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Recall data is sourced from official U.S. government agencies (CPSC, FDA, NHTSA, USDA) and processed using AI to improve readability. This site is not affiliated with or endorsed by any government agency. Always refer to the original agency notice for authoritative information.

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Medium RiskFDA Drug
Medications & Supplements/Prescription Drugs

Glenmark and Northstar Medications Recalled for Manufacturing Deviations

Agency Publication Date: April 8, 2025
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Summary

Glenmark Pharmaceuticals Inc., USA has recalled 39 different prescription and over-the-counter medications due to manufacturing deviations, specifically Current Good Manufacturing Practice (CGMP) deviations. The recall includes various drugs such as Gabapentin (anti-seizure), Metformin (diabetes), Nitroglycerin (heart/chest pain), and Acetaminophen with Ibuprofen (pain relief). These products were manufactured by Glenmark Pharmaceuticals Limited in India and distributed across the United States.

Risk

Manufacturing deviations indicate that these medications may not have been produced according to required quality and safety standards. This could potentially affect the purity, strength, or effectiveness of the drugs. No injuries or specific health incidents have been reported in the provided documentation.

What You Should Do

  1. This recall affects 39 different medications including Gabapentin, Metformin, Solifenacin, Voriconazole, Nitroglycerin, and others sold under the Glenmark, Northstar Rx LLC, Amazon, and Walmart brands.
  2. Identify if your medication is affected by checking the brand, generic name, strength, and package size on the label. Compare these against the National Drug Code (NDC) numbers and package descriptions.
  3. Check the lot number and expiration date printed on your medication bottle or blister packet. Because of the high volume of affected batches, please see the Affected Products section below for the full list of affected codes.
  4. If you have health concerns, contact your healthcare provider or pharmacist. Return any unused product to the place of purchase for a refund, throw it away, or contact the manufacturer for further instructions.
  5. Call the FDA Consumer Complaint hotline at 1-888-723-3332 (1-888-SAFEFDA) or visit www.fda.gov/safety/recalls for additional information regarding this agency-monitored recall.

Your Remedy Options

You have 2 options:

๐Ÿ’ฐOption 1: Full Refund
How to: Contact your healthcare provider or pharmacist for guidance, or return any unused product to the place of purchase for a refund
๐Ÿ—‘๏ธOption 2: Dispose of Product
How to: Throw the product away. For prescription medications, a DEA take-back location or pharmacy mail-back program is preferred when available.

Affected Products

Product: Fenofibrate Capsules (100-count bottle)
Variants: 67 mg, USP
Lot Numbers:
17230834 (Exp Mar-25)
17230835 (Exp Mar-25)
NDC:
68462-580-01

Rx Only. Manufactured for Glenmark Pharmaceuticals Inc. USA.

Product: Propafenone Hydrochloride Extended-Release Capsules (60-count bottle)
Variants: 225mg
Lot Numbers:
17230819 (Exp Mar-25)
NDC:
68462-408-60

Rx Only. Manufactured for Glenmark Pharmaceuticals Inc. USA.

Product: Propafenone Hydrochloride Extended-Release Capsules (60-count bottle)
Variants: 325mg
Lot Numbers:
17230767 (Exp Mar-25)
NDC:
68462-409-60

Rx Only. Manufactured for Glenmark Pharmaceuticals Inc. USA.

Product: Solifenacin Succinate Tablets (30-count and 90-count bottles)
Variants: 10MG
Lot Numbers:
17230762 (Exp Mar-25)
NDC:
68462-387-30
68462-387-90

Rx Only. Manufactured for Glenmark Pharmaceuticals Inc. USA.

Product: Voriconazole Tablets (30-count bottle)
Variants: 200 mg
Lot Numbers:
17230853 (Exp Mar-25)
17231271 (Exp May-25)
17231300 (Exp May-25)
17242050 (Exp Oct-26)
17231046 (Exp Apr-25)
17241156 (Exp Jun-26)
17241388 (Exp Jul-26)
17241800 (Exp Sep-26)
NDC:
68462-573-30

Rx Only. Manufactured for Glenmark Pharmaceuticals Inc. USA.

Product: Voriconazole Tablets (30-count bottle)
Variants: 50mg
Lot Numbers:
17231045 (Exp Apr-25)
NDC:
68462-572-30

Rx Only. Manufactured for Glenmark Pharmaceuticals Inc. USA.

