FDA Recall of Prazosin Hydrochloride Capsules by Biocon Pharma
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Appco Pharma LLC is voluntarily recalling 28,157 bottles of Prazosin Hydrochloride Capsules due to detected impurities above acceptable limits, affecting nationwide distribution in the U.S.
What this FDA recall tells you, and what most readers miss
This notice was issued by FDA on April 14, 2026 and geographically references United States. Its severity classification of "medium" signals how the issuing agency weighs the risk of harm if no action is taken - "critical" and "high" tier alerts typically carry direct consumer actions, while "medium" and "low" tend toward informational guidance or monitoring advisories. The category it belongs to - FDA Recalls - determines the consumer-protection framework behind it, which shapes what remedies (refunds, replacements, repairs, or the recall itself) are available to affected consumers and which agency holds statutory responsibility for enforcement.
Most readers skim a notice like this, check whether they are personally affected, and move on. The more useful lens is to verify its scope, source, and timestamp, then compare related notices without assuming that one record proves a broader trend.
Areazine pairs this record with the original agency URL so you can check the primary source before acting. Its related labels are recall, product-safety, fda, Drugs.
Recall of Prazosin Hydrochloride Capsules
What Happened
Appco Pharma LLC is initiating a voluntary recall of the affected drug due to a cGMP deviation involving the detection of Nitrosamine Drug Substance-Related Impurities, specifically N-nitroso-prazosin impurity C (NNP), above acceptable limits.
Which Products Are Affected
The recall involves Prazosin Hydrochloride Capsules, USP, 5mg, in 100-count bottles. The affected NDCs are 70377-066, 70377-067, and 70377-068, with package NDCs including 70377-066-11, 70377-067-11, and 70377-068-11. A total of 28,157 bottles are affected, distributed nationwide in the U.S. The specific lots are: 2406255UC (Exp. 2026/MAY), 2406256UC (Exp. 2026/JUL), 2407313UC (Exp. 2026/JUL), 2408351UC (Exp. 2026/JUL), 2408352UC (Exp. 2026/JUL), and 2509311UC (Exp. 2027/SEP). The product is manufactured for Biocon Pharma Inc. and by Appco Pharma LLC, with recall number D-0421-2026.
What You Should Do
Consumers who have the affected lots of Prazosin Hydrochloride Capsules should follow the initial firm notification via e-mail and contact Appco Pharma LLC for instructions on returns or refunds. The recalling firm is located at 262 Old New Brunswick Rd Ste N, Piscataway, NJ 08854-3888.
Why This Matters
This recall highlights potential safety concerns in prescription drugs due to impurities, affecting thousands of bottles distributed across the United States and emphasizing the importance of quality control in pharmaceuticals.
Source
FDA recall notice for event ID 98658, available at the FDA website under recall number D-0421-2026.
Original source: FDA Official Notice ↗
Related FDA Recalls
All FDA Recalls →Nationwide notices with similar length or severity timing 8
Two Areazine-derived peer sets for this FDA recall: nearest notices by body length and by same severity near the same agency date. Peers come from other categories so they are not the same-feed Related list above.
Similar body length
Nearest notices by article body length (1,598 characters here).
Similar severity timing
Same severity (medium) notices issued closest in time to April 14, 2026.
Frequently Asked Questions
Common questions about this FDA recall.