CLASS II Drug recall · Reported 24 Jun 2015 · FDA Enforcement Report
Famotidine Tablets, USP, Over the Counter recalled by Allegiant Health
Allegiant Health is recalling Famotidine Tablets, USP, Over the Counter, distributed nationwide in the US. The recall was initiated on 12 May 2015 and the FDA has classified it as Class II.
Check your package
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-1134-2015
- FDA event ID
- 71266
- Recalling firm
- Allegiant Health, Deer Park, NY
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 12 May 2015
- FDA classified
- 12 Jun 2015
- Reported
- 24 Jun 2015
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Manufacturing (CGMP) Deviations
- Drug class
- Stomach & Acid Reflux Medication
Timeline
| 12 May 2015 | Recall initiated by company | |
| 12 Jun 2015 | Classified by FDA | +31 days |
| 24 Jun 2015 | Published in enforcement report | +12 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
CGMP Deviations: Failure of the manufacturer, Wockhardt Ltd, to adequately investigate customer complaints.
Product as listed by the FDA
Famotidine Tablets, USP, 20 mg Tablets, Over the Counter, Made in India and labeled: a) freds Acid Controller, 25 Tablet Cartons, DISTRIBUTED BY: fred's, Inc. 4300 NEW GETWELL RD, MEMPHIS, TN 38118. UPC: 0 84579 12592 0. b) HARMON FACE VALUES MAXIMUM STRENGTH Heartburn RELIEF, 25 Tablet Cartons, Distributed by Harmon Stores, Inc. 650 Liberty Ave. Union, NJ 07083, UPC: 3 62211 93292 2. c) Health A2Z Maximum Strength HEARTBURN RELIEF, 8 Tablet Cartons, Manufactured for: A&Z Pharmaceutical Inc. Hauppauge, NY 11788. UPC: 3 62211 34929 4. d) MARKET BASKET Maximum Strength HEARTBURN RELIEF ACID CONTROL, 30 Tablet Cartons, Distributed by: Demoulas Supermarkets, Inc. 875 East St. Tewksbury, MA 01876, UPC: 0 49705 83147 2.
Where it was distributed
US Nationwide
Questions about this recall
Why was it recalled?
CGMP Deviations: Failure of the manufacturer, Wockhardt Ltd, to adequately investigate customer complaints.
Which lots are affected?
Lot #: 3K34915, Expiry: 07/2015
Where was it sold?
US 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 II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
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 Allegiant Health
All 3| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | HealthA2Z Chewable Aspirin (Nsaid) 81 mg, Orange Flavor, a) recalled | Allegiant Health | Particulate Matter | Nationwide |
| Drug | CLASS III | col-rite (docusate sodium) stool softener softgels, 50 mg recalled | Allegiant Health | Potency & Assay | Nationwide |
Other Famotidine recalls
All 15| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Famotidine Injection in Sodium Chloride Injection, 20 mg recalledFamotidine | Baxter Healthcare | Manufacturing (CGMP) Deviations | Nationwide |
| Drug | CLASS I | Famotidine Injection, USP, 20 mg per (10 mg per mL) vials recalledFamotidine | Fresenius Kabi USA | Sterility | Nationwide |
| Drug | CLASS II | Famotidine Tablets, USP, 20mg bottle within recalledFamotidine | Glenmark Therapeutics | Other | Nationwide |
| Drug | CLASS II | Famotidine Tablets USP 40mg recalled by Aurobindo Pharma USAFamotidine | Aurobindo Pharma USA | Other | 4 states |
| Drug | CLASS III | Famotidine Injection, USP, 20 mg/ vial recalled by HF Acquisition CoFamotidine | HF Acquisition | Temperature Abuse | CT |