CLASS II Drug recall · Reported 29 Mar 2017 · FDA Enforcement Report
Atenolol Tablets, USP, 50 mg recalled by Zydus Pharmaceuticals USA
Zydus Pharmaceuticals USA is recalling Atenolol Tablets, USP, 50 mg, distributed nationwide in the US. The recall was initiated on 6 Mar 2017 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-0605-2017
- FDA event ID
- 76673
- Recalling firm
- Zydus Pharmaceuticals USA, Pennington, NJ
- Brand
- Atenolol
- Manufacturer
- Zydus Pharmaceuticals USA Inc.
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 6 Mar 2017
- FDA classified
- 21 Mar 2017
- Reported
- 29 Mar 2017
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Packaging Defects
- Drug class
- Blood Pressure Medication
Timeline
| 6 Mar 2017 | Recall initiated by company | |
| 21 Mar 2017 | Classified by FDA | +15 days |
| 29 Mar 2017 | Published in enforcement report | +8 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Presence of Foreign Tablets/Capsules: Customer complaint that a bottle of atenolol 50 mg Tablets USP contained a paroxetine 20 mg tablet.
Packaging recalls include wrong labels, wrong products in the wrong bottle, missing leaflets, short-filled or empty capsules and seals that fail.
Product as listed by the FDA
ATENOLOL Tablets, USP, 50 mg, packaged in a) 100-count bottles (NDC 68382-023-01) and b) 1000-count bottles (NDC 68382-023-10), Rx only, Manufactured by: Cadila Healthcare Ltd., India; Distributed by: Zydus Pharmaceuticals USA Inc., Pennington, NJ 08534.
Where it was distributed
Nationwide in the USA and Puerto Rico.
Questions about this recall
Why was it recalled?
Presence of Foreign Tablets/Capsules: Customer complaint that a bottle of atenolol 50 mg Tablets USP contained a paroxetine 20 mg tablet.
Which lots are affected?
Lot #: a) Z600724, Exp 04/18; Z600725, Exp 04/18
Where was it sold?
Nationwide in the USA 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 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 | ZyGenerics Atenolol Tablets, USP 25 mg recalledAtenolol | Zydus Pharmaceuticals USA | Potency & Assay | Nationwide |
| Drug | CLASS II | Atenolol Tablet, 12.5 mg (1/2 of 25 mg) recalled by Aidapak Services | Aidapak Services | Labeling Errors | 4 states |