Famciclovir Tablets — Class II drug recall D-0415-2018
Terminated recall by Hetero Labs Limited Unit V, reported 2018-02-21, distributed nationwide. Temperature Abuse: Complaints of tablets being wet and stuck together with tablet coating peeled and disintegr
| Recall number | D-0415-2018 |
|---|---|
| Product type | Drug |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Hetero Labs Limited Unit V, Jadcherla Mandal, Mahaboob Nagar, India |
| Recall initiated | 2017-12-22 |
| Classified | 2018-02-15 |
| Reported by FDA | 2018-02-21 |
| Terminated | 2020-02-05 |
| Distributed | Nationwide (US) |
| Quantity | 8,436 bottles |
| Reason classes | temperature control |
| NDC | 31722-0706, 31722-0706-01, 31722-0706-05, 31722-0706-10, 31722-0706-30, 31722-0706-60, 31722-0707, 31722-0707-01, 31722-0707-05, 31722-0707-10, 31722-0707-30, 31722-0707-60, 31722-0708, 31722-0708-01, 31722-0708-05, 31722-0708-10, 31722-0708-30, 31722-0708-60 |
| Lot numbers | FMC17039 |
| Expiration dates | 2019-07 |
Product
Famciclovir Tablets, 500 mg, 30-count bottles, Rx Only, Manufactured For: Camber Pharmaceuticals. Inc. Piscataway, NJ 08854 By: HETERO, Hetero Labs Limited, Unit V, Polepally, Jadcherla, Mahaboob Nagar-509 301, India. NDC 31722-708-30
Reason for recall
Temperature Abuse: Complaints of tablets being wet and stuck together with tablet coating peeled and disintegrated as a result of prolonged exposure to high temp during distribution.
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-0415-2018. 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.