The Recall Desk
Agency classClass IIOur severity:ModerateFDA (Drugs)·D-1270-2015·Announced 2015-07-29

Wockhardt Recalls Metoprolol Succinate Extended-Release Tablets Due to CGMP Deviations

Wockhardt USA Inc. is recalling Metoprolol Succinate Extended-Release Tablets, 100 mg, because the firm did not adequately investigate customer complaints.

The agency’s classification

FDA (Drugs): Class II

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.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 2/5 (Moderate).

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 due to CGMP deviations (inadequate complaint investigation) without reported injuries or illnesses, fitting the 'Moderate' criteria for minor labeling or process errors.

Plain-English summary

Wockhardt USA Inc. is recalling Metoprolol Succinate Extended-Release Tablets, USP, 100 mg. The affected products are packaged in 100-count bottles, 500-count bottles, and 12 x 30 tablet dispenser pack cartons. The tablets are prescription-only and were manufactured by Wockhardt Limited in Mumbai, India, and distributed by Wockhardt USA LLC in Parsippany, New Jersey.

The recall was initiated due to Current Good Manufacturing Practice (CGMP) deviations. Specifically, the firm did not adequately investigate customer complaints. This is an FDA Class II recall, which indicates a violation of CGMPs or labeling that may cause temporary or medically reversible adverse health consequences.

The affected lots were distributed nationwide, including Puerto Rico. 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 pharmacy or distributor for a refund or replacement.

The recalled product

Product
Metoprolol Succinate Extended-Release Tablets, USP, 100 mg Tablets, Packaged in A) 100 Count Bottles (NDC: 64679-0736-02), B) 500 Count Bottles (NDC: 64679-0736-03), and C) 12 x 30 Tablet Dispenser Pack Cartons (NDC: 64679-0736-09), Rx Only. Manufactured by: Wockhardt Limited…
Manufacturer
Wockhardt Usa Inc.
Category
Drug — Cardiovascular
Hazard

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 (20)

  • A) Lot #: LN11010
  • Expiry: 4/30/2015
  • Lot #: LN11011
  • Lot #: LN11135
  • Expiry: 5/31/2015
  • Lot #: LN11136
  • Lot #: LN11137
  • Lot #: LN11138
  • Lot #: LN11242
  • Expiry: 6/30/2015
  • Lot #: LN11243
  • Expiry: 6/30/2015. B) Lot #: LN11033
  • Lot #: LN11034
  • Lot #: LN11157
  • Lot #: LN11158
  • Lot #: LN11159
  • Lot #: LN11160
  • Lot #: LN11218
  • Lot #: LN11219
  • Lot #: LN11220

Distribution

Distributed nationwide across the United States.

The notice also names 1 state specifically:

Part of a larger recall action

This product is one of 35 recalled by Wockhardt Usa Inc. under a single FDA (Drugs) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 35 products in this recall →

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