Ranitidine Hydrochloride Tablets — Class II drug recall D-884-2013
Terminated recall by Dr. Reddy's Laboratories, Inc., reported 2013-08-21, distributed nationwide. Microbial Contamination of Non-Sterile Products: A lot of raw material used in the manufacture of Ranitidine w
| Recall number | D-884-2013 |
|---|---|
| Product type | Drug |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Dr. Reddy's Laboratories, Inc., Bridgewater, NJ, United States |
| Recall initiated | 2013-08-02 |
| Classified | 2013-08-12 |
| Reported by FDA | 2013-08-21 |
| Terminated | 2014-03-19 |
| Distributed | Nationwide (US) |
| Reason classes | microbial contamination, sterility |
| Pathogens | pseudomonas |
| NDC | 00363-0404-34, 41163-0404-61, 49035-0404-61 |
| Lot numbers | 03/13, 03/15, 04/15, 5055822, 5056317, 5056507, 7956571C, 7956572A |
Product
Ranitidine Hydrochloride Tablets, USP, 150 mg, OTC, a) Equate brand Maximum Strength Acid Reducer, 65 count bottle Dist. By: Wal-Mart Stores, Inc., Bentonville, AR 72710, NDC 49035-404-61 b)Equaline brand maximum strength heartburn relief, , DISTRIBUTED BY SUPERVALU INC., EDEN PRAIRIE, MN 55344, NDC 41163-404-61, c)Wal-Zan brand 150, MAXIMUM STRENGTH, 24 count bottlle, DISTRIBUTED BY: WALGREEN CO., 200 WILMOT RD., DEERFIELD, IL 63015, NDC 0363-0404-34
Reason for recall
Microbial Contamination of Non-Sterile Products: A lot of raw material used in the manufacture of Ranitidine was positive for Pseudomonas sp.
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-884-2013. 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.