Pregabalin Capsules 50mg recall
FDA recall D-0541-2024 · initiated May 16, 2024
Rising Pharma Holding, Inc. recalled Pregabalin Capsules 50mg in May 2024 — an FDA Class III recall (D-0541-2024) because 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.
Unlikely to cause harm but violates FDA labeling or manufacturing regulations.
Why it was 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.
Something got into the product
A physical or chemical contaminant was found — glass or metal fragments, or a solvent that should not be there.
This is a manufacturing or quality failure, not a finding that the medicine is unsafe to take — across every recall we hold, none was issued for that reason. It does not mean the batch was harmless.
Is your product affected? Check the lot number
A recall covers only specific lots. Find the lot number and expiration date on your package and compare them to the affected codes below — if yours is not listed, it was not part of this recall.
Quantity recalled: N/A
Details
- Product
- 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
- Recalling company
- Rising Pharma Holding, Inc.
- Classification
- Class III
- Status
- Ongoing
- Type
- Voluntary: Firm initiated
- Distribution
- Nationwide in the USA
- Initiated
- May 16, 2024
- FDA report date
- Jun 12, 2024
Frequently asked
- Was Pregabalin Capsules 50mg recalled?
- Rising Pharma Holding, Inc. recalled Pregabalin Capsules 50mg in May 2024 — an FDA Class III recall (D-0541-2024) because 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. Unlikely to cause harm but violates FDA labeling or manufacturing regulations.
- Why was Pregabalin Capsules 50mg recalled?
- Per the FDA enforcement record, the reason for recall D-0541-2024 was: 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.
- Is a recalled Pregabalin Capsules 50mg dangerous to take?
- An FDA recall removes specific lots from the market for a defined reason and does not by itself mean the medicine is unsafe for everyone — your specific lot may never have been affected. Unlikely to cause harm but violates FDA labeling or manufacturing regulations. Check the FDA notice for the affected lot numbers and expiration dates, and ask your pharmacist or doctor before stopping a prescribed medicine. This reproduces public FDA data and is not medical advice.
- Which lots of Pregabalin Capsules 50mg are affected?
- Distributed: Nationwide in the USA. The recall covers these lots — Lot: 23132611, Exp 07/31/2026. Check the lot number and expiration date on your package against this list; if yours is not listed, it was not part of recall D-0541-2024.