Severity
Moderate
ModerateClass IITerminated
FDA Drug recall · Reported December 5, 2012
Mylan, Tacrolimus Capsules 0.5 mg, 100 count bottle, Rx only, Mylan Pharmaceuticals Inc., Morgantown, WV 26505 NDC 0378-2045-01
Failed USP Content Uniformity Requirements: OOS result reported on retained samples.
Compiled from official public sources by the editorial team.
Verify with FDA Drug →
Mylan LLC. recalled Mylan, Tacrolimus Capsules 0.5 mg, 100 count bottle, Rx only, Mylan Pharmaceuticals Inc.,… - a moderate-severity action.
Mylan, Tacrolimus Capsules 0.5 mg, 100 count bottle, Rx only, Mylan Pharmaceuticals Inc.,… was recalled by Mylan LLC. in December 5, 2012. Reason: Failed USP Content Uniformity Requirements: OOS result reported on retained samples.. Check the official notice for the remedy. Verify recall #D-066-2013 with the FDA Drug before acting.
The recall
Mylan LLC. issued this moderate-severity FDA Drug recall-Failed USP Content Uniformity Requirements: OOS result reported on retained samples..
- Moderate
- severity level
- Class II
- classification
- December 5, 2012
- reported
Sourced from official FDA Drug enforcement records. Verify recall #D-066-2013 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.
Recall Insight
This FDA Drug action (record #D-066-2013) was formally reported on December 5, 2012, with the manufacturer initiating the action on June 29, 2012. It is classified under Moderate severity (Class II), with a current status of Terminated. Mylan LLC. is listed as the recalling firm, operating out of Caguas, PR. Federal records list the affected scope as 15181 bottles..
The documented reason for this recall is: Failed USP Content Uniformity Requirements: OOS result reported on retained samples. Distribution data in the federal record shows the product reached: Natiowide. 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 - 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.
Children & Baby Products recalls over time
Where this recall sits in its category - 3,731 children & baby products 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
15181 bottles.
Related Recalls
6
0 from same agency
Product description
Mylan, Tacrolimus Capsules 0.5 mg, 100 count bottle, Rx only, Mylan Pharmaceuticals Inc., Morgantown, WV 26505 NDC 0378-2045-01
Reason for recall
Failed USP Content Uniformity Requirements: OOS result reported on retained samples.
Recall Profile
| Attribute | Value |
|---|---|
| Agency | U.S. Food and Drug Administration |
| Severity class | Moderate (Class II) |
| Status | Terminated |
| Recall number | D-066-2013 |
| Date reported | December 5, 2012 |
| Date initiated | June 29, 2012 |
| Recalling firm | Mylan LLC. |
| Firm location | Caguas, PR |
| Affected scope | 15181 bottles. |
| Distribution | Natiowide |
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-066-2013) 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? ▼
Mylan, Tacrolimus Capsules 0.5 mg, 100 count bottle, Rx only, Mylan Pharmaceuticals Inc., Morgantown, WV 26505 NDC 0378-2045-01. Recalled by Mylan LLC.. Units affected: 15181 bottles..
Why was this product recalled? ▼
Failed USP Content Uniformity Requirements: OOS result reported on retained samples.
Which agency issued this recall? ▼
This recall was issued by the FDA Drug on December 5, 2012. Severity: Moderate. Recall number: D-066-2013.
Where was the recalled product distributed? ▼
Distribution: Natiowide.
How do I check if my product is affected by a recall? ▼
Check the product description and recall number (D-066-2013) 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.
CPSC Moderate
AMASKY Nursing Pillows Recalled Due to Risk of Serious Injury or Death from Suffocation; Violate Mandatory Standards fo…
Xishentang Dongguan Trading Co, Ltd., dba Pretty-Life, of China · 2026-07-02
CPSC Moderate
Diamond Wipes International Recalls CVS Health Medicated Hemorrhoidal Wipes Due to Risk of Serious Injury or Death from…
Diamond Wipes International, Inc. of Chino, California · 2026-07-02
CPSC Moderate
Junpower CR2032 Lithium Coin Batteries Recalled Due to Risk of Serious Injury or Death from Battery Ingestion Hazard; V…
· 2026-07-02
CPSC Moderate
Target Recalls Gigglescape™ Under the Sea Popping Toy Due to Choking Hazard
· 2026-07-02
CPSC Moderate
Vevor Recalls Baby Loungers Due to Risk of Serious Injury or Death from Entrapment and Fall Hazards; Violate Mandatory …
Sanven Technology Ltd., dba Vevor, of Rancho Cucamonga, California · 2026-07-02
Compare this recall with AMASKY Nursing Pillows Recalled Due to Risk of Serious Inju… →
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 December 5, 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.