Class II · Moderate risk
Pregabalin Capsules
Failed Tablet/Capsule Specifications: Out of Specification results for particle Size Distribution and Bulk Density of the Active Pharmaceutical Ingredient.
Pregabalin Capsules 50mg
Class III — Low risk. Unlikely to cause harm, but violates FDA 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.
Cause type: Particulate / foreign matter
Visible foreign particles - glass, metal, fibers or other material - found in the product. Particles can enter from equipment wear, containers or the process, and are dangerous in injectables. All particulate / foreign matter recalls.
What was recalled
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
Affected NDC
64980-0411-10
Compare with the code on your package — it is the most precise check available.
Drug: Pregabalin
Product details
From the FDA NDC directory, for the product code this recall names. Compare with the label on your package.
| Product | Strength | Form & route | Labeler | Type |
|---|---|---|---|---|
| Pregabalin NDC 64980-0411 |
50 mg/1 | Capsule Oral |
Rising Pharma Holdings, Inc. | Rx · CV |
- Recalling firm
- Rising Pharma Holding, Inc.
- NDC code
- 64980-411-10
- Origin
- NJ, United States
- Initiated by
- Voluntary: Firm initiated
- FDA recall number
- D-0541-2024 · FDA notice
Low risk, still worth a check. Class III means the product is unlikely to cause harm but breaks an FDA rule (often labeling). If your lot matches, your pharmacy will normally swap it; there is no need for alarm.
Other Pregabalin recalls
See all
Class II · Moderate risk
Lyrica CR (pregabalin)
Failed Dissolution Specifications
Class II · Moderate risk
LYRICA (pregabalin)
CGMP Deviations: Intermittent exposure to temperature excursion during storage.
Class II · Moderate risk
Pregabalin Capsules 300mg 90
CGMP Deviations: Intermittent exposure to temperature excursion during storage.
Class II · Moderate risk
Lyrica (pregabalin)
FAILED TABLET/CAPSULE SPECIFICATIONS: Firm is recalling specific lots of pregabalin capsules due to the potential presence of deformed or damaged capsules.
Other recalls by Rising Pharma Holding, Inc.
All 2024 recalls
Class II · Moderate risk
Rising
Presence of Precipitate: medication was crystallizing and particles floating in the bottle
Class II · Moderate risk
Product label: Temozolomide Capsules
Failed Impurities/Degradation Specifications: An out-of-specification result observed during 9th-month long term stability testing
Class II · Moderate risk
Carbidopa
Product mix up: complaint received that sealed medication bottle contained Carbidopa, Levodopa, and Entacapone film-coated tablets (37.5 mg/150 mg/200 mg) instead of labelled lower strength Carbidopa, Levodopa, and Entacapone film-coated tablets (25 mg/100 mg/200 mg).
Class II · Moderate risk
Duloxetine Delayed-Release Capsules
CGMP Deviations: Presence of N-nitroso-duloxetine impurity above recommended interim limit.
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