Mylan Recalls Tacrolimus Capsules for Failed USP Content Uniformity Requirements
Mylan LLC is recalling 15,181 bottles of Tacrolimus Capsules 0.5 mg nationwide because retained samples failed USP content uniformity requirements.
What this means for you
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II, which typically involves a situation that might cause temporary or medically reversible adverse health consequences. The hazard is a quality control failure (content uniformity) without reported injuries or illnesses, fitting the Moderate severity criteria for low-risk contamination or voluntary precautionary recalls.
Plain-English summary
Mylan LLC is recalling 15,181 bottles of Tacrolimus Capsules 0.5 mg, 100 count, prescription only. The affected product is distributed nationwide. The recall involves specific lots: 3027684 (Exp. 5/13), 3027688 (Exp. 6/13), and 2002157 (Exp. 9/12).
The recall was initiated because retained samples reported an out-of-specification (OOS) result for USP Content Uniformity Requirements. This indicates that the amount of active ingredient in the capsules may not be consistent with the required standard.
Consumers and healthcare providers should check their inventory for the specific lot numbers and expiration dates listed above. If the product matches the recalled lots, it should be returned to the pharmacy or point of purchase for a refund or replacement. Patients should consult their healthcare provider regarding alternative treatment options if they are currently using the affected medication.
The recalled product
- Product
- TACROLIMUS (TACROLIMUS)
- Brand
- TACROLIMUS
- Manufacturer
- Mylan LLC.
- Category
- Drug — Prescription Medication
- Hazard
- Affected units
- 15,181
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (2)
- Lots: 3027684 Exp. 5/13
- 3027688 Exp. 6/13 2002157 Exp. 9/12
UPCs (3)
- 0303782046014
- 0303782045017
- 0303782047011
Distribution
Distribution scope not specified by the agency.
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