FDA Drug recall D-0361-2022
Pregabalin Capsules, 50 mg, 100 count bottle, Rx only, Distributed by: Sun Pharmaceutical Industries, Inc., Cranbury, NJ 08512, Manufacture…
- FDA Drug
- Class II
- terminated
- Published 2022-01-12
On 2022-01-12 the FDA classified a Class II recall of Pregabalin Capsules, 50 mg, 100 count bottle, Rx only, Distributed by: Sun Pharmaceutical Industries, Inc., Cranbury, NJ 08512, Manufacture… by Sun Pharmaceutical Industries, citing failed Tablet/Capsule Specifications: Out of Specification results for particle Size Distribution and Bulk Density of the Active Pharmaceutical Ingredient.
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-0361-2022 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2021-10-22 |
| Published | 2022-01-12 |
| Last updated | 2026-09-13 11:52 UTC |
| Company | Sun Pharmaceutical Industries |
| Distribution | US |
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
Failed Tablet/Capsule Specifications: Out of Specification results for particle Size Distribution and Bulk Density of the Active Pharmaceutical Ingredient.
Identifiers
| ndc | 47335-686-83 |
|---|---|
| ndc | 47335-686-88 |
| ndc | 47335-686-08 |
| ndc | 47335-686-18 |
| ndc | 47335-687-83 |
| ndc | 47335-687-88 |
| ndc | 47335-687-08 |
| ndc | 47335-687-18 |
| ndc | 47335-688-83 |
| ndc | 47335-688-88 |
| ndc | 47335-688-08 |
| ndc | 47335-688-18 |
| ndc | 47335-689-83 |
| ndc | 47335-689-88 |
| ndc | 47335-689-08 |
| ndc | 47335-689-18 |
| ndc | 47335-690-83 |
| ndc | 47335-690-88 |
| ndc | 47335-690-08 |
| ndc | 47335-690-18 |
| ndc | 47335-691-83 |
| ndc | 47335-691-88 |
| ndc | 47335-691-08 |
| ndc | 47335-691-18 |
| ndc | 47335-692-83 |
| ndc | 47335-692-88 |
| ndc | 47335-692-08 |
| ndc | 47335-692-18 |
| ndc | 47335-693-83 |
| ndc | 47335-693-88 |
| ndc | 47335-693-08 |
| ndc | 47335-693-18 |
| code_info | Lot number: DNC0432A, expiration 01/2023 |
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:52 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0361-2022%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.