 68462-680-30, 68462-680-60, 68462-680-10, 68462-681-30, 68462-681-60, 68462-681-10
D-0338-2025Prochlorperazine Maleate Tablets, 10mg, 100-count bottles, Rx Only, Manufactured by: Glenmark Pharmaceuticals Limited, Pithampur, Madhya Pradesh 454775, India, Manufactured for: Glenmark Pharmaceuticals Inc. USA, Mahwah, NJ 07430. NDC# 68462-890-01; Lot # 17240254, exp. date Jan-26 17240257, exp. date Jan-26—
D-0339-2025Rosuvastatin Tablets 40mg, 30-count bottle, Rx Only, Manufactured by: Glenmark Pharmaceuticals Limited, Pithampur, Madhya Pradesh 454775, India, Manufactured for: Glenmark Pharmaceuticals Inc. USA, Mahwah, NJ 07430. NDC# 68462-264-30; Lot # 17240389, exp. date Feb-26 17240390, exp. date Feb-26 17240426, exp. date Feb-26 17240427, exp. date Feb-26 17240428, exp. date Feb-26 17240778, exp. date Apr-26 17241055, exp. date May-26 17241074, exp. date Jun-26 17241075, exp. date Jun-26 17241091, exp. date Jun-26 17241100, exp. date Jun-2668462-261-30, 68462-261-50, 68462-261-90, 68462-261-01, 68462-261-10, 68462-261-11, 68462-262-30, 68462-262-50, 68462-262-90, 68462-262-01, 68462-262-10, 68462-262-11, 68462-263-30, 68462-263-50, 68462-263-90, 68462-263-01, 68462-263-10, 68462-263-11, 68462-264-30, 68462-264-50, 68462-264-90, 68462-264-01, 68462-264-05, 68462-264-10
D-0340-2025Colesvelam Hydrocholoride Tablets 625mg, 180-count bottle, Rx Only, Manufactured by: Glenmark Pharmaceuticals Limited, Pithampur, Madhya Pradesh 454775, India, Manufactured for: Glenmark Pharmaceuticals Inc. USA, Mahwah, NJ 07430. NDC# 68462-433-18; Lot # 17240669, exp. date Mar-26 17240876, exp. date Apr-26 17240883, exp. date May-26 17240909, exp. date May-26 17240914, exp. date May-26 17240927, exp. date May-2668462-433-90, 68462-433-18
D-0341-2025Pravastatin Sodium Tablets, 20mg, a).500-count bottle (NDC# 68462-196-05), b). 90-count bottle (NDC# 68462-196-90), Rx only, Manufactured by: Glenmark Pharmaceuticals Limited, Pithampur, Madhya Pradesh 454775, India, Manufactured for: Glenmark Pharmaceuticals Inc. USA, Mahwah, NJ 07430.; Lot # 17230810, exp. date Mar-26 17230811, exp. date Mar-26 17230810, exp. date Mar-26 17232501, exp. date Nov-26 17232502, exp. date Nov-2668462-195-90, 68462-195-05, 68462-196-90, 68462-196-05, 68462-197-90, 68462-197-05, 68462-198-90, 68462-198-05
D-0342-2025Diltiazem Hydrochloride Extended-Release Capsules 12HR 120mg, 100-count bottle, Rx, Only. Manufactured by: Glenmark Pharmaceuticals Limited, Pithampur, Madhya Pradesh 454775, India, Manufactured for: Glenmark Pharmaceuticals Inc. USA, Mahwah, NJ 07430. NDC# 68462-562-01; Lot # 17241067, exp. date May-26 17241628, exp. date Aug-2668462-850-01, 68462-851-01, 68462-562-01
D-0343-2025Lacosamide Tablets 150mg, 60-count bottle, Rx Only, Manufactured by: Glenmark Pharmaceuticals Limited, Pithampur, Madhya Pradesh 454775, India, Manufactured for: Glenmark Pharmaceuticals Inc. USA, Mahwah, NJ 07430.NDC# 68462-680-60.; Lot # 17241125, exp. date Jun-26 17242202, exp. date Nov-26 17242204, exp. date Dec-2668462-678-30, 68462-678-60, 68462-678-10, 68462-679-30, 68462-679-60, 68462-679-10, 68462-680-30, 68462-680-60, 68462-680-10, 68462-681-30, 68462-681-60, 68462-681-10
D-0344-2025Clindamycin Hydrochloride Capsules, USP, 300mg, 100-count bottles, Manufactured by: Glenmark Pharmaceuticals Limited, Pithampur, Madhya Pradesh 454775, India, Manufactured for: Glenmark Pharmaceuticals Inc. USA, Mahwah, NJ 07430.NDC# 68462-144-01; Lot # 17241278, exp. date Jul-26 17241297, exp. date Jul-26 17241304, exp. date Jul-26 17241315, exp. date Jul-26 17241327, exp. date Jul-2668462-142-01, 68462-143-01, 68462-143-05, 68462-144-01, 68462-144-81
