CLASS III Drug recall · Reported 3 Sep 2014 · FDA Enforcement Report
Famotidine for Oral Suspension, USP 40 mg recalled by Novel Laboratories
Novel Laboratories is recalling Famotidine for Oral Suspension, USP 40 mg, distributed nationwide in the US. The recall was initiated on 20 Jun 2014 and the FDA has classified it as Class III.
Check your package
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
Recall details
- Recall number
- D-1484-2014
- FDA event ID
- 68722
- Recalling firm
- Novel Laboratories, Somerset, NJ
- Brand
- Famotidine
- Manufacturer
- Lupin Pharmaceuticals,Inc.
- Classification
- Class III
- Status
- Terminated
- Recall initiated
- 20 Jun 2014
- FDA classified
- 22 Aug 2014
- Reported
- 3 Sep 2014
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Potency & Assay
- Drug class
- Stomach & Acid Reflux Medication
Timeline
| 20 Jun 2014 | Recall initiated by company | |
| 22 Aug 2014 | Classified by FDA | +63 days |
| 3 Sep 2014 | Published in enforcement report | +12 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Failed Impurity/Degradation Specification; 12-month stability time point
Potency and specification recalls happen when a batch tests outside its approved limits for strength, purity or dissolution, which can mean the dose delivered is higher or lower than labelled.
Product as listed by the FDA
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.
Where it was distributed
Nationwide
Questions about this recall
Why was it recalled?
Failed Impurity/Degradation Specification; 12-month stability time point
Which lots are affected?
Lot #'s M13075A, M13076A, M13076B, M13077A, M13077B all with expiry dated 2/2015 and M13490A with expiry date 3/2016.
Where was it sold?
Nationwide
What should I do if I have it?
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
What does Class III mean?
Class III recalls are for products unlikely to cause any adverse health consequence, usually labelling or quality issues.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
More recalls from Novel Laboratories
All 3| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS III | Lupin Hydrocodone Bitartrate recalled by Novel LaboratoriesHydrocodone Bitartrate And Homatropine Methylbromide | Novel Laboratories | Potency & Assay | Nationwide |
| Drug | CLASS III | Fluocinolone Acetonide Topical Solution recalled by Novel LaboratoriesFluocinolone Acetonide | Novel Laboratories | Other | Nationwide |
Other Famotidine recalls
All 15| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Famotidine Injection in Sodium Chloride Injection, 20 mg recalledFamotidine | Baxter Healthcare | Manufacturing (CGMP) Deviations | Nationwide |
| Drug | CLASS I | Famotidine Injection, USP, 20 mg per (10 mg per mL) vials recalledFamotidine | Fresenius Kabi USA | Sterility | Nationwide |
| Drug | CLASS II | Famotidine Tablets, USP, 20mg bottle within recalledFamotidine | Glenmark Therapeutics | Other | Nationwide |
| Drug | CLASS II | Famotidine Tablets USP 40mg recalled by Aurobindo Pharma USAFamotidine | Aurobindo Pharma USA | Other | 4 states |
| Drug | CLASS III | Famotidine Injection, USP, 20 mg/ vial recalled by HF Acquisition CoFamotidine | HF Acquisition | Temperature Abuse | CT |