PREGABALIN

Generic: PREGABALIN

FOURRTS (INDIA) LABORATORIES PRIVATE LIMITEDManufacturer

ORALRoute

PREGABALINActive Substance

2026-02-24Original Approval

PREGABALIN is FDA application ANDA218529, sponsored by CAPLIN. Any recalls listed below come from FDA drug enforcement reports, and reaction counts are the number of FAERS adverse event reports that mention the drug and that reaction; a report does not prove the drug caused it.

Recalls

Class II2021-03-15

PREGABALIN CAPSULES 300MG 90 ; NDC 43598-298-90; RX; CAPSULES

CGMP Deviations: Intermittent exposure to temperature excursion during storage.

Class III2024-05-16

Pregabalin Capsules 50mg, 1000-count bottle, Rx Only, Manufactured for: Rising Pharma Holdings, Inc., East Brunswick, NJ

Presence of Foreign Tablets/Capsules: Complaint received from a re-packager, American Health Packagi

Class II2021-10-22

Pregabalin Capsules, 50 mg, 100 count bottle, Rx only, Distributed by: Sun Pharmaceutical Industries, Inc., Cranbury, NJ

Failed Tablet/Capsule Specifications: Out of Specification results for particle Size Distribution an

Top Reported Reactions

1

DRUG INEFFECTIVE

7,401 reports

2

OFF LABEL USE

5,586 reports

3

FATIGUE

5,560 reports

4

PAIN

4,949 reports

5

NAUSEA

4,897 reports

6

TOXICITY TO VARIOUS AGENTS

4,402 reports

7

HEADACHE

4,318 reports

8

DYSPNOEA

4,134 reports

9

DIZZINESS

4,083 reports

10

DIARRHOEA

3,756 reports