Ranitidine Syrup — Class III drug recall D-0809-2016
Terminated recall by Bio-pharm, Inc., reported 2016-04-13, distributed nationwide. Failed Impurities/Degradation Specifications: Product recalled due to elevated impurity result detected during
| Recall number | D-0809-2016 |
|---|---|
| Product type | Drug |
| Classification | Class III |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Bio-pharm, Inc., Levittown, PA, United States |
| Recall initiated | 2015-12-17 |
| Classified | 2016-04-01 |
| Reported by FDA | 2016-04-13 |
| Terminated | 2017-05-08 |
| Distributed | Nationwide (US) |
| Quantity | 103,664 bottles |
| Reason classes | specification failure |
| NDC | 23155-0291-51 |
| Lot numbers | 14G008, 14G010, 14G013, 14G015, 14G016, 14G021, 14G026, 14G028, 14K023, 14K027, 15B040, 15B041, 15E042, 15F019, 15F021, 15G038, 15H004, 15H008 |
| Expiration dates | 2016-01, 2016-04, 2016-08, 2016-11, 2016-12, 2017-01, 2017-02 |
Product
Ranitidine Syrup (Ranitidine Oral Solution, USP), 15 mg/mL (75 mg/5 mL), 16 fl oz Bottle, Rx only, Mfd For: Heritage Pharmaceuticals Inc., Eatontown, NJ 07724, NDC 23155-291-51
Reason for recall
Failed Impurities/Degradation Specifications: Product recalled due to elevated impurity result detected during routine stability testing.
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-0809-2016. 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.