FDA Drug recall D-603-2013
HydrOXYzine Hydrochloride Oral Solution, USP, 10 mg/5 mL, 16 fl. oz. (473 mL), Rx Only, HI-TECH PHARMACAL CO., INC. AMITYVILLE, NY, NDC 503…
- FDA Drug
- Class III
- terminated
- Published 2013-06-26
On 2013-06-26 the FDA classified a Class III recall of HydrOXYzine Hydrochloride Oral Solution, USP, 10 mg/5 mL, 16 fl. oz. (473 mL), Rx Only, HI-TECH PHARMACAL CO., INC. AMITYVILLE, NY, NDC 503… by Hi Tech Pharmacal, citing subpotent; 24 month stability test station.
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-603-2013 |
| Classification | Class III |
| Status | terminated |
| Initiated | 2013-04-30 |
| Published | 2013-06-26 |
| Last updated | 2026-09-13 11:51 UTC |
| Company | Hi Tech Pharmacal |
| Distribution | US |
Product
HydrOXYzine Hydrochloride Oral Solution, USP, 10 mg/5 mL, 16 fl. oz. (473 mL), Rx Only, HI-TECH PHARMACAL CO., INC. AMITYVILLE, NY, NDC 50383-796-16
Reason
Subpotent; 24 month stability test station
Identifiers
| code_info | Batch 608917 (exp. 02/2014), and Batch 608204 (exp. 01/2014) |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:51 UTC. Current status: terminated.
Other recalls by Hi Tech Pharmacal
- Rx CHOICE brand LIQUID VITAMIN C, 16 FL OZ (473 mL), NDC 50383-167-16 --- HI-TECH PHARMACAL CO., INC. Amityville, NY 11701
FDA Food · Class III · 2016-12-28 · Hi Tech Pharmacal - Rx CHOICE brand LIQUID VITAMIN C, 16 FL OZ (473 mL), NDC 50383-167-16 --- HI-TECH PHARMACAL CO., INC. Amityville, NY 11701
FDA Food · Class III · 2016-12-28 · Hi Tech Pharmacal - FERROUS SULFATE ELIXIR 220 mg/5 mL, UPC 350838778059, NDC 50383-778-05 --- HI-TECH PHARMACAL CO, INC. AMITYVILLE, NY 11701
FDA Food · Class II · 2015-03-11 · Hi Tech Pharmacal - HydrOXYzine Hydrochloride Oral Solution, USP, 10 mg / 5mL, Net Wt 16 fl oz (473 mL), NDC 50383-796-16, Rx Only, Manufactured by: Hi-Tech Ph…
FDA Drug · Class II · 2014-11-05 · Hi Tech Pharmacal - Acyclovir Oral Suspension, USP 200 mg/5 mL, Net Wt. 16 fl oz (473 mL), Rx only, Hi-Tech Pharmacal Co, Inc
FDA Drug · Class III · 2014-01-01 · Hi Tech Pharmacal
Source
Official record: https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-603-2013%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.