Pregabalin Capsules — Class II drug recall D-0361-2022
Terminated recall by SUN PHARMACEUTICAL INDUSTRIES INC, reported 2022-01-12, distributed nationwide. Failed Tablet/Capsule Specifications: Out of Specification results for particle Size Distribution and Bulk Den
| Recall number | D-0361-2022 |
|---|---|
| Product type | Drug |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | SUN PHARMACEUTICAL INDUSTRIES INC, Princeton, NJ, United States |
| Recall initiated | 2021-10-22 |
| Classified | 2022-01-06 |
| Reported by FDA | 2022-01-12 |
| Terminated | 2023-04-06 |
| Distributed | Nationwide (US) |
| Quantity | 696 bottles |
| Reason classes | specification failure |
| NDC | 47335-0686, 47335-0686-08, 47335-0686-18, 47335-0686-83, 47335-0686-88, 47335-0687, 47335-0687-08, 47335-0687-18, 47335-0687-83, 47335-0687-88, 47335-0688, 47335-0688-08, 47335-0688-18, 47335-0688-83, 47335-0688-88, 47335-0689, 47335-0689-08, 47335-0689-18, 47335-0689-83, 47335-0689-88, 47335-0690, 47335-0690-08, 47335-0690-18, 47335-0690-83, 47335-0690-88 and 15 more |
| Lot numbers | DNC0432A |
| Expiration dates | 2023-01 |
Product
Pregabalin Capsules, 50 mg, 100 count bottle, Rx only, Distributed by: Sun Pharmaceutical Industries, Inc., Cranbury, NJ 08512, Manufactured by: Sun Pharmaceutical Industries Ltd., Survey No. 259/15 Dadra-396 191, (U.T. of D & NH), India, NDC 47335-687-88.
Reason for recall
Failed Tablet/Capsule Specifications: Out of Specification results for particle Size Distribution and Bulk Density of the Active Pharmaceutical Ingredient.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/D-0361-2022. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.