CLASS II Drug recall · Reported 15 Oct 2014 · FDA Enforcement Report
ZyGenerics Atenolol Tablets, USP 25 mg recalled
Zydus Pharmaceuticals USA is recalling ZyGenerics Atenolol Tablets, USP 25 mg, distributed nationwide in the US. The recall was initiated on 5 Aug 2014 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-0007-2015
- FDA event ID
- 68988
- Recalling firm
- Zydus Pharmaceuticals USA, Pennington, NJ
- Brand
- Atenolol
- Manufacturer
- Zydus Pharmaceuticals USA Inc.
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 5 Aug 2014
- FDA classified
- 3 Oct 2014
- Reported
- 15 Oct 2014
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Potency & Assay
- Drug class
- Blood Pressure Medication
Timeline
| 5 Aug 2014 | Recall initiated by company | |
| 3 Oct 2014 | Classified by FDA | +59 days |
| 15 Oct 2014 | 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
Superpotent Drug: A complaint was reported by a pharmacist who stated several tablets were noticeably thicker in appearance.
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
ZyGenerics ATENOLOL Tablets, USP 25 mg 1000 count bottle, Rx Only Manufactured by: Cadila Healthcare Ltd. Ahmedabad, India Distributed by: Zydus Pharmaceuticals USA Inc. Pennington, NJ 08634 USA NDC 68382-022-01
Where it was distributed
Nationwide
Questions about this recall
Why was it recalled?
Superpotent Drug: A complaint was reported by a pharmacist who stated several tablets were noticeably thicker in appearance.
Which lots are affected?
MP2292 Exp. 01/16
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 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 Zydus Pharmaceuticals USA
All 41| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Ethacrynate Sodium for Injection, USP, 50mg/vial, Single Dose Vial recalled | Zydus Pharmaceuticals USA | Manufacturing (CGMP) Deviations | Nationwide |
| Drug | CLASS II | Pramipexole Dihydrochloride Tablets 1 mg recalled | Zydus Pharmaceuticals USA | Manufacturing (CGMP) Deviations | Nationwide |
| Drug | CLASS II | MethylPREDNISolone Tablets, USP 32 mg recalledMethylprednisolone | Zydus Pharmaceuticals USA | Manufacturing (CGMP) Deviations | Nationwide |
| Drug | CLASS II | Pramipexole Dihydrochloride Tablets 0.25 mg recalled | Zydus Pharmaceuticals USA | Manufacturing (CGMP) Deviations | Nationwide |
| Drug | CLASS II | Pramipexole Dihydrochloride Tablets 0.125 mg recalled | Zydus Pharmaceuticals USA | Manufacturing (CGMP) Deviations | Nationwide |
Other Atenolol recalls
All 5| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS I | Atenolol Tablets, USP, 25 mg recalled by Golden State Medical Supply | Golden State Medical Supply | Other | Nationwide |
| Drug | CLASS II | Atenolol Tablets, USP, 50 mg recalled by Legacy Pharmaceutical | Legacy Pharmaceutical Packaging | Packaging Defects | Nationwide |
| Drug | CLASS II | Atenolol Tablets, USP, 50 mg recalled by Zydus Pharmaceuticals USAAtenolol | Zydus Pharmaceuticals USA | Packaging Defects | Nationwide |
| Drug | CLASS II | Atenolol Tablet, 12.5 mg (1/2 of 25 mg) recalled by Aidapak Services | Aidapak Services | Labeling Errors | 4 states |