CLASS III Drug recall · Reported 7 Oct 2015 · FDA Enforcement Report
Verapamil Hydrochloride Extended-Release tablets, USP, 240 mg recalled
Apotex is recalling Verapamil Hydrochloride Extended-Release tablets, USP, 240 mg, distributed nationwide in the US. The recall was initiated on 21 Jul 2015 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
- D1834-2015
- FDA event ID
- 72118
- Recalling firm
- Apotex, Toronto, Ontario
- Classification
- Class III
- Status
- Terminated
- Recall initiated
- 21 Jul 2015
- FDA classified
- 30 Sep 2015
- Reported
- 7 Oct 2015
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Potency & Assay
- Drug class
- Blood Pressure Medication
Timeline
| 21 Jul 2015 | Recall initiated by company | |
| 30 Sep 2015 | Classified by FDA | +71 days |
| 7 Oct 2015 | 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 Dissolution Specification: One lot of product did not meet the first stage dissolution specification limits.
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
Verapamil Hydrochloride Extended-Release tablets, USP, 240 mg, 500-count bottles, Rx Only, Apotex Corp. Manufactured by Apotex Research Private Limited, Bangalore, Karnataka 560 099, India; Manufactured for: Apotex Corp., Weston, FL 33326. NDC 60505-2742-5.
Where it was distributed
Nationwide and Puerto Rico
Questions about this recall
Is Verapamil Hydrochloride Extended-Release tablets, USP, 240 mg recalled?
Yes. Apotex recalled Verapamil Hydrochloride Extended-Release tablets, USP, 240 mg on 21 Jul 2015. The recall is Class III and its status is Terminated. Recall number D1834-2015.
Why was it recalled?
Failed Dissolution Specification: One lot of product did not meet the first stage dissolution specification limits.
Which lots are affected?
Lot #: KP2621, Exp 8/2015
Where was it sold?
Nationwide and Puerto Rico
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 Apotex
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|---|---|---|---|---|---|
| Drug | CLASS II | Paxil CR, Paroxetine, Extended-Release Tablets, 5mg recalled by Apotex | Apotex | Potency & Assay | Nationwide |
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Other Verapamil recalls
All 8| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS III | Verapamil Hydrochloride Injection, USP 10 mg/ 5 mg/mL) recalledVerapamil Hydrochloride | Zydus Pharmaceuticals (USA) | Other | Nationwide |
| Drug | CLASS III | Verapamil Hydrochloride Injection, USP 5 mg /(2.5 mg/mL) recalledVerapamil Hydrochloride | Zydus Pharmaceuticals (USA) | Packaging Defects | Nationwide |
| Drug | CLASS II | Verapamil Hydrochloride Extended-Release Tablets recalled | Amerisource Health Services | Potency & Assay | Nationwide |
| Drug | CLASS II | Verapamil Hydrochloride Extended-Release Tablets, USP, 120 mg recalled | Amerisource Health Services | Potency & Assay | Nationwide |
| Drug | CLASS II | Verapamil Hydrochloride Extended-Release Tablets USP 120 mg recalledVerapamil Hydrochloride | Cardinal Health | Manufacturing (CGMP) Deviations | FL, GA, SC |