FDA Drug recall D-0009-2018
Famotidine tablets, 10 mg, packaged in 30-count bottle, OTC, labeled as a) CVS Pharmacy Acid Controller, NDC 55111-118-30, Distributed by:…
- FDA Drug
- Class III
- terminated
- Published 2017-10-18
On 2017-10-18 the FDA classified a Class III recall of Famotidine tablets, 10 mg, packaged in 30-count bottle, OTC, labeled as a) CVS Pharmacy Acid Controller, NDC 55111-118-30, Distributed by:… by Dr Reddy S Laboratories, citing failed impurities/degradation specifications: Famotodine has an out of specification result for an individual related substance observed during routine stability testing of a batc….
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-0009-2018 |
| Classification | Class III |
| Status | terminated |
| Initiated | 2017-10-03 |
| Published | 2017-10-18 |
| Last updated | 2026-09-13 11:51 UTC |
| Company | Dr Reddy S Laboratories |
| Distribution | US |
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
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.
Identifiers
| ndc | 55111-118-30 |
|---|---|
| ndc | 55111-118-40 |
| ndc | 55111-118-60 |
| ndc | 55111-118-90 |
| ndc | 55111-118-04 |
| ndc | 55111-118-18 |
| ndc | 55111-118-24 |
| ndc | 55111-118-35 |
| ndc | 55111-118-81 |
| ndc | 55111-118-79 |
| ndc | 55111-118-12 |
| ndc | 55111-396-35 |
| ndc | 55111-396-50 |
| ndc | 55111-396-65 |
| ndc | 55111-396-90 |
| ndc | 55111-396-44 |
| ndc | 55111-396-01 |
| ndc | 55111-396-13 |
| ndc | 55111-396-32 |
| ndc | 55111-396-08 |
| ndc | 55111-396-16 |
| ndc | 49035-118-30 |
| code_info | Lot #: a) 79C408882B, 79C408884C, 79C408886B, Exp 10/17; 79C501523B, Exp 01/18; 79C501524B, Exp 01/18; 79C502318B, Exp…Lot #: a) 79C408882B, 79C408884C, 79C408886B, Exp 10/17; 79C501523B, Exp 01/18; 79C501524B, Exp 01/18; 79C502318B, Exp 3/18; b) 79C408885B, 79C408886A, Exp 10/17; 79C500967, 79C501523C, 79C501525A, 79C501525B, 79C501525C, 79C501526B, Exp 01/18; 79C502317A, Exp 3/18; 79C504087B, 79C504088A, Exp 5/18; 79C505926A, Exp 7/18. |
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:51 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0009-2018%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.