Acyclovir Oral Suspension — Class III drug recall D-389-2014
Terminated recall by Hi-Tech Pharmacal Co., Inc., reported 2014-01-01, distributed nationwide. Failed Stability Specification; product viscosity and or pH are below specification.
| Recall number | D-389-2014 |
|---|---|
| Product type | Drug |
| Classification | Class III |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Hi-Tech Pharmacal Co., Inc., Amityville, NY, United States |
| Recall initiated | 2013-10-28 |
| Classified | 2013-12-24 |
| Reported by FDA | 2014-01-01 |
| Terminated | 2016-05-16 |
| Distributed | Nationwide (US) |
| Quantity | 51.948 bottles |
| Reason classes | specification failure |
| NDC | 50383-0810-16 |
| Expiration dates | 2013-12, 2014-03, 2014-05, 2014-07 |
Product
Acyclovir Oral Suspension, USP 200 mg/5 mL, Net Wt. 16 fl oz (473 mL), Rx only, Hi-Tech Pharmacal Co, Inc. Amityville, NY 11701. NDC 50383-810-16.
Reason for recall
Failed Stability Specification; product viscosity and or pH are below specification.
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-389-2014. 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.