D-0345-2025Saxagliptin Tablets, USP, 2.5mg, a). 30-count bottle (NDC# 68462-726-30), b).90-count bottle(NDC# 68462-726-90), Manufactured by: Glenmark Pharmaceuticals Limited, Pithampur, Madhya Pradesh 454775, India, Manufactured for: Glenmark Pharmaceuticals Inc. USA, Mahwah, NJ 07430.; 30-Count Bottle Lots: 17241788, exp. date Sep-26 17241821, exp. date Sep-26 17241822, exp. date Sep-26 90-Count Bottle Lot: 17241822, exp. date Sept 2668462-726-30, 68462-726-90, 68462-726-05, 68462-727-30, 68462-727-90, 68462-727-05, 68462-727-14
D-0346-2025Naproxen Sodium Tablets, USP, 550mg, 100-count bottles, Rx Only, Manufactured by: Glenmark Pharmaceuticals Limited, Pithampur, Madhya Pradesh 454775, India, Manufactured for: Glenmark Pharmaceuticals Inc. USA, Mahwah, NJ 07430. NDC# 68462-179-01; Lot # 17231956, exp. date Aug-2568462-188-01, 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-0347-2025Acetaminophen and Ibuprofen (NSAID) Tablets, 250 mg/125 mg a). 144-count packets (NDC# 72657-157-74), b). 216-count packets( 72657-157-76),Distributed by: Glenmark Therapeutics Inc., USA, Mahwah, NJ 07430, Product of India; Lot # 17241302, exp. date Jul-26 Amazon & Walmart 17241140, exp. date Jul-26 Amazon & Walmart 17241141, exp. date Jul-26 Amazon & Walmart72657-157-18, 72657-157-36, 72657-157-72, 72657-157-74, 72657-157-76, 72657-157-20, 72657-157-05
D-0348-2025Cetirizine Hydrochloride Tablets, USP, 10mg, 365-count packs, Rx Only, Manufactured for: Glenmark Therapeutics Inc., Distributed by: Amazon. NDC# 72657-129-35; Lot # 17231980, ep.. date Aug-25 Amazon 17232044, ep.. date Aug-25 Walmart 17241436, ep.. date Jul-26 Amazon 17241437, ep.. date Jul-26 Amazon 17241455, ep.. date Jul-26 Amazon 17241456, ep.. date Aug-26 Amazon 17241457, ep.. date Aug-26 Amazon 17241892, ep.. date Oct-26 Amazon 17241893, ep.. date Oct-26 Amazon72657-128-30, 72657-128-45, 72657-128-60, 72657-128-70, 72657-128-90, 72657-128-08, 72657-128-14, 72657-128-15, 72657-128-18, 72657-128-24, 72657-128-03, 72657-128-35, 72657-128-04, 72657-128-81, 72657-128-82, 72657-128-84, 72657-128-86, 72657-128-41, 72657-129-30, 72657-129-45, 72657-129-60, 72657-129-70, 72657-129-90, 72657-129-08, 72657-129-14, 72657-129-15, 72657-129-18, 72657-129-24, 72657-129-03, 72657-129-35, 72657-129-04, 72657-129-81, 72657-129-82, 72657-129-84, 72657-129-86, 72657-129-41, 72657-130-05, 72657-131-89
D-0349-2025Pravastatin Sodium Tablets, USP, 20mg, a).90-count bottle, Rx Only, Mfd for: Northstar Rx LLC, Memphis, TN 38141, Mfd by: Glenmark Pharmaceuticals Limited, Pithampur, Madhya Pradesh 454775, India. NDC# 16714-559-01; Lot # 17230810, exp. date Mar-2616714-558-01, 16714-558-02, 16714-559-01, 16714-559-02, 16714-560-01, 16714-560-02, 16714-570-01, 16714-570-02
D-0350-2025Pravastatin Sodium Tablets, USP, 80mg, a).90-count bottle (16714-570-01), b). 500-count bottle (NDC 16714-570-02), Rx Only, Mfd for: Northstar Rx LLC, Memphis, TN 38141, Mfd by: Glenmark Pharmaceuticals Limited, Pithampur, Madhya Pradesh 454775, India; Lot # 17221770, exp. date Aug-25 17221774, exp. date Aug-25 17231251, exp. date May-26 17231262, exp. date May-26 17232112, exp. date Sep-26 17232133, exp. date Sep-2616714-558-01, 16714-558-02, 16714-559-01, 16714-559-02, 16714-560-01, 16714-560-02, 16714-570-01, 16714-570-02
D-0351-2025Propafenone Hydrochloride Extended-Release Capsules USP, 225mg 60-count bottles, Rx Only, Mfd by: Glenmark Pharmaceuticals Limited, Pithampur, Madhya Pradesh 454775, India. NDC# 16714-825-01.; Lot # 17230819, exp. date Mar-2516714-825-01, 16714-826-01, 16714-827-01
D-0352-2025Propafenone Hydrochloride Extended-Release Capsules, USP 325mg,60-count bottles, Rx Only, Mfd for: Northstar Rx LLC, Memphis, TN 38141, Mfd by: Glenmark Pharmaceuticals Limited, Pithampur, Madhya Pradesh 454775, India. NDC# 16714-826-01; Lot # 17230767, exp. date Mar-2516714-825-01, 16714-826-01, 16714-827-01
Based on the official FDA remedy