Product: Gabapentin Tablets (500-count bottles)
Variants: 600mg
Lot Numbers:
17231015 (Exp Apr-25)
17231128 (Exp Apr-25)
17231138 (Exp Apr-25)
17231139 (Exp Apr-25)
17231143 (Exp Apr-25)
17231144 (Exp Apr-25)
17231848 (Exp Aug-25)
17231898 (Exp Aug-25)
17231977 (Exp Aug-25)
17231978 (Exp Aug-25)
17232015 (Exp Aug-25)
17232016 (Exp Aug-25)
17232017 (Exp Aug-25)
17232034 (Exp Aug-25)
17232041 (Exp Aug-25)
17232396 (Exp Nov-25)
17232406 (Exp Nov-25)
17232410 (Exp Nov-25)
17232490 (Exp Nov-25)
17240326 (Exp Jan-26)
17240327 (Exp Jan-26)
17240383 (Exp Feb-26)
17240395 (Exp Feb-26)
17241863 (Exp Oct-26)
17241869 (Exp Oct-26)
17241870 (Exp Oct-26)
17231256 (Exp May-25)
17231386 (Exp May-25)
17231387 (Exp May-25)
17231407 (Exp May-25)
17231417 (Exp May-25)
17231418 (Exp May-25)
17231754 (Exp Jul-25)
17240085 (Exp Dec-25)
17240117 (Exp Dec-25)
17240131 (Exp Dec-25)
NDC:
68462-126-05

Rx Only. Manufactured for Glenmark Pharmaceuticals Inc. USA.

Product: Lacosamide Tablets (60-count bottle)
Variants: 200mg
Lot Numbers:
17230982 (Exp Apr-25)
17230986 (Exp Apr-25)
17231001 (Exp Apr-25)
17240197 (Exp Jan-26)
17240198 (Exp Jan-26)
17240215 (Exp Jan-26)
17240846 (Exp Apr-26)
17240847 (Exp Apr-26)
NDC:
68462-681-60

Rx Only. Manufactured for Glenmark Pharmaceuticals Inc. USA.

Product: Frovatriptan Succinate Tablets (9-count bottle)
Variants: 2.5mg
Lot Numbers:
17231352 (Exp Jun-25)
17231649 (Exp Jul-25)
NDC:
68462-694-97

Rx Only. Manufactured for Glenmark Pharmaceuticals Inc. USA.

Product: Rufinamide Tablets (120-count bottle)
Variants: 200mg
Lot Numbers:
17231643 (Exp Jul-25)
17231644 (Exp Jul-25)
NDC:
68462-713-08

Rx Only. Manufactured for Glenmark Pharmaceuticals Inc. USA.

Product: Nitroglycerin Sublingual Tablets (100-count carton)
Variants: 0.4MG
Lot Numbers:
17232024 (Exp Aug-25)
17232071 (Exp Sep-25)
17232072 (Exp Sep-25)
NDC:
68462-639-45

Rx Only. Manufactured for Glenmark Pharmaceuticals Inc. USA.

Product: Pravastatin Sodium Tablets (90-count bottle)
Variants: 80mg
Lot Numbers:
17221771 (Exp Aug-25)
17230930 (Exp Apr-26)
17230931 (Exp Apr-26)
17231252 (Exp May-26)
17231274 (Exp May-26)
17231855 (Exp Aug-26)
17231916 (Exp Aug-26)
17231917 (Exp Aug-26)
17231945 (Exp Aug-26)
NDC:
68462-198-90

Rx Only. Manufactured for Glenmark Pharmaceuticals Inc. USA.

Product: Fluphenazine Hydrochloride Tablets (100-count bottle)
Variants: 10mg
Lot Numbers:
17232206 (Exp Sep-25)
NDC:
68462-338-01

Rx Only. Manufactured for Glenmark Pharmaceuticals Inc. USA.

Product: Fluphenazine Hydrochloride Tablets (100-count bottle)
Variants: 2.5mg
Lot Numbers:
17232214 (Exp Sep-25)
NDC:
68462-336-01

Rx Only. Manufactured for Glenmark Pharmaceuticals Inc. USA.

Product: Metformin Hydrochloride Extended-Release Tablets (90-count bottle)
Variants: 1000mg
Lot Numbers:
17232088 (Exp Sep-25)
17232093 (Exp Sep-25)
NDC:
68462-521-90

Manufactured for Glenmark Pharmaceuticals Inc. USA.

Product: Indomethacin Extended-Release Capsules (60-count bottle)
Variants: 75mg
Lot Numbers:
17232323 (Exp Oct-25)
17232335 (Exp Oct-25)
NDC:
68462-325-60

Manufactured for Glenmark Pharmaceuticals Inc. USA.

