Food, drugs, devices › Wockhardt Usa Inc.
Drug recall: Captopril Tablets, USP 12.5 mg, Rx Only, a) 100 count bottles NDC 64679-902-01, b) 1000 count bottles NDC 64679-902-02,
FDA enforcement event 70740 is a drug recall by Wockhardt Usa Inc. of Parsippany, NJ, initiated 12 Mar 2015 and classified Class II, with 1 product record.
FDA defines Class II as a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote. 52% of the 292 drug enforcement events initiated in 2015 carry the same class.
Status: Terminated, terminated 14 Dec 2017. Initiation: voluntary: firm initiated. Wockhardt Usa Inc. has 10 enforcement events on this register, with a median of 1 product record per event.
Recall classification reflects the relative degree of health hazard. Text in quotation marks is FDA's. openFDA export dated 28 Sep 2026.
Recalling firm
Wockhardt Usa Inc., Parsippany, NJ.
Reason for recall
"Failed Tablet/Capsule Specifications: out of specification for thickness."
Distribution
"Nationwide"
Product records
| Recall number | Product | Quantity | Class | Status | Report date |
|---|---|---|---|---|---|
| D-0975-2015 | Captopril Tablets, USP 12.5 mg, Rx Only, a) 100 count bottles NDC 64679-902-01, b) 1000 count bottles NDC 64679-902-02, Manufactured by Wockhardt Limited, Mumbai, India, Distributed by: Wockhardt USA LLC., 20 Waterview Boulevard, Parsippany, NJ 07054 USA | 93,393 bottles | Class II | Terminated | 13 May 2015 |
Context
Other enforcement events for Wockhardt Usa Inc.
All 10 events for Wockhardt Usa Inc.
Questions and answers
Why was this drug recalled?
FDA's record gives the reason for recall as: "Failed Tablet/Capsule Specifications: out of specification for thickness."
What does Class II mean?
FDA classifies recalls by relative degree of health hazard. Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote.
Where was the product distributed?
FDA's distribution pattern field reads: "Nationwide"
Is the recall still ongoing?
FDA lists the status as Terminated; the termination date is 14 Dec 2017. "Terminated" means FDA has determined that all reasonable efforts to remove or correct the product have been made.
Where does this data come from?
openFDA enforcement reports (food, drug and device), CC0, export dated 28 Sep 2026. Text in quotation marks is FDA's. The FDA enforcement report linked above is authoritative.
Provenance
Source: openFDA drug enforcement reports (CC0), export dated 28 Sep 2026; records grouped by FDA event number. The class shown for the event is the most severe class among its records. Errors in processing are corrected at the next build; see corrections.