What to do — step by step

  1. Contact Pharmacy

    Since the recall does not specify a remedy, contact your pharmacy for guidance on replacement or alternatives.

Where it went and when

Where it was distributed

Distributed nationwide.

Alaska: yesAKMaine: yesMEVermont: yesVTNew Hampshire: yesNHWashington: yesWAIdaho: yesIDMontana: yesMTNorth Dakota: yesNDMinnesota: yesMNIllinois: yesILWisconsin: yesWIMichigan: yesMINew York: yesNYRhode Island: yesRIMassachusetts: yesMAOregon: yesORNevada: yesNVWyoming: yesWYSouth Dakota: yesSDIowa: yesIAIndiana: yesINOhio: yesOHPennsylvania: yesPANew Jersey: yesNJConnecticut: yesCTCalifornia: yesCAUtah: yesUTColorado: yesCONebraska: yesNEMissouri: yesMOKentucky: yesKYWest Virginia: yesWVVirginia: yesVAMaryland: yesMDDelaware: yesDEArizona: yesAZNew Mexico: yesNMKansas: yesKSArkansas: yesARTennessee: yesTNNorth Carolina: yesNCSouth Carolina: yesSCDistrict of Columbia: yesDCOklahoma: yesOKLouisiana: yesLAMississippi: yesMSAlabama: yesALGeorgia: yesGAHawaii: yesHITexas: yesTXFlorida: yesFL

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

Distributed nationwide.

Recall timeline

FDA published this recall 34 days after the firm started it.

1. Firm started the recall: Mar 13, 202512. FDA classified it Class II: Apr 8, 202523. Published in FDA’s Enforcement Report: Apr 16, 202532025
  1. Firm started the recall
  2. FDA classified it Class II
  3. Published in FDA’s Enforcement Report

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

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May 27, 2026Glenmark Pharmaceuticals Inc., USA recalls Ondansetron Orally Disintegrating Tablets, USP, 4mg, 30 Tablets (3 blistercards each containing 10 tablets), Rx only,
December 30, 2025Glenmark Pharmaceuticals Inc., USA recalls Bisoprolol Fumarate and Hydrochlorothiazide Tablets, USP, 2.5 mg/6.25 mg, packaged as (a) 30-count bottles,
November 21, 2025Glenmark Pharmaceuticals Inc., USA recalls Nebivolol Tablets, 20 mg, 90 Tablets, Rx Only, Manufactured by: Glenmark Pharmaceuticals Limited, Pithampur, Madhya
November 18, 2025

Latest drug recalls

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Keep exploring

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-0348-2025 (March 13, 2025) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for D-0348-2025 to see it in context.
  • Plain-language summary written by qwen3:4b on August 17, 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.
GovInfoNow is an independent guide. We are not FDA or any government agency. Always confirm details with the official recall.Data: CPSC · FDA · NHTSA · USDA