Sun Pharma Recalls Pregabalin 50mg Due to Spec Failures
Sun Pharmaceutical recalls 696 bottles of Pregabalin 50mg capsules due to failed particle size and bulk density specifications. Check your lot number.
Use caution until it’s fixed
Failed Tablet/Capsule Specifications: Out of Specification results for particle Size Distribution and Bulk Density of the Active Pharmaceutical Ingredient.
Contact the company
What happened, in plain English
Sun Pharmaceutical Industries Inc. is recalling one lot of Pregabalin Capsules, 50 mg, because the active ingredient failed specifications for particle size distribution and bulk density. The recall involves 696 bottles distributed nationwide in the USA. No specific remedy or action steps are currently listed in the record. Read more at govinfonow.com/recall/35639-sun-pharma-recalls-pregabalin-50mg-due-to-spec-failures.
Source Summary by GovInfoNow · govinfonow.com/recall/35639-sun-pharma-recalls-pregabalin-50mg-due-to-spec-failures · Updated October 10, 2026 · FDA enforcement record: FDA #D-0361-2022
Cite this page
“Sun Pharma Recalls Pregabalin 50mg Due to Spec Failures.” GovInfoNow, updated October 10, 2026. https://govinfonow.com/recall/35639-sun-pharma-recalls-pregabalin-50mg-due-to-spec-failures. Based on FDA recall #D-0361-2022 (https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0361-2022%22&limit=1).
Why it’s dangerous
The capsules failed specifications for particle size distribution and bulk density of the active pharmaceutical ingredient. This deviation means the product does not meet its established quality standards, which could potentially affect how the medication performs in the body.
Who’s affected
Patients in the USA who have been prescribed Pregabalin Capsules, 50 mg, by Sun Pharmaceutical Industries Inc. The risk is limited to those with the specific lot number DNC0432A.
How to tell if you have this one
Check your bottle for NDC 47335-687-88 and Lot number DNC0432A with an expiration date of 01/2023. The product is a 100 count bottle, Rx only, distributed by Sun Pharmaceutical Industries, Inc., Cranbury, NJ.
- Brand
Sun Pharmaceutical Industries- Category
Drug
What to do — step by step
Check Your Bottle
Verify if your Pregabalin Capsules match NDC 47335-687-88 and Lot number DNC0432A.
Contact Your Pharmacist
Speak with your healthcare provider or pharmacist to determine the appropriate next steps for this specific lot.
Where it went and when
Where it was distributed
Distributed nationwide.
FDA distribution: “Nationwide in the USA” States read from FDA’s own wording; “not listed” means the notice does not name it.
Distributed nationwide.
Recall timeline
FDA terminated this recall 17 months after the firm started it.
- Firm started the recall
- FDA classified it Class II
- Published in FDA’s Enforcement Report
- FDA terminated the recall
Dates from the agency record only; steps without a date are left out.
Similar recalls
Other Sun Pharmaceutical Industries recalls
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Where this comes from
The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
- Official source: FDA Recall #D-0361-2022 (October 22, 2021) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for D-0361-2022 to see it in context.
- Plain-language summary written by qwen3.6:35b-a3b on October 10, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
- GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.