CLASS II Drug recall · Reported 7 May 2014 · FDA Enforcement Report

Venlafaxine Hydrochloride Extended-Release Tablets, 37.5 mg recalled

Caraco Pharmaceutical Laboratories is recalling Venlafaxine Hydrochloride Extended-Release Tablets, 37.5 mg, distributed nationwide in the US. The recall was initiated on 20 Mar 2014 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesLot #: a) JKL4344A, Exp 07/14; JKL5460A, Exp 10/14; JKL5458A, Exp 11/14; b) JKL4344B, Exp 07/14; JKL5460B, Exp 10/14; JKL5458B, Exp 11/14.

Quantity recalled91,777 bottles

Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.

Recall details

Recall number: D-1284-2014
FDA event ID: 67784
Recalling firm: Caraco Pharmaceutical Laboratories, Detroit, MI
Classification: Class II
Status: Terminated
Recall initiated: 20 Mar 2014
FDA classified: 29 Apr 2014
Reported: 7 May 2014
Type: Voluntary: Firm initiated
Customers notified by: Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Reason category: Potency & Assay
Drug class: Antidepressants

Timeline

20 Mar 2014	Recall initiated by company
29 Apr 2014	Classified by FDA	+40 days
7 May 2014	Published in enforcement report	+8 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

Reason for recall

Failed Dissolution Specifications: Stability results found the product did not meet the drug release dissolution specifications.

Potency and specification recalls happen when a batch tests outside its approved limits for strength, purity or dissolution, which can mean the dose delivered is higher or lower than labelled.

Product as listed by the FDA

Venlafaxine Hydrochloride Extended-Release Tablets, 37.5 mg, packaged in a) 30-count bottles (NDC 41616-760-83, UPC 3 41616 76083 5); and b) 90-count bottles (NDC 41616-760-81, UPC 3 41616 76081 1), Rx only, Distributed by: Caraco Pharmaceutical Laboratories, Ltd., 1150 Elijah McCoy Drive, Detroit, MI 48202; Manufactured at: Sun Pharmaceutical Ind. Ltd., Halol-Baroda Highway, Halol-389 350, Gujarat, India.

Where it was distributed

Nationwide and Puerto Rico

Nationwide Puerto Rico

Questions about this recall

Why was it recalled?

Failed Dissolution Specifications: Stability results found the product did not meet the drug release dissolution specifications.

Which lots are affected?

Lot #: a) JKL4344A, Exp 07/14; JKL5460A, Exp 10/14; JKL5458A, Exp 11/14; b) JKL4344B, Exp 07/14; JKL5460B, Exp 10/14; JKL5458B, Exp 11/14.

Where was it sold?

Nationwide and Puerto Rico

What should I do if I have it?

Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.

What does Class II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

Other products in this recall event

1 other product · FDA event 67784

Reported	Class	Recall	Company	Reason	Where
7 May 2014	CLASS II	Venlafaxine Hydrochloride Extended-Release Tablets, 150 mg recalled	Caraco Pharmaceutical Laboratories	Potency & Assay	Nationwide

More recalls from Caraco Pharmaceutical Laboratories

All 12

Reported	Class	Recall	Company	Reason	Where
13 Aug 2014Drug	CLASS II	Cephalexin Capsules, USP, 500 mg recalled by Caraco Pharmaceutical	Caraco Pharmaceutical Laboratories	Manufacturing (CGMP) Deviations	Nationwide
13 Aug 2014Drug	CLASS II	Cephalexin Capsules, USP, 250 mg recalled by Caraco Pharmaceutical	Caraco Pharmaceutical Laboratories	Manufacturing (CGMP) Deviations	Nationwide
9 Jul 2014Drug	CLASS II	Venlafaxine Hydrochloride Extended-Release Tablets, 150 mg recalled	Caraco Pharmaceutical Laboratories	Potency & Assay	Nationwide
2 Jul 2014Drug	CLASS II	Gemcitabine For Injection USP, (lyophilized) recalled	Caraco Pharmaceutical Laboratories	Lead & Heavy Metals	OH
7 May 2014Drug	CLASS III	Children's Cetirizine Hydrochloride Chewable Tablets, 10 mg recalled	Caraco Pharmaceutical Laboratories	Potency & Assay	Nationwide

Other Venlafaxine recalls

All 26

Reported	Class	Recall	Company	Reason	Where
16 Apr 2025Drug	CLASS II	Venlafaxine Tablets, USP, 75 mg recalled by Zydus Pharmaceuticals (USA)Venlafaxine	Zydus Pharmaceuticals	Foreign Material	Nationwide
29 Jan 2025Drug	CLASS III	Venlafaxine Extended-Release Tablets, 150mg recalled by Appco PharmaVenlafaxine	Appco Pharma	Other	Nationwide
31 Jul 2024Drug	CLASS II	Venlafaxine Hydrochloride Extended-Release Capsules, USP 37.5mg recalledVenlafaxine Hydrochloride	Zydus Pharmaceuticals	Potency & Assay	Nationwide
10 Jul 2024Drug	CLASS II	Venlafaxine Hydrochloride, extended-release capsules recalled	The Harvard Drug Group	Potency & Assay	Nationwide
18 Aug 2021Drug	CLASS II	Venlafaxine Tablets, USP 50 mg* recalled	SUN Pharmaceutical Industries	Other	TN