CLASS III ONGOING Drug recall · Reported 12 Jun 2024 · FDA Enforcement Report
Pregabalin Capsules 50mg recalled by Rising Pharma Holding
Rising Pharma Holding is recalling Pregabalin Capsules 50mg, distributed nationwide in the US. The recall was initiated on 16 May 2024 and the FDA has classified it as Class III.
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-0541-2024
- FDA event ID
- 94642
- Recalling firm
- Rising Pharma Holding, East Brunswick, NJ
- Brand
- Pregabalin
- Manufacturer
- Rising Pharma Holdings, Inc.
- Classification
- Class III
- Status
- Ongoing
- Recall initiated
- 16 May 2024
- FDA classified
- 4 Jun 2024
- Reported
- 12 Jun 2024
- Type
- Voluntary: Firm initiated
- Customers notified by
- N/A
- Reason category
- Packaging Defects
- Drug class
- Pain Medication
Timeline
| 16 May 2024 | Recall initiated by company | |
| 4 Jun 2024 | Classified by FDA | +19 days |
| 12 Jun 2024 | Published in enforcement report | +8 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: Complaint received from a re-packager, American Health Packaging (AHP), where a foreign tablet was discovered in one of the bottles during packaging set up. Tablet identified as pantoprazole tablet 20mg.
Packaging recalls include wrong labels, wrong products in the wrong bottle, missing leaflets, short-filled or empty capsules and seals that fail.
Product as listed by the FDA
Pregabalin Capsules 50mg, 1000-count bottle, Rx Only, Manufactured for: Rising Pharma Holdings, Inc., East Brunswick, NJ 08816, Manufactured by: Laurus Labs Limited, Anakapalli-531011, India, NDC 64980-411-10
Where it was distributed
Nationwide in the USA
Questions about this recall
Why was it recalled?
Presence of Foreign Tablets/Capsules: Complaint received from a re-packager, American Health Packaging (AHP), where a foreign tablet was discovered in one of the bottles during packaging set up. Tablet identified as pantoprazole tablet 20mg.
Which lots are affected?
Lot: 23132611, Exp 07/31/2026
Where was it sold?
Nationwide in the USA
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 III mean?
Class III recalls are for products unlikely to cause any adverse health consequence, usually labelling or quality issues.
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 Rising Pharma Holding
All 13| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Rising, Cyproheptadine Hydrochloride Syrup, 2mg recalledCyproheptadine Hydrochloride | Rising Pharma Holding | Particulate Matter | Nationwide |
| Drug | CLASS II | Product label: Temozolomide Capsules, 5mg recalledTemozolomide | Rising Pharma Holding | Potency & Assay | Nationwide |
| Drug | CLASS II | Carbidopa, Levodopa, Entacapone Tablets, 25 mg/100 mg/200 mg recalledCarbidopa, Levodopa And Entacapone | Rising Pharma Holding | Packaging Defects | Nationwide |
| Drug | CLASS II | Duloxetine Delayed-Release Capsules, USP, 30 mg recalled | Rising Pharma Holding | Nitrosamine Impurity | Nationwide |
| Drug | CLASS II | Duloxetine Delayed-Release Capsules USP 20 mg recalled | Rising Pharma Holding | Nitrosamine Impurity | Nationwide |
Other Pregabalin recalls
All 7| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Pregabalin Capsules, 50 mg recalled by Sun Pharmaceutical IndustriesPregabalin | SUN Pharmaceutical Industries | Potency & Assay | Nationwide |
| Drug | CLASS II | Pregabalin Capsules 300mg recalled by Cardinal HealthPregabalin | Cardinal Health | Manufacturing (CGMP) Deviations | FL, GA, SC |
| Drug | CLASS II | Lyrica (pregabalin) capsules, 50 mg recalled by PfizerLyrica | Pfizer | Other | Nationwide |
| Drug | CLASS II | Lyrica (pregabalin) capsules, 75 mg recalled by PfizerLyrica | Pfizer | Other | Nationwide |
| Drug | CLASS II | Pregabalin, Capsule, 25 mg recalled by Aidapak Services | Aidapak Services | Labeling Errors | 4 states |