Product: Lacosamide Tablets (60-count bottle)
Variants: 100mg
Lot Numbers:
17232533 (Exp Nov-25)
17232534 (Exp Nov-25)
17240606 (Exp Mar-26)
17240619 (Exp Mar-26)
17240911 (Exp May-26)
17240912 (Exp May-26)
17241121 (Exp Jun-26)
17241124 (Exp Jun-26)
NDC:
68462-679-60

Rx Only. Manufactured for Glenmark Pharmaceuticals Inc. USA.

Product: Nitroglycerin Sublingual Tablets (100-count bottle)
Variants: 0.3MG
Lot Numbers:
17232361 (Exp Nov-25)
17232367 (Exp Nov-25)
17240037 (Exp Dec-25)
17240038 (Exp Dec-25)
NDC:
68462-638-01

Manufactured for Glenmark Pharmaceuticals Inc. USA.

Product: Saxagliptin Tablets (30-count and 90-count bottles)
Variants: 5mg
Lot Numbers:
17232460 (Exp Nov-25)
17241194 (Exp Jun-26)
NDC:
68462-727-30
68462-727-90

Rx Only. Manufactured for Glenmark Pharmaceuticals Inc. USA.

Product: Solifenacin Succinate Tablets (30-count and 90-count bottles)
Variants: 5mg
Lot Numbers:
17232395 (Exp Nov-25)
17232400 (Exp Nov-25)
NDC:
68462-386-30
68462-386-90

Rx Only. Manufactured for Glenmark Pharmaceuticals Inc. USA.

Product: Teriflunomide Tablets (30-count bottle)
Variants: 14mg
Lot Numbers:
17232462 (Exp Nov-25)
NDC:
68462-424-30

Rx Only. Manufactured for Glenmark Pharmaceuticals Inc. USA.

Product: Ranolazine Extended-Release Tablets (60-count bottle)
Variants: 1000mg
Lot Numbers:
17240040 (Exp Dec-25)
NDC:
68462-320-60

Rx Only. Manufactured for Glenmark Pharmaceuticals Inc. USA.

Product: Carvedilol Tablets, USP (500-count bottle)
Variants: 12.5 mg
Lot Numbers:
17240238 (Exp Jan-26)
17240243 (Exp Jan-26)
17240245 (Exp Jan-26)
17240248 (Exp Jan-26)
NDC:
68462-164-05

Rx Only. Manufactured for Glenmark Pharmaceuticals Inc. USA.

Product: Lacosamide Tablets (60-count bottle)
Variants: 50mg
Lot Numbers:
17240221 (Exp Jan-26)
17240222 (Exp Jan-26)
NDC:
68462-678-60

Rx Only. Manufactured for Glenmark Pharmaceuticals Inc. USA.

Product: Prochlorperazine Maleate Tablets (100-count bottle)
Variants: 10mg
Lot Numbers:
17240254 (Exp Jan-26)
17240257 (Exp Jan-26)
NDC:
68462-890-01

Rx Only. Manufactured for Glenmark Pharmaceuticals Inc. USA.

Product: Rosuvastatin Tablets (30-count bottle)
Variants: 40mg
Lot Numbers:
17240389 (Exp Feb-26)
17240390 (Exp Feb-26)
17240426 (Exp Feb-26)
17240427 (Exp Feb-26)
17240428 (Exp Feb-26)
17240778 (Exp Apr-26)
17241055 (Exp May-26)
17241074 (Exp Jun-26)
17241075 (Exp Jun-26)
17241091 (Exp Jun-26)
17241100 (Exp Jun-26)
NDC:
68462-264-30

Rx Only. Manufactured for Glenmark Pharmaceuticals Inc. USA.

Product: Colesvelam Hydrochloride Tablets (180-count bottle)
Variants: 625mg
Lot Numbers:
17240669 (Exp Mar-26)
17240876 (Exp Apr-26)
17240883 (Exp May-26)
17240909 (Exp May-26)
17240914 (Exp May-26)
17240927 (Exp May-26)
NDC:
68462-433-18

Rx Only. Manufactured for Glenmark Pharmaceuticals Inc. USA.

Product: Pravastatin Sodium Tablets (500-count and 90-count bottles)
Variants: 20mg
Lot Numbers:
17230810 (Exp Mar-26)
17230811 (Exp Mar-26)
17232501 (Exp Nov-26)
17232502 (Exp Nov-26)
NDC:
68462-196-05
68462-196-90

Rx only. Manufactured for Glenmark Pharmaceuticals Inc. USA.

Product: Diltiazem Hydrochloride Extended-Release Capsules (100-count bottle)
Variants: 120mg, 12HR
Lot Numbers:
17241067 (Exp May-26)
17241628 (Exp Aug-26)
NDC:
68462-562-01

Rx Only. Manufactured for Glenmark Pharmaceuticals Inc. USA.

