Famotidine Tablets USP — Class III drug recall D-1703-2012
Terminated recall by Mylan Pharmaceuticals Inc., reported 2012-10-10, distributed nationwide. Impurities/Degradation Products: Out of specification results for Related Compound during routine stability te
| Recall number | D-1703-2012 |
|---|---|
| Product type | Drug |
| Classification | Class III |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Mylan Pharmaceuticals Inc., Morgantown, WV, United States |
| Recall initiated | 2012-06-28 |
| Classified | 2012-09-28 |
| Reported by FDA | 2012-10-10 |
| Terminated | 2013-03-29 |
| Distributed | Nationwide (US) |
| Quantity | 31,867 bottles |
| Reason classes | specification failure |
| NDC | 00378-3020-01 |
| Lot numbers | 08/12, 3018952 |
Product
Famotidine Tablets USP, 20 mg, 100 count bottles, Rx Only, Mylan Pharmaceuticals, Inc., Morgantown, WV 26505 U.S.A. NDC 0378-3020-01
Reason for recall
Impurities/Degradation Products: Out of specification results for Related Compound 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-1703-2012. 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.