GILTUSS ANTITUSSIVE EXPECTORANT AND NASAL DECONGESTANT — Class III drug recall D-66207-001
Terminated recall by Hi-Tech Pharmacal Co., Inc., reported 2013-10-30, distributed in PR. Subpotent; phenylephrine HCl
| Recall number | D-66207-001 |
|---|---|
| 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 | 2013-09-04 |
| Classified | 2013-10-22 |
| Reported by FDA | 2013-10-30 |
| Terminated | 2015-04-29 |
| Distributed | PR |
| Quantity | 50,848 bottles |
| Reason classes | potency |
| NDC | 58552-0122-01, 58552-0122-08, 58552-0125-16 |
| Lot numbers | 615649, 615688, 617689 |
| Expiration dates | 2014-05, 2014-06, 2014-11 |
Product
GILTUSS ANTITUSSIVE EXPECTORANT AND NASAL DECONGESTANT, 1 fl. oz. (NDC 58552-122-01) and 8 fl. oz. (NDC 58552-122-08), and EXACTUSS ANTITUSSIVE EXPECTORANT AND NASAL DECONGESTANT, 16 fl. oz. (NDC 58552-125-16) --- Manufactured for: GIL PHARMACEUTICAL CORP. PONCE, PUERTO RICO 00716
Reason for recall
Subpotent; phenylephrine HCl
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-66207-001. 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.