Product: Lacosamide Tablets (60-count bottle)
Variants: 150mg
Lot Numbers:
17241125 (Exp Jun-26)
17242202 (Exp Nov-26)
17242204 (Exp Dec-26)
NDC:
68462-680-60

Rx Only. Manufactured for Glenmark Pharmaceuticals Inc. USA.

Product: Clindamycin Hydrochloride Capsules, USP (100-count bottle)
Variants: 300mg
Lot Numbers:
17241278 (Exp Jul-26)
17241297 (Exp Jul-26)
17241304 (Exp Jul-26)
17241315 (Exp Jul-26)
17241327 (Exp Jul-26)
NDC:
68462-144-01

Manufactured for Glenmark Pharmaceuticals Inc. USA.

Product: Saxagliptin Tablets, USP (30-count and 90-count bottles)
Variants: 2.5mg
Lot Numbers:
17241788 (Exp Sep-26)
17241821 (Exp Sep-26)
17241822 (Exp Sep-26)
NDC:
68462-726-30
68462-726-90

Manufactured for Glenmark Pharmaceuticals Inc. USA.

Product: Naproxen Sodium Tablets, USP (100-count bottle)
Variants: 550mg
Lot Numbers:
17231956 (Exp Aug-25)
NDC:
68462-179-01

Rx Only. Manufactured for Glenmark Pharmaceuticals Inc. USA.

Product: Acetaminophen and Ibuprofen (NSAID) Tablets (144-count and 216-count packets)
Variants: 250 mg/125 mg
Lot Numbers:
17241302 (Exp Jul-26)
17241140 (Exp Jul-26)
17241141 (Exp Jul-26)
NDC:
72657-157-74
72657-157-76

Distributed by Glenmark Therapeutics Inc., USA.

Product: Cetirizine Hydrochloride Tablets, USP (365-count pack)
Variants: 10mg
Lot Numbers:
17231980 (Exp Aug-25)
17232044 (Exp Aug-25)
17241436 (Exp Jul-26)
17241437 (Exp Jul-26)
17241455 (Exp Jul-26)
17241456 (Exp Aug-26)
17241457 (Exp Aug-26)
17241892 (Exp Oct-26)
17241893 (Exp Oct-26)
NDC:
72657-129-35

Rx Only. Distributed by Amazon.

Product: Northstar Pravastatin Sodium Tablets, USP (90-count bottle)by Northstar Rx LLC
Variants: 20mg
Lot Numbers:
17230810 (Exp Mar-26)
NDC:
16714-559-01

Rx Only. Manufactured by Glenmark for Northstar Rx LLC.

Product: Northstar Pravastatin Sodium Tablets, USP (90-count and 500-count bottles)by Northstar Rx LLC
Variants: 80mg
Lot Numbers:
17221770 (Exp Aug-25)
17221774 (Exp Aug-25)
17231251 (Exp May-26)
17231262 (Exp May-26)
17232112 (Exp Sep-26)
17232133 (Exp Sep-26)
NDC:
16714-570-01
16714-570-02

Rx Only. Manufactured by Glenmark for Northstar Rx LLC.

Product: Northstar Propafenone Hydrochloride Extended-Release Capsules USP (60-count bottle)by Northstar Rx LLC
Variants: 225mg
Lot Numbers:
17230819 (Exp Mar-25)
NDC:
16714-825-01

Rx Only. Manufactured by Glenmark for Northstar Rx LLC.

Product: Northstar Propafenone Hydrochloride Extended-Release Capsules, USP (60-count bottle)by Northstar Rx LLC
Variants: 325mg
Lot Numbers:
17230767 (Exp Mar-25)
NDC:
16714-826-01

Rx Only. Manufactured by Glenmark for Northstar Rx LLC.

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 96474
Status: Active
Manufacturer: Glenmark Pharmaceuticals Inc., USA
Sold By: Amazon; Walmart; Retail Pharmacies; Wholesalers
Manufactured In: India, United States
Distributed To: Nationwide
Agency Last Updated: April 24, 2025

Were You Affected by This Recall?

If you or a family member were harmed by this recalled product, you may have legal rights. Consider consulting a consumer protection attorney to understand your options for compensation.

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This is general information, not legal advice. Go Backs is not a law firm and does not provide legal services.

AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.

Sources: FDA iRES ยท Raw API Response

openFDA Disclaimer: This recall information is sourced from the openFDA API. Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Refer to the openFDA terms of service for more information.