Famotidine for Oral Suspension — Class III drug recall D-1484-2014
Terminated recall by Novel Laboratories, Inc., reported 2014-09-03, distributed nationwide. Failed Impurity/Degradation Specification; 12-month stability time point
| Recall number | D-1484-2014 |
|---|---|
| Product type | Drug |
| Classification | Class III |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Novel Laboratories, Inc., Somerset, NJ, United States |
| Recall initiated | 2014-06-20 |
| Classified | 2014-08-22 |
| Reported by FDA | 2014-09-03 |
| Terminated | 2015-06-29 |
| Distributed | Nationwide (US) |
| Quantity | 25,776 containers |
| Reason classes | specification failure |
| NDC | 43386-0500, 43386-0500-11 |
| Lot numbers | M13075A, M13076A, M13076B, M13077A, M13077B |
| Expiration dates | 2015-02, 2016-03 |
Product
Famotidine for Oral Suspension, USP 40 mg/5 mL, Rx Only, Cherry-Banana-Mint Flavored, Not for Injection, Manufactured by: Novel Laboratories, Inc., Somerset, NJ 08873. Distributed by: Gavis Pharmaceuticals, LLC, Somerset, NJ 08873, NDC 43386-500-11.
Reason for recall
Failed Impurity/Degradation Specification; 12-month stability time point
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-1484-2014. 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.