FDA Drug recall D-0552-2022
Legatrin (Acetaminophen 500 mg, Diphenhydramine HCl 50 mg) Bulk Container, ULTRAtab Laboratories, Inc., Highland, NY NDC 62959-785-00
- FDA Drug
- Class II
- terminated
- Published 2022-02-16
On 2022-02-16 the FDA classified a Class II recall of Legatrin (Acetaminophen 500 mg, Diphenhydramine HCl 50 mg) Bulk Container, ULTRAtab Laboratories, Inc., Highland, NY NDC 62959-785-00 by Ultratab Laboratories, citing CGMP Deviations.
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-0552-2022 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2022-01-26 |
| Published | 2022-02-16 |
| Last updated | 2026-09-13 11:52 UTC |
| Company | Ultratab Laboratories |
| Distribution | n/a |
Product
Legatrin (Acetaminophen 500 mg, Diphenhydramine HCl 50 mg) Bulk Container, ULTRAtab Laboratories, Inc., Highland, NY NDC 62959-785-00
Reason
CGMP Deviations
Identifiers
| code_info | Product Codes: M785L Bulk Lots: 18K029, 18L059, 18M100, 19B013, 19D024, 19D059, 19E029, 19J050 |
|---|
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-0552-2022%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.