PlainRecalls
ModerateClass IITerminated

FDA Drug recall · Reported July 17, 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 Sun Pharmaceutical Industries, Inc.

Crystallization; crystallized nimodipine

Recall #
D-687-2013
Affected scope
46387 Cartons
Initiated
May 21, 2013
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Sun Pharmaceutical Industries Inc. recalled Nimodipine Capsules 30 mg, Rx Only, For Institutional Use Only, a) 30-count unit dose Cap… - a moderate-severity action.

Nimodipine Capsules 30 mg, Rx Only, For Institutional Use Only, a) 30-count unit dose Cap… was recalled by Sun Pharmaceutical Industries Inc. in July 17, 2013. Reason: Crystallization; crystallized nimodipine. Check the official notice for the remedy. Verify recall #D-687-2013 with the FDA Drug before acting.

The recall

Sun Pharmaceutical Industries Inc. issued this moderate-severity FDA Drug recall-Crystallization; crystallized nimodipine.

Moderate
severity level
Class II
classification
July 17, 2013
reported

Sourced from official FDA Drug enforcement records. Verify recall #D-687-2013 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.

Recall Insight

This recall's affected scope, documented in the Recall Profile below, stays within a single-region or limited-distribution footprint. Distribution scope (see Distribution below) directly affects the consumer exposure window and determines whether a recall remains regional or escalates into a nationwide advisory.

Within the same product category the archive holds 6 closely related recalls, 6 from FDA Drug - clustering in a narrow category often points to a systemic quality-control or supplier issue rather than a one-off defect. Always verify the recall number against the official agency record before acting.

Drugs & Medications recalls over time

Where this recall sits in its category - 14,472 drugs & medications recalls on record

05001,0001,5002,000 2006201220152018202120242026 448
Severity1906864652High severity (most serious)Moderate severityLow severity
Where this agency-classified recall sits among FDA Class I/II/III notices

Of 88,244 recalls with an agency hazard classification, 19,068 are high severity, 64,652 moderate, and 4,524 low. A further 16,179 CPSC/NHTSA recalls have no agency class and are excluded from this split. This recall is classified moderate severity.

Counts reflect market size and reporting activity, not inherent danger, we do not rank products by risk from raw recall volume.

Product description

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 Sun Pharmaceutical Industries, Inc.

Reason for recall

Crystallization; crystallized nimodipine

Recall Profile

Structured summary of the FDA Drug recall record
Attribute Value
Agency U.S. Food and Drug Administration
Severity class Moderate (Class II)
Status Terminated
Recall number D-687-2013
Date reported July 17, 2013
Date initiated May 21, 2013
Recalling firm Sun Pharmaceutical Industries Inc.
Firm location Cranbury, NJ
Affected scope 46387 Cartons
Distribution Nationwide and Puerto Rico

Profile values are sourced directly from the official FDA Drug enforcement record. Source: U.S. Food and Drug Administration.

What to do with this recall

Match your product against the recall record, then act on the agency remedy.

  • Check the recall number (D-687-2013) and product description against the item you own. Search the archive
  • Confirm the current status with FDA Drug before acting, recall details can be updated.
  • Follow the documented remedy (refund, replacement, repair, or disposal) rather than general advice. What to do next

This page summarizes the official FDA Drug record for research and awareness; it is not legal, medical, or safety advice. Verify with the issuing agency before acting.

Frequently Asked Questions

What product was recalled?
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 Sun Pharmaceutical Industries, Inc.. Recalled by Sun Pharmaceutical Industries Inc.. Units affected: 46387 Cartons.
Why was this product recalled?
Crystallization; crystallized nimodipine
Which agency issued this recall?
This recall was issued by the FDA Drug on July 17, 2013. Severity: Moderate. Recall number: D-687-2013.
Where was the recalled product distributed?
Distribution: Nationwide and Puerto Rico.
Should I stop using a recalled medication or medical device?
Do not stop using a recalled medication or device without consulting your healthcare provider first, as abruptly discontinuing treatment could pose its own health risks. Your doctor can advise on alternatives or whether the recall applies to your specific product lot. Check the recall number and lot information against your product packaging.

Nationwide recalls with similar severity or category timing

Drug and device notices outside this firm and state, matched by severity timing and product category.

Compare this recall with Kian Pee Wan Capsules, 30-count bottles → · All Drugs & Medications recalls

This recall: FDA Drug, reported July 17, 2013. Severity classes follow each agency's own taxonomy; related-recall context is computed across the full archive.

Methodology · Corrections · Archive as of August 2026