CLASS III Drug recall · Reported 18 Oct 2017 · FDA Enforcement Report

Famotidine tablets, 10 mg recalled by Dr. Reddy's Laboratories

Dr. Reddy's Laboratories is recalling Famotidine tablets, 10 mg, distributed nationwide in the US. The recall was initiated on 3 Oct 2017 and the FDA has classified it as Class III.

Check your package

Lot, batch or date codesLot #: 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.

NDC55111-118, 55111-396

Quantity recalled569376 bottles

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-0009-2018
FDA event ID: 78220
Recalling firm: Dr. Reddy's Laboratories, Princeton, NJ
Brand: Famotidine
Manufacturer: Dr.Reddys Laboratories Limited
Classification: Class III
Status: Terminated
Recall initiated: 3 Oct 2017
FDA classified: 11 Oct 2017
Reported: 18 Oct 2017
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Potency & Assay
Drug class: Stomach & Acid Reflux Medication

Timeline

3 Oct 2017	Recall initiated by company
11 Oct 2017	Classified by FDA	+8 days
18 Oct 2017	Published in enforcement report	+7 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

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.

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, 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

Where it was distributed

Nationwide

Stores named: Walmart, CVS

Questions about this recall

Why was it recalled?

Which lots are affected?

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.

Where was it sold?

Nationwide

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 Dr. Reddy's Laboratories

All 165

Reported	Class	Recall	Company	Reason	Where
17 Dec 2025Drug	CLASS III	Varenicline Tablets, 1mg recalled by Dr. Reddy's LaboratoriesVarenicline Tartrate	Dr. Reddy's Laboratories	Potency & Assay	Nationwide
15 Oct 2025Drug	CLASS II	Succinylcholine Chloride Injection, USP, 200 mg/ (20 mg/mL) recalledSuccinylcholine	Dr. Reddy's Laboratories	Potency & Assay	Nationwide
23 Jul 2025Drug	CLASS II	Omeprazole Delayed-release Capsules, USP, 20mg recalledOmeprazole	Dr. Reddy's Laboratories	Other	Nationwide
23 Apr 2025Drug	CLASS I	Levetiracetam 0.75% in Sodium Chloride Injection 1,000 mg recalledLevetiracetam	Dr. Reddy's Laboratories	Labeling Errors	Nationwide
18 Dec 2024Drug	CLASS III	Javygtor (sapropterin dihydrochloride) Tablets 100mg recalledJavygtor	Dr. Reddy's Laboratories	Potency & Assay	Nationwide

Other Famotidine recalls

All 15

Reported	Class	Recall	Company	Reason	Where
9 Sep 2026Drug	CLASS II	Famotidine Injection in Sodium Chloride Injection, 20 mg recalledFamotidine	Baxter Healthcare	Manufacturing (CGMP) Deviations	Nationwide
3 Dec 2025Drug	CLASS I	Famotidine Injection, USP, 20 mg per (10 mg per mL) vials recalledFamotidine	Fresenius Kabi USA	Sterility	Nationwide
26 Jul 2023Drug	CLASS II	Famotidine Tablets, USP, 20mg bottle within recalledFamotidine	Glenmark Therapeutics	Other	Nationwide
10 Mar 2021Drug	CLASS II	Famotidine Tablets USP 40mg recalled by Aurobindo Pharma USAFamotidine	Aurobindo Pharma USA	Other	4 states
29 Jul 2020Drug	CLASS III	Famotidine Injection, USP, 20 mg/ vial recalled by HF Acquisition CoFamotidine	HF Acquisition	Temperature Abuse	CT