CLASS III Drug recall · Reported 6 Jul 2016 · FDA Enforcement Report
CVS pharmacy Original Strength Acid Controller tablets, 10 mg recalled
Dr. Reddy's Laboratories is recalling CVS pharmacy Original Strength Acid Controller tablets, 10 mg, distributed nationwide in the US. The recall was initiated on 22 Apr 2016 and the FDA has classified it as Class III.
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-1058-2016
- FDA event ID
- 74220
- Recalling firm
- Dr. Reddy's Laboratories, Princeton, NJ
- Classification
- Class III
- Status
- Terminated
- Recall initiated
- 22 Apr 2016
- FDA classified
- 30 Jun 2016
- Reported
- 6 Jul 2016
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Potency & Assay
Timeline
| 22 Apr 2016 | Recall initiated by company | |
| 30 Jun 2016 | Classified by FDA | +69 days |
| 6 Jul 2016 | Published in enforcement report | +6 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 specification: An out of specification results has been determined for an individual related substance during stability testing at the 18th month interval for the Famotidine 10 mg Tablet, USP.
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
CVS pharmacy Original Strength Acid Controller tablets, 10 mg, 30-count bottle, OTC, Distributed by: CVS Pharmacy, Inc. One CVS Drive, Woonsocket, RI 02895, UPC 150049523
Where it was distributed
Nationwide
Stores named: CVS
Questions about this recall
Is CVS pharmacy Original Strength Acid Controller tablets, 10 mg recalled?
Yes. Dr. Reddy's Laboratories recalled CVS pharmacy Original Strength Acid Controller tablets, 10 mg on 22 Apr 2016. The recall is Class III and its status is Terminated. Recall number D-1058-2016.
Why was it recalled?
Failed impurities/degradation specification: An out of specification results has been determined for an individual related substance during stability testing at the 18th month interval for the Famotidine 10 mg Tablet, USP.
Which lots are affected?
Lot # 79405008A, 79405008B, 79405008C, Exp 05/2017
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 21 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
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|---|---|---|---|---|---|
| Drug | CLASS III | Varenicline Tablets, 1mg recalled by Dr. Reddy's LaboratoriesVarenicline Tartrate | Dr. Reddy's Laboratories | Potency & Assay | Nationwide |
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| Drug | CLASS II | Omeprazole Delayed-release Capsules, USP, 20mg recalledOmeprazole | Dr. Reddy's Laboratories | Other | Nationwide |
| Drug | CLASS I | Levetiracetam 75% in Sodium Chloride Injection 1,000 mg recalledLevetiracetam | Dr. Reddy's Laboratories | Labeling Errors | Nationwide |
| Drug | CLASS III | Javygtor (sapropterin dihydrochloride) Tablets 100mg recalledJavygtor | Dr. Reddy's Laboratories | Potency & Assay | Nationwide |