Maalox Nighttime Antacid with Acid Reflux Barrier — Class III drug recall D-909-2013
Terminated recall by Novartis Consumer Health, reported 2013-08-28, distributed nationwide. Labeling: Incorrect Or Missing Lot and/or Exp Date: The lot number and/or expiration date may be illegible on
| Recall number | D-909-2013 |
|---|---|
| Product type | Drug |
| Classification | Class III |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Novartis Consumer Health, Lincoln, NE, United States |
| Recall initiated | 2013-08-06 |
| Classified | 2013-08-20 |
| Reported by FDA | 2013-08-28 |
| Terminated | 2014-11-04 |
| Distributed | Nationwide (US) |
| Countries outside the US | CA, PA |
| Quantity | 23,856 bottles |
| Reason classes | labeling |
| UPC / GTIN / UDI-DI | 00058478100913 |
| Lot numbers | 01/14, 07/13, 10107000, 10114319 |
Product
Maalox Nighttime Antacid with Acid Reflux Barrier (calcium carbonate and alginic acid) chewable tablets, 500 mg/200 mg, Mint flavor, 65-count tablets per bottle, Novartis Consumer Health Canada Inc., Mississauga, ON L5N 2X7, foreign labeling containing English and French, NPN 80000899, UPC 0 58478 10091 3.
Reason for recall
Labeling: Incorrect Or Missing Lot and/or Exp Date: The lot number and/or expiration date may be illegible on the outer plastic bottle packaging.
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-909-2013. 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.