CLASS III Drug recall · Reported 10 Oct 2012 · FDA Enforcement Report
Famotidine Tablets USP, 20 mg recalled by Mylan Pharmaceuticals
Mylan Pharmaceuticals is recalling Famotidine Tablets USP, 20 mg, distributed nationwide in the US. The recall was initiated on 28 Jun 2012 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-1703-2012
- FDA event ID
- 62911
- Recalling firm
- Mylan Pharmaceuticals, Morgantown, WV
- Classification
- Class III
- Status
- Terminated
- Recall initiated
- 28 Jun 2012
- FDA classified
- 28 Sep 2012
- Reported
- 10 Oct 2012
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Potency & Assay
- Drug class
- Stomach & Acid Reflux Medication
Timeline
| 28 Jun 2012 | Recall initiated by company | |
| 28 Sep 2012 | Classified by FDA | +92 days |
| 10 Oct 2012 | 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
Impurities/Degradation Products: Out of specification results for Related Compound during routine stability testing.
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 Tablets USP, 20 mg, 100 count bottles, Rx Only, Mylan Pharmaceuticals, Inc., Morgantown, WV 26505 U.S.A. NDC 0378-3020-01
Where it was distributed
Nationwide and PR
Questions about this recall
Why was it recalled?
Impurities/Degradation Products: Out of specification results for Related Compound during routine stability testing.
Which lots are affected?
Lot: 3018952, Exp 08/12
Where was it sold?
Nationwide and PR
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 Mylan Pharmaceuticals
All 84| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Prasugrel Tablets, USP, 10mg recalled by Mylan PharmaceuticalsPrasugrel | Mylan Pharmaceuticals | Potency & Assay | Nationwide |
| Drug | CLASS II | Carton label: Mycophenolate Mofetil for injection recalledMycophenolate Mofetil | Mylan Pharmaceuticals | Potency & Assay | Nationwide |
| Drug | CLASS II | Acamprosate Calcium, Delayed-Release Tablets, 333 mg recalledAcamprosate Calcium | Mylan Pharmaceuticals | Potency & Assay | Nationwide |
| Drug | CLASS II | Mycophenolate Mofetil for Injection USP, 500 mg/Vial recalledMycophenolate Mofetil | Mylan Pharmaceuticals | Other | Nationwide |
| Drug | CLASS II | Amnesteem (Isotretinoin) Capsules, USP 40 mg recalledAmnesteem | Mylan Pharmaceuticals | Potency & Assay | 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 |