D-0975-2015 Class II Terminated
FDA drug recall D-0975-2015 was initiated by Wockhardt Usa Inc. on Mar 12, 2015 and is designated Class II. Reason for recall: Failed Tablet/Capsule Specifications: out of specification for thickness. The recall status is terminated (terminated Dec 14, 2017). Affected quantity: 93,393 bottles.
Recall details
- Product Type
- Drugs
- Report Date
- May 13, 2015
- Initiation Date
- Mar 12, 2015
- Termination Date
- Dec 14, 2017
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 93,393 bottles
Product description
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
Reason for recall
Failed Tablet/Capsule Specifications: out of specification for thickness.
Distribution pattern
Nationwide
Code information
Lot #s: a) LM10525, Exp 03/15; LM10727, Exp 04/15; LM11519, Exp 08/15; LN10008, Exp 11/15; LN10121, Exp 12/15; LN10887, Exp 04/16; LM11248, Exp 06/16 Lot #s: b) LM10522, Exp 03/15; LM10726, Exp 04/15; LN10007, Exp 11/15; LN10116, Exp 12/15; LN10888, Exp 04/16; LN11281 Exp 07/16
Source
- Dataset
- openFDA drug recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for D-0975-2015
- openFDA file date
- Nov 10, 2026
- Loaded by RegDataLab
- Nov 11, 2026