CLASS III Drug recall · Reported 18 Jul 2018 · FDA Enforcement Report
Enalapril Maleate Tablets recalled by Wockhardt
Wockhardt is recalling Enalapril Maleate Tablets USP, distributed nationwide in the US. The recall was initiated on 19 Jun 2018 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-0912-2018
- FDA event ID
- 80356
- Recalling firm
- Wockhardt, Karodi
- Classification
- Class III
- Status
- Terminated
- Recall initiated
- 19 Jun 2018
- FDA classified
- 9 Jul 2018
- Reported
- 18 Jul 2018
- Reason category
- Potency & Assay
- Drug class
- Blood Pressure Medication
Timeline
| 19 Jun 2018 | Recall initiated by company | |
| 9 Jul 2018 | Classified by FDA | +20 days |
| 18 Jul 2018 | Published in enforcement report | +9 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 Specifications
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
Enalapril Maleate Tablets USP; 5 mg NDC code 64679-924-03. 1000 Tablets HDPE container pack with Non CRC cap and 2 desiccants further packed in E-flute cartons.
Where it was distributed
Nationwide.
Questions about this recall
Is Enalapril Maleate Tablets USP recalled?
Yes. Wockhardt recalled Enalapril Maleate Tablets USP on 19 Jun 2018. The recall is Class III and its status is Terminated. Recall number D-0912-2018.
Why was it recalled?
Failed Impurities/Degradation Specifications
Which lots are affected?
Batch# DR10445 (Exp: 4/19); Batch# DR10637 (Exp: 5/19); Batch# DR10646 (Exp: 5/19); Batch# DR10647 (Exp: 5/19); Batch# DR10725 (Exp: 7/19); Batch# DR10755 (Exp: 7/19); Batch# DR10811 (Exp: 9/19); Batch# DS10040 (Exp: 12/19); Batch# DS10041 (Exp: 12/19); Batch# DS10024 (Exp: 12/19); and Batch# DS10048 (Exp: 12/19).
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 Wockhardt
All 2| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS III | Enalapril Maleate Tablets recalled by Wockhardt | Wockhardt | Potency & Assay | Nationwide |
Other Enalapril recalls
All 16| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Enalapril Maleate Tablets, USP, 20 mg recalled by JB Chemicals andEnalapril Maleate | JB Chemicals and Pharmaceuticals | Potency & Assay | Nationwide |
| Drug | CLASS II | Enalapril Maleate Tablets recalled by Golden State Medical SupplyEnalapril Maleate | Golden State Medical Supply | Manufacturing (CGMP) Deviations | Nationwide |
| Drug | CLASS II | Enalapril Maleate Tablets recalled by Golden State Medical SupplyEnalapril Maleate | Golden State Medical Supply | Manufacturing (CGMP) Deviations | Nationwide |
| Drug | CLASS II | Enalapril Maleate Tablets recalled by Golden State Medical SupplyEnalapril Maleate | Golden State Medical Supply | Manufacturing (CGMP) Deviations | Nationwide |
| Drug | CLASS II | Enalapril Maleate Tablets recalled by Golden State Medical SupplyEnalapril Maleate | Golden State Medical Supply | Manufacturing (CGMP) Deviations | Nationwide |