The Recall Desk
ModerateFDA (Drugs)·D-0975-2015·Announced 2015-05-13

Wockhardt Recalls Captopril Tablets for Thickness Specification Failures

Wockhardt USA is recalling specific lots of Captopril Tablets 12.5 mg because they failed to meet thickness specifications.

What this means for you

Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.

Our severity reasoning: The recall is classified as FDA Class II, which typically corresponds to a Moderate severity score (2) when no specific serious injury or death is reported, and the defect (thickness) is a quality control issue rather than a direct toxicological hazard.

Plain-English summary

Wockhardt USA LLC is recalling Captopril Tablets, USP 12.5 mg, Rx Only. The affected products are distributed in 100-count and 1,000-count bottles under NDC 64679-902-01 and NDC 64679-902-02. The tablets were manufactured by Wockhardt Limited in Mumbai, India.

The recall was initiated because the tablets failed to meet specifications for thickness. This is a Class II recall, indicating that use of, or exposure to, the violative product may cause temporary or medically reversible adverse health consequences.

Consumers and healthcare providers should check their inventory for the specific lot numbers and expiration dates listed in the recall notice. If the product is found, it should be returned to the distributor or disposed of according to local regulations. Patients should consult their healthcare provider for alternative medication if necessary.

The recalled product

Product
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
Manufacturer
Wockhardt Usa Inc.
Category
Drug — Prescription Medication
Hazard
Affected units
93,393

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (19)

  • 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
  • LM10726
  • LN10007
  • LN10116
  • LN10888
  • LN11281 Exp 07/16

Distribution

Distributed nationwide across the United States.

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