Pfizer Recalls Subpotent Xanax Alprazolam Tablets Nationwide
Pfizer is voluntarily recalling 21,120 bottles of Xanax (alprazolam) 0.25 mg tablets because the medication contains less active ingredient than labeled.
The agency’s classification
FDA (Drugs): Class II
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.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall is classified as FDA Class II, which indicates a reasonable probability of temporary or medically reversible adverse health consequences. The hazard is a subpotent drug, which may lead to treatment failure but is not typically associated with immediate severe injury or death, fitting the 'High' severity criteria for risk-of-harm products where injury has not yet been reported.
Plain-English summary
Pfizer Inc. is voluntarily recalling 21,120 bottles of Xanax (alprazolam) tablets, 0.25 mg, 100-count. The recall was initiated on September 24, 2015, and is classified as FDA Class II. The specific lot affected is # C111054, with an expiration date of 02/16. The product is distributed by Pharmacia & Upjohn Co., a division of Pfizer Inc., in New York, NY.
The reason for the recall is that the tablets are subpotent, meaning they contain less of the active ingredient, alprazolam, than the amount stated on the label. Alprazolam is a benzodiazepine used to treat anxiety and panic disorders. A subpotent drug may be less effective in treating the intended medical condition.
The affected product was distributed nationwide. Consumers and healthcare providers should check their inventory for bottles matching the specific lot number and expiration date. If the product is found, it should be returned to the pharmacy or point of distribution for replacement or refund. No specific instructions for immediate disposal are provided in the source text, but standard pharmacy return procedures apply.
The recalled product
- Product
- XANAX (ALPRAZOLAM)
- Brand
- XANAX
- Manufacturer
- Pfizer Inc.
- Category
- Drug — Prescription Medication
- Affected units
- 21,120
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)
- Lot # C111054
- Exp. 02/16
UPCs (4)
- 0300090094010
- 0300090090012
- 0300090029012
- 0300090055011
Distribution
Distributed nationwide across the United States.
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