The Recall Desk
Agency classClass IIOur severity:ModerateFDA (Drugs)·D-1283-2014·Announced 2014-05-07

Caraco Recalls Venlafaxine Hydrochloride Extended-Release Tablets for Dissolution Failures

Caraco Pharmaceutical Laboratories is recalling 160,105 bottles of Venlafaxine Hydrochloride Extended-Release Tablets, 150 mg, because stability results showed the product did not meet drug release dissolution specifications.

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, and the source text does not report any illnesses or injuries, fitting the criteria for a moderate severity score related to potential therapeutic failure without immediate harm.

Plain-English summary

Caraco Pharmaceutical Laboratories, Ltd. is recalling 160,105 bottles of Venlafaxine Hydrochloride Extended-Release Tablets, 150 mg. The affected products are packaged in 30-count and 90-count bottles and were distributed nationwide and in Puerto Rico. The recall was initiated because stability results indicated that the product did not meet the required drug release dissolution specifications.

The recall covers specific lot numbers with expiration dates ranging from April 2014 to October 2014. The products were manufactured by Sun Pharmaceutical Ind. Ltd. in Gujarat, India, and distributed by Caraco Pharmaceutical Laboratories, Ltd. in Detroit, Michigan.

Consumers who have these specific products should stop using them and contact their healthcare provider or pharmacist for guidance on alternative treatment options. The recalled items should be returned to the pharmacy or disposed of according to local regulations.

The recalled product

Product
Venlafaxine Hydrochloride Extended-Release Tablets, 150 mg, packaged in a) 30-count bottles (NDC 41616-758-83, UPC 3 41616 75883 2); and b) 90-count bottles (NDC 41616-758-81, UPC 3 41616 75881 8), Rx only, Distributed by: Caraco Pharmaceutical Laboratories, Ltd., 1150 Elijah…
Manufacturer
Caraco Pharmaceutical Laboratories, Ltd.
Category
Drug — Antidepressant
Hazard
Affected units
160,105

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 (17)

  • Lot #: a) JKL3354A
  • Exp 04/14
  • JKL5444A
  • Exp 08/14
  • JKL5457B
  • JKL5445A
  • Exp 09/14
  • JKL5840A
  • Exp 10/14
  • JKL6588A
  • Exp 11/14
  • b) JKL3354B
  • JKL5444B
  • JKL5457C
  • JKL5445B
  • JKL5840B
  • Exp 10/14.

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 2 recalled by Caraco Pharmaceutical Laboratories, Ltd. 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 2 products in this recall →

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