Heritage Ranitidine Syrup Recall: Impurity Risk
Heritage Pharmaceuticals recalls Ranitidine Syrup due to elevated impurities. Check lot numbers and expiration dates for affected batches.
Use caution until it’s fixed
Failed Impurities/Degradation Specifications: Product recalled due to elevated impurity result detected during routine stability testing.
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What happened, in plain English
Bio-pharm, Inc. is recalling Ranitidine Syrup manufactured for Heritage Pharmaceuticals because routine stability testing detected elevated impurity results that failed specifications. The recall affects 103,664 bottles distributed nationwide and in Puerto Rico. Consumers should check their specific lot numbers against the list provided to determine if they are affected. Read more at govinfonow.com/recall/43323-heritage-ranitidine-syrup-recall-impurity-risk.
Source Summary by GovInfoNow · govinfonow.com/recall/43323-heritage-ranitidine-syrup-recall-impurity-risk · Updated October 11, 2026 · FDA enforcement record: FDA #D-0809-2016
Cite this page
“Heritage Ranitidine Syrup Recall: Impurity Risk.” GovInfoNow, updated October 11, 2026. https://govinfonow.com/recall/43323-heritage-ranitidine-syrup-recall-impurity-risk. Based on FDA recall #D-0809-2016 (https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0809-2016%22&limit=1).
Why it’s dangerous
The product failed impurity specifications due to elevated impurity results detected during routine stability testing. While the specific health effects of these impurities are not detailed in the record, the failure indicates the drug does not meet quality standards for safety and efficacy.
Who’s affected
Individuals who have purchased Ranitidine Syrup from Heritage Pharmaceuticals between the manufacturing dates and expiration dates listed in the record. Patients relying on this prescription medication for acid reduction may be at risk of consuming product with elevated impurities.
How to tell if you have this one
Look for a 16 fl oz bottle of Ranitidine Syrup (Ranitidine Oral Solution, USP), 15 mg/mL (75 mg/5 mL), Rx only, manufactured for Heritage Pharmaceuticals. Check the NDC 23155-291-51 and verify if your lot number matches one of the following: 14G008, 14G013, 14G010, 14G015, 14G016, 14G021, 14G026, 14G028 (Exp. 01/2016); 14K027, 14K023 (Exp. 04/2016); 15B040, 15B041 (Exp. 08/2016); 15E042 (Exp. 11/2016); 15F019, 15F021 (Exp. 12/2016); or 15G038 (Exp. 01/2017); 15H004, 15H008 (Exp. 02/2017).
- Brand
Heritage Pharmaceuticals- Category
Drug
What to do — step by step
Check Your Lot Number
Compare the lot number and expiration date on your bottle against the list of recalled lots provided in the record.
Contact Your Pharmacist
If you have an affected lot, contact your pharmacist or healthcare provider for guidance on replacement or disposal.
Where it went and when
Where it was distributed
Distributed nationwide.
FDA distribution: “Nationwide and Puerto Rico” States read from FDA’s own wording; “not listed” means the notice does not name it.
Distributed nationwide.
Recall timeline
FDA terminated this recall 17 months after the firm started it.
- Firm started the recall
- FDA classified it Class III
- Published in FDA’s Enforcement Report
- FDA terminated the recall
Dates from the agency record only; steps without a date are left out.
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Where this comes from
The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
- Official source: FDA Recall #D-0809-2016 (December 17, 2015) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for D-0809-2016 to see it in context.
- Plain-language summary written by qwen3.6:35b-a3b on October 11, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
- GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.