Famotidine tablets — Class III drug recall D-0009-2018
Terminated recall by Dr. Reddy's Laboratories, Inc., reported 2017-10-18, distributed nationwide. Failed impurities/degradation specifications: Famotodine has an out of specification result for an individual
| Recall number | D-0009-2018 |
|---|---|
| Product type | Drug |
| Classification | Class III |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Dr. Reddy's Laboratories, Inc., Princeton, NJ, United States |
| Recall initiated | 2017-10-03 |
| Classified | 2017-10-11 |
| Reported by FDA | 2017-10-18 |
| Terminated | 2019-03-15 |
| Distributed | Nationwide (US) |
| Quantity | 569,376 bottles |
| Reason classes | specification failure |
| NDC | 49035-0118-30, 55111-0118, 55111-0118-04, 55111-0118-12, 55111-0118-18, 55111-0118-24, 55111-0118-30, 55111-0118-35, 55111-0118-40, 55111-0118-60, 55111-0118-79, 55111-0118-81, 55111-0118-90, 55111-0396, 55111-0396-01, 55111-0396-08, 55111-0396-13, 55111-0396-16, 55111-0396-32, 55111-0396-35, 55111-0396-44, 55111-0396-50, 55111-0396-65, 55111-0396-90 |
Product
Famotidine tablets, 10 mg, packaged in 30-count bottle, OTC, labeled as a) CVS Pharmacy Acid Controller, NDC 55111-118-30, Distributed by: CVS Pharmacy, Inc., One CVS Drive, Woonsocket, RI 02895, Made in India, b) Equate Famotidine, NDC 49035-118-30, Distributed by: Wal-Mart Stores, Inc. Bentonville, AR 72716, Made in India
Reason for recall
Failed impurities/degradation specifications: Famotodine has an out of specification result for an individual related substance observed during routine stability testing of a batch for related substances -impurity 8 at 24 month stability interval.
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-0009-2018. 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.