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Unrated Drug recall · FDA · Published March 18, 2020

Aurobindo Pharma Gabapentin Capsules Recall: Water Leakage Risk

Aurobindo Pharma recalls 100mg gabapentin capsules due to water leakage during manufacturing. Products may pose contamination risks. Check NDC 65862-198-99 and lot numbers for affected items.

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

🇺🇸 FDA recall #D-1232-2020DrugAurobindo Pharma ›
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Contact the company

Recalling firmAurobindo Pharma USA Inc.279 Princeton Hightstown Rd · East Windsor, NJ 08520-1401
✎ GovInfoNow plain-language explainer

Aurobindo Pharma is recalling 100mg gabapentin capsules that were manufactured with water leakage issues. This could lead to contamination risks for patients using these medications. Read more at govinfonow.com/recall/37298-aurobindo-pharma-gabapentin-capsules-recall-water-leakage-risk.

Source Summary by GovInfoNow · govinfonow.com/recall/37298-aurobindo-pharma-gabapentin-capsules-recall-water-leakage-risk · Updated October 5, 2026 · FDA enforcement record: FDA #D-1232-2020

Cite this page

“Aurobindo Pharma Gabapentin Capsules Recall: Water Leakage Risk.” GovInfoNow, updated October 5, 2026. https://govinfonow.com/recall/37298-aurobindo-pharma-gabapentin-capsules-recall-water-leakage-risk. Based on FDA recall #D-1232-2020 (https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-1232-2020%22&limit=1).

Aurobindo Pharma USA Inc. recalled Gabapentin Capsules, USP 100mg 1,000-count bottles due to cGMP deviations involving water leakage during manufacturing, the FDA said on March 18, 2020.

How to tell if you have it

  • Brand: Aurobindo Pharma
  • Product: Gabapentin Capsules, USP 100mg 1,000-count bottles
  • NDC: 65862-198-99
  • Lot #: 198180048A, Exp. Date 04/2021; 198180061A, Exp. Date 06/2020; 19819017A1, Exp. Date 02/2021
  • Distributed by: Aurobindo Pharma USA, Inc. Dayton, NJ 08810
  • Units affected: 26,625

The hazard

The FDA stated that the products were manufactured in a processing area where water leakage was observed, constituting cGMP deviations.

Context

GovInfoNow's records show Aurobindo Pharma USA Inc. has had 32 other recalls on record since April 9, 2013. Other recent recalls of similar products include Lupin Sertraline Tablets Recall: Defective Bottle Seal Risk (Nov. 5, 2025), Golden State Medical Supply Primidone Tablets Recall: Cross Contamination Risk (April 27, 2026), and Keystone Burkhart Anesthetic Gel Recall: Defective Container Risk (May 21, 2026).

How to tell if you have this one

Check for NDC code 65862-198-99 and lot numbers 198180048A (expiring April 2021), 198180061A (expiring June 2020), or 19819017A1 (expiring February 2021).

  • Brand
    Aurobindo Pharma
  • Category
    Drug
FDA recall event · 9 products

All 9 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 within the United States
Recall numberProduct, codes & lotsQuantityNDC
D-1229-2020Acetaminophen and Codeine Phosphate Tablets, USP, 300 mg/15 mg, 100-count bottles, Rx Only, Distributed by: Aurobindo Pharma USA, Inc., Dayton, NJ 08810, NDC 13107-058-01; Lot #: 058180015A, 058180016A, Exp. Date 07/2021; 05818017B1, Exp. Date 09/202114194 units13107-058-30, 13107-058-01, 13107-058-05, 13107-058-99, 13107-059-30, 13107-059-01, 13107-059-05, 13107-059-99, 13107-060-30, 13107-060-01, 13107-060-05, 13107-060-99
D-1230-2020Acetaminophen and Codeine Phosphate Tablets, USP, 300 mg/30 mg, 100-count bottles, Rx Only, Distributed by: Aurobindo Pharma USA, Inc., Dayton, NJ 08810, NDC 13107-059-99; Lot #: 059180023A, 059180024A and 059180025A, Exp. Date 05/20214332 units13107-058-30, 13107-058-01, 13107-058-05, 13107-058-99, 13107-059-30, 13107-059-01, 13107-059-05, 13107-059-99, 13107-060-30, 13107-060-01, 13107-060-05, 13107-060-99
D-1231-2020Acetaminophen and Codeine Phosphate Tablets, USP, 300 mg/60 mg, 100-count bottles, Rx Only, Distributed by: Aurobindo Pharma USA, Inc., Dayton, NJ 08810, NDC 13107-060-01; Lot #: 060180017A, 060180019B1, 060180020A and 060180021A, Exp. Date 06/202157337 units13107-058-30, 13107-058-01, 13107-058-05, 13107-058-99, 13107-059-30, 13107-059-01, 13107-059-05, 13107-059-99, 13107-060-30, 13107-060-01, 13107-060-05, 13107-060-99
D-1232-2020Gabapentin Capsules, USP 100mg 1,000-count bottles, Rx only, Distributed by: Aurobindo Pharma USA, Inc. Dayton, NJ 08810, NDC 65862-198-99; Lot #: 198180048A, Exp. Date 04/2021; 198180061A, Exp. Date 06/2020; 19819017A1, Exp. Date 02/202126625 units65862-198-01, 65862-198-05, 65862-198-99, 65862-198-10, 65862-198-90, 65862-198-18, 65862-198-27, 65862-199-01, 65862-199-05, 65862-199-99, 65862-199-10, 65862-199-30, 65862-199-60, 65862-199-90, 65862-199-18, 65862-199-27, 65862-200-01, 65862-200-05, 65862-200-10, 65862-200-90, 65862-200-27
D-1233-2020Levetiracetam Tablets USP 750 mg 120-count bottles, Rx Only, Distributed by: Aurobindo Pharma USA, Inc. 279 Princeton-Hightstown Road East Windsor, NJ 08520, NDC 65862-247-08; Lot #: 24719001A1, Exp. Date 03/20218040 units65862-245-08, 65862-245-05, 65862-246-08, 65862-246-05, 65862-247-08, 65862-247-05, 65862-315-30, 65862-315-60, 65862-315-05
D-1234-2020Simvastatin Tablets, USP 40mg 90-count bottles, Rx Only, Distributed by: Aurobindo Pharma USA, Inc. Dayton, NJ 08810, NDC 65862-053-90; Lot #: 05319004A1, Exp. Date 03/202226976 units65862-050-30, 65862-050-45, 65862-050-90, 65862-050-01, 65862-050-00, 65862-050-99, 65862-050-26, 65862-051-30, 65862-051-45, 65862-051-90, 65862-051-01, 65862-051-00, 65862-051-99, 65862-051-26, 65862-052-30, 65862-052-45, 65862-052-90, 65862-052-01, 65862-052-00, 65862-052-99, 65862-052-26, 65862-053-30, 65862-053-45, 65862-053-90, 65862-053-01, 65862-053-00, 65862-053-99, 65862-053-22, 65862-054-30, 65862-054-45, 65862-054-90, 65862-054-00, 65862-054-99, 65862-054-39
D-1235-2020Mirtazapine Tablets, USP 15mg, 30-count bottles, Rx Only, Distributed by: Aurobindo Pharma USA, Inc. Dayton, NJ 08810, NDC 13107-031-34; Lot #: 031180028A, Exp. Date 03/202156208 units13107-001-30, 13107-001-60, 13107-001-90, 13107-001-01, 13107-001-05, 13107-031-30, 13107-031-34, 13107-031-60, 13107-031-90, 13107-031-01, 13107-031-05, 13107-031-32, 13107-003-30, 13107-003-34, 13107-003-60, 13107-003-90, 13107-003-01, 13107-003-05, 13107-003-32, 13107-032-34, 13107-032-60, 13107-032-90, 13107-032-01, 13107-032-05, 13107-032-32
D-1236-2020Phentermine Hydrochloride Capsules, USP 15mg, 100-count bottles, Distributed by: Aurobindo Phama USA, Inc. Dayton, NJ 08810, NDC 13107-105-01; Lot #: 105180004A, Exp. Date 03/20202101 units13107-105-30, 13107-105-01, 13107-106-30, 13107-106-01
D-1237-2020Oxycodone and Acetaminophen Tablets, USP 10 mg*/325 mg 100-count bottles, Rx Only, Distributed by: Aurobindo Pharma USA, Inc. Dayton, NJ 08810, NDC 13107-046-01; Lot #: 046180056A, Exp. Date 05/202014707 units13107-043-30, 13107-043-01, 13107-043-05, 13107-043-99, 13107-044-30, 13107-044-01, 13107-044-05, 13107-044-99, 13107-045-30, 13107-045-01, 13107-045-05, 13107-045-99, 13107-046-30, 13107-046-01, 13107-046-05, 13107-046-99
Based on the official FDA remedy

What to do — step by step

  1. Check Product Details

    Identify the NDC code and lot numbers listed in the recall notice to confirm if your product is affected.

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

Distributed nationwide.

Recall timeline

FDA terminated this recall 4 years after the firm started it.

1. Firm started the recall: Mar 18, 202012. FDA classified it Class II: Apr 13, 202023. Published in FDA’s Enforcement Report: Apr 22, 202034. FDA terminated the recall: Mar 25, 2024420202024
  1. Firm started the recall
  2. FDA classified it Class II
  3. Published in FDA’s Enforcement Report
  4. FDA terminated the recall

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

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Aurobindo Pharma USA Inc recalls Dicyclomine Hydrochloride Capsules, USP, 10mg, 1,000 bottles, Rx only, Distributed by: Aurobindo Pharma USA, Inc., 279
July 23, 2026Aurobindo Pharma USA Inc recalls Healthy Living Acetaminophen, Aspirin (NSAID) and Caffeine, tablets USP, 250 mg/250 mg/65 mg, 100-count bottles,
July 11, 2024

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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-1232-2020 (March 18, 2020) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for D-1232-2020 to see it in context.
  • Plain-language summary written by qwen3:4b on October 5, 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