Severity
Moderate
ModerateClass IITerminated
FDA Drug recall · Reported October 10, 2012
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: Presence of crystals of Nimodipine within the capsule solution.
Compiled from official public sources by the editorial team.
Verify with FDA Drug →
Caraco Pharmaceutical Laboratories Ltd. 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 Caraco Pharmaceutical Laboratories Ltd. in October 10, 2012. Reason: Crystallization: Presence of crystals of Nimodipine within the capsule solution.. Check the official notice for the remedy. Verify recall #D-003-2013 with the FDA Drug before acting.
The recall
Caraco Pharmaceutical Laboratories Ltd. issued this moderate-severity FDA Drug recall-Crystallization: Presence of crystals of Nimodipine within the capsule solution..
- Moderate
- severity level
- Class II
- classification
- October 10, 2012
- reported
Sourced from official FDA Drug enforcement records. Verify recall #D-003-2013 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.
Recall Insight
This FDA Drug action (record #D-003-2013) was formally reported on October 10, 2012, with the manufacturer initiating the action on August 21, 2012. It is classified under Moderate severity (Class II), with a current status of Terminated. Caraco Pharmaceutical Laboratories Ltd. is listed as the recalling firm, operating out of Cranbury, NJ. Federal records list the affected scope as a) 2424 Cartons b) 2675 Cartons.
The documented reason for this recall is: Crystallization: Presence of crystals of Nimodipine within the capsule solution. Distribution data in the federal record shows the product reached: One direct account - Caraco Pharmaceutical Labroatories, LTD Detroit, Michigan 78 sub accounts. Distribution scope 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, 5 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 - 14,287 drugs & medications recalls on record
Of 101,704 recalls in the database, 24,878 are high severity, 72,426 moderate, and 4,400 low. 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.
Affected scope
a) 2424 Cartons b) 2675 Cartons
Related Recalls
6
5 from same agency
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: Presence of crystals of Nimodipine within the capsule solution.
Recall Profile
| Attribute | Value |
|---|---|
| Agency | U.S. Food and Drug Administration |
| Severity class | Moderate (Class II) |
| Status | Terminated |
| Recall number | D-003-2013 |
| Date reported | October 10, 2012 |
| Date initiated | August 21, 2012 |
| Recalling firm | Caraco Pharmaceutical Laboratories Ltd. |
| Firm location | Cranbury, NJ |
| Affected scope | a) 2424 Cartons b) 2675 Cartons |
| Distribution | One direct account - Caraco Pharmaceutical Labroatories, LTD Detroit, Michigan 78 sub accounts |
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-003-2013) 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 Caraco Pharmaceutical Laboratories Ltd.. Units affected: a) 2424 Cartons b) 2675 Cartons.
Why was this product recalled? ▼
Crystallization: Presence of crystals of Nimodipine within the capsule solution.
Which agency issued this recall? ▼
This recall was issued by the FDA Drug on October 10, 2012. Severity: Moderate. Recall number: D-003-2013.
Where was the recalled product distributed? ▼
Distribution: One direct account - Caraco Pharmaceutical Labroatories, LTD Detroit, Michigan 78 sub accounts.
How do I check if my product is affected by a recall? ▼
Check the product description and recall number (D-003-2013) against your product. Visit the official FDA Drug website for the most current information. You can also use our Recall Checker tool to search by product name or brand.
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.
Nearby Recalls in This Category
Other recalls in the same product category, useful for spotting patterns across the same defect class or manufacturer.
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Every figure on PlainRecalls is rendered directly from official FDA, CPSC and NHTSA recall records, no number is typed in by an editor. This recall: FDA Drug, reported October 10, 2012. Severity classes follow each agency's own taxonomy (FDA Class I/II/III; CPSC and NHTSA by hazard type), and related-recall context is computed across the full archive. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error. Data current as of July 2026.