Food, drugs, devices › Caraco Pharmaceutical Laboratories, Ltd.

Drug recall: Venlafaxine Hydrochloride Extended-Release Tablets, 150 mg, Rx only, Packaged in 30 Count and 90 Count Bottles. Distribu

FDA enforcement event 68637 · Class II · initiated 12 Jun 2014 · status Terminated · terminated 6 May 2015

DrugVoluntary: Firm initiated1 product recordDetroit, MI

FDA enforcement event 68637 is a drug recall by Caraco Pharmaceutical Laboratories, Ltd. of Detroit, MI, initiated 12 Jun 2014 and classified Class II, with 1 product record.

FDA defines Class II as 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. 58% of the 313 drug enforcement events initiated in 2014 carry the same class.

Status: Terminated, terminated 6 May 2015. Initiation: voluntary: firm initiated. Caraco Pharmaceutical Laboratories, Ltd. has 9 enforcement events on this register, with a median of 1 product record per event.

Recall classification reflects the relative degree of health hazard. Text in quotation marks is FDA's. openFDA export dated 28 Sep 2026.

Recalling firm

Caraco Pharmaceutical Laboratories, Ltd., Detroit, MI.

Reason for recall

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

Distribution

"Nationwide including Puerto Rico"

Product records

Recall number	Product	Quantity	Class	Status	Report date
D-1415-2014	Venlafaxine Hydrochloride Extended-Release Tablets, 150 mg, Rx only, Packaged in 30 Count and 90 Count Bottles. 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.…	26,530 30-Count Bottles; 14,597 90-Count Bottles	Class II	Terminated	9 Jul 2014

Context

58%of 2014 drug events are Class II313 events that year

1product record in this eventfirm median: 1

9events on this register for the firm

Other enforcement events for Caraco Pharmaceutical Laboratories, Ltd.

Initiated	Product (first record)	Type	Class	Records
26 Jun 2014	Cephalexin Capsules, USP, 250 mg, packaged in a) 100-count bottles (NDC 62756-293-88) and b) 500-count bottles (NDC 6275	Drug	Class II	2
9 Apr 2014	Cetirizine Hydrochloride Chewable Tablets, 5 mg, 30 count bottle, OTC Manufactured by Sun Pharma, Gujarat, India, NDC 47	Drug	Class III	2
9 Apr 2014	Gemcitabine For Injection USP, 1 g, (lyophilized), For Intravenous Use Only, Sterile Single Use Vial, Rx only, Manufactu	Drug	Class II	1
20 Mar 2014	Venlafaxine Hydrochloride Extended-Release Tablets, 150 mg, packaged in a) 30-count bottles (NDC 41616-758-83, UPC 3 416	Drug	Class II	2
29 Jan 2014	Oxcarbazepine Tablets, 300 mg, 100 tablet bottles, Rx Only. Distributed by: Caraco Pharmaceutical Laboratories, Ltd., 11	Drug	Class II	1
28 Jan 2014	Metformin HCl Extended-Release Tablets, USP, 500 mg, Rx only, 500 count bottles, Manufactured by: Sun Pharmaceutical Inc	Drug	Class II	1
5 Nov 2012	traMADOL Hydrochloride Tablets, USP 50 mg, 1000-count tablets per bottle, Manufactured by: Sun Pharmaceuticals Industrie	Drug	Class II	1
21 Aug 2012	Nimodipine Capsules 30 mg, Rx Only, For Institutional Use Only, a) 30-count unit dose Capsules (5x6 blister cards per ca	Drug	Class II	1

All 9 events for Caraco Pharmaceutical Laboratories, Ltd.

Questions and answers

Why was this drug recalled?

FDA's record gives the reason for recall as: "Failed Dissolution Specifications: Stability results found the product did not meet the drug dissolution specifications."

What does Class II mean?

FDA classifies recalls by relative degree of health hazard. 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.

Where was the product distributed?

FDA's distribution pattern field reads: "Nationwide including Puerto Rico"

Is the recall still ongoing?

FDA lists the status as Terminated; the termination date is 6 May 2015. "Terminated" means FDA has determined that all reasonable efforts to remove or correct the product have been made.

Where does this data come from?

openFDA enforcement reports (food, drug and device), CC0, export dated 28 Sep 2026. Text in quotation marks is FDA's. The FDA enforcement report linked above is authoritative.

Provenance

Source: openFDA drug enforcement reports (CC0), export dated 28 Sep 2026; records grouped by FDA event number. The class shown for the event is the most severe class among its records. Errors in processing are corrected at the next build; see corrections.