CLASS II Drug recall · Reported 25 Dec 2019 · FDA Enforcement Report
Gabapentin Capsules, USP 100 mg recalled by AuroMedics Pharma
AuroMedics Pharma is recalling Gabapentin Capsules, USP 100 mg, distributed nationwide in the US. The recall was initiated on 19 Nov 2019 and the FDA has classified it as Class II.
Check your package
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-0653-2020
- FDA event ID
- 84308
- Recalling firm
- AuroMedics Pharma, East Windsor, NJ
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 19 Nov 2019
- FDA classified
- 8 Jan 2020
- Reported
- 25 Dec 2019
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Other Reasons
- Drug class
- Pain Medication
Timeline
| 19 Nov 2019 | Recall initiated by company | |
| 25 Dec 2019 | Published in enforcement report | +36 days |
| 8 Jan 2020 | Classified by FDA | +14 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Presence of Foreign Tablets/Capsules: One Losartan/HCTZ tablet was found in Gabapentin 1000 count bottles..
Product as listed by the FDA
Gabapentin Capsules, USP 100 mg, Rx Only, Distributed by: Aurobindo Pharma USA, Inc. Dayton, NJ 08810, NDC 65682-198-99
Where it was distributed
Nationwide within the United States
Questions about this recall
Why was it recalled?
Presence of Foreign Tablets/Capsules: One Losartan/HCTZ tablet was found in Gabapentin 1000 count bottles..
Which lots are affected?
Lot #: 19819029A3, Exp. 08/2021
Where was it sold?
Nationwide within the United States
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.
More recalls from AuroMedics Pharma
All 36| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Fondaparinux Sodium Injection, USP, 7.5 mg per, Single Dose recalledFondaparinux Sodium | AuroMedics Pharma | Potency & Assay | Nationwide |
| Drug | CLASS II | Acyclovir Sodium Injection, 500mg/ (50mg/mL) Single Dose Vial recalledAcyclovir Sodium | AuroMedics Pharma | Particulate Matter | Nationwide |
| Drug | CLASS III | Tranexamic Acid Injection, USP, 1000mg recalled by AuroMedics PharmaTranexamic Acid | AuroMedics Pharma | Particulate Matter | Nationwide |
| Drug | CLASS I | Polymyxin B for Injection USP per Vial vials recalledPolymyxin B | AuroMedics Pharma | Particulate Matter | Nationwide |
| Drug | CLASS II | Acetaminophen Injection 1,000 mg recalled by AuroMedics PharmaAcetaminophen | AuroMedics Pharma | Other | Nationwide |
Other Gabapentin recalls
All 22| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Gabapentin Capsules, USP, 100 mg ( blister packs) recalled | The Harvard Drug Group | Potency & Assay | Nationwide |
| Drug | CLASS II | Gabapentin Capsules, USP, 100 mg ( blister pack) recalledGabapentin | The Harvard Drug Group | Potency & Assay | Nationwide |
| Drug | CLASS II | Gabapentin Capsules, USP, 100 mg recalled by The Harvard Drug GroupGabapentin | The Harvard Drug Group | Packaging Defects | Nationwide |
| Drug | CLASS II | Gabapentin Capsules, USP, 100 mg , blister pack recalled | The Harvard Drug Group | Packaging Defects | Nationwide |
| Drug | CLASS III | Gabapentin Capsules, USP 300 mg recalledGabapentin | SUN Pharmaceutical Industries | Packaging Defects | Nationwide |