Food, drugs, devices › Caraco Pharmaceutical Laboratories Ltd.

Drug recall: Nimodipine Capsules 30 mg, Rx Only, For Institutional Use Only, a) 30-count unit dose Capsules (5x6 blister cards per ca

FDA enforcement event 63031 · Class II · initiated 21 Aug 2012 · status Terminated · terminated 19 Nov 2013

DrugVoluntary: Firm initiated1 product recordCranbury, NJ

Caraco Pharmaceutical Laboratories Ltd. (Cranbury, NJ) initiated this drug recall on 21 Aug 2012; FDA lists 1 product record under event 63031, classified Class II.

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. 56% of the 209 drug enforcement events initiated in 2012 carry the same class.

Status: Terminated, terminated 19 Nov 2013. 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., Cranbury, NJ.

Reason for recall

"Crystallization: Presence of crystals of Nimodipine within the capsule solution."

Distribution

"One direct account - Caraco Pharmaceutical Labroatories, LTD Detroit, Michigan 78 sub accounts"

Product records

Recall number	Product	Quantity	Class	Status	Report date
D-003-2013	Nimodipine Capsules 30 mg, Rx Only, For Institutional Use Only, a) 30-count unit dose Capsules (5x6 blister cards per carton), NDC 57664-135-64, b) 100-count unit dose Capsules (25x4 blister cards per carton), NDC 57664-135-65, Distributed by: Caraco Pharmaceutical Laboratories, Ltd. Detroit, MI 48202 Affiliate of…	a) 2424 Cartons b) 2675 Cartons	Class II	Terminated	10 Oct 2012

Context

56%of 2012 drug events are Class II209 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
12 Jun 2014	Venlafaxine Hydrochloride Extended-Release Tablets, 150 mg, Rx only, Packaged in 30 Count and 90 Count Bottles. Distribu	Drug	Class II	1
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

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: "Crystallization: Presence of crystals of Nimodipine within the capsule solution."

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: "One direct account - Caraco Pharmaceutical Labroatories, LTD Detroit, Michigan 78 sub accounts"

Is the recall still ongoing?

FDA lists the status as Terminated; the termination date is 19 Nov 2013. "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.