CLASS II Drug recall · Reported 29 Mar 2017 · FDA Enforcement Report
Atenolol Tablets, USP, 50 mg recalled by Legacy Pharmaceutical
Legacy Pharmaceutical Packaging is recalling Atenolol Tablets, USP, 50 mg, distributed nationwide in the US. The recall was initiated on 7 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-0606-2017
- FDA event ID
- 76666
- Recalling firm
- Legacy Pharmaceutical Packaging, Earth City, MO
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 7 Mar 2017
- FDA classified
- 21 Mar 2017
- Reported
- 29 Mar 2017
- Type
- Voluntary: Firm initiated
- Customers notified by
- Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
- Reason category
- Packaging Defects
- Drug class
- Blood Pressure Medication
Timeline
| 7 Mar 2017 | Recall initiated by company | |
| 21 Mar 2017 | Classified by FDA | +14 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, 30-count bottle, Rx only, Distributed by: The Kroger Co., 1014 Vine Street, Cincinnati, OH 45202; Manufactured for: Zydus Pharmaceuticals USA Inc., Pennington, NJ 08534; Packaged by: Legacy Pharmaceutical Packaging LLC, Earth City, MO 63045; NDC 68645-493-54.
Where it was distributed
Product was shipped to distribution centers in TN, IN, and AZ then further shipped the product to retail pharmacies nationwide in the USA.
Nationwide ArizonaIndianaTennessee
Stores named: Kroger
Questions about this recall
Is Atenolol Tablets, USP, 50 mg recalled?
Yes. Legacy Pharmaceutical Packaging recalled Atenolol Tablets, USP, 50 mg on 7 Mar 2017. The recall is Class II and its status is Terminated. Recall number D-0606-2017.
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 # 161901, Exp 04/18
Where was it sold?
Product was shipped to distribution centers in TN, IN, and AZ then further shipped the product to retail pharmacies nationwide in the USA.
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 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 Legacy Pharmaceutical Packaging
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|---|---|---|---|---|---|
| Drug | CLASS II | Sertraline Tablets, USP 100 mg recalled by Legacy PharmaceuticalSertraline Hydrochloride | Legacy Pharmaceutical Packaging | Manufacturing (CGMP) Deviations | AR, CA |
| Drug | CLASS III | Metformin Hydrochloride Tablets USP, 1000 mg recalled | Legacy Pharmaceutical Packaging | Packaging Defects | AR, GA |
| Drug | CLASS II | Losartan Potassium Tablets, USP, 50 mg recalled by Legacy Pharmaceutical | Legacy Pharmaceutical Packaging | Nitrosamine Impurity | AZ, TN |
| Drug | CLASS II | Losartan Potassium Tablets, USP, 50 mg recalled by Legacy Pharmaceutical | Legacy Pharmaceutical Packaging | Nitrosamine Impurity | AZ, IN, TN |
| Drug | CLASS II | Losartan Potassium Tablets, USP, 50 mg recalled by Legacy Pharmaceutical | Legacy Pharmaceutical Packaging | Nitrosamine Impurity | 5 states |
Other Atenolol recalls
All 5| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS I | Atenolol Tablets, USP, 25 mg recalled by Golden State Medical SupplyAtenolol | Golden State Medical Supply | Other | Nationwide |
| Drug | CLASS II | Atenolol Tablets, USP, 50 mg recalled by Zydus Pharmaceuticals USAAtenolol | Zydus Pharmaceuticals USA | Packaging Defects | Nationwide |
| Drug | CLASS II | ZyGenerics Atenolol Tablets, USP 25 mg recalledAtenolol | Zydus Pharmaceuticals USA | Potency & Assay | Nationwide |
| Drug | CLASS II | Atenolol Tablet, 5 mg (1/2 of 25 mg) recalled by Aidapak Services | Aidapak Services | Labeling Errors | 